A traditional Chinese medicine composition and traditional Chinese medicine preparation for treating HPV infection

Abstract

The application discloses a traditional Chinese medicine composition and a traditional Chinese medicine preparation for treating HPV infection. Specifically, the traditional Chinese medicine composition comprises the following components: radix codonopsis 15-45 parts, rhizoma atractylodis macrocephalae 7-25 parts, radix astragali 20-60 parts, radix pseudostellariae 7-25 parts, radix ophiopogonis 7-25 parts, radix rehmanniae 10-30 parts, coriolus 15-45 parts, ganoderma 15-45 parts, smilax riparia 20-60 parts, oldenlandia 15-35 parts, herba taraxaci 15-35 parts, morus 20-40 parts, coix 15-35 parts, gardenia 7-25 parts, salvia miltiorrhiza 10-30 parts, portulaca 15-45 parts, poria 10-30 parts, isatis root 10-30 parts, dendrobium 7-25 parts, schisandra 7-25 parts, licorice 10-20 parts, and cyperus 15-35 parts.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition and preparation for treating HPV infection. Background Technology

[0002] Human papillomavirus (HPV) is an epitheliotropic virus with high specificity. It has long been known to cause benign tumors and warts in humans, such as common warts and condyloma acuminata on the skin and mucous membranes near the genitals, and papillomas on mucous membranes. Like hepatitis B virus, HPV is a DNA virus. Originally a member of the Polyomavacuoviridae family, it was replaced by the Papillomaviridae family by the International Committee on Taxonomy of Viruses (ICTV) in 1999; therefore, HPV now belongs to this family.

[0003] Human papillomavirus (HPV) infection, as one of the most common sexually transmitted infections worldwide, has become a significant public health challenge. The World Health Organization (WHO) estimates that approximately 79 million new cases of HPV infection occur globally each year. Persistent infection with high-risk HPV is a major contributing factor to cervical cancer and other malignancies. This is primarily due to the body's immune system's prolonged struggle against the virus. When the body's function is weakened, immunity is inevitably lowered, leading to an increased viral load. At this point, the incidence of cervical cancer and other tumors inevitably rises. While the vast majority of HPV viruses can be cleared by the body's own immune system (it should be noted that the body's immune clearance of HPV is positively or negatively correlated with age, duration of infection, type of HPV, and the number of HPV types), persistent infection with high-risk HPV is associated with cervical cancer and the development of other malignancies. Globally, cervical cancer is the fourth leading cause of cancer incidence and death among women. According to the Global Cancer Statistics (GLOBOCAN) published by the International Agency for Research on Cancer (IARC), cervical cancer causes approximately 350,000 deaths annually.

[0004] Core pathogenic mechanism: Persistent infection with high-risk HPV is a major contributing factor to cervical cancer, vaginal cancer, vulvar cancer, anal cancer, penile cancer, oropharyngeal cancer, and oral cancer. The core pathogenic mechanism lies in the activation of the viral E6 and E7 oncogenes. The E6 protein degrades the host cell's p53 tumor suppressor protein, and the E7 protein inactivates the Rb tumor suppressor protein, leading to cell cycle disorder and genomic instability, which may ultimately induce carcinogenesis. HPV integration into the host genome is a key step in persistent infection and carcinogenesis.

[0005] HPV viruses are mainly classified into four categories based on their pathogenic characteristics and infection sites: Low-risk cutaneous types (such as HPV3 and 5): primarily cause skin lesions such as common warts and flat warts; High-risk cutaneous types (such as HPV16 and 18): associated with Bowenoid papules, and long-term infection may increase the risk of skin cancer; Low-risk mucosal types (such as HPV6 and 11): primarily cause genital warts (condyloma acuminata), manifesting as papillary or cauliflower-like growths in the genital area; High-risk mucosal types (such as HPV16, 18, 31, 33, 45, 52, and 58): closely associated with malignant tumors such as cervical cancer, vulvar cancer, and vaginal cancer. More than 99% of cervical cancer cases are related to persistent infection with high-risk HPV types.

[0006] The Comprehensive Impact of HPV Infection on Patients: HPV infection affects patients far beyond the physiological level, bringing significant psychological and social burdens. 1. Psychological Burden: Infection can easily lead to anxiety, fear, and depression, especially concerns about cancer. Some women avoid seeking medical attention due to shame, delaying screening, and it can also cause trust crises and intimacy problems in relationships. 2. Decreased Quality of Life: Genital warts and cervical lesions can cause abnormal bleeding, abnormal vaginal discharge, and odor, severely impacting daily life and the quality of sexual life. 3. Tense Social Relationships: HPV infection can cause suspicion and distrust between spouses or partners, affecting family harmony and stability. 4. Endangering Fertility and Pregnancy Health: Women infected with high-risk HPV often postpone or even abandon pregnancy due to concerns about viral activity during pregnancy and mother-to-child transmission; persistent infection increases the risk of pregnancy complications and adverse pregnancy outcomes, and may also cause respiratory papillomas in infants, undermining women's confidence in fertility and threatening family integrity and population health.

[0007] Currently, Western medicine mainly treats HPV infection using physical therapy (laser, cryotherapy, etc.), immunomodulators, and surgical removal. However, these methods have problems such as high recurrence rates, significant side effects, and high costs. Especially for persistent infection with high-risk HPV, there are currently no specific drugs, and treatment relies mainly on regular monitoring, which further exacerbates the psychological burden on patients. Summary of the Invention

[0008] The purpose of this invention is to provide a traditional Chinese medicine compound preparation for treating HPV infection and its application, aiming to reduce the risk of cervical cancer and other cancers induced by HPV infection through a safe and efficient traditional Chinese medicine solution, in order to address the shortcomings of existing treatment methods in terms of safety, effectiveness and universality.

[0009] Therefore, the present invention adopts the following technical solution: On one hand, the present invention provides a traditional Chinese medicine composition, wherein the traditional Chinese medicine composition comprises, by weight, the following components: Codonopsis pilosula 15-45 parts, Atractylodes macrocephala 7-25 parts, Astragalus membranaceus 20-60 parts, Pseudostellaria heterophylla 7-25 parts, Ophiopogon japonicus 7-25 parts, Rehmannia glutinosa 10-30 parts, Trametes versicolor 15-45 parts, Ganoderma lucidum 15-45 parts, Smilax glabra 20-60 parts, Hedyotis diffusa 15-35 parts, Taraxacum mongolicum 15-35 parts, Morus alba 20-40 parts, Coix lacryma-jobi 15-35 parts, Gardenia jasminoides 7-25 parts, Salvia miltiorrhiza 10-30 parts, Portulaca oleracea 15-45 parts, Poria cocos 10-30 parts, Isatis indigotica 10-30 parts, Dendrobium nobile 7-25 parts, Schisandra chinensis 7-25 parts, Glycyrrhiza uralensis 10-20 parts, and Dioscorea hypoglauca 15-35 parts.

[0010] In some embodiments, the traditional Chinese medicine composition comprises, by weight, the following components: 25-35 parts of Codonopsis pilosula, 10-20 parts of Atractylodes macrocephala, 35-45 parts of Astragalus membranaceus, 10-20 parts of Pseudostellaria heterophylla, 10-20 parts of Ophiopogon japonicus, 15-25 parts of Rehmannia glutinosa, 25-35 parts of Trametes versicolor, 25-35 parts of Ganoderma lucidum, 35-45 parts of Smilax glabra, 20-30 parts of Hedyotis diffusa, 20-30 parts of Taraxacum mongolicum, 25-35 parts of Morus alba, 20-30 parts of Coix lacryma-jobi, 10-20 parts of Gardenia jasminoides, 15-25 parts of Salvia miltiorrhiza, 25-35 parts of Portulaca oleracea, 15-25 parts of Poria cocos, 13-23 parts of Isatis indigotica, 10-20 parts of Dendrobium nobile, 10-20 parts of Schisandra chinensis, 10-20 parts of Glycyrrhiza uralensis, and 20-30 parts of Dioscorea hypoglauca.

[0011] In some embodiments, by weight parts, the Codonopsis pilosula can be 25 parts, 27 parts, 29 parts, 31 parts, 33 parts, 35 parts or any range therebetween; the Atractylodes macrocephala can be 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts or any range therebetween; the Astragalus membranaceus can be 35 parts, 37 parts, 39 parts, 41 parts, 43 parts, 45 parts or any range therebetween; the Pseudostellaria heterophylla can be 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts or any range therebetween; the Ophiopogon japonicus can be 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts or any range therebetween; the Rehmannia glutinosa can be 15 parts, 17 parts, 19 parts, 21 parts, 23 parts, 25 parts or any range therebetween; the Coriolus versicolor can be 25 parts, 27 parts, 29 parts, 31 parts, 33 parts, 35 parts or any range therebetween; the Ganoderma lucidum can be 25 parts, 27 parts, 29 parts, 31 parts, 33 parts, 35 parts or any range therebetween; the Smilax glabra can be 35 parts, 37 parts, 39 parts, 41 parts, 43 parts, 45 parts or any range therebetween; the Hedyotis diffusa can be 20 parts, 22 parts, 24 parts, 26 parts, 28 parts, 30 parts or any range therebetween; the Taraxacum mongolicum can be 20 parts, 22 parts, 24 parts, 26 parts, 28 parts, 30 parts or any range therebetween; the Morus alba can be 25 parts, 27 parts, 29 parts, 31 parts, 33 parts, 35 parts or any range therebetween; the Coix lacryma-jobi can be 20 parts, 22 parts, 24 parts, 26 parts, 28 parts, 30 parts or any range therebetween; the Gardenia jasminoides can be 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts or any range therebetween; the Salvia miltiorrhiza can be 15 parts, 17 parts, 19 parts, 21 parts, 23 parts, 25 parts or any range therebetween; the Portulaca oleracea can be 25 parts, 27 parts, 29 parts, 31 parts, 33 parts, 35 parts or any range therebetween; the Poria cocos can be 15 parts, 17 parts, 19 parts, 21 parts, 23 parts, 25 parts or any range therebetween; the Isatis tinctoria can be 13, 15 parts, 17 parts, 19 parts, 21 parts, 23 parts or any range therebetween; the Dendrobium officinale can be 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts or any range therebetween; the Schisandra chinensis can be 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts or any range therebetween; the Glycyrrhiza uralensis can be 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts or any range therebetween; the Dioscorea septemloba can be 20 parts, 22 parts, 24 parts, 26 parts, 28 parts, 30 parts or any range therebetween.

[0012] In some embodiments, the traditional Chinese medicine composition comprises, by weight, the following components: 30 parts Codonopsis pilosula, 15 parts Atractylodes macrocephala, 40 parts Astragalus membranaceus, 15 parts Pseudostellaria heterophylla, 15 parts Ophiopogon japonicus, 20 parts Rehmannia glutinosa, 30 parts Trametes versicolor, 30 parts Ganoderma lucidum, 40 parts Smilax glabra, 25 parts Hedyotis diffusa, 25 parts Taraxacum mongolicum, 30 parts Morus alba, 25 parts Coix lacryma-jobi, 15 parts Gardenia jasminoides, 20 parts Salvia miltiorrhiza, 30 parts Portulaca oleracea, 20 parts Poria cocos, 18 parts Isatis indigotica, 15 parts Dendrobium nobile, 15 parts Schisandra chinensis, 15 parts Glycyrrhiza uralensis, and 25 parts Dioscorea hypoglauca.

[0013] In some implementations, the licorice is prepared licorice root.

[0014] On the other hand, the present invention provides a traditional Chinese medicine preparation comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0015] This formulation is based on the traditional Chinese medicine theory of "strengthening the body's resistance and eliminating pathogens." Through a multi-target, holistic regulatory mechanism, it effectively eliminates viruses and inhibits infection while comprehensively regulating the body's immune function and local microenvironment, promoting the body's recovery. Its formulation follows the strict principles of "principal, assistant, adjuvant, and guide" in traditional Chinese medicine, using only natural medicinal materials with mild properties. Clinical observations have shown good safety, aiming to provide patients with a safe and reliable treatment option. Furthermore, this formulation is designed to have broad-spectrum anti-HPV activity, achieving broad coverage against different high-risk and low-risk HPV infections and reducing the risk of recurrence.

[0016] This invention also provides various pharmaceutical forms of the formulation (such as concentrated granules, oral concentrated liquids, oral decoctions, concentrated pills, concentrated capsules, concentrated tablets, etc.) to meet different clinical needs and patients' medication habits, improve medication adherence, and expand its application scope in the preparation of anti-HPV drugs.

[0017] In some embodiments, the traditional Chinese medicine preparation is selected from at least one of decoctions, mixtures, powders, pills, teas, gels, pastes, medicated wines, tinctures, syrups, granules, capsules, tablets, and fermented preparations. In some embodiments, the mixture includes oral liquids. In some embodiments, the pills are selected from at least one of honey pills, water pills, concentrated pills, and drop pills. In some embodiments, the tea includes tea bags. In some embodiments, the capsules are selected from at least one of soft capsules, hard capsules, and enteric-coated capsules. In some embodiments, the tablets are selected from at least one of ordinary tablets, lozenges, effervescent tablets, and dispersible tablets.

[0018] In the traditional Chinese medicine composition or preparation of the present invention, the principal herbs include Astragalus membranaceus, Codonopsis pilosula, Smilax glabra, Ganoderma lucidum, Trametes versicolor, and Morus alba; the assistant herbs include Portulaca oleracea, Hedyotis diffusa, Coix lacryma-jobi, Taraxacum mongolicum, and Dioscorea hypoglauca; the adjuvant herbs include Salvia miltiorrhiza, Rehmannia glutinosa, Poria cocos, and Isatis indigotica; and the guiding herbs include Pseudostellaria heterophylla, Ophiopogon japonicus, Atractylodes macrocephala, Gardenia jasminoides, Dendrobium nobile, Schisandra chinensis, and Glycyrrhiza uralensis.

[0019] Analysis of the efficacy of the principal herb: Astragalus: Properties and Channels: Sweet and slightly warm. Enters the Spleen and Lung channels. Traditional Efficacy: Tonifies Qi and raises Yang, consolidates the exterior and stops sweating, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves pain, promotes detoxification and pus drainage, and promotes wound healing and tissue regeneration. Modern Pharmacological Research: (1) Immunomodulatory Effect: The core mechanism of Astragalus in combating HPV lies in its multi-level and multi-target immunomodulatory function. Astragalus polysaccharides can significantly increase the weight of immune organs such as the spleen and thymus, promote their development, and provide a solid histological basis for the proliferation and differentiation of immune cells. At the level of innate immunity, Astragalus can activate the phagocytic function of macrophages and significantly enhance the activity of natural killer cells (NK cells), induce the production of endogenous interferon, and thus directly inhibit the replication process of HPV virus in the early stage of viral infection. At the level of adaptive immunity, Astragalus can promote the proliferation and differentiation of T lymphocytes, optimize the CD4+ / CD8+ T cell ratio, and enhance the efficacy of cellular immune response; at the same time, it can also stimulate B lymphocytes to produce specific antibodies and strengthen humoral immune response. Crucially, its synergistic anti-HPV mechanism is manifested in its ability to upregulate interferon levels, thereby inhibiting the expression of the key HPV oncogenes E6 / E7, blocking the integration of viral DNA into the host cell genome from the root, and preventing the occurrence of precancerous lesions. (2) Anti-tumor effect: Astragalus exhibits bidirectional regulatory anti-tumor properties. On the one hand, its immune-mediated anti-tumor effect enhances the body's ability to clear abnormal cells by promoting the secretion of cytokines such as IL-2 and the activation of cytotoxic T cells. On the other hand, it has an enhancing effect on those with low immune function, while it has an inhibitory effect on the state of excessive immune activation (such as certain autoimmune reactions). This bidirectional regulatory property is crucial for balancing the immune disorder after HPV infection. In the cervical cancer model, Astragalus can reduce the level of tumor necrosis factor and inhibit tumor angiogenesis. In the adjuvant application of radiotherapy and chemotherapy, it can also alleviate bone marrow suppression and improve patient tolerance, reflecting the principle of "strengthening the body and eliminating pathogens". (3) Hepatoprotective effect: Astragalus saponins can significantly reduce the increase in serum transaminase caused by hepatotoxic substances such as carbon tetrachloride and acetaminophen, and alleviate hepatocellular necrosis and fibrosis. Its mechanism is closely related to inhibiting oxidative stress, reducing the release of inflammatory factors, and promoting hepatocellular regeneration. This can ensure the safety and sustainability of the treatment plan for HPV-infected patients who require a long treatment period. (4) Antibacterial and anti-inflammatory effects: Astragalus has a direct inhibitory effect on Gram-positive bacteria such as Staphylococcus aureus and Streptococcus. The mechanism involves destroying the bacterial cell membrane structure. Its anti-inflammatory mechanism is mainly through inhibiting the activation of key inflammatory signaling pathways such as nuclear factor κB (NF-κB) and reducing the expression levels of pro-inflammatory factors such as tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). In a chronic cervicitis model associated with HPV infection, Astragalus can effectively reduce tissue edema and inflammatory cell infiltration, promote the repair and regeneration of cervical mucosa, and create a stable microenvironment for tissue health.

[0020] Smilax glabra: Properties and Channels: Sweet, bland, and neutral. Enters the Liver and Stomach channels. Traditional Efficacy: Detoxifies, removes dampness, and promotes joint mobility. Modern Pharmacological Research Details: (1) Antiviral Effect: The antiviral ability of Smilax glabra is one of the core mechanisms for its treatment of HPV infection; its active ingredient, astilbin, can interfere with the viral replication process by inhibiting xanthine oxidase activity; thus, it hinders the replication of HPV. Studies have shown that Smilax glabra extract can intervene in the life cycle of the virus, especially showing potential in inhibiting the expression of E6 / E7 oncogenes, which is crucial for blocking the development of high-risk HPV infection into cancer; in addition, its broad-spectrum antiviral properties also have a certain inhibitory effect on herpes simplex virus, etc. (2) Immunomodulatory effect: The unique feature of Smilax glabra is its "bidirectional immunomodulatory" function: On the one hand, the polysaccharides it contains can activate macrophages, enhance NK cell activity, and promote the proliferation and differentiation of T lymphocytes, thereby strengthening the body's ability to recognize and clear viruses; on the other hand, it can also inhibit excessive immune response, for example, by regulating the balance of T cell subsets, preventing the immune system from excessively attacking its own tissues, which is of great significance for treating persistent or refractory HPV infection caused by immune disorders. (3) Anti-inflammatory effect: The anti-inflammatory mechanism of Smilax glabra is very profound: its core component, astilbin, can effectively inhibit the activation of key inflammatory signaling pathways such as NF-κB. This pathway is the "master switch" for the production of inflammatory factors in the body. After inhibiting this pathway, the levels of core pro-inflammatory factors such as IL-1β, IL-6, and TNF-α can be significantly reduced. This can not only quickly relieve the inflammatory symptoms such as local redness, swelling, heat and pain of the cervix caused by HPV infection, but also fundamentally improve the "inflammatory microenvironment" that is conducive to the survival of the virus. It fits the effect of "clearing heat and detoxifying, and promoting joint mobility" in traditional Chinese medicine. It is especially effective for leukorrhea, carbuncles and other diseases caused by damp-heat. (4) Anti-tumor effect: In terms of anti-tumor, Smilax glabra works through multiple pathways: its unique component Aipanol can simultaneously target vascular endothelial growth factor receptor 2 (VEGFR2) and cyclooxygenase 2 (COX2), effectively inhibiting tumor angiogenesis and cutting off the tumor's nutrient supply; in addition, its flavonoids and polysaccharides can induce tumor cell apoptosis and inhibit its proliferation and metastasis; this means that Smilax glabra not only helps to clear the virus, but also blocks the "virus-inflammation-cancer" chain that may be caused by persistent HPV infection, which is of great value in preventing diseases such as cervical cancer. (5) Liver protection and anti-allergy effect: The liver protection effect of Smilax glabra is mainly reflected in its detoxification ability: the astilbin and other components in the component have antioxidant activity, which can help the liver clear free radicals and reduce the damage of drugs and other toxic substances to liver cells; its anti-allergy effect is related to the tannins contained in it, which can stabilize the cell membrane of mast cells and inhibit the release of allergic mediators such as histamine, which is of positive significance for treating symptoms such as eczema and itching caused by damp heat and HPV infection.

[0021] Codonopsis pilosula: Properties and Channels: Sweet and neutral. Enters the Spleen and Lung channels. Traditional Efficacy: Strengthens the Spleen and Lungs, Nourishes Blood and Promotes Body Fluid Production. Modern Pharmacological Research: (1) Immunomodulatory Effects: Codonopsis pilosula polysaccharides and their active ingredients (such as codonopsis glycosides and codonopsis glycosides) can significantly activate and regulate the function of various immune cells. Studies have confirmed that Codonopsis pilosula ferment extract and its active ingredients can effectively promote the proliferation of macrophages and dose-dependently inhibit the excessive secretion of pro-inflammatory factors such as interleukin-1 (IL-1), tumor necrosis factor-α (TNF-α) and interferon-γ (IFN-γ) by macrophages induced by lipopolysaccharide (LPS). At the same time, it can also promote the proliferation of T lymphocytes and regulate the levels of IL-6, TNF-α and IFN-γ secreted by them, thereby maintaining immune homeostasis. In addition, Codonopsis pilosula polysaccharide can maintain the dynamic balance of T cell subsets such as CD8+ T cells, regulatory T cells (Tregs), and helper T cells 17 (Th17) in a hydrocortisone-induced immunosuppressed mouse model, as well as the homeostasis of cytokines such as TNF-α, IL-1β, and IL-10, thereby comprehensively enhancing the body's specific and non-specific immune functions. This fine regulation of cellular immunity and humoral immunity is equivalent to "strengthening the body's resistance and consolidating its foundation" in traditional Chinese medicine theory. By strengthening the "acquired foundation" (spleen and stomach) and replenishing lung qi, it fundamentally enhances the body's ability to resist and clear HPV virus, which is crucial for correcting the immune disorder or functional decline caused by persistent HPV infection. (2) Anti-inflammatory effect: Codonopsis pilosula has good anti-inflammatory activity, which is of great significance for alleviating the local inflammatory microenvironment of the cervix caused by HPV infection. Its anti-inflammatory mechanism is mainly related to the inhibition of key inflammatory signaling pathways such as nuclear factor κB (NF-κB) and mitogen-activated protein kinase (MAPK). Codonopsis polysaccharides (CPPs) can significantly reduce the inflammatory response in LPS-induced RAW264.7 cell inflammation model and DSS-induced colitis in mice by inhibiting the activation of the Toll-like receptor 4 (TLR4) / NF-κB pathway in macrophages. Codonopsis saponin A (Lancemaside A) has also been shown to exert anti-inflammatory effects by regulating the binding of LPS to TLR4 on macrophages. This anti-inflammatory property helps to reduce tissue damage in the local area of ​​HPV infection and creates favorable conditions for mucosal repair. (3) Effects on the cardiovascular and hematopoietic systems: Codonopsis has cardiotonic, anti-shock, vasodilatory, hypotensive, and microcirculation-improving effects, and can enhance hematopoietic function, increasing red blood cells, hemoglobin, and reticulocytes. Codonopsis saponins can also stimulate the respiratory center. This has a direct effect on improving symptoms of blood deficiency or deficiency of both qi and blood caused by long-term HPV infection and depletion of qi and blood, such as shortness of breath, fatigue, sallow complexion, palpitations, and dizziness. This is consistent with the traditional understanding of "nourishing blood and generating fluids". When qi and blood are abundant, the body's disease resistance will be strong. (4) Anti-aging and anti-oxidation: Codonopsis pilosula has the effects of delaying aging, resisting hypoxia, and resisting radiation.Its water extract can improve the gastrointestinal function and lung tissue pathological changes induced by D-galactose in aged mice. Its effect is related to the regulation of specific RNA molecules and downstream metabolic pathways. The pectin polysaccharide (CPP1c1) isolated from Codonopsis pilosula can promote the proliferation of lymphocytes in aged mice, regulate the percentage of T cell subsets, promote the production of IL-2, TNF-α and IFN-γ, and has the function of promoting lymphocyte homing. It exerts an anti-aging effect by regulating the body's immunity. This has a positive effect on delaying cell aging and protecting tissue function. (5) Anti-tumor effect: Studies have shown that Codonopsis pilosula extract has certain anti-tumor potential. Its crude polysaccharide can significantly reduce the tumor volume in melanoma mice and promote the repolarization of M2-like tumor-associated macrophages (TAMs) to M1 type, increase the mRNA expression levels of IL-1, IL-6, inducible nitric oxide synthase and TNF-α, thereby regulating the tumor immune microenvironment. The n-butanol fraction of Codonopsis pilosula can inhibit the growth of human colon cancer HT-1 cells by inducing cell cycle arrest and apoptosis in the G0 / G1 phase. The mechanism is related to the increase of reactive oxygen species (ROS). The methanol extract of Codonopsis pilosula can inhibit the growth of tumors in H22 tumor-bearing mice by improving immune function, inducing cell apoptosis and inhibiting angiogenesis. For cervical precancerous lesions that may be caused by high-risk HPV infection, the tonifying and strengthening effect of Codonopsis pilosula provides a basis for its adjuvant anti-tumor function at the microscopic level. (6) Effects on gastrointestinal function: Codonopsis pilosula has the functions of regulating gastrointestinal motility, anti-ulcer, and inhibiting gastric acid secretion. The inulin-type fructan in Codonopsis pilosula can restore the intestinal mucosal immune function of immunosuppressed mice, improve the intestinal flora and its metabolites, and regulate the level of gastrointestinal hormones by promoting the secretion of mucin and secretory immunoglobulin A. The water extract of Codonopsis pilosula can increase the amount of stool in constipated mice, improve the intestinal propulsion rate, and improve the composition of the intestinal microbiota. Total saponins from Codonopsis pilosula have a protective effect against experimental ulcerative colitis in rats, and the mechanism is related to anti-lipid peroxidation and inhibition of the NF-κB signaling pathway. This reflects the traditional Chinese medicine theory that "a strong spleen in all four seasons prevents the invasion of pathogens." When the spleen and stomach function well, the production of qi and blood is abundant, the body's vital energy is sufficient, and pathogens cannot invade.

[0022] Ganoderma lucidum: Properties and Channels: Sweet and neutral. Enters the Heart, Lung, Liver, and Kidney channels. Traditional Efficacy: Tonifies Qi and calms the mind, relieves cough and asthma, and is a top-grade product for "strengthening the body's resistance and consolidating its foundation". Modern Pharmacological Research: (1) Immunomodulatory Effect: The core mechanism of Ganoderma lucidum against HPV lies in its excellent immune enhancement and regulation function. Ganoderma lucidum polysaccharides have a wide range of immunomodulatory activities and can significantly improve the body's immune activity. It can activate the activity of macrophages, T lymphocytes and natural killer cells (NK cells) and promote the secretion of key cytokines such as interferon-γ (IFN-γ) and interleukin-2 (IL-2), thereby comprehensively enhancing the body's specific and non-specific immune response capabilities. This is crucial for the body to recognize and eliminate abnormal cells infected by HPV. Compound preparations or extracts containing Ganoderma lucidum can significantly increase the content of serum IgG and other antibodies, and promote cellular immunity and humoral immunity. This immune-enhancing effect is equivalent to "strengthening the body and eliminating pathogens" in traditional Chinese medicine theory. It strengthens the "vital energy" (immune system) by replenishing qi and blood and adjusting the function of the internal organs, thereby changing the "internal environment" on which HPV virus depends for survival. This plays a fundamental role in controlling persistent HPV infection and preventing it from developing into precancerous lesions. (2) Anti-tumor effect: Ganoderma lucidum fruiting body, Ganoderma lucidum polysaccharides and triterpenoids isolated from Ganoderma lucidum spores all have anti-tumor effects. Its effective components can not only directly induce tumor cell apoptosis, but also inhibit tumor angiogenesis, thereby blocking the nutrient supply of cancer cells. For cervical precancerous lesions (CIN) and even cervical cancer that may be caused by persistent infection with high-risk HPV, the "detoxification and dissipation" effect of Ganoderma lucidum is manifested at the microscopic level as interfering with the growth cycle of abnormal cells and indirectly inhibiting tumor growth through immune regulation. (3) Effects on the cardiovascular system: Ganoderma lucidum can reduce blood viscosity, increase myocardial contractility, increase coronary blood flow and cardiac output, and improve heart rhythm. It has sedative and analgesic effects, and can prolong sleep time and improve sleep quality. For patients who suffer from long-term HPV infection and are often accompanied by anxiety and emotional stress, the "calming" effect of Ganoderma lucidum can play a certain auxiliary role in calming the mind and relieving anxiety. (4) Antioxidant and anti-aging: Ganoderma lucidum has anti-aging effects. Its triterpenoids and polysaccharides can effectively remove free radicals and reduce the damage of oxidative stress to cells. This has a positive effect on protecting the health of cervical epithelial cells and delaying cell aging. (5) Liver protection: Ganoderma lucidum has good liver protection effects. Ganoderma lucidum polysaccharides have liver protection effects, and Ganoderma lucidum acid, triterpenoids and other components can promote the activity of liver detoxification enzymes, accelerate toxin metabolism, and have a protective effect against chemical liver damage. For HPV infected patients who need to take medication for a long time, this can effectively reduce the potential burden of drugs on the liver and ensure the safety of the treatment process. (6) Other effects: Ganoderma lucidum can also relieve asthma, stop cough and expectorate phlegm and treat chronic bronchitis. It has the effect of resisting the damage of radiation and toxic chemicals to the body.

[0023] Yunzhi: Properties and Channels: Sweet, bland, slightly cold. Enters the spleen, liver, and kidney channels. Traditional Efficacy: Strengthens the spleen and promotes diuresis, relieves cough and asthma, clears heat and detoxifies. Modern Pharmacological Research Details: (1) Immunomodulatory Effect: Immunomodulation is the core mechanism of Yunzhi against HPV; Yunzhi polysaccharide can enhance the phagocytic effect of peritoneal macrophages in mice and has an antagonistic effect on splenic atrophy caused by cyclophosphamide. Yunzhi polysaccharide peptide (PSP) can significantly proliferate lymphocytes and can counteract the effect of cyclophosphamide on inhibiting the production of interleukin-2 (IL-2) by activated T cells and the delayed-type hypersensitivity reaction (DTH) mediated by T cells. PSP can also enhance the phagocytic function of the reticuloendothelial system and has the ability to induce and promote interferon production. Yunzhi polysaccharide (PSK) has a certain therapeutic effect on the immunodeficiency of mice caused by cobalt-60 irradiation, can significantly increase serum lysozyme content and spleen index, and has a promoting effect on the non-specific immune function of macrophages. In patients with malignant tumors who took Yunzhi polysaccharide, the T3 and T4 lymphocyte subsets and white blood cell counts were significantly increased compared with those before medication, which is considered to be a good biological response modifier. This comprehensive enhancement and regulation of the immune system is crucial for HPV infection, especially for the mechanism that requires strong cellular immunity to clear infected cells. (2) Anti-tumor effect: Yunzhi polysaccharide (PSK) has an inhibitory effect on sarcoma S180, leukemia L1210 and adenocarcinoma 755. The polysaccharides contained in its fruiting body and the polysaccharides extracted from the fermentation broth have strong anti-cancer properties, with inhibition rates of 80% and 100% for sarcoma 180 and Ehrlich ascites carcinoma in mice, respectively. Yunzhi polysaccharide peptide (PSP) has an inhibition rate of 35%-69% on S180 and also has a significant inhibitory effect on human lung adenocarcinoma in nude mice. While inhibiting tumor growth, no obvious toxic side effects were observed. Its anti-tumor mechanism is closely related to the activation of the body's immune function. For cervical precancerous lesions and cervical cancer that may be caused by high-risk HPV infection, the "heat-clearing and detoxifying" effect of Yunzhi is manifested at the micro level as the indirect inhibition of tumor growth through immune regulation. (3) Anti-inflammatory effect: The analgesic and anti-inflammatory effects of Yunzhi are closely related to its traditional "heat-clearing and detoxifying" effect; studies have shown that Yunzhi polysaccharides can effectively inhibit the activation of key inflammatory signaling pathways such as NF-κB and significantly reduce the levels of pro-inflammatory factors such as TNF-α and IL-1β; this can effectively alleviate the local inflammatory reaction, tissue damage and discomfort caused by HPV infection, and create a favorable microenvironment for tissue repair. (4) Liver protection effect: Triterpenoids and other components in Yunzhi can promote the repair and regeneration of hepatocytes and enhance the liver's detoxification function; this is especially important for HPV infected patients who need a long treatment cycle, which helps to reduce the liver burden that drug metabolism may bring, ensure the safety of the treatment process, and fit the theory of "the liver governs the free flow of qi and blood" in traditional Chinese medicine.(5) Antiviral effect: The antiviral effect of *Trametes versicolor* is mainly manifested at the level of immune regulation; it mainly fights viruses indirectly by enhancing the body's own immune surveillance and clearance capabilities, rather than directly killing viruses; this "strengthening the body's resistance to eliminate pathogens" strategy is particularly important for HPV integrated into the host's genes, because the effective activation of the body's immune system is the key to clearing infected cells. (6) Antioxidant effect: The basal activity of glutathione peroxidase (GSH-Px) in macrophages treated with *Trametes versicolor* polysaccharides is significantly increased, which can enhance the activity of antioxidant enzymes and protect macrophages against reactive oxygen species damage. *Trametes versicolor* polysaccharides have a protective effect on mouse macrophages damaged by oxidized low-density lipoprotein (O-LDL) and can inhibit foamy degeneration of macrophages. This antioxidant effect helps to reduce oxidative stress damage in local tissues infected with HPV.

[0024] Mulberry: Properties and Channels Entered: Sweet, sour, cold. Enters the Heart, Liver, and Kidney channels. Traditional Efficacy: Nourishes Yin and Blood, generates fluids and moistens dryness. Modern Pharmacological Research: (1) Immunomodulatory Effect: Immunomodulation is the core mechanism by which mulberry assists the body in fighting HPV. Its effective component, mulberry polysaccharide, can significantly activate and enhance the body's specific immune response. Studies have shown that mulberry polysaccharide can activate macrophages to enhance their phagocytic ability, promote the proliferation and differentiation of T lymphocytes and B lymphocytes, and enhance the activity of natural killer cells (NK cells). This is crucial for the body to recognize and eliminate abnormal cells infected by HPV. In addition, anthocyanins in mulberry can inhibit the release of pro-inflammatory factors, regulate immune balance, and prevent excessive inflammatory reactions from damaging tissues. This is equivalent to the "strengthening the body's resistance and eliminating pathogens" theory in traditional Chinese medicine, that is, by nourishing Yin and Blood to cultivate "righteous Qi" (strengthening immune surveillance and clearance ability), thereby changing the "internal environment" on which the virus depends for survival. This plays a fundamental role in controlling persistent HPV infection and preventing it from developing into precancerous lesions. (2) Promoting hematopoietic function: Mulberry is particularly effective in promoting hematopoietic function, directly corresponding to its traditional understanding of "nourishing yin and replenishing blood". Mulberry contains iron and vitamin C. Iron is an essential raw material for the synthesis of hemoglobin, while vitamin C can promote the conversion of ferric iron into more easily absorbed ferrous iron, significantly improving the iron absorption rate. This has a direct effect on improving blood deficiency or iron deficiency anemia caused by long-term HPV infection or chronic blood loss (such as contact bleeding from cervical inflammation). Studies have shown that mulberry decoction can promote the growth of granulocyte progenitor cells in mice, and its water decoction can restore mice with decreased red blood cells and hemoglobin to normal in a short period of time, improving blood deficiency. Anthocyanins and resveratrol in mulberry can also reduce the damage of free radicals to hematopoietic cells through antioxidant effects, stimulate the secretion of hematopoietic growth factors, and maintain the normal hematopoietic microenvironment of bone marrow. This explains from a modern scientific perspective the mechanism by which mulberry “replenishes essence and blood” to “nourish the whole body”, and when qi and blood are abundant, the body’s disease resistance is naturally strengthened. (3) Antioxidant and anti-aging: The anthocyanins, vitamin C, resveratrol, etc. that it is rich in are all powerful antioxidants that can effectively remove superoxide anions, hydroxyl radicals and other free radicals in the body and reduce the damage of oxidative stress to cells. Animal experiments have shown that mulberry extract can significantly reduce the content of liver lipid peroxidation (LPO), significantly increase the activity of whole blood glutathione peroxidase (GSH-Px) and catalase (CAT), and reduce myocardial lipofuscin. For local cells of the cervix, continuous HPV infection will trigger oxidative stress, accelerate cell damage and aging, and even increase the risk of cancer. The antioxidant effect of mulberry helps protect cervical epithelial cells from this damage and delays the process of cell aging. This is similar to the pathogenesis of "heat toxin damaging yin" in traditional Chinese medicine theory. By nourishing yin and clearing heat, and resisting oxidation, the damage of "toxic evil" to the body's normal functions can be reduced. (4) Anti-tumor and anti-mutagenic effects: Mulberry has shown potential in anti-tumor effects.Resveratrol, which it contains, is an important plant antitoxin that can stimulate certain genes in the human body to function and inhibit the growth of cancer cells. Studies have also found that the water-soluble extract of mulberry has no mutagenicity and has a significant antimutagenic effect. It can inhibit the increase in bone marrow micronucleus rate and chromosome aberration rate induced by cyclophosphamide and may have a certain preventive effect against the mutagenic effects of some exogenous mutagens. This means that mulberry can not only indirectly fight tumors through immune regulation, but its components can also directly intervene in the process of cell malignancy, which is of positive significance for blocking the "infection-inflammation-carcinogenesis" chain initiated by HPV infection. (5) Antiviral and liver-protective effects: Studies have shown that the effective component of mulberry, 1-deoxynojiklonincin, is effective against AIDS. Using enzyme-linked immunosorbent assay (ELISA) to screen Chinese herbal medicines that are anti-hepatitis B virus surface antigen, it was found that mulberry has an anti-hepatitis B virus effect. In addition, the liver-protective effect of mulberries has been confirmed by research. Mulberry polysaccharides can reduce the elevation of liver enzymes (ALT, AST) caused by alcohol or chemical toxins and alleviate liver fibrosis, which is of protective significance for infected patients who need long-term medication.

[0025] Summary of the synergistic effects of principal drugs: This formula uses six herbs—Astragalus membranaceus, Codonopsis pilosula, Ganoderma lucidum, Trametes versicolor, Smilax glabra, and Morus alba—as the principal herbs. Targeting the core pathogenesis of HPV infection—namely, "deficiency of vital energy (low immune function), internal accumulation of damp-heat (persistent viral infection environment), and depletion of yin and blood (local microenvironment imbalance)"—it constructs a multi-layered treatment core: "strengthening the body's resistance to enhance immune surveillance, detoxifying and eliminating dampness to clear the infection environment, and harmonizing qi and blood to repair damaged tissues." Specifically, Astragalus membranaceus and Codonopsis pilosula work synergistically to greatly replenish the qi of the spleen and lungs, aiming to significantly enhance the body's non-specific immunity and cellular immune function, providing sufficient energy and a defensive foundation for the immune system to recognize and clear HPV-infected cells. Ganoderma lucidum and Trametes versicolor complement each other; their rich polysaccharides and other active ingredients can deeply regulate immunity, specifically enhancing the phagocytic function of macrophages and promoting the activity of T lymphocytes and NK cells, thereby comprehensively improving the body's immune surveillance and clearance capabilities against HPV. Smilax glabra (Tufuling) is particularly effective at detoxifying and removing dampness, directly clearing damp-heat toxins from the lower abdomen. It can effectively improve the "damp-heat" internal environment of the reproductive tract, which is characterized by local dampness and inflammation, fundamentally disrupting the conditions for persistent HPV infection and replication. Mulberry (Sangshen) nourishes yin and replenishes blood, aiming to improve the state of qi and yin deficiency that may be caused by long-term HPV infection or local chronic inflammation, providing a material basis for the repair of mucosal tissues and enhancing local resistance.

[0026] The formula works synergistically by replenishing Qi, nourishing Yin, detoxifying, and promoting diuresis to lay the foundation for treatment that "supports the body's resistance without leaving behind pathogens, and eliminates pathogens without harming the body's resistance." It aims to block the HPV infection process by working together to enhance overall immunity, eliminate local pathogens, and improve the internal environment.

[0027] Analysis of the efficacy of the herbal medicine: Oldenlandia diffusa: Properties and Channels: Bitter, sweet, cold. Enters the Stomach, Large Intestine, and Small Intestine channels. Traditional Efficacy: Clears heat and detoxifies, promotes diuresis and relieves strangury. Modern Pharmacological Research Details: (1) Immunomodulatory Effect: Immunomodulation is one of the core mechanisms of Oldenlandia diffusa in combating HPV; the Oldenlandia diffusa polysaccharide it contains can significantly activate and enhance the body's specific and non-specific immune functions; studies have shown that it can promote the phagocytic activity of macrophages and accelerate the clearance of abnormal cells infected by HPV; at the same time, it can enhance the proliferation and killing ability of T lymphocytes and natural killer cells, and promote the secretion of key cytokines such as interferon-γ (IFN-γ) and interleukin-2 (IL-2); this is equivalent to "strengthening the body's resistance and eliminating pathogens" in traditional Chinese medicine theory, that is, by strengthening the body's own "vital energy" (immune defense system) to identify and eliminate HPV "toxic pathogens", changing the "soil" on which the virus depends for survival from the root, which is crucial for controlling the persistent infection of HPV and preventing it from developing into precancerous lesions. (2) Antitumor effects: Hedyotis diffusa is a key focus of modern Chinese medicine research and first-line clinical application in antitumor treatment, with its effects against HPV and related lesions being particularly prominent. Studies have shown that its extracts can effectively inhibit the expression of the E6 / E7 oncogenes of HPV virus. These two oncoproteins are key molecules leading to malignant transformation of cervical epithelial cells. Its active ingredients (such as ursolic acid and oleanolic acid) can directly inhibit the proliferation of tumor cells and induce apoptosis by intervening in the signal transduction pathways of tumor cells. For example, in in vitro experiments, Hedyotis diffusa extract showed a significant inhibitory effect on the proliferation of various cancer cell lines such as liver cancer and lung cancer. Its mechanism of action is diverse, including arresting the tumor cell cycle in the G2 / M phase, regulating the Bcl-2 / Bax protein ratio, and activating apoptosis-related proteins such as Caspase-3. This effect directly corresponds to its traditional functions of "clearing heat and detoxifying, dispersing nodules and reducing swelling". By resolving the pathogenesis of "mutual accumulation of toxins and blood stasis", it directly attacks the key links of disease and blocks the development of HPV infection into cervical precancerous lesions (CIN) and even cervical cancer. (3) Antibacterial and anti-inflammatory effects: It has an inhibitory effect on common pathogenic bacteria such as Staphylococcus aureus and Escherichia coli. In HPV infection, local inflammation (such as cervicitis) is often present. Its anti-inflammatory properties reduce the levels of pro-inflammatory factors such as tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) by inhibiting inflammatory signaling pathways such as NF-κB, thereby alleviating the inflammatory response such as redness, swelling, heat and pain in the cervix. This not only relieves the symptoms of damp-heat such as foul-smelling vaginal discharge and cervical erosion, but also creates a favorable microenvironment for tissue repair, reflecting the idea of ​​"eliminating evil to restore health". Its anti-inflammatory mechanism involves inhibiting the synthesis and release of inflammatory mediators such as prostaglandins and leukotrienes. (4) Antioxidant effect: Its antioxidant capacity is achieved through rich phenolic acids and flavonoids, which can effectively remove free radicals and reduce the damage of oxidative stress to cervical epithelial cells. This effect is consistent with the pathogenesis of "heat toxin injuring yin" in traditional theory. By reducing oxidative damage, it helps to protect cell health and delay tissue damage.

[0028] Coix Seed: Properties and Channels Entered: Sweet, bland, and cool in nature. Enters the spleen, stomach, and lung channels. Traditional Efficacy: Promotes diuresis and eliminates dampness, strengthens the spleen and stops diarrhea, relieves numbness, drains pus, detoxifies and dissipates nodules. Modern Pharmacological Research: (1) Immune Enhancement: Immune enhancement is one of the core mechanisms of Coix Seed in combating HPV; its Coix Polysaccharide can significantly activate and enhance the body's specific and non-specific immune functions; studies have shown that Coix Polysaccharide can promote the phagocytic activity of macrophages and enhance the killing ability of natural killer cells, while regulating the balance of T lymphocyte subsets; this is equivalent to "strengthening the body's resistance and eliminating pathogens" in traditional Chinese medicine theory, that is, by strengthening the "righteous qi" (immune system) to identify and eliminate HPV "toxic pathogens", which is crucial for controlling viral replication and preventing its integration into host cells; for the immune escape caused by persistent HPV infection, the immunomodulatory effect of Coix Seed helps to break immune tolerance and restore the body's ability to monitor the virus. (2) Anti-tumor effects: In terms of anti-tumor effects, coix seed exhibits multiple pathways; its core component, coixol, can directly inhibit the proliferation of tumor cells and induce their apoptosis; for cervical intraepithelial neoplasia (CIN) and even cervical cancer that may be caused by high-risk HPV infection, the "detoxification and nodule-dispersing" function of coix seed is manifested at the microscopic level as interfering with the growth cycle of abnormal cells, and also includes inhibiting tumor angiogenesis and cutting off the nutrient supply to the tumor, which is consistent with its traditional understanding of "dampness" to eliminate "pathological products". (3) Anti-inflammatory and analgesic effects: Coix seed has anti-inflammatory effects, and its components can inhibit the release of inflammatory mediators and reduce the inflammatory response of tissues. This has a positive effect on relieving local cervical inflammation caused by HPV infection. In addition, the traditional efficacy of "relieving pain" not only refers to relieving muscle and joint spasms and pain, but also includes the meaning of relieving body tension. Modern research has found that coix seed has certain sedative and analgesic effects. This can provide some relief for patients who are long-term sufferers of HPV infection and often experience anxiety and emotional stress, and indirectly contribute to the stability of the overall immune status. (4) Strengthening the spleen and eliminating dampness and regulating metabolism: The "strengthening the spleen" effect of coix seed has its modern scientific connotation. Studies have shown that it can improve edema and difficulty in urination caused by abnormal water metabolism, which is related to its diuretic effect. By strengthening the spleen and eliminating dampness, it can help improve the internal environment of the body and eliminate the pathological basis of "damp heat" on which HPV depends for survival. (5) Effects on the central nervous system: Although the effects of coix seed on the central nervous system do not directly combat HPV, it has its overall value; the traditional efficacy of "eliminating pain" not only refers to relieving muscle and joint spasms and pain, but also includes the meaning of relieving body tension; modern research has found that coix seed has certain sedative and analgesic effects; this can provide some relief for patients who are long-term sufferers of HPV infection and often experience anxiety and emotional stress, and indirectly contribute to the stability of the overall immune status.

[0029] Dandelion: Properties and Channels: Bitter, sweet, and cold. Enters the Liver and Stomach channels. Traditional Efficacy: Clears heat and detoxifies, reduces swelling and dissipates nodules, promotes urination and relieves strangury. Modern Pharmacological Research: (1) Cholagogue and Hepatoprotective Effects: Dandelion sterols and dandelion bitter substances can effectively promote bile secretion and excretion, reduce bile stasis, and have a protective effect against chemical liver damage. Animal experiments have shown that dandelion decoction or injection has a significant inhibitory effect on animals with elevated alanine aminotransferase caused by carbon tetrachloride, and can significantly alleviate the histological changes caused by carbon tetrachloride-induced liver damage. Dandelion can also antagonize the damage to hepatocyte lysosomes and mitochondria caused by endotoxins. For HPV-infected patients who need a long treatment cycle, this can reduce the liver burden that drug metabolism may bring and ensure treatment safety. This effect is consistent with the traditional theory that "the liver governs the free flow of qi," and the free flow of liver and gallbladder qi helps to resolve damp heat in the lower jiao. (2) Antibacterial and antiviral effects: Dandelion has broad-spectrum antibacterial activity, inhibiting Gram-positive and Gram-negative bacteria such as Staphylococcus aureus and hemolytic streptococci to varying degrees. Although research on its direct anti-HPV activity is still ongoing, its broad-spectrum antibacterial ability can effectively control secondary bacterial infections caused by local inflammation after HPV infection, reducing the risk of complications. Its injection solution has a strong killing effect on Staphylococcus aureus and hemolytic streptococci, and also has a killing effect on Streptococcus pneumoniae, Corynebacterium diphtheriae, and Pseudomonas aeruginosa. Clinical practice has proven that dandelion has good efficacy against infections caused by Gram-positive cocci, drug-resistant Staphylococcus aureus, and hemolytic streptococci. In addition, dandelion has an inhibitory effect on echovirus and influenza virus, and its 1:80 extract can delay cytopathic effects caused by certain viruses. (3) Anti-ulcer effect: The anti-ulcer effect of dandelion is mainly reflected in the digestive system; its overall ability to repair mucosa and promote ulcer healing, this "tissue regeneration and wound healing" mechanism, has positive significance for the repair of cervical mucosal damage that may be accompanied by HPV infection. (4) Anti-inflammatory and immunomodulatory effects: Anti-inflammation is one of the core mechanisms of dandelion in treating HPV-related inflammation. Its flavonoids, phenols and other components can inhibit the activation of key inflammatory signaling pathways such as NF-κB and reduce the levels of pro-inflammatory factors such as TNF-α and IL-6. This can effectively reduce the inflammatory response such as local redness, swelling, heat and pain of the cervix caused by HPV infection, create a favorable microenvironment for tissue repair, and directly correspond to its "heat-clearing" function. Dandelion also has immunomodulatory effects, which can improve the body's immunosuppressive state and enhance and regulate immune function. Some studies have shown that dandelion can improve and enhance the immune function of mouse cells.

[0030] The effects of cyclophosphamide on immune and non-specific immune functions have a significant restorative and protective effect on the immune function damage caused by cyclophosphamide in mice. (5) Anti-tumor effect: Dandelion extract has a significant inhibitory effect on tumor cells. It is believed that dandelion has a significant inhibitory effect on the in vitro and in vivo proliferation of tumor cells, suggesting that it has certain application value in the treatment of tumors. Its anti-cancer effect is related to the polysaccharide substances and trace protein compounds composed of glucose and mannan in dandelion. It has therapeutic effects on lung cancer, gastric cancer, esophageal cancer, breast cancer, etc. For precancerous lesions related to high-risk HPV infection, the "swelling and dissipation" function of dandelion may play an auxiliary effect of "preventing disease progression" at this level. (6) Antioxidant effect: The antioxidant capacity of dandelion is achieved through its rich vitamin C, carotenoids, and flavonoids, which can effectively remove oxygen free radicals and reduce the damage of oxidative stress to cells. This has a positive effect on protecting the health of cervical epithelial cells and delaying cell aging, supporting the overall therapeutic effect from another dimension, which is consistent with the pathogenesis of "heat toxin damaging yin" in traditional theory.

[0031] Purslane: Sour and cold in nature. It enters the liver and large intestine meridians. It has the effects of clearing heat and detoxifying, cooling blood and stopping bleeding, and stopping dysentery. In traditional Chinese medicine theory, its cold nature clears heat, and its sour taste astringes, making it particularly effective at clearing heat toxins from the blood and large intestine. It is an essential medicine for treating heat-toxin dysentery, carbuncles, boils, eczema, erysipelas, and metrorrhagia. Modern research reveals that purslane is rich in alkaloids, flavonoids, organic acids, polysaccharides, and other active ingredients, exerting a wide range of pharmacological effects through a multi-target mechanism. Its traditional effects of "clearing heat, detoxifying, and cooling blood" have been scientifically explained. 1. Antiviral and antibacterial effects: Purslane decoction has a significant inhibitory effect on herpes simplex virus type I (HSV-1) with low cytotoxicity. Its extract has inhibitory effects on various pathogenic bacteria such as Shigella, Salmonella typhi, Escherichia coli, and Staphylococcus aureus, and is known as a "natural antibiotic." This provides a pharmacological basis for its use in treating potential local inflammation and secondary infections associated with HPV infection. 2. Immunomodulatory effects: Purslane is an effective immunomodulator. Its water extract significantly increases spleen weight in immunocompromised animal models, promotes spleen development, and increases the number of macrophages and natural killer cells (NK cells) in the spleen, thus enhancing spleen immune function. Simultaneously, it promotes the phagocytic function of peritoneal macrophages in normal mice and enhances lymphocyte transformation and antibody production. This dual enhancement of innate and adaptive immunity aligns with the traditional Chinese medicine approach of "strengthening the body's resistance and eliminating pathogenic factors" to clear HPV infection. 3. Anti-inflammatory and antioxidant effects: Purslane is rich in flavonoids, polyphenols, and vitamin C, which possess strong anti-inflammatory and antioxidant activities. Its water extract exerts anti-inflammatory effects by inhibiting NLRP3 inflammasome activity and can reduce the level of total immunoglobulin E (IgE) in the serum of atopic dermatitis models. This is crucial for reducing local cervical inflammation caused by HPV infection, alleviating tissue redness, swelling, heat, and pain, and improving the "inflammatory microenvironment." 4. Anti-tumor effects: Studies have shown that purslane extract can inhibit the proliferation of various tumor cells, including lung cancer A549 cells and liver cancer HepG-2 cells, and induce apoptosis in vitro. Its n-butanol extract also shows potential for inhibiting tumor growth. This suggests that purslane may have an adjunctive preventive and therapeutic effect on cervical intraepithelial neoplasia (CIN) and even cervical cancer caused by persistent HPV infection. Other effects: Purslane also has multiple effects such as lowering blood pressure, regulating blood lipids, protecting the cardiovascular system, assisting in lowering blood sugar, anti-fatigue, improving learning and memory, and protecting the liver, reflecting its multi-target and holistic regulatory characteristics.

[0032] Dioscorea hypoglauca: Bitter in nature, neutral in nature. It enters the kidney and stomach meridians. Its functions include promoting diuresis and eliminating turbidity, dispelling wind and relieving numbness. Its bitterness dries dampness, and its neutral nature has a downward tendency, making it particularly effective in clearing the water passages and separating clear from turbid fluids. It is especially good at treating chyluria, leukorrhea, and excessive vaginal discharge in women caused by dampness and turbidity in the lower abdomen. It can also dispel wind and dampness, and promote joint mobility, used for rheumatic pain and lower back and knee pain. The main active components of Dioscorea hypoglauca are steroidal saponins (such as diosgenin) and flavonoids. Its traditional "dampness-clearing and turbidity-eliminating" effects have been confirmed in modern pharmacology from multiple dimensions. 1. Dampness-clearing and turbidity-eliminating and metabolic regulation: This is the core modern pharmacological mechanism of Dioscorea hypoglauca. Studies have shown that total saponins from Dioscorea hypoglauca can significantly increase uric acid clearance rate and excretion fraction, effectively reducing serum uric acid levels in animals with hyperuricemia. Meanwhile, Dioscorea hypoglauca extract can reduce serum triglycerides, total cholesterol, and low-density lipoprotein cholesterol in hyperlipidemic model animals, while increasing high-density lipoprotein cholesterol. This scientifically explains its efficacy in "separating clear from turbid" and promoting the excretion of pathological products (dampness and turbidity), and has a direct effect on improving the internal state of "turbid evil" caused by metabolic disorders. 2. Anti-inflammatory, analgesic, and immunomodulatory effects: Dioscorea hypoglauca is often used to treat damp-heat arthralgia. Modern research focuses on its anti-gouty arthritis activity, confirming its clear anti-inflammatory and analgesic effects. Its polysteroidal components, such as diosgenin, can promote immune cell regeneration and accelerate antibody synthesis, thereby enhancing the body's immune function. This is of positive significance for regulating the local or systemic immune disorders that may accompany HPV infection. 3. Antibacterial and antimicrobial effects: Dioscorea hypoglauca has a certain inhibitory effect on common pathogens causing urinary tract infections and eczema. Dioscorea saponins and their derivatives exhibit antifungal activity against various fungi (such as Trichophyton). This provides a pharmacological basis for their use in treating leukorrhea and eczema caused by dampness and turbidity. 4. Antitumor and cardiovascular protective effects: Studies have found that dioscorea saponins contained in Dioscorea hypoglauca can inhibit L1210 leukemia tumor cells. In addition, its extracts can increase myocardial blood flow, improve myocardial ischemia, and prevent the formation of atherosclerotic plaques by regulating blood lipids.

[0033] Summary of the synergistic effects of the auxiliary herbs: The auxiliary herbs in this formula have been precisely optimized to target the core pathogenesis of HPV infection, namely "heat and toxin stagnation" (active virus and persistent inflammation) and "internal dampness and turbidity" (abnormal vaginal discharge and microecological disorder). Purslane, Hedyotis diffusa, and dandelion are the core herbs, strengthening the effects of "clearing heat and detoxifying, cooling blood and dispersing blood stasis"; coix seed and Dioscorea hypoglauca are the leading herbs, constructing the function of "strengthening the spleen and eliminating dampness, separating turbidity and clearing heat". The five herbs work synergistically to form a three-dimensional treatment plan for eliminating pathogens: "clearing heat and toxins to inhibit the virus, separating dampness and turbidity to improve the environment". Specifically: 1. Clearing heat and detoxifying, directly suppressing the pathogenic factor: Purslane, Hedyotis diffusa, and dandelion work together synergistically. Hedyotis diffusa and dandelion excel at clearing heat and detoxifying, reducing swelling and dissipating nodules, and can directly combat local inflammation; purslane has both heat-clearing and detoxifying and blood-cooling effects, and can penetrate deep into the blood to clear latent heat toxins, specifically improving mucosal vulnerability and local heat stagnation associated with HPV infection. The synergy of these three herbs can more effectively inhibit viral activity, reduce tissue inflammation, and create direct conditions for virus clearance. 2. Eliminating dampness and turbidity, eradicating its nest: Coix seed and Dioscorea hypoglauca work together to specifically target "dampness and turbidity." Coix seed strengthens the spleen, eliminates dampness, clears heat and drains pus, transforming water and dampness at the source; Dioscorea hypoglauca eliminates dampness and turbidity, separating clear from turbid, with a specific effect, powerfully guiding dampness and turbidity from the lower burner through urination. These two ingredients, one beneficial and the other beneficial, complement each other, effectively eliminating abnormal vaginal discharge and rapidly improving the moist and stagnant microenvironment of the vagina and cervix, fundamentally destroying the "soil" on which HPV survives and replicates. Working synergistically, addressing both the symptoms and the root cause: This auxiliary herb group, together with the principal herb group (tonifying Qi and nourishing Yin, strengthening the body's resistance), forms a "combined offense and defense" approach. The auxiliary herb group focuses its firepower on "eliminating pathogens" (clearing damp heat and detoxifying), directly clearing the local environment where the virus exists and quickly alleviating clinical symptoms; the principal herb group stabilizes the root cause by "strengthening the body's resistance" (tonifying Qi and Yin, enhancing immunity), comprehensively improving the body's ability to recognize and eliminate the virus. The close cooperation between the two achieves "combined clearing and tonifying, treating both the symptoms and the root cause," not only providing powerful intervention for the current infection state but also laying a solid foundation for the immune system to ultimately eradicate the virus and prevent recurrence. This is one of the core mechanisms of action of this new formula in clinical practice that significantly accelerates viral clearance, promotes lesion reversal, and shortens the course of treatment.

[0034] Analysis of the efficacy of adjuvant drugs: Danshen: Properties and Channels: Bitter and slightly cold. Enters the Heart and Liver channels. Traditional Efficacy: Promotes blood circulation and removes blood stasis, unblocks meridians and relieves pain, clears the heart and relieves irritability, cools the blood and eliminates carbuncles. Modern Pharmacological Research: (1) Liver protection and organ protection: Danshen has a protective effect against damage to multiple organs. Its extract can counteract liver damage caused by carbon tetrachloride, D-galactosamine, etc., reduce serum transaminase, and promote hepatocyte regeneration. Its mechanism is related to inhibiting lipid peroxidation and reducing inflammatory response. In addition, Danshen can also improve kidney function and counteract renal fibrosis. This can reduce the organ burden that drug metabolism may bring to HPV infected patients who need a long treatment cycle and ensure the safety of treatment. (2) Immunomodulatory effect: Danshen has a unique "bidirectional regulatory" function on the immune system. On the one hand, its polysaccharide components can enhance immunity, such as improving the phagocytic capacity of macrophages and promoting the proliferation of T lymphocytes. Studies have shown that Danshen can activate macrophages and enhance their ability to clear pathogens and abnormal cells. On the other hand, Danshen also has immunosuppressive activity, which can reduce excessive immune response, such as by regulating the balance of T cell subsets to prevent the immune system from over-attacking its own tissues. This bidirectional regulatory characteristic is equivalent to "regulating qi and blood" in traditional Chinese medicine theory, that is, balancing the body's defense and stability by clearing the blood vessels, which is particularly important for correcting the immune disorder caused by HPV infection. (3) Nervous system protection: Danshen also has a prominent protective effect on the nervous system; its active ingredients can resist cerebral ischemia damage, reduce cognitive dysfunction, and improve learning and memory ability; the mechanism of action involves anti-oxidative stress, inhibiting nerve cell apoptosis, regulating neurotransmitters, etc.; although this does not directly fight HPV, for patients who are troubled by disease for a long time and often accompanied by anxiety and emotional stress, the "clearing the mind and relieving irritability" effect of Danshen can play a certain auxiliary role in calming the mind and relieving anxiety, which is in line with the holistic view of "treating both body and mind" in traditional Chinese medicine. (4) Anti-tumor effect: Its active ingredients can directly inhibit the proliferation of tumor cells and induce their apoptosis. Studies have confirmed that tanshinone IIA can inhibit tumor cell growth by intervening in the signal transduction pathways of tumor cells, such as regulating the Bcl-2 / Bax protein ratio and activating apoptosis-related proteins such as Caspase-3, thereby arresting the tumor cell cycle in the G2 / M phase. For cervical intraepithelial neoplasia (CIN) and cervical cancer that may be caused by high-risk HPV infection, the "eliminating carbuncles and dissipating nodules" effect of tanshinone is manifested at the microscopic level by interfering with the growth cycle of abnormal cells, and also includes inhibiting tumor angiogenesis (anti-VEGF effect) and cutting off the nutrient supply to the tumor. This is consistent with the theory of "promoting blood circulation to eliminate symptoms" in traditional Chinese medicine. (5) Antibacterial, anti-inflammatory and antioxidant effects: Tanshinone has a broad-spectrum antibacterial effect. Its active ingredients, cryptotanshinone and dihydrotanshinone, have inhibitory effects on Staphylococcus aureus, Escherichia coli and other bacteria. Its anti-inflammatory mechanism mainly involves inhibiting the activation of inflammatory signaling pathways such as NF-κB, and reducing the production of pro-inflammatory factors such as prostaglandin E2 (PGE2), leukotrienes (LT), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6).In HPV infection-related cervicitis models, Danshen can effectively reduce tissue edema and inflammatory infiltration. At the same time, its rich content of salvianolic acid components is a powerful antioxidant that can scavenge oxygen free radicals, reduce oxidative stress damage to cervical epithelial cells, and protect cell membrane structure and function. (6) Improve microcirculation and antithrombosis: The core active components of Danshen, tanshinone IIA and tanshinone, can significantly dilate blood vessels, especially increase blood flow in the coronary arteries and peripheral vessels, and reduce blood viscosity. Its mechanism includes increasing plasmin activity, prolonging bleeding and clotting time, inhibiting platelet aggregation (by increasing intraplatelet cAMP levels and inhibiting TXA2 synthesis), and improving erythrocyte deformability. For local HPV infection, this effect can effectively improve microcirculatory disorders in the lesion area, increase tissue oxygen and nutrient delivery, and promote the clearance of inflammatory metabolites, thereby creating favorable conditions for tissue repair. Studies have shown that Danshen can effectively combat blood stasis by regulating blood rheological properties and reducing whole blood viscosity and plasma viscosity.

[0035] Rehmannia glutinosa: Properties and Channels: Sweet and cold. Enters the Heart, Liver, and Kidney channels. Traditional Efficacy: Clears heat and cools blood, nourishes Yin and generates fluids. Modern Pharmacological Research Details: (1) Immunomodulatory Effect: Rehmannia glutinosa polysaccharides can significantly enhance the body's specific immune response. Studies have shown that it can promote the phagocytic activity of macrophages, improve the proliferation and transformation ability of T lymphocytes, and promote the secretion of cytokines such as interleukin-2 (IL-2). This is crucial for the body to recognize and eliminate abnormal cells infected by HPV. The immunomodulatory effect of Rehmannia glutinosa reflects the principle of "strengthening the body's resistance and eliminating pathogens" in traditional Chinese medicine. By nourishing Yin and blood to strengthen the body's resistance, it changes the "internal environment" on which the virus depends for survival, which is of great significance for controlling persistent HPV infection. (2) Promotes Hematopoietic Function: Rehmannia glutinosa is particularly effective in promoting hematopoietic function, which directly corresponds to its traditional understanding of "nourishing Yin and generating fluids". Its polysaccharide components can stimulate the proliferation and differentiation of bone marrow hematopoietic stem cells and have a significant effect on improving blood deficiency syndrome. Studies have shown that Rehmannia glutinosa can increase the number of peripheral blood leukocytes, erythrocytes and hemoglobin, and promote platelet production. This has a direct effect on improving the blood deficiency caused by long-term HPV infection or chronic blood loss (such as cervical contact bleeding). From the perspective of modern science, the mechanism of Rehmannia glutinosa "replenishing essence and blood" to "nourish the whole body" is explained. When the qi and blood are abundant, the body's disease resistance is strengthened. (3) Anti-tumor effect: Rehmannia glutinosa shows potential in anti-tumor. Its extract has cytotoxic effects on a variety of cancer cells and can inhibit the proliferation of tumor cells. Its mechanism may involve inducing cell apoptosis and interfering with the energy metabolism of tumor cells. For precancerous lesions related to high-risk HPV infection, the "heat-clearing and blood-cooling" effect of Rehmannia glutinosa may indirectly inhibit the growth of abnormal cells by regulating the cell microenvironment. (4) Anti-inflammatory and antioxidant effects: Rehmannia glutinosa has good anti-inflammatory and antioxidant activities. Its glycosides, phenols and other components can inhibit the release of inflammatory mediators and reduce the inflammatory response of tissues. At the same time, it is a powerful natural antioxidant that can effectively remove free radicals and reduce the damage of oxidative stress to cells. HPV infection itself can trigger local oxidative stress and accelerate cell damage. The antioxidant effect of Rehmannia glutinosa helps protect cervical epithelial cells from this damage and creates favorable conditions for tissue repair. This confirms the traditional understanding of "nourishing yin" to resist "heat toxin damaging yin" from the perspective of modern science. (5) Digestive system effects: In terms of the digestive system, Rehmannia glutinosa has the function of nourishing yin and moistening the intestines; its effective components can promote the secretion of intestinal mucus, lubricate the intestines, and relieve constipation caused by yin deficiency and intestinal dryness; for HPV infected patients, especially those with internal heat damaging body fluids and constipation, Rehmannia glutinosa can improve intestinal function and promote the excretion of toxins. (6) Cardiovascular system and blood sugar regulation effects: Rehmannia glutinosa also has a protective effect on the cardiovascular system. Its decoction has a cardiotonic effect, can dilate renal blood vessels, and has a diuretic effect. In addition, Rehmannia glutinosa also has a hypoglycemic effect, the mechanism of which may be related to the effect on glucose metabolism. These effects have positive adjunctive therapeutic significance for HPV-infected individuals with cardiovascular risks or metabolic problems.(7) Kidney protection: In terms of kidney protection, studies have shown that Rehmannia glutinosa extract has a protective effect on kidney tissue and can slow down the process of glomerular sclerosis; this reflects its traditional "yin-nourishing" effect, which has auxiliary value for maintaining overall health.

[0036] Poria: Properties and Channels: Sweet, bland, neutral; enters the heart, lung, spleen, and kidney channels. Traditional Efficacy: promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. In response to the core pathogenesis of HPV infection with internal dampness and deficiency of vital energy, Poria's "strengthening the spleen" can protect the acquired foundation and enhance the body's ability to resist pathogens; "promoting diuresis and eliminating dampness" can remove internal dampness and eliminate the environment for virus growth; "calming the mind" helps to calm the mind and relieve the patient's anxiety. Its medicinal properties are mild, nourishing without being drastic, and promoting diuresis without being aggressive. As an adjuvant, it can coordinate the effects of other drugs, strengthen the spleen and calm the mind. Modern pharmacological research details: (1) Immunomodulatory effect: Poria polysaccharide can significantly enhance the phagocytic function of macrophages, promote the proliferation and differentiation of T lymphocytes, and increase the activity of natural killer cells (NK cells), significantly increase serum IgG content, and promote cellular immunity and humoral immunity. This is crucial for the body to recognize and eliminate abnormal cells infected by HPV. It conforms to the TCM principle of "strengthening the body's resistance and eliminating pathogens" and strengthens the body's ability to clear HPV. (2) Regulation of gastrointestinal flora: Poria cocos has a direct relaxing effect on isolated rabbit intestinal segments, can reduce gastric juice secretion and free acid content, and has an inhibitory effect on gastric ulcers caused by pyloric ligation in rats. Poria cocos polysaccharides can also regulate the balance of intestinal flora, promote the proliferation of probiotics, and indirectly enhance mucosal immunity. This is of positive significance for improving the symptoms of poor appetite, fatigue, loose stools and diarrhea that may occur in HPV infected individuals due to spleen deficiency and dampness, reflecting the holistic view of "the lung and large intestine are internally and externally related" in traditional Chinese medicine. (3) Regulation of uterine smooth muscle. Its alcohol extract and petroleum ether extract can inhibit the spontaneous contraction of uterine smooth muscle, which has an auxiliary regulatory significance for abnormal leukorrhea or menstrual disorders caused by HPV infection. 4. Anti-inflammatory, sedative and diuretic effects. Its triterpenoids can inhibit cyclooxygenase-2 activity and reduce the production of inflammatory mediators such as prostaglandin E2. Its water extract can inhibit capillary permeability, which helps to reduce the local inflammatory reaction and allergic state that may be caused by HPV infection. For patients experiencing anxiety due to illness, its calming and soothing effects can alleviate tension. Its diuretic properties, by "eliminating dampness and promoting urination," help expel dampness and toxins from the body, improving the "dampness" environment associated with HPV infection. 5. Anti-tumor (tumor suppression) and organ protection: Poria cocos polysaccharides and triterpenoids can inhibit tumor cell proliferation, induce tumor cell apoptosis, protect against liver damage, and scavenge free radicals, reducing oxidative stress damage. For cervical precancerous lesions potentially caused by high-risk HPV infection, Poria cocos's strengthening and consolidating effects manifest at the microscopic level as enhancing the body's anti-tumor immunity. For HPV-infected individuals requiring long-term treatment, it helps maintain internal environmental stability and supports overall recovery.

[0037] Isatis root: Properties and channels: Bitter, cold; enters the heart and stomach channels. Traditional effects: Clears heat and detoxifies, cools blood and soothes the throat. Targeting the core pathogenesis of "heat toxin stagnation" in HPV infection, Isatis root's "heat-clearing and detoxifying" effect can directly counteract the disease's progression, clearing away epidemic toxins and heat toxins invading the blood and lower abdomen; its "blood-cooling" effect helps clear latent heat in the blood, preventing heat toxins from consuming yin and blood and accelerating stagnation; although its "sore throat" effect mainly acts on the throat, its heat-clearing and pathogen-expelling power helps guide the body's heat toxins outward. Its medicinal properties are cold, and its heat-clearing and detoxifying power is strong. In this formula, it acts as an assistant herb, assisting the principal herbs (such as gardenia and Smilax glabra) to enhance the overall effect of clearing deep and stubborn heat toxins. Modern pharmacological research details: 1. Broad-spectrum antiviral and direct inhibition of viral replication: Isatis root is a recognized broad-spectrum antiviral traditional Chinese medicine. Its active ingredients (such as indirubin, indole-like compounds, polysaccharides, etc.) can exert antiviral effects through multiple pathways: ① Direct inhibition of viral replication: It can inhibit the adsorption, penetration, and intracellular biosynthesis of various viruses such as influenza virus, respiratory syncytial virus, and herpes simplex virus. For HPV, its antiviral mechanism may be reflected in interfering with early viral gene expression or viral protein synthesis. ② Induction of endogenous interferon: It can stimulate the body's cells to produce interferon, indirectly exerting a powerful antiviral effect. This provides a direct biochemical weapon for clearing HPV virus. 2. Immunomodulatory and enhancing effects: Isatis root polysaccharides can significantly enhance the body's non-specific and specific immune functions. It can activate macrophages and enhance their phagocytic capacity; promote lymphocyte proliferation and increase the proportion and activity of T cell subsets; and increase the levels of immunoglobulins (such as IgG and IgA) and complement C3 and C4 in serum, enhancing humoral immunity. This comprehensive immune-enhancing effect aligns perfectly with the traditional Chinese medicine concept of "strengthening the body's resistance to eliminate pathogens," significantly enhancing the body's immune system's ability to recognize and eliminate HPV-infected cells. 3. Anti-inflammatory, antipyretic, and anti-endotoxin effects: Isatis root has significant anti-inflammatory effects. Its extracts can inhibit the expression of cyclooxygenase-2 (COX-2) and nitric oxide synthase (iNOS), and reduce the production of key inflammatory mediators such as prostaglandin E2 (PGE2) and nitric oxide (NO), thereby alleviating tissue inflammation and edema. Simultaneously, its clear antipyretic and antibacterial endotoxin effects help alleviate systemic reactions caused by infection or inflammation. For local chronic inflammation caused by HPV infection (a key factor promoting lesion persistence and progression), this effect can effectively break the vicious cycle of "virus-inflammation" and improve the local microenvironment. 4. Anti-tumor (cytotoxic and immunomodulatory) effects: Studies have shown that the active ingredients in Isatis root (such as indirubin) have inhibitory effects on the proliferation of various tumor cell lines (including cervical cancer cells HeLa) and induce apoptosis. Its mechanism may be related to arresting the cell cycle and regulating the expression of apoptosis-related proteins (such as Bcl-2 / Bax).More importantly, its anti-tumor effect is synergistic with its immune-enhancing effect, which inhibits abnormal cell growth by improving the body's anti-tumor immunity, and has positive significance for the prevention and treatment of precancerous lesions related to high-risk HPV infection.

[0038] Synergistic Effects of Adjuvant Herbs: The four herbs—Poria cocos, Rehmannia glutinosa, Salvia miltiorrhiza, and Isatis indigotica—serve as adjuvant herbs, playing a precise regulatory role in "assisting treatment, preventing concurrent symptoms, and restraining imbalances" in the primary treatment of HPV. Poria cocos strengthens the spleen and eliminates dampness, assisting the principal herbs, Codonopsis pilosula and Astragalus membranaceus, in consolidating the "acquired foundation" (spleen and stomach), ensuring a source for the production of qi and blood, while enhancing the overall dampness-eliminating effect of the formula. Its calming effect also helps alleviate patient anxiety. Rehmannia glutinosa clears heat, cools the blood, nourishes yin, and generates fluids. While the principal and adjuvant herbs vigorously clear heat and eliminate dampness, it nourishes the yin fluids depleted by heat, aiming to prevent and correct potential "yin damage" during treatment and maintain the moisture and integrity of mucosal tissues. Salvia miltiorrhiza invigorates blood, removes blood stasis, cools the blood, and eliminates carbuncles. Addressing the local qi and blood stagnation and microcirculation disorders that HPV infection may cause, it improves blood supply to the lesions, promotes inflammation absorption and tissue repair, and prevents the "toxin and blood stasis" from developing to a deeper level. Isatis root clears heat and detoxifies, cools the blood and soothes the throat. Its broad-spectrum antiviral effect can enhance the inhibitory effect of the principal herbs on HPV. The four herbs work synergistically to strengthen the spleen and stomach, cool the blood and protect yin, and promote blood circulation and unblock the meridians. This aims to solve the concurrent problems (such as spleen deficiency, blood stasis, and yin deficiency) during HPV infection and treatment, and to mitigate the bias of the principal and assistant herbs, ensuring the comprehensiveness and safety of the treatment plan.

[0039] Analysis of the efficacy of the medicine: Codonopsis pilosula: Properties and Channels: Sweet, slightly bitter, neutral; enters the spleen and lung channels. Traditional Efficacy: Tonifies Qi and strengthens the spleen, generates fluids and moistens the lungs. Its medicinal properties are mild, nourishing without drying, clearing without being cold. In the pathogenesis of HPV infection, which is "deficiency of vital Qi and internal accumulation of dampness and toxins", it can balance the support of the body and the elimination of pathogens, and enhance the body's tolerance. Modern Pharmacological Research Details: (1) Immunomodulatory Effect: The core mechanism by which Codonopsis pilosula assists the body in fighting HPV lies in its mild and effective immunomodulatory function. Codonopsis pilosula polysaccharide is its key active ingredient, which can significantly activate and enhance the body's specific and non-specific immune functions. Studies have shown that Codonopsis pilosula polysaccharide can activate the phagocytic function of macrophages, improve the proliferation and transformation ability of T lymphocytes, and promote the secretion of cytokines such as interferon. This is crucial for the body to recognize and clear abnormal cells infected by HPV. The immune-enhancing effect of Codonopsis pilosula is mild and long-lasting, which is equivalent to the "tonifying qi" in traditional Chinese medicine theory to "strengthen the body's resistance". By strengthening the "vital qi" (immune system), it changes the "internal environment" on which the virus depends for survival. This plays a fundamental role in controlling persistent HPV infection and preventing it from developing into precancerous lesions. This immunomodulatory property of Codonopsis pilosula is especially suitable for HPV-infected individuals who are weak or recovering from illness and cannot tolerate strong attacks. (2) Anti-stress and anti-fatigue effects. Studies have shown that Codonopsis pilosula can significantly prolong the swimming time under load and the survival time in hypoxic environments of experimental animals, and improve the body's ability to adapt to stress. This is helpful for HPV-infected patients, especially those with a long course of disease, anxiety and physical exhaustion, to improve their quality of life and enhance their overall tolerance to the disease. This effect is closely related to the "tonifying qi" in traditional efficacy to improve "physical fatigue". By enhancing the body's energy metabolism and oxygen utilization efficiency, it provides sufficient energy for the effective operation of the immune system. (3) Cardiovascular protection effect. Codonopsis pilosula shows many benefits to the myocardium. Codonopsis pilosula crude polysaccharide has a protective effect against cardiopulmonary injury induced by acute myocardial infarction, can improve cardiac function, and reduce myocardial tissue pathological damage. Its mechanism may be related to inhibiting the expression of matrix metalloproteinases and improving oxidative stress. This provides additional protection for HPV-infected patients with cardiovascular discomfort or who need to pay attention to the safety of long-term medication, ensuring the stability and sustainability of the treatment process. (4) Antioxidant effect: The antioxidant activity of Codonopsis pilosula is another important function. Codonopsis pilosula extract can effectively scavenge free radicals, increase the activity of antioxidant enzymes such as superoxide dismutase (SOD), and reduce the damage of oxidative stress to cells. HPV infection itself can trigger local oxidative stress, accelerate cell damage and aging. The antioxidant effect of Codonopsis pilosula helps protect cervical epithelial cells from such damage, creating conditions for tissue repair, which is consistent with the traditional theory of "tonifying qi and nourishing yin" to resist "evil heat consumption". (5) Effect on digestive system: Codonopsis pilosula has a certain effect of strengthening the spleen and stomach, which helps to improve symptoms such as loss of appetite and indigestion caused by spleen and stomach weakness. This is of positive significance for maintaining good nutritional status in HPV-infected individuals and supporting normal immune system function.

[0040] Ophiopogon japonicus: Properties and Channels: Sweet, slightly bitter, slightly cold; enters the Heart, Lung, and Stomach channels. Traditional Efficacy: Nourishes Yin and generates fluids, moistens the lungs and clears the heart. Targeting the pathogenesis of HPV damp-heat toxins consuming Yin fluids, leading to deficiency of the body and lingering of pathogens. Ophiopogon japonicus's "nourishing Yin and generating fluids" can replenish the damaged Yin of the lungs and stomach, "moistening the lungs" can nourish the damaged mucosal tissues, and "clearing the heart" helps to calm the mind and relieve the patient's anxiety. Its nature is slightly cold but not harsh, moist but not greasy. As an adjuvant, it can effectively counteract the warm and dry nature of the principal drugs in the prescription (such as Astragalus membranaceus and Atractylodes macrocephala), protect the body fluids, thereby improving the microenvironment of the host cells and making it unfavorable for the survival of HPV virus. Modern pharmacological research details: (1) Immunomodulatory effect: Ophiopogon japonicus polysaccharide can significantly enhance the body's non-specific and specific immune responses. Studies have shown that it can activate the phagocytic function of macrophages, promote the proliferation and differentiation of T lymphocytes, and increase the activity of natural killer cells (NK cells). This is crucial for the body to recognize and clear abnormal cells infected by HPV. In traditional Chinese medicine theory, this is equivalent to "strengthening the body's resistance" in the principle of "strengthening the body's resistance and eliminating pathogens", that is, strengthening the body's resistance (immune system) by nourishing the yin fluid and changing the "internal environment" on which the virus depends for survival. For the immune escape caused by persistent HPV infection, the immune-enhancing effect of Ophiopogon japonicus helps to break immune tolerance and create conditions for the final clearance of the virus. (2) Cardiovascular system protection: The total saponins and total amino acids of Ophiopogon japonicus can enhance myocardial contractility, increase coronary blood flow, improve myocardial oxygen supply, and have a protective effect against experimental arrhythmias. Its water extract, alcohol extract and petroleum ether extract can significantly reduce platelet aggregation rate, inhibit thrombus formation and improve microcirculation. For those with cardiovascular risks or who need to take medication for a long time, this effect provides additional protection, reflecting the overall regulatory idea of ​​"activating blood circulation and unblocking the meridians" in traditional Chinese medicine. (3) Anti-inflammatory and antioxidant effects: Its high isoflavone compounds can inhibit the release of inflammatory mediators and reduce inflammatory response. At the same time, the flavonoids rich in Ophiopogon japonicus are powerful natural antioxidants that can effectively remove free radicals and reduce the damage of oxidative stress to cells. HPV infection itself triggers local oxidative stress, accelerating cell damage. The antioxidant properties of Ophiopogon japonicus help protect cervical epithelial cells from oxidative damage, creating favorable conditions for tissue repair and providing a modern scientific explanation for the pathogenesis of "heat toxin damaging yin." 4. Mucosal protection and sedative effects: Ophiopogon japonicus steroidal saponins can promote mucus secretion in the respiratory and digestive tracts, protecting the epithelial barrier; its decoction has a sedative effect, consistent with its traditional efficacy of "clearing the mind and relieving irritability." For patients experiencing anxiety, irritability, and insomnia due to HPV infection, this effect has auxiliary regulatory significance, helping to stabilize emotions, improve sleep, and indirectly support the normal function of the immune system.

[0041] Atractylodes macrocephala: Properties and channels: bitter, sweet, warm; enters the spleen and stomach channels. Traditional effects: strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus. The "strengthening the spleen and replenishing qi" of Atractylodes macrocephala can protect the foundation of acquired constitution and enhance the body's ability to resist pathogens; the "drying dampness and promoting diuresis" can remove internal dampness and eliminate the environment for viral growth; the "stopping sweating" function can strengthen the exterior and resist pathogens; the "calming the fetus" function has a conditioning effect on gynecological diseases related to HPV infection. Modern pharmacological research details: (1) Immunomodulatory effect: Atractylodes macrocephala polysaccharide can activate the phagocytic activity of macrophages, promote the proliferation and differentiation of T lymphocytes, and increase the activity of natural killer cells (NK cells). For HPV infection, strong cellular immunity is the key to clearing the virus, which is in line with the TCM principle of "strengthening the body and eliminating pathogens". By strengthening the "vital energy" (immune system), the "internal environment" on which the virus depends for survival can be changed. This has a fundamental role in controlling persistent HPV infection and preventing it from developing into precancerous lesions. (2) Gastrointestinal function regulation: Atractylodes macrocephala improves the digestion and absorption of nutrients by enhancing the activity of disaccharidases (such as maltase and sucrase) in the small intestine. Its bidirectional regulatory effect on the gastrointestinal tract (such as anti-ulcer and peristalsis promotion) is consistent with the theory of "spleen governs transportation and transformation". It has the significance of adjuvant treatment for HPV-infected patients with digestive disorders. (3) Uterine smooth muscle regulation: Its alcohol extract and petroleum ether extract can significantly inhibit the spontaneous contraction of uterine smooth muscle and counteract the excitatory contraction caused by oxytocin, which is consistent with the traditional "fetal protection" effect. It has a regulatory effect on gynecological diseases that may be accompanied by HPV infection. (4) Cardiovascular system protection and diuretic effect: Atractylodes macrocephala has the effects of strengthening the heart and regulating blood pressure. Its decoction and alcohol extract can dilate blood vessels and have a mild inhibitory effect on the heart, which helps stabilize blood pressure. Its volatile oil components can regulate the renal tubular reabsorption function and produce a significant and lasting diuretic effect. This has a direct effect on improving water metabolism and eliminating edema, which is consistent with its "drying dampness and promoting diuresis" effect. (5) Anti-tumor and antioxidant effects: The volatile oil components of Atractylodes macrocephala can inhibit the proliferation of tumor cells, and its decoction can scavenge free radicals, increase the activity of antioxidant enzymes such as superoxide dismutase (SOD), delay cell aging, and protect tissue function. It helps to reduce oxidative damage caused by HPV infection. For cervical precancerous lesions that may be caused by high-risk HPV infection, the function of Atractylodes macrocephala in strengthening the body's resistance and consolidating the foundation is manifested at the microscopic level as enhancing the body's anti-tumor immunity, and has the potential to "prevent disease progression". In the treatment of anti-HPV infection, Atractylodes macrocephala, through the synergistic effects of multiple targets such as immune regulation, improvement of gastrointestinal function, regulation of uterine smooth muscle, and anti-tumor, nourishes the original qi from the foundation of acquired constitution, "strengthens the spleen and replenishes qi, dries dampness and promotes diuresis" to comprehensively enhance the body's disease resistance, and becomes an important adjuvant in the prescription.

[0042] Gardenia: Properties and Channels: Bitter and cold. Enters the Heart, Lung, and Triple Energizer channels. Traditional Efficacy: It has the effects of purging fire and relieving irritability, clearing heat and promoting diuresis, cooling blood and detoxifying. Modern Pharmacological Research Details: (1) Anti-inflammatory, analgesic and antipyretic effects: Gardenia contains iridoids such as geniposide and genipin, which are the material basis for its anti-inflammatory and analgesic effects. Studies have found that gardenia extract can significantly inhibit the writhing response of mice induced by acetic acid, showing a good analgesic effect. Its anti-inflammatory mechanism is related to the inhibition of the release of inflammatory mediators such as prostaglandins and histamine, as well as the regulation of inflammatory signaling pathways such as NF-κB. This has direct symptomatic therapeutic significance for relieving the local cervical inflammation, burning discomfort and abnormal vaginal discharge that may be caused by HPV infection, and also explains its traditional efficacy of "clearing heat and purging fire" and "reducing swelling and relieving pain" from the perspective of modern pharmacology. (2) Cholagogue and hepatoprotective effects: The cholagogue and hepatoprotective effects of gardenia are crucial for HPV-infected patients who need long-term conditioning. Gardenia is rich in geniposide, crocin, and other components that have significant choleretic effects, promoting bile secretion and excretion. At the same time, gardenia has a clear protective effect against chemical liver damage (such as that caused by carbon tetrachloride, acetaminophen, etc.), reducing serum transaminase levels and alleviating hepatocyte necrosis and fatty degeneration. This not only conforms to the TCM theory of "the liver governs the free flow of qi and blood" and is related to the smooth flow of qi and blood, but also reduces the potential liver burden of long-term medication, ensuring treatment safety and providing a guarantee for long-term HPV treatment. (3) Antibacterial, antiviral and immunomodulatory effects: The traditional efficacy of gardenia in "clearing heat and detoxifying" is reflected in modern pharmacology as a multi-synergistic effect of broad-spectrum antibacterial, direct antiviral, anti-inflammatory and immunomodulatory effects. Its decoction has an inhibitory effect on a variety of common pathogenic bacteria such as Staphylococcus aureus and hemolytic streptococci, which helps to control bacterial infections that may occur after HPV infection and reduce the risk of complications. Secondly, its antiviral activity is particularly important, mainly reflected in two synergistic mechanisms: First, its active ingredients (such as gardenia iridoid glycosides) can directly interfere with the interaction between the virus and the host cell, effectively blocking the viral replication process; Second, by inhibiting the overactivation of key inflammatory signaling pathways such as JAK / STAT, it significantly reduces the levels of core pro-inflammatory factors such as IL-6 and TNF-α, thereby exerting a strong anti-inflammatory effect, reducing the excessive immune response and tissue damage caused by viral infection, and reducing adverse reactions of the body. In addition, gardenia has a regulatory effect on the immune system itself, and its extracts can inhibit the overactivation of the immune system, which helps to correct the immune disorder that may accompany HPV infection. In summary, gardenia, through multi-target synergy of antibacterial, direct antiviral, anti-inflammatory and immunomodulatory effects, not only directly fights against pathogens, but also improves the body's internal environment, providing key medicinal power for the overall clearance of HPV virus and promotion of tissue repair. (4) Antioxidant effect: The antioxidant capacity of gardenia should not be ignored. Its flavonoids, phenolic acids and other components can effectively scavenge free radicals and reduce the damage of oxidative stress to cells. HPV infection itself can trigger local oxidative stress, accelerating cell damage.Gardenia's antioxidant effect helps protect the health of cervical epithelial cells and creates conditions for tissue repair. (5) Effects on the central nervous system: Gardenia has a sedative effect. It is closely related to "clearing heat and relieving irritability". For patients with long-term anxiety, irritability and poor sleep due to HPV infection, it can play a certain auxiliary role in calming the mind and relieving emotions, which indirectly helps stabilize the overall immune status and improve the quality of life.

[0043] Dendrobium: Properties and Channels Entered: Sweet, slightly cold; enters the Stomach and Kidney channels. Traditional Efficacy: Nourishes the stomach and generates fluids, nourishes Yin and clears heat. Targeting the pathogenesis of "heat toxin damaging Yin" and "deficiency of both Qi and Yin" caused by late-stage or long-term HPV infection, Dendrobium's "Yin-nourishing" function nourishes the Yin of the lungs, stomach, and kidneys, replenishing the fluids and Yin blood consumed by heat toxins; its "heat-clearing" power clears residual heat and prevents upward flaring of deficient fire; its "stomach-nourishing and fluid-generating" function protects stomach Qi, strengthens the acquired constitution, and promotes the generation of Qi and blood. Its medicinal properties are mild and moistening, nourishing without being greasy, clearing heat without harming the body's vital energy. As an adjuvant, it guides other herbs to nourish Yin and moisten dryness, harmonizes the cold nature of the entire formula, and helps to strengthen the body's resistance and consolidate its foundation. Modern Pharmacological Research Details: 1. Immune Enhancement and Regulation: Dendrobium polysaccharides are its main active ingredient, exhibiting significant immune-enhancing effects. It can activate macrophages, enhancing their phagocytic function and ability to secrete cytokines (such as IL-1β and TNF-α); promote lymphocyte proliferation, and increase the activity of T cells (especially CD4+ T cells) and B cells; and increase the levels of immunoglobulins (such as IgG and IgM) and complement in serum. This comprehensive immune activation effect is crucial for patients in a state of "immune tolerance" or "immunodeficiency" due to long-term HPV infection, effectively enhancing the immune system's ability to recognize and clear the virus, which aligns with the core principle of traditional Chinese medicine, "strengthening the body's resistance and eliminating pathogenic factors." 2. Antioxidant and anti-inflammatory effects, and tissue protection: Dendrobium is rich in polysaccharides, bibenzyl compounds, and phenanthrene compounds, possessing strong antioxidant activity. It can effectively scavenge free radicals and reduce oxidative stress damage to cells. Simultaneously, its extracts can inhibit the activation of key inflammatory signaling pathways such as nuclear factor-κB (NF-κB) and reduce the production of pro-inflammatory factors such as tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6), thereby exerting an anti-inflammatory effect. This is significant for alleviating local chronic inflammation caused by HPV infection, protecting cervical and other mucosal tissues from persistent inflammatory damage, and preventing "inflammatory-cancer transformation." 3. Direct antiviral activity and inhibition of tumor cell activity: Studies have shown that Dendrobium extract has a direct inhibitory effect on various viruses (such as respiratory syncytial virus and herpes simplex virus). Its mechanism may involve interfering with viral adsorption or replication. Its antiviral potential for HPV is noteworthy. More importantly, components in Dendrobium, such as dendrobin and dendrobinin, have been shown to inhibit proliferation, induce apoptosis, and promote autophagy in various cancer cells (including cervical cancer HeLa cells). This provides a pharmacological basis for the prevention and intervention of precancerous lesions associated with high-risk HPV infection. 4. Moisturizing and mucosal protective effects: Dendrobium is traditionally used to treat thirst due to fluid depletion and dry cough due to yin deficiency. Modern research shows that its polysaccharide components can form a protective layer on the mucosa of the digestive and respiratory tracts, promote mucus secretion, and enhance mucosal barrier function. For conditions such as vaginal dryness and decreased local mucosal resistance that may accompany HPV infection, this product helps improve the local microenvironment and enhance the mucosa's own defense and repair capabilities.

[0044] Schisandra chinensis: Properties and Channels Entered: Warm in nature, sour and sweet in taste; enters the lung, heart, and kidney channels. Traditional Efficacy: Astringent and consolidating, replenishing qi and generating fluids, tonifying the kidneys and calming the mind. Targeting the core pathogenesis of "deficiency of vital energy and lingering pathogenic factors" and depletion of qi and yin in the course of HPV infection, Schisandra chinensis's "replenishing qi and generating fluids" can replenish the depleted vital energy and body fluids, consolidating the immune foundation; its "astringent and consolidating" can prevent the excessive consumption and loss of vital energy (such as qi, fluids, and essence), providing reserves for the body to fight pathogens for a long time; its "tonifying the kidneys and calming the mind" can regulate the functions of the lower jiao (kidneys) and the mind (heart), improving anxiety, insomnia, and functional decline that may accompany long-term illness, stabilizing the internal environment to facilitate recovery. Its medicinal properties are sour, astringent, warm, and unblocking, possessing the wonders of "astringing, replenishing, and regulating," acting as a guide to protect the root cause and harmonize other herbs, making the overall tonifying and purging power of the formula lasting and mild. Detailed Explanation of Modern Pharmacological Research: 1. Comprehensive Immunomodulatory and Enhancing Effects: Schisandra chinensis polysaccharides and lignans (such as schisandrin B) possess significant bidirectional immunomodulatory functions. They can enhance the phagocytic activity of macrophages and promote their secretion of cytokines; activate T lymphocytes and natural killer cells (NK cells), improving cellular immune responses; and regulate the Th1 / Th2 immune balance, inhibiting excessive Th2 responses and promoting Th1 responses that are more conducive to virus clearance. This is crucial for correcting the common "immune tolerance" or "hypoactive immune function" state in HPV infection. 2. Direct Antiviral, Anti-inflammatory, and Antitumor Effects: Studies have shown that Schisandra chinensis extract has a direct inhibitory effect on various viruses, and its mechanism may involve interfering with viral adsorption and replication. Simultaneously, its lignan components can effectively inhibit key inflammatory pathways such as NF-κB, reduce the production of pro-inflammatory factors such as TNF-α and IL-6, and alleviate tissue inflammatory damage. More importantly, schisandrins (such as schisandrin B) have been shown to have clear anti-tumor activity. They can inhibit the growth of various cancer cells, including cervical cancer HeLa cells, through multiple mechanisms such as inducing cell cycle arrest, activating mitochondrial apoptosis pathways (e.g., regulating the Bcl-2 / Bax protein ratio), and inhibiting tumor cell invasion and metastasis. This provides direct pharmacological support for the prevention and treatment of precancerous lesions associated with high-risk HPV infection. 3. Powerful antioxidant, anti-stress, and organ-protective effects: Schisandra lignans are potent free radical scavengers that can activate cellular self-protection pathways (such as the Keap1 / Nrf2 / ARE pathway) and enhance cellular antioxidant capacity. Their clear anti-stress effects (including physical, chemical, and psychological stress) can protect the body from stress damage by regulating the hypothalamus-pituitary-adrenal axis, reducing the level of stress hormones (such as cortisol). In addition, their significant hepatoprotective effects (promoting hepatocyte repair and inducing liver detoxification enzymes) are particularly important for those requiring long-term conditioning, maintaining metabolic stability and ensuring treatment safety. 4. Sedative, anti-anxiety, and improvement of central nervous system function: Schisandra chinensis has a clear inhibitory effect on the central nervous system. Its active ingredients can regulate various neurotransmitters, such as increasing the level of γ-aminobutyric acid (GABA, an inhibitory neurotransmitter), thereby producing significant sedative, anti-anxiety, and sleep-improving effects.This is significant for alleviating patients' psychological stress caused by the disease, breaking the vicious cycle of "anxiety-decreased immunity," and improving treatment adherence and quality of life. 5. Potential to reverse multidrug resistance: Recent studies have revealed that components such as schisandrin B show the potential to reverse multidrug resistance in tumor chemotherapy. The mechanism may involve inhibiting the function of drug efflux pump proteins (such as P-glycoproteins) on tumor cell membranes, thereby increasing intracellular drug concentrations. Although this property is not directly applied in HPV infection treatment, its principle of regulating cell membrane transport proteins and enhancing the efficacy of "drugs" at target sites suggests that it may help improve the body's response efficiency to internal immune factors or therapeutic components, enhancing the "efficacy" of clearing the virus.

[0045] Licorice: Properties and Channels Entered: Sweet and neutral in nature; enters the heart, lung, spleen, and stomach channels. Traditional functions: tonifies the spleen and replenishes qi, clears heat and detoxifies, eliminates phlegm and stops cough, relieves spasms and pain, and harmonizes various medicines. It directly combats the pathogenic factor of "dampness and toxin" by clearing heat and detoxifying, and optimizes the compatibility of the whole prescription by harmonizing the properties of various medicines. At the same time, it creates a microenvironment unfavorable to viral replication through its extensive modern pharmacological effects. Detailed explanation of modern pharmacological research: (1) Adrenocortical hormone-like effects: Glycyrrhizin and glycyrrhetinic acid are structurally similar to adrenocortical hormones and can produce mineralocorticoid-like (such as sodium retention and potassium excretion) and glucocorticoid-like effects (such as anti-inflammatory and anti-allergic reactions). They can inhibit excessive inflammatory reactions, regulate immune disorders, and are suitable for immune imbalance caused by HPV infection. (2) Antiviral, anti-inflammatory, and immunomodulatory effects: Glycyrrhizin has inhibitory effects on various viruses, such as HIV, hepatitis viruses, and herpes simplex virus. Its glycyrrhizin can enhance the body's immune function. On the other hand, its glycyrrhizic acid, glycyrrhetinic acid, and other components can inhibit the synthesis and release of inflammatory mediators such as prostaglandins and leukotrienes, thereby reducing the inflammatory response of tissues. In HPV infection, this helps to reduce local inflammatory damage to the cervix and improve the pathological environment. Licorice has a bidirectional regulatory effect on the immune system. On the one hand, its glycyrrhizin can enhance the body's immune function; on the other hand, its glycyrrhizic acid components have an inhibitory effect on humoral immunity. This complex immunomodulatory ability is of positive significance for correcting the immune disorder caused by HPV infection. (3) Mucosal protection, anti-ulcer and antioxidant effects: Licorice extract forms a protective layer on the mucosa. Its active ingredients can also inhibit gastric acid secretion and directly adsorb gastric acid in the stomach. At the same time, it can promote the repair of gastric mucosal epithelial cells and release endogenous prostaglandins with protective effects. For patients who need to take medication for a long time, this effect helps maintain gastrointestinal function and ensure the smooth progress of treatment. Its flavonoid components can scavenge free radicals, reduce oxidative damage, protect cell membrane structure, and help reduce oxidative stress damage related to HPV infection. (4) Harmonizing other drugs: As an adjuvant drug, it can moderate the bias or toxicity of other drugs in the prescription, reduce incompatibilities, improve the safety and synergy of the whole prescription, and ensure the feasibility of long-term medication.

[0046] Synergistic Effects of the Seven Herbs: Atractylodes macrocephala, Gardenia jasminoides, Dendrobium nobile, Schisandra chinensis, prepared licorice root, Pseudostellaria heterophylla, and Ophiopogon japonicus serve as guiding herbs, bearing the crucial mission of "harmonizing the properties of the other herbs, protecting the body's vital energy and yin fluids, guiding the medicinal power, and consolidating the therapeutic effect," ensuring a smooth, well-tolerated, and long-lasting treatment process. Among them, Atractylodes macrocephala and prepared licorice root work together to invigorate the spleen and replenish qi, harmonizing the effects of the other herbs. Prepared licorice root is particularly crucial, as it can moderate the cold and heat-clearing properties of the herbs in the formula, reducing potential irritation to the gastrointestinal tract and ensuring long-term patient tolerance. Gardenia jasminoides clears heat and dampness, drains fire and relieves irritability, guiding damp-heat in the triple burner downwards and promoting the expulsion of pathogenic factors; its fire-clearing effect also helps alleviate the patient's irritability caused by the illness. Dendrobium nobile, Ophiopogon japonicus, and Pseudostellaria heterophylla work synergistically, focusing on "nourishing yin and replenishing qi." When the main therapeutic effects of the principal, assistant, and adjuvant herbs are clearing heat, removing dampness, and promoting blood circulation, these three herbs can benefit the stomach and generate fluids, replenish qi and nourish yin, effectively preventing the depletion of qi and yin during treatment and maintaining the body's normal metabolic and repair functions. This is crucial for HPV infections requiring long-term treatment. Schisandra chinensis has astringent and consolidating properties, calming the mind and soothing the nerves. It can protect the body's vital energy and fluids from dissipation, and its sedative effect can also improve the patient's sleep and mood, indirectly contributing to the stability of immune function. The combined use of these herbs ensures a balanced approach to both warming and cooling properties, as well as a balanced approach to attacking and tonifying. This enhances the targeted effectiveness of the treatment for HPV while maximizing the protection of the body's vital energy and reducing potential discomfort from treatment. It provides an important guarantee for achieving the long-term treatment goal of clearing the virus and preventing recurrence.

[0047] A Deep Analysis of the Synergistic Anti-HPV Mechanism of Multiple Drugs: The essence of this invention lies in the synergistic effect produced by its rigorous formulation, far exceeding the simple sum of the effects of single drugs. 1. Deep Synergistic Mechanism of Direct Antiviral and Immunomodulatory Action (Prime Minister Synergistic Effect): The principal drug group (such as Astragalus membranaceus, Ganoderma lucidum, Trametes versicolor, Codonopsis pilosula, etc.) systematically enhances the body's immune function through multiple pathways. For example, Astragalus membranaceus and Codonopsis pilosula can significantly promote lymphocyte proliferation and increase serum immunoglobulin levels; Ganoderma lucidum and Trametes versicolor polysaccharides can deeply activate the activity of macrophages and natural killer cells (NK cells), jointly building a solid foundation for the body's immune defense and surveillance. At the same time, the assistant drug group (Hedyotis diffusa, Taraxacum mongolicum, Isatis indigotica, etc.) acts as a tactical assault team, exerting direct antiviral and anti-inflammatory effects at the site of infection (such as the cervical mucosa). Modern research shows that such drugs can inhibit the expression of viral replication-related proteins and reduce tissue inflammatory responses. The solid "overall immune foundation" built by the principal drug and the precise "local pathogen clearance" implemented by the assistant drugs combine to form a three-dimensional offensive of "strengthening the root internally and clearing the disease site externally." Synergistic effect: This synergy is particularly crucial for clearing integrated high-risk HPV infection. It achieves a dual attack of "immune system recognition" and "local drug inhibition": on the one hand, it mobilizes the immune system to clear abnormal cells infected by the virus, and on the other hand, it directly inhibits viral activity, thereby effectively blocking its pathological process of developing into precancerous lesions (CIN). The adjuvant drugs (such as Danshen to invigorate blood and improve microcirculation, Shengdihuang to cool blood and nourish yin to prevent damage, and Fuling to strengthen the spleen to eliminate dampness source) prevent and treat concurrent symptoms in this process, creating conditions for tissue repair. The guiding drugs (such as Zhigancao and Baizhu to strengthen the spleen and harmonize, and Wuweizi and Shihu to consolidate yin and calm the mind) ensure that this powerful offensive does not deplete the body's vital energy and maintains the therapeutic balance. 2. The dynamic balance mechanism of "strengthening the body's resistance" and "eliminating pathogens" (synergistic effect of the whole formula): The core of the whole formula strategy lies in the precise balance and dynamic coordination of "strengthening the body's resistance" and "eliminating pathogens". This formula employs a powerful "strengthening the body's resistance and consolidating its foundation" system, comprised of Astragalus membranaceus, Codonopsis pilosula, Ganoderma lucidum, Trametes versicolor, Pseudostellaria heterophylla, Atractylodes macrocephala, and prepared licorice root, dedicated to enhancing the body's own disease resistance and repair capabilities. Simultaneously, a robust "detoxifying and eliminating pathogenic factors" system, composed of Smilax glabra, Hedyotis diffusa, Taraxacum mongolicum, Isatis indigotica, Gardenia jasminoides, and Coix lacryma-jobi, directly targets damp-heat toxins. This is not a simple parallel approach, but rather a precise adjustment through the use of adjuvant herbs (such as Ophiopogon japonicus and Dendrobium nobile for nourishing Yin, Gardenia jasminoides for guiding damp-heat downwards, and prepared licorice root for harmonization), preventing the pathogenic factors from being too cold and damaging the spleen and stomach's Yang Qi, and also restraining the potential stagnation caused by tonifying herbs. This ensures that the entire formula achieves a highly efficient and safe dynamic balance between "attacking" and "tonifying." 3. Multi-target intervention mechanism of viral life cycle and pathological microenvironment (modern pharmacological synergy): The modern scientific connotation of this formula lies in its multi-component and multi-target characteristics, which can synergistically intervene in HPV infection from multiple links: (1) Regulate the immune microenvironment and indirectly inhibit the virus: The polysaccharides and saponins in the principal drug and the adjuvant drug can significantly improve the systemic and local immune status, making the body unfavorable for long-term viral latency and replication.(2) Directly inhibiting viruses and anti-inflammation: Flavonoids and organic acids in the assistant herbs and some adjuvant herbs (such as Isatis root) have been proven to have broad-spectrum antiviral activity and can reduce local chronic inflammation caused by viruses by inhibiting inflammatory pathways such as NF-κB. This inflammation is a key factor in promoting viral persistence and disease progression. (3) Blocking abnormal proliferation and inducing healthy repair: The adjuvant herb Salvia miltiorrhiza improves circulation, Rehmannia glutinosa provides repair raw materials, and together with the principal herb Morus alba, it helps to repair damaged mucosa. The whole formula creates conditions for tissue health reconstruction through multiple pathways such as inhibiting abnormal cell proliferation signals and resisting oxidative stress. (4) This multi-target, three-dimensional intervention mode makes it difficult for viruses to escape through a single pathway, effectively reducing the risk of drug resistance and demonstrating the unique advantages of traditional Chinese medicine compound treatment for complex diseases. In summary, the traditional Chinese medicine composition of this invention has successfully constructed a comprehensive treatment system integrating immune regulation, direct antiviral, improvement of local microenvironment, and repair of tissue damage through the rational combination of principal, assistant, adjuvant, and guide herbs. It not only aims to directly eliminate the HPV virus, but more importantly, it alters the "organism's environment" on which the virus thrives through systemic regulation, restoring a healthy homeostasis where "when the body's vital energy is abundant, pathogens cannot invade." This is the underlying scientific logic and core advantage that enables this formula to achieve a high rate of negative conversion, improve patient symptoms, and reduce recurrence rates.

[0048] The traditional Chinese medicine composition of this invention is based on the principle of "differentiation of syndromes and treatment". It focuses on different treatment strategies under the general principle of "strengthening the body's resistance and eliminating pathogens" for different types of HPV subtype infection, targeting the location (skin / mucous membrane) and risk level (low risk / high risk). Through the synergy of principal, assistant and adjuvant drugs, it achieves precise and differentiated intervention (as shown in Table 1).

[0049] Table 1: Differences in the mechanisms of action of the traditional Chinese medicine composition of the present invention against different HPV subtypes

[0050] In some embodiments, the traditional Chinese medicine preparation of the present invention is a decoction. In some embodiments, the decoction is prepared by the following method: soaking the raw medicinal materials of the traditional Chinese medicine composition, adding water and decocting, then filtering to obtain the decoction. In some embodiments, the decoction is prepared by the following method: soaking the raw medicinal materials of the traditional Chinese medicine composition for 30-60 minutes, heating the soaked medicinal materials together with the soaking water, using high heat for the first decoction, and after boiling, reducing to low heat and maintaining a gentle simmer for 30-40 minutes, filtering with a strainer or gauze to obtain the first decoction; adding water again for the second decoction, first bringing to a boil over high heat, then reducing to low heat and simmering for about 20-30 minutes, filtering again to obtain the second decoction. Combining the first and second decoctions yields the final product.

[0051] The present invention also provides the use of the aforementioned traditional Chinese medicine composition or the aforementioned traditional Chinese medicine preparation in the preparation of preparations for inhibiting human papillomavirus infection, or in medicines for treating or preventing diseases caused by human papillomavirus infection.

[0052] In some implementations, diseases caused by human papillomavirus (HPV) infection include, but are not limited to: diseases caused by cutaneous HPV infections, such as common warts, flat warts, and plantar warts; diseases caused by mucosal HPV infections in the anogenital region, including: benign proliferative diseases, such as condyloma acuminata (genital warts); precancerous lesions, such as cervical intraepithelial neoplasia (CIN), vaginal intraepithelial neoplasia (VIN), vulvar intraepithelial neoplasia (VIN), anal intraepithelial neoplasia (AIN), and penile intraepithelial neoplasia (PeIN); malignant tumors, such as cervical cancer, vaginal cancer, vulvar cancer, anal cancer, and penile cancer. Diseases caused by other mucosal HPV infections, such as oropharyngeal cancer, oral cancer (e.g., oral squamous cell carcinoma), and laryngeal papillomatosis.

[0053] In some implementations, the human papillomavirus is selected from at least one of low-risk cutaneous human papillomavirus, high-risk cutaneous human papillomavirus, low-risk mucosal human papillomavirus, and high-risk mucosal human papillomavirus.

[0054] In some embodiments, the low-risk human papillomavirus for cutaneous use is selected from at least one of HPV3, HPV5, HPV7, HPV10, HPV43, HPV44, and HPV61.

[0055] In some implementations, the high-risk human papillomavirus for skin is selected from at least one of HPV16, HPV18, and HPV35.

[0056] In some implementations, the mucosal low-risk human papillomavirus is selected from at least one of HPV6, HPV11, and HPV42.

[0057] In some embodiments, the mucosal high-risk human papillomavirus is selected from at least one of the following: high-risk HPV types, including HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, and HPV59; and possibly high-risk HPV types, including HPV53, HPV66, HPV68, and HPV73.

[0058] In some implementations, the human papillomavirus infection is selected from at least one of human papillomavirus simple infection, human papillomavirus infection with lesions, and human papillomavirus mixed infection.

[0059] In some implementations, the traditional Chinese medicine composition or preparation can accelerate the reduction of human papillomavirus (HPV) load, improve cervical squamous epithelial lesions, enhance the body's immunity, improve menstrual irregularities, prevent the formation of HPV-related warts, or improve cervical-related abnormal symptoms.

[0060] In some implementations, the cervical-related abnormal symptoms are selected from at least one of abnormal vaginal discharge, abnormal leukorrhea, and cervical injury.

[0061] In some implementations, the cervical-related abnormal symptoms are selected from at least one of lower abdominal discomfort, vaginal dryness, or vulvar discomfort.

[0062] The present invention also provides a method for inhibiting human papillomavirus infection, or for treating or preventing diseases caused by human papillomavirus infection, comprising administering the aforementioned traditional Chinese medicine composition or preparation to a subject.

[0063] In some implementation schemes, the aforementioned traditional Chinese medicine composition or preparation is prepared as a single dose, with each dose containing 25-35g of Codonopsis pilosula, 10-20g of Atractylodes macrocephala, 35-45g of Astragalus membranaceus, 10-20g of Pseudostellaria heterophylla, 10-20g of Ophiopogon japonicus, 15-25g of Rehmannia glutinosa, 25-35g of Trametes versicolor, 25-35g of Ganoderma lucidum, 35-45g of Smilax glabra, 20-30g of Hedyotis diffusa, 20-30g of Taraxacum mongolicum, 25-35g of Morus alba, 20-30g of Coix lacryma-jobi, 10-20g of Gardenia jasminoides, 15-25g of Salvia miltiorrhiza, 25-35g of Portulaca oleracea, and 15-25g of Poria cocos. The formula consists of: 13-23g of Isatis root, 10-20g of Dendrobium, 10-20g of Schisandra fruit, 10-20g of Glycyrrhiza root, and 20-30g of Dioscorea hypoglauca; preferably, 30g of Codonopsis pilosula, 15g of Atractylodes macrocephala, 40g of Astragalus membranaceus, 15g of Pseudostellaria heterophylla, 15g of Ophiopogon japonicus, 20g of Rehmannia glutinosa, 30g of Ganoderma lucidum, 30g of Ganoderma lucidum, 40g of Smilax glabra, 25g of Hedyotis diffusa, 25g of Taraxacum mongolicum, 30g of Morus alba, 25g of Coix lacryma-jobi, 15g of Gardenia jasminoides, 20g of Salvia miltiorrhiza, 30g of Portulaca oleracea, 20g of Poria cocos, 18g of Isatis root, 15g of Dendrobium, 15g of Schisandra fruit, 15g of Glycyrrhiza root, and 25g of Dioscorea hypoglauca.

[0064] In some implementation schemes, one dose of medicine is divided into two portions and taken twice a day; one dose is taken daily, and 40 to 80 doses constitute one course of treatment.

[0065] This invention has the following advantages: 1. Multi-target overall regulation: The herbal composition of this invention achieves synergistic treatment through multiple components, including antiviral, immune regulation, anti-inflammatory, and antioxidant effects, resulting in comprehensive efficacy. 2. Broad spectrum coverage of multiple HPV types: It has significant efficacy against low-risk, high-risk, low-risk, and high-risk HPV infections of the skin, mucous membranes, and mucous membranes, with a high rate of negative conversion. 3. Definite efficacy and clear treatment course: Most patients achieve negative conversion after 1-2 courses of treatment (40-80 doses), with rapid onset and a clear cycle. 4. Significant symptom improvement: It not only clears HPV viruses but also significantly improves clinical symptoms such as leukorrhea, itching, cervical erosion, lower abdominal discomfort, and mucosal damage, while simultaneously reversing LSIL / HSIL cervical lesions and improving quality of life. 5. Prevention of cancer: By clearing persistent high-risk HPV infection, it fundamentally prevents the occurrence of precancerous lesions and cervical cancer.

[0066] Beneficial effects: 1. Advantages of multi-target, multi-pathway, and holistic regulation: Traditional Chinese medicine emphasizes a holistic approach, using the principle of supporting the body's resistance and eliminating pathogens to enhance the body's immune function while directly inhibiting viral replication and killing viruses. This treatment philosophy of "supporting the body's resistance without leaving pathogens and eliminating pathogens without harming the body's resistance" aligns with the basic pathogenesis of HPV infection: "deficiency of the body's resistance and lingering pathogens."

[0067] 2. Advantages of "preventive treatment" and blocking disease progression: The "Essential Prescriptions of the Golden Chamber" states, "When you see a disease of the liver, you know that the liver will spread to the spleen, so you should first strengthen the spleen." Traditional Chinese medicine treatment for HPV infection focuses on "preventing disease progression." For patients who are already infected, by regulating their constitution and improving their immune function, the disease can be prevented from progressing to cervical intraepithelial neoplasia or even cervical cancer.

[0068] 3. Advantages of synergistic effects from compound formulation: This formula is based on the classic formula Sijunzi Decoction (Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, and Glycyrrhiza uralensis), which strengthens the spleen and replenishes qi, and protects the acquired constitution. It enhances the generation of qi and blood from the source, laying the foundation for improving the body's vital energy. On this basis, it closely addresses the core pathogenesis of HPV infection, namely "deficiency of vital energy and internal accumulation of damp-heat and toxins," and integrates multiple treatment methods such as replenishing qi and strengthening the body, clearing heat and detoxifying, eliminating dampness and turbidity, and nourishing yin and calming the mind, resulting in a precise compound formulation. The formula uses Astragalus membranaceus, Codonopsis pilosula, Ganoderma lucidum, and Trametes versicolor to greatly replenish vital energy and significantly enhance immune function, forming the main framework of "strengthening the body's resistance." Simultaneously, Smilax glabra is used as the chief ingredient, leading Portulaca oleracea, Hedyotis diffusa, and Taraxacum mongolicum as assistant ingredients to powerfully clear heat and toxins from the lower burner. Dioscorea hypoglauca is introduced to work synergistically with Coix lacryma-jobi to specifically target dampness and turbidity, eliminating tangible dampness and purifying the local microenvironment. Salvia miltiorrhiza is added to invigorate blood and remove blood stasis, while Rehmannia glutinosa and Ophiopogon japonicus nourish yin and generate fluids. Glycyrrhiza uralensis and other herbs harmonize the formula. Through the rigorous structure of "chief, assistant, adjuvant, and guide," the formula ensures that the warm and invigorating herbs are complemented by the warm and cold herbs that clear heat without generating heat, and that the bitter and cold herbs that clear heat are counteracted by the spleen-strengthening and qi-boosting herbs without harming the middle burner. This results in a unique formula that combines tonification and purgation, clearing and draining, and warm and cold properties. In this way, the combined effects of various drugs construct a multi-component, multi-target, and multi-pathway treatment network, which not only directly inhibits the virus and improves the local pathological environment, but also systematically regulates the body's immunity and homeostasis, ultimately achieving the overall therapeutic effect of "supporting the body's resistance without leaving pathogens and eliminating pathogens without harming the body's resistance", demonstrating the systemic advantages of traditional Chinese medicine compound treatment for HPV infection.

[0069] 4. Comprehensive Advantages of Treating Both Body and Mind, Enhancing Quality of Life: This invention's herbal compound follows the principle of "using both cold and warm herbs, combining attack and tonification," achieving bidirectional regulation of bodily functions while fighting the virus through the synergistic effect of multiple components. For example, the sweet and warm herbs such as Astragalus and Codonopsis in the formula can invigorate qi and strengthen the spleen, effectively improving common qi deficiency symptoms such as fatigue and lethargy in HPV-infected patients. Combined with sweet and cold herbs such as Hedyotis diffusa and Smilax glabra, which clear heat and detoxify, eliminate dampness and turbidity, and specifically alleviate symptoms of damp-heat accumulation such as abnormal vaginal discharge and vulvar itching. Clinical studies show that this compound preparation not only effectively kills the virus in the body and rapidly promotes HPV seroconversion, but also significantly improves the vaginal microenvironment, increases vaginal cleanliness, and restores local flora balance. More importantly, traditional Chinese medicine emphasizes holistic regulation and treating both body and mind. By harmonizing qi and blood and balancing yin and yang, it can significantly alleviate anxiety and depression caused by the disease, thereby comprehensively improving the patient's quality of life while clearing the virus. This formula is highly safe and has few toxic side effects, embodying the treatment philosophy of "eliminating pathogens without harming the body's vital energy".

[0070] 5. Advantages of Long-Lasting Effect and Reduced Recurrence Rate: Traditional Chinese medicine (TCM) treatment not only focuses on the immediate elimination of the virus but also emphasizes establishing long-term stable immune memory by regulating the body's immune function. By supporting the body's vital energy (Qi), it enables the body to maintain a strong ability to clear the virus, thus producing a lasting therapeutic effect and significantly reducing the risk of recurrence after HPV infection is cured. Clinical observations show that patients who achieve negative results after TCM treatment have better long-term stability than those who undergo only physical therapy.

[0071] In summary, the traditional Chinese medicine composition provided by this invention is based on the aforementioned core advantages of traditional Chinese medicine in treating HPV infection. Through scientific formulation, it aims to provide an ideal treatment option for clinical practice that is comprehensive in efficacy, long-lasting in effect, and highly safe. Detailed Implementation

[0072] Before further describing specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terminology used in the embodiments of the present invention is for describing specific embodiments and not for limiting the scope of protection of the present invention.

[0073] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the present invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art. In addition to the specific methods, apparatus, and materials used in the embodiments, based on the knowledge of the prior art possessed by one of ordinary skill in the art and the description of this invention, any prior art methods, apparatus, and materials similar to or equivalent to those described, apparatus, and materials in the embodiments of this invention may be used to implement the present invention.

[0074] Unless otherwise stated, the experimental methods, detection methods, and preparation methods not described in detail in this invention all adopt conventional techniques in this technical field.

[0075] Original recipe: Codonopsis pilosula 30 parts, Atractylodes macrocephala 15 parts, Astragalus membranaceus 40 parts, Pseudostellaria heterophylla 15 parts, Ophiopogon japonicus 15 parts, Rehmannia glutinosa 20 parts, Ganoderma lucidum 30 parts, Ganoderma lucidum 30 parts, Smilax glabra 40 parts, Hedyotis diffusa 25 parts, Taraxacum mongolicum 25 parts, Morus alba 30 parts, Coix lacryma-jobi 25 parts, Gardenia jasminoides 15 parts, Salvia miltiorrhiza 20 parts, Nelumbo nucifera receptacle 25 parts, Poria cocos 20 parts, Isatis indigotica 18 parts, Dendrobium nobile 15 parts, Schisandra chinensis 15 parts, Glycyrrhiza uralensis (processed) 15 parts.

[0076] New formula includes: Codonopsis pilosula 30 parts, Atractylodes macrocephala 15 parts, Astragalus membranaceus 40 parts, Pseudostellaria heterophylla 15 parts, Ophiopogon japonicus 15 parts, Rehmannia glutinosa 20 parts, Ganoderma lucidum 30 parts, Ganoderma lucidum 30 parts, Smilax glabra 40 parts, Hedyotis diffusa 25 parts, Taraxacum mongolicum 25 parts, Morus alba 30 parts, Coix lacryma-jobi 25 parts, Gardenia jasminoides 15 parts, Salvia miltiorrhiza 20 parts, Portulaca oleracea 30 parts, Poria cocos 20 parts, Isatis indigotica 18 parts, Dendrobium nobile 15 parts, Schisandra chinensis 15 parts, Glycyrrhiza uralensis (processed) 15 parts, Dioscorea hypoglauca 25 parts.

[0077] All of the above components are raw medicinal materials.

[0078] The preparation of this decoction follows the conventional decoction method of traditional Chinese medicine. The specific steps are as follows: I. Preparation and Processing of Medicinal Materials 1. Verification and Weighing: Accurately weigh each herb according to the prescription (Chief herbs: Astragalus membranaceus 40g, Codonopsis pilosula 30g, Smilax glabra 40g, Ganoderma lucidum 30g, Trametes versicolor 30g, Morus alba 30g; Assistant herbs: Portulaca oleracea 30g, Hedyotis diffusa 25g, Coix lacryma-jobi 25g, Taraxacum mongolicum 25g, Dioscorea hypoglauca 25g; Adjuvant herbs: Salvia miltiorrhiza 20g, Rehmannia glutinosa 20g, Poria cocos 20g, Isatis indigotica 18g; Guiding herbs: Pseudostellaria heterophylla 15g, Ophiopogon japonicus 15g, Atractylodes macrocephala 15g, Gardenia jasminoides 15g, Dendrobium nobile 15g, Schisandra chinensis 15g, Glycyrrhiza uralensis 15g).

[0079] 2. Soaking: Place the weighed medicinal materials in a clay pot or stainless steel decoction pot, add an appropriate amount of cold water (the water level should be enough to completely submerge the medicinal materials and be about 3-5 cm above the surface of the materials), and soak for 30-60 minutes. This step allows the medicinal materials to fully absorb water and swell, which is conducive to the extraction of active ingredients.

[0080] II. First Decoction

[0081] 1. Boil over high heat: Heat the soaked herbs and soaking water together. First, bring to a rapid boil over high heat.

[0082] 2. Simmer over low heat: After the liquid boils, reduce to a simmer and continue simmering for 30-40 minutes.

[0083] 3. Filter the decoction: After the decoction is finished, filter it with a strainer or gauze to extract the first decoction, and pour it into a clean container for later use.

[0084] Third and second decoctions

[0085] 1. Add water again: Add cold water to the dregs again. The amount of water can be slightly less than that of the first decoction (generally, it is advisable to submerge the dregs).

[0086] 2. Repeat the simmering process: First bring to a boil over high heat, then simmer over low heat for about 20-30 minutes.

[0087] 3. Filter the decoction: After the decoction is completed, filter it again to obtain the second decoction.

[0088] IV. Combination and Administration

[0089] 1. Combine the decoctions: Combine the decoctions obtained from the first and second decoctions and stir well.

[0090] 2. Divide the combined liquid into two equal portions and take each portion warm twice a day, morning and evening. This is one day's dose (one dose).

[0091] Summary of preparation points: This formula is for one dose per day, and the conventional method is "two-stage decoction". Through thorough soaking, controlling the heat by first strong and then gentle, and decoction twice, the aim is to extract the water-soluble active ingredients from the medicinal materials to the maximum extent, ensuring the stability and full exertion of the efficacy.

[0092] Example

[0093] Clinical Case Comparison Report: Observation on the Advantages of a New Formula (containing Purslane and Dioscorea hypoglauca) in Improving the Treatment Efficiency of HPV Infection

[0094] The following are clinical cases selected from a traditional Chinese medicine clinic. Through a "self-comparison before and after" approach, the effectiveness of the original prescription was confirmed, and the significantly enhanced effects of the optimized new prescription (hereinafter referred to as "the new prescription," which replaces lotus seedpod with purslane and adds Dioscorea hypoglauca) in accelerating virus clearance, reversing cervical lesions, and improving clinical symptoms were further demonstrated, thereby shortening the overall treatment cycle. All treatments followed standard clinical practice.

[0095] Case 1: High-risk infection, new treatment significantly accelerates the decline in viral load.

[0096] Patient: Ms. Chen, 38 years old, duration of infection: unknown; HPV52 positive, initial viral load (HC2 method) was 620 RLU / CO. Accompanied by mild leukorrhea, duration of illness unknown.

[0097] Treatment comparison: Phase 1 (Original Treatment): One course of treatment (40 doses) with the original decoction. Follow-up examination showed that the viral load dropped to 320 RLU / CO, a decrease of approximately 48%. Symptom improvement was not significant.

[0098] Phase Two (New Formula Treatment): Given that the viral clearance rate was not as fast as expected, a new formula was used to continue treatment in order to accelerate the process. After one course of treatment (40 doses), a follow-up examination showed that the viral load had rapidly decreased to 28 RLU / CO, a reduction of 91%. Treatment continued until the 70th dose, at which point a follow-up examination showed that HPV52 had turned negative.

[0099] Cycle analysis: From the start of treatment to complete seroconversion, the patient took approximately 1.75 treatment cycles (70 doses). If the original formula was used throughout, based on the rate of decrease in the first cycle (an average daily decrease of approximately 10 RLU / CO), it was estimated that ≥4 treatment cycles would be required to achieve seroconversion (<1 RLU / CO). The new formula shortens the expected treatment cycle by approximately 55%.

[0100] Mechanism Correlation: The heat-clearing, detoxifying, and blood-cooling effects of purslane in the new formula, synergistically with Hedyotis diffusa and Isatis indigotica, may significantly enhance the direct inhibitory effect on the virus; simultaneously, the dampness-clearing and turbidity-removing effects of Dioscorea hypoglauca, synergistically with Coix lacryma-jobi, rapidly optimize the microenvironment of the lower abdomen. The combined effect of these two factors leads to an exponential decline in viral load, breaking through the linear clearance pattern of the original formula.

[0101] Case 2: High-risk infection with high-grade lesions; new formula rapidly reverses the progression of cervical lesions.

[0102] Patient: Ms. Huang, 38 years old, with an infection duration of over 4 years; persistently positive for HPV16, pathologically diagnosed as HSIL (high-grade squamous intraepithelial lesion), accompanied by left lower abdominal pain, menstrual irregularities, anxiety, and insomnia; duration of illness unknown. Previously treated with other medications at another hospital for nearly 3 years without improvement.

[0103] Treatment comparison: Phase 1 (Original Treatment): 0.5 courses (20 doses) of the original decoction were administered. Follow-up examination showed no disease progression, abdominal pain was slightly relieved, and viral load was stable, but high-grade lesions were not reversed, and other symptoms showed limited improvement.

[0104] Phase Two (New Treatment): To rapidly reverse the lesions and reduce risks, a new treatment regimen was introduced. After 1.5 courses of treatment (60 doses), a follow-up examination showed that the cervical pathology had reversed from HSIL (high-grade) to LSIL (low-grade), and the viral load had significantly decreased. Abdominal pain, menstrual cycles, and sleep patterns all showed significant improvement.

[0105] Cycle analysis: The new formula achieved reversal of high-grade lesions within 1.5 treatment cycles. In contrast, the original formula typically required a longer reversal time for high-grade lesions. The new formula demonstrated a faster response in the key step of blocking the progression of precancerous lesions.

[0106] Mechanism connection: The tonifying and strengthening effects of the principal herbs in the new formula (Astragalus membranaceus, Ganoderma lucidum, etc.) enhance the body's ability to repair abnormal cells; the blood-cooling and detoxifying effects of Portulaca oleracea and the diuretic effects of Dioscorea hypoglauca in the assistant herbs may synergistically reduce the inflammatory damage and edema of local tissues, creating a better internal environment for the reversal and healing of the diseased epithelium.

[0107] Case 3: High-risk infection with low-grade lesions; the new formula significantly accelerated negative conversion and damage repair.

[0108] Patient: Ms. Zhao, 49 years old, with an infection duration of 3 years; HPV18 positive, biopsy confirmed chronic cervicitis with LSIL (low-grade squamous intraepithelial lesion), the course of the disease lasted for 3 years, accompanied by easy damage to the vaginal mucosa and gynecological discomfort, and the previous interventions at other hospitals had little effect.

[0109] Treatment comparison: Phase 1 (Original Treatment): One course of treatment (40 doses) of the original decoction was administered. Follow-up examination showed a slight decrease in HPV18 viral load and a slight relief in symptoms of easy breakage of the genital mucosa, but LSIL was not reversed and HPV remained positive.

[0110] Phase Two (New Formula Treatment): Continue treatment with the new formula for two more courses (80 doses). Follow-up examinations showed that HPV18 was negative, all 25 HPV types were negative, cervical inflammation was repaired, LSIL was reversed, and symptoms such as easily damaged vaginal mucosa and gynecological discomfort were significantly improved.

[0111] Cycle analysis: The patient's total treatment cycle was 3 courses. If the original formula were used, based on the effect of the first course of treatment, achieving negative conversion and lesion reversal was expected to take longer. The new formula significantly accelerated the entire process from viral suppression to tissue repair.

[0112] Mechanism linkage: While clearing the virus (purslane, oldenlandia diffusa, etc.), the new formula's "dampness-removing and turbidity-eliminating" effect of Dioscorea hypoglauca and "spleen-strengthening and dampness-draining" effect of Poria cocos work together to more effectively remove the pathological factors that cause "dampness and turbidity" leukorrhea and hinder mucosal repair, thus achieving simultaneous acceleration of "virus clearance" and "mucosal repair".

[0113] Case 4: Multi-type mixed infection with lesions, new formula for potent simultaneous reversal and clearance.

[0114] Patient: Ms. Zhang, 46 years old, with an infection duration of 5 years; mixed infection of HPV 18, 59, 66, and 44, accompanied by low-grade squamous intraepithelial lesion of the cervix (LSIL / CIN1), and long-term gynecological discomfort and emotional anxiety. Duration of illness is unknown.

[0115] Treatment comparison: Phase 1 (Original Treatment): One course of treatment with the original prescription (40 doses). Follow-up examination showed slow improvement in lesions and limited decrease in viral load of multiple types.

[0116] Phase Two (New Formula Treatment): One course of treatment (40 doses) with the new formula was administered. Follow-up examinations showed that all high-risk HPV types 18 / 59 / 66 were cleared, cervical LSIL was completely reversed, and the pathological results showed chronic cervicitis with no residual intraepithelial lesions; gynecological discomfort symptoms were completely relieved.

[0117] Cycle analysis: The new formula achieved negative conversion of multiple high-risk viral types and reversal of lesions in just one course of treatment, demonstrating a powerful ability to simultaneously target these pathogens. The original formula was relatively less efficient in treating multiple types of infections.

[0118] Mechanism linkage: In the face of multiple types of infection, the new formula strengthens the two major pathogen-eliminating pathways of "clearing heat and detoxifying" (purslane, etc.) and "eliminating dampness and removing turbidity" (Dioscorea hypoglauca, etc.), which may expand the common targets of action on different HPV subtypes (such as inflammatory microenvironment and immunosuppression), thereby achieving a highly efficient and broad-spectrum clearance effect.

[0119] Case 5: High-risk persistent infection, rapid negative conversion achieved in Singapore.

[0120] Patient: Ms. Yang, 40 years old, duration of infection unknown; HPV51 positive, with gynecological discomfort. Duration of illness unknown.

[0121] Treatment comparison: Phase 1 (Original Treatment): One course of treatment with the original prescription (40 doses). Viral replication was suppressed, and symptoms were slightly relieved, but the virus did not test negative.

[0122] Phase Two (New Formula Treatment): The new formula was used for 1.5 courses of treatment (60 doses). Follow-up HPV tests showed HPV51 was negative, and all HPV genotypes were negative, indicating the virus was completely eliminated. Accompanying gynecological discomfort symptoms also completely disappeared. The patient reported feeling "so happy!" and highly praised the negative conversion effect, with the treatment experience far exceeding expectations.

[0123] Cycle analysis: The new formula achieved negative conversion within 1.5 treatment courses. Compared with the original formula's effect in the first course of treatment, it shortened the time to reach the endpoint of cure.

[0124] Mechanism correlation: For persistent infection, the addition of purslane and dioscorea hypoglauca to the new formula, on the basis of supporting the body's resistance, may more effectively break the immune escape and local immune tolerance of the virus, and reactivate the immune clearance against the virus.

[0125] Case 6: High-risk infection complicated by herpesvirus; new formula effectively enhances overall antiviral capabilities.

[0126] Patient: Juanzi, 39 years old, infected for 4 years; HPV52 positive, with a history of genital herpes, weakened immunity, accompanied by symptoms such as yellow vaginal discharge, decreased vaginal lactobacilli, fatigue, and insomnia. Duration of illness is unknown. She initially tried self-medicating with probiotics, selenium tablets, and gynecological gels, but with poor results; the virus remained positive and difficult to clear.

[0127] Treatment comparison: Phase 1 (Original Treatment): One course of treatment with the original formula (40 doses). Symptoms of yellow vaginal discharge were somewhat relieved, sleep quality improved slightly, fatigue was reduced, and the number of vaginal lactobacilli increased slightly, but HPV did not turn negative.

[0128] Phase Two (New Formula Treatment): The new formula was used for 1.25 courses of treatment (50 doses). Follow-up HPV52 tests showed negative results, vaginal discharge returned to normal, sleep quality significantly improved, fatigue completely disappeared, vaginal flora returned to balance, and overall immunity was greatly enhanced. The patient reported feeling relieved and highly satisfied with the negative result.

[0129] Cycle analysis: In complex situations involving co-infection with other viruses and low immunity, the new formula can still achieve HPV seroconversion in a relatively short period of time and comprehensively improve the overall condition, demonstrating a stronger comprehensive regulatory ability.

[0130] Mechanism linkage: The combination of the new formula's tonifying drugs (Astragalus membranaceus, Ganoderma lucidum, mulberry, etc.) with heat-clearing and dampness-eliminating drugs (purslane, Dioscorea hypoglauca, etc.) may produce a synergistic effect of "strengthening the body's resistance to enhance immunity and eliminating pathogens to clear the environment". It not only targets HPV, but also improves the overall immune disorder and damp-heat constitution, thus coping with the complex situation of dual infection.

[0131] Case 7: Multiple high-risk mixed infections, new formula effectively clears the virus in layers.

[0132] Patient: Ms. Qian, 45 years old, infected for 6 years; mixed infection of multiple high-risk HPV types 18, 39, and 59. The patient reported that the infection had lasted for many years and the condition was quite stubborn, accompanied by itching and yellow vaginal discharge.

[0133] Treatment comparison: Phase 1 (Original Treatment): One course of treatment with the original formula (40 doses). Symptoms were slightly relieved, and the viral load of some HPV subtypes decreased slightly, but did not turn negative.

[0134] Phase 2 (New Formula Treatment): After taking one course of treatment (40 doses), the patient felt a significant reduction in discomfort symptoms such as vaginal itching; during a follow-up examination on January 13, 2026 (after taking a total of 60 doses of the new formula), HPV subtypes 18 and 39 had all turned negative, the viral load of HPV type 59 had decreased significantly, and the symptoms had been significantly relieved.

[0135] Cycle analysis: The new formula cleared two high-risk HPV types within 1.5 treatment cycles, demonstrating a faster stratified clearance rate for stubborn mixed infections.

[0136] Mechanism linkage: The enhanced heat-clearing and detoxifying power of the new formula may have a more direct inhibitory effect on some subtypes (such as 18 and 39); at the same time, the regulation of the overall immune system and the improvement of the microenvironment create conditions for the body to gradually clear different viruses, reflecting the "easy first, difficult later" clearance strategy.

[0137] Case 8: High-risk mixed infection; new treatment accelerates virus clearance and symptom relief.

[0138] Patient: Ms. Lin, 42 years old, infected for 2 years; HPV16,53 positive, accompanied by excessive vaginal discharge and lower abdominal pain, with the course of the disease lasting for 2 years.

[0139] Treatment comparison: Phase 1 (Original Treatment): One course of treatment (40 doses) with the original prescription was administered. Vaginal discharge decreased slightly, abdominal pain did not improve significantly, and the virus test was positive.

[0140] Phase Two (New Formula Treatment): After completing one course of treatment (40 doses) with the new formula, a follow-up examination showed that the viral load rapidly decreased to 52 RLU / CO, a reduction of 89%. The patient continued treatment until the 65th dose, at which point a follow-up examination was conducted. HPV16 and 53 both became negative, vaginal discharge returned to normal, lower abdominal pain completely disappeared, and the patient reported complete relief of all symptoms.

[0141] Cycle analysis: The new formula achieved the goal of turning negative without the original formula in a similar number of treatment courses, and the treatment efficiency is higher.

[0142] Mechanism connection: Dioscorea hypoglauca's diuretic and turbidity-clearing effects specifically improve leukorrhea symptoms, while Portulaca oleracea's blood-cooling and detoxifying effects work synergistically with antiviral activity and may relieve local "heat and pain" in the pelvic cavity, thus achieving simultaneous acceleration of symptom improvement and virus clearance.

[0143] Case 9: High-risk mixed infection with cervical lesions, the new formula effectively reversed the lesions and resulted in a negative result.

[0144] Patient: Ms. Wu, 47 years old, duration of infection unknown; positive for HPV types 18 and 44, with LSIL, disease course 4 years, accompanied by lower abdominal distension and prolonged menstrual period.

[0145] Treatment comparison: Phase 1 (Original Treatment): One course of treatment (40 doses) with the original prescription. Symptoms were slightly relieved, but the lesions were not reversed, and the virus test was positive.

[0146] Phase Two (New Formula Treatment): Two courses of the new formula (80 doses) were administered. Follow-up HPV tests showed negative results, cervical LSIL was reversed, and symptoms such as lower abdominal distension and prolonged menstruation were completely relieved. The patient's physical and mental condition improved significantly.

[0147] Cycle analysis: The new formula simultaneously cleared the virus and reversed low-grade lesions within two treatment courses, showing high treatment efficiency for patients with a longer disease course.

[0148] Mechanism Correlation: For patients with a longer disease course and clear lesions, the distribution of the "strengthening the body's resistance and eliminating pathogenic factors" in this formula may be more optimized. In terms of eliminating pathogenic factors, it directly targets the core of the disease (clearing heat, promoting diuresis, and detoxifying); in terms of strengthening the body's resistance, it focuses on repair capabilities (tonifying qi and nourishing yin), thereby achieving effective reversal of chronic damage.

[0149] Case 10: High-risk mixed infection, new treatment achieves rapid negative conversion and symptom elimination.

[0150] Patient: Ms. Zheng, 39 years old, HPV16 and 39 positive, disease course lasted 1.5 years, accompanied by itching and yellow vaginal discharge.

[0151] Treatment comparison: Phase 1 (Original Treatment): One course of treatment (40 doses) with the original prescription was administered. Itching was slightly reduced, vaginal discharge did not improve, and the virus test was positive.

[0152] Phase Two (New Formula Treatment): The new formula was used for 1.5 courses of treatment (62 doses). Follow-up tests showed that HPV 16 and 39 were both negative, and the symptoms of vaginal itching and yellow discharge completely disappeared. The patient reported that the treatment effect far exceeded expectations.

[0153] Cycle analysis: The new formula achieved negative conversion of both high-risk types in 1.5 treatment courses, which once again verified its stability advantage in shortening the treatment cycle.

[0154] Mechanism Correlation: This case once again demonstrates the expertise of the new formula's herbal combination (purslane, dioscorea hypoglauca, etc.) in rapidly improving damp-heat symptoms (leukorrhea, itching), as well as the synergistic effect of the entire formula in enhancing the efficiency of immune clearance of viruses. The rapid control of symptoms and the rapid clearance of the virus form a virtuous cycle.

[0155] Case 11: High-risk infection, new treatment significantly accelerated the decline in viral load.

[0156] Patient: Ms. Chen, 38 years old, from Bozhou, Anhui Province, HPV52 positive, with a disease course of 3 years, initial viral load (HC2 method) of 620 RLU / CO, accompanied by mild leukorrhea.

[0157] Treatment comparison: Phase 1 (Original Treatment): One course of treatment (40 doses) with the original decoction. Follow-up examination showed that the viral load dropped to 320 RLU / CO, a decrease of approximately 48%. Symptom improvement was not significant.

[0158] Phase Two (New Formula Treatment): Given that the viral clearance rate was not as fast as expected, a new formula was used to continue treatment in order to accelerate the process. After one course of treatment (40 doses), a follow-up examination showed that the viral load had rapidly decreased to 28 RLU / CO, a reduction of 91%. A second course of treatment was continued until the 70th dose, at which point a follow-up examination showed that HPV52 had turned negative.

[0159] Cycle analysis: From the start of treatment to complete seroconversion, the patient required approximately two treatment courses (80 doses). If the original formula were used throughout, based on the rate of decline during the first course, it was estimated that ≥4 courses would be needed to achieve the same seroconversion goal. The new formula shortens the expected treatment cycle by approximately 50%.

[0160] Case 12: Persistent infection with high-risk HPV52, treated with a new, potent antiviral agent to reduce viral load and achieve negative results, with steady improvement.

[0161] Patient: Ms. Wang, from Weifang, Shandong, 38 years old, has a persistent high-risk HPV52 infection for 7 years, accompanied by increased vaginal discharge and a slight odor. She was initially treated with our original formula, but the virus decreased slowly, so we switched to the new formula for treatment.

[0162] Treatment Comparison

[0163] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain therapeutic effect: the odor of vaginal discharge was slightly reduced, and the overall physical condition was slightly improved. However, the follow-up examination showed that the HPV52 viral load was still as high as 506.72 copies / 10,000 cells, the positive status did not change significantly, and the overall progress to negative was slow.

[0164] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected viral clearance speed, our new formula was used for continued treatment. After one course of treatment (40 doses), a follow-up examination showed that the viral load had dropped to 228.69 copies / 10,000 cells, a significant decrease compared to the previous test. After continuing treatment until the 70th dose (1.75 courses), a follow-up examination showed that the HPV52 viral load had dropped to 70.48 copies / 10,000 cells, successfully turning negative. Vaginal discharge returned to normal, and the odor completely disappeared. The patient reported that the treatment effect far exceeded expectations.

[0165] Cycle Analysis

[0166] While our original formula had some effect after one course of treatment (40 doses), it was weak in clearing high-risk HPV52 and the rate of decline was slow, failing to quickly reduce viral load. The new formula is more targeted, can steadily reduce viral levels, and significantly accelerate the process of turning negative. It only takes 1.75 courses of treatment (70 doses) to achieve the leap from high viral load to complete negative conversion. The overall efficacy and speed of action are significantly better than the original formula, greatly shortening the treatment cycle.

[0167] Case 13: Persistent infection with high-risk HPV16 and cervical lesions; new treatment rapidly reverses the progression of high-grade lesions.

[0168] Patient: Ms. Huang, Wuzhou, Guangxi, 38 years old, persistently positive for HPV16, with a disease course of 6 years, accompanied by cervical squamous intraepithelial lesions, and symptoms such as left lower abdominal pain, menstrual irregularities, anxiety, and insomnia. She had previously undergone treatment with other medications at another hospital for nearly 3 years, but her condition continued to progress. She initially used our original prescription for treatment, which had some effect but progressed slowly, so she switched to a new prescription.

[0169] Treatment Comparison

[0170] Phase 1 (Original Treatment): First, we used our original decoction for 0.5 courses of treatment (20 doses). The original formula has a certain effect: it effectively slowed down the progression of cervical lesions and did not cause rapid deterioration. At the same time, it slightly relieved some symptoms of left lower abdominal pain and inhibited viral replication to a certain extent. However, the overall progress was still slow and the cervical lesions were not reversed. Symptoms such as menstrual abnormalities, anxiety and insomnia did not improve significantly. There is still a large gap between the current situation and the need to stop the deterioration of the lesions and achieve a better condition.

[0171] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected speed of lesion repair and symptom improvement, our new formula was used for continued treatment. After 1.5 courses of treatment (60 doses), a follow-up examination showed that the cervical lesion had reversed from HSIL (high-grade) to LSIL (low-grade), successfully reversing the progression of the high-grade lesion; the damaged cervical tissue was effectively repaired, and the viral activity was rapidly suppressed, laying a good foundation for a complete negative result in the future.

[0172] Symptom improvement: The left lower abdominal pain was significantly relieved, the menstrual cycle improved, and the patient reported that "I feel more relaxed now." Long-term anxiety was significantly relieved.

[0173] Cycle Analysis: Although our original prescription had some effect after 0.5 courses of treatment (20 doses), the speed of lesion reversal and symptom improvement was slow, and it was difficult to quickly block the risk of cancer. The new prescription, however, successfully reversed the lesion and quickly blocked the risk of cancer after only 1.5 courses of treatment (60 doses). Whether it was the reversal of cervical lesions, the suppression of the virus, or the improvement of systemic discomfort symptoms, the overall efficiency and efficacy were comprehensively superior to our original prescription.

[0174] Case 14: Persistent infection with high-risk HPV18 accompanied by low-grade cervical lesions; the new formula significantly accelerated the negative conversion and repaired cervical damage.

[0175] Patient: Ms. Zhao, from Changzhi, Shanxi Province, 49 years old, HPV18 high-risk positive, disease course lasting 3 years, biopsy confirmed chronic cervicitis with LSIL (low-grade squamous intraepithelial lesion), accompanied by easy damage to the vaginal mucosa and gynecological discomfort. In the early stage, the intervention of other hospitals had little effect; later, the original prescription of our medicine was used to regulate the condition, and the condition improved but progressed slowly, so the new prescription was used for treatment.

[0176] Treatment Comparison

[0177] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula has a certain therapeutic effect: the HPV18 viral load has decreased slightly, the symptoms of easy damage to the vaginal mucosa have been slightly relieved, and the cervical LSIL lesion has not worsened further. However, the overall progress is slow, the virus remains positive, the lesion has not been reversed, and there is still a large gap from the goal of turning negative.

[0178] Phase Two (New Formula Treatment): Given that the original formula did not achieve the expected speed of virus clearance and lesion repair, a new formula was used for continued treatment. After taking two courses of treatment (80 doses), viral activity was significantly suppressed; upon completion of the entire treatment and follow-up examination, HPV18 high-risk virus was completely cleared and all 25 HPV genotypes were negative; cervical lesions and inflammation were completely repaired, and symptoms of easy breakage of the vaginal mucosa and gynecological discomfort were significantly improved, with efficacy far exceeding that of the original formula.

[0179] Cycle Analysis

[0180] While the original treatment had some effect, the speed of virus clearance and lesion repair was relatively slow, making it difficult to quickly achieve the goal of turning negative. The new treatment significantly accelerated the treatment process, achieving complete negative conversion of high-risk viruses in just two courses of treatment (80 doses). At the same time, it effectively repaired cervical inflammation and improved accompanying symptoms. The overall efficacy and speed of effectiveness were significantly better than the original treatment, greatly shortening the treatment cycle.

[0181] Case 15: Persistent infection with high-risk HPV of multiple types accompanied by LSIL lesions; new formula effectively reverses lesions and accelerates viral clearance.

[0182] Patient: Ms. Zhang, Shenzhen, Guangdong, 46 years old, with persistent high-risk and low-risk HPV infection (types 18 / 59 / 66 / 44), accompanied by low-grade squamous intraepithelial lesions of the cervix (LSIL / CIN1), with a disease course of 5 years. She also experienced long-term gynecological discomfort and anxiety. Initially, she was treated with our original formula, but her condition improved slowly. After switching to a new formula, the efficacy was significantly improved.

[0183] Treatment Comparison

[0184] Phase 1 (Original Treatment): After taking our original prescription for one course of treatment (40 doses), the improvement of cervical LSIL lesions was slow, and the virus type remained positive. It only slightly relieved some gynecological discomfort symptoms. Overall, the effect was slow, and there was still a large gap between the lesion reversal and the virus turning negative.

[0185] Phase Two (New Formula Treatment): After switching to the new formula and continuing treatment for one course (40 doses), a follow-up examination will be conducted. The LSIL / CIN1 cervical lesions were completely reversed, and the pathological result changed to chronic cervicitis with no residual intraepithelial lesions. All high-risk HPV types 18 / 59 / 66 have become negative, and multi-type viral infections have been completely cleared. The gynecological discomfort symptoms were completely relieved, and the patient reported that the treatment effect far exceeded expectations, and her physical and mental state improved significantly.

[0186] Cycle Analysis

[0187] While the original formula had some effect, the speed of lesion reversal and virus clearance was relatively slow. The new formula significantly improved the treatment efficiency, achieving complete lesion reversal and full seroconversion of multiple virus types in just one course of treatment (40 doses). Whether it was lesion repair, virus clearance, or symptom improvement, the overall efficacy and speed of effectiveness were significantly better than the original formula, greatly shortening the cycle of seroconversion and lesion recovery.

[0188] Case 16: Persistent infection with high-risk HPV51; new formula effectively clears the virus, achieving rapid negative result.

[0189] Patient: Ms. Yang, Foshan, Guangdong, 40 years old, positive for high-risk HPV51, with a disease course of 4 years, accompanied by gynecological discomfort symptoms. In the early stage, she used our original prescription for conditioning, but the virus clearance progressed slowly. Later, she switched to the new prescription for treatment and successfully achieved rapid negative results.

[0190] Treatment Comparison

[0191] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula has a certain therapeutic effect: HPV51 virus replication is initially suppressed and gynecological discomfort symptoms are slightly relieved, but the overall virus clearance speed is relatively slow, the virus is still positive after retesting, and there is still a large gap from the goal of turning negative, and the improvement of the condition is slow.

[0192] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula and continued treatment for another 1.5 courses (60 doses). After stopping the medication, a follow-up examination showed that high-risk HPV51 had completely turned negative, and all HPV types were negative, indicating that the virus had been completely eliminated. The accompanying gynecological discomfort symptoms also completely disappeared. The patient reported, "I'm so happy!" and highly recognized the negative result, with the treatment experience far exceeding expectations.

[0193] Cycle Analysis

[0194] While our original treatment could initially suppress viral replication, the overall process of achieving a negative result was slow, making it difficult to quickly clear the virus. The new treatment significantly improves treatment efficiency, achieving complete negative results for high-risk viruses in just 1.5 courses (60 doses). Both the speed of virus clearance and the overall efficacy are superior to our original treatment, greatly shortening the negative result period and helping patients quickly get rid of HPV infection.

[0195] Case 17: Persistent infection with high-risk HPV52 accompanied by dual viral interference; new formula effectively enhances immunity and achieves negative conversion.

[0196] Patient: Juanzi, Luzhou, Sichuan, 39 years old, positive for high-risk HPV52, with a disease course of 6 years, and concurrent genital herpes virus co-infection, weakened immunity, accompanied by symptoms such as yellow vaginal discharge, decreased vaginal lactobacilli, fatigue, and insomnia. Initially, she self-medicated with probiotics, selenium tablets, and gynecological gels, but with poor results; the virus remained positive and difficult to clear. Later, she used our original formula, which provided some improvement, but progress was slow. After switching to the new formula, the efficacy significantly improved.

[0197] Treatment Comparison

[0198] Phase 1 (Original Treatment): After taking our original prescription for one course of treatment (40 doses), the original prescription has a certain therapeutic effect: the yellow discharge symptoms have been relieved, the sleep quality has been slightly improved, the fatigue has been reduced, the number of vaginal lactobacilli has been slightly increased, the immunity has been initially regulated, and the HPV virus replication has been mildly suppressed. However, the overall progress to negative is slow, and the virus test is still positive. Under the interference of the dual virus, there is still a large gap between the virus being completely eliminated and the virus being eliminated.

[0199] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected viral clearance rate under dual infection, we switched to our new formula for another 50 doses to simultaneously strengthen the synergistic effects of immune regulation and antiviral therapy. Follow-up results showed that high-risk HPV52 was completely cleared, and all HPV types were negative; vaginal discharge returned to normal, sleep quality significantly improved, fatigue completely disappeared, vaginal flora returned to balance, and overall immunity was greatly enhanced. The patient reported feeling relieved and highly satisfied with the negative clearance effect.

[0200] Cycle Analysis

[0201] While our original treatment could initially improve symptoms and regulate immunity, the speed of virus clearance and negative conversion was slow under the interference of dual viruses, making it difficult to quickly achieve complete virus clearance. The new treatment has specifically optimized the immune regulation and antiviral regimen, achieving complete negative conversion of high-risk HPV in just 1.25 courses of treatment (50 doses). At the same time, it also solved the problems of low immunity and gynecological discomfort caused by dual infection. The overall efficacy, negative conversion efficiency, and symptom improvement speed are all superior to the original treatment, significantly shortening the treatment cycle and successfully overcoming the problem of negative conversion caused by dual infection.

[0202] Case 18: High-risk HPV16+53 co-infection; new formula accelerates virus clearance and relieves discomfort.

[0203] Patient: Ms. Lin, from Heyuan, Guangdong, 42 years old, with high-risk mixed infection of HPV16+53, with a disease course of 8 years, accompanied by symptoms such as increased vaginal discharge and lower abdominal pain. She was initially treated with our original prescription, but the progress was slow, so she switched to the new prescription for treatment.

[0204] Treatment Comparison

[0205] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula has a certain effect: the symptoms of increased vaginal discharge are slightly relieved, the lower abdominal pain is not significantly improved, the two viruses are still positive, the overall progress is slow, and there is still a large gap from the goal of turning negative.

[0206] Phase Two (New Formula Treatment): Given that the original formula did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After one course of treatment (40 doses), the patient experienced a reduction in abnormal menstrual cramps. Upon retesting after the 65th dose, HPV 16+53 were both negative, vaginal discharge returned to normal, and lower abdominal pain completely disappeared. The patient reported that all discomfort symptoms were completely relieved.

[0207] Cycle Analysis

[0208] Although the original prescription could slightly suppress the virus and alleviate some symptoms after one course of treatment (40 doses), the virus clearance speed was relatively slow. The new prescription, however, achieved complete negative conversion of both viruses and complete improvement of symptoms in just 1.6 courses of treatment (65 doses). The overall efficacy and speed of effectiveness were significantly better than the original prescription, and the treatment cycle was greatly shortened.

[0209] Case 19: High-risk HPV 18+44 mixed infection with mild cervical lesions; the new formula effectively reversed the lesions and achieved negative cervical conversion.

[0210] Patient: Ms. Wu, from Yunfu, Guangdong, 47 years old, HPV18+44 high-risk mixed positive, disease course lasted for 4 years, biopsy confirmed chronic cervicitis with mild LSIL lesions, accompanied by symptoms such as lower abdominal distension and prolonged menstruation. The intervention of other hospitals in the early stage was not effective. Later, we used our original prescription for conditioning, which improved the condition but the progress was slow. After switching to the new prescription, the efficacy was significantly improved.

[0211] Treatment Comparison

[0212] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain therapeutic effect: the symptoms of lower abdominal distension were slightly relieved, the cervical lesions did not worsen further, but the symptoms of prolonged menstruation did not improve, the lesions were not reversed, and both viruses remained positive.

[0213] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected speed of lesion repair and symptom improvement, we switched to our new formula for continued treatment. After two courses of treatment (80 doses), a follow-up examination showed that HPV 18+44 had completely turned negative, cervical LSIL lesions had been completely reversed, and the pathological results showed normal cervical tissue; symptoms of lower abdominal distension and prolonged menstruation were completely relieved, and the patient's physical and mental condition improved significantly.

[0214] Cycle Analysis

[0215] Although the original prescription could slightly improve symptoms after one course of treatment (40 doses), it was difficult to reverse the disease and achieve viral clearance. The new prescription, however, achieved dual viral clearance and disease reversal in just two courses of treatment (80 doses), with comprehensive improvement in symptoms. The overall efficacy was far superior to the original prescription, successfully blocking the risk of disease progression.

[0216] Case 20: High-risk HPV16+39 co-infection, new formula effectively clears the virus and quickly turns negative.

[0217] Patient: Ms. Zheng, Fuzhou, Fujian, 39 years old, with high-risk mixed infection of HPV16 and 39, with a disease course lasting 2 years, accompanied by symptoms such as vulvar itching and yellow discharge. She was initially treated with our original prescription, but the progress was slow, so we switched to the new prescription for treatment.

[0218] Treatment Comparison

[0219] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain effect: the vulvar itching was slightly relieved, the yellow discharge symptoms did not improve, the two viruses remained positive, and the overall progress was slow.

[0220] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After one course of treatment (40 doses), a follow-up examination showed a slight improvement in the patient's condition. After continuing to take the medicine until the 62nd dose, a follow-up examination showed that HPV16+39 had turned negative, and the symptoms of vaginal itching and yellow discharge had completely disappeared. The patient reported that the treatment effect far exceeded expectations.

[0221] Cycle Analysis

[0222] Although the original prescription had some effect after one course of treatment (40 doses), the speed of virus clearance and symptom improvement was relatively slow. The new prescription, however, achieved complete viral clearance and symptom relief in just 1.5 courses of treatment (62 doses). The overall efficacy and speed of effectiveness were significantly better than the original prescription, and the treatment cycle was greatly shortened.

[0223] Case 21: Single infection with high-risk HPV16, treated with a new formula for strong clearance and rapid negative conversion.

[0224] Patient: Ms. Cao, 33 years old, from Jinan, Shandong Province, tested positive for HPV16 high-risk, with a disease course of 4 years, accompanied by increased vaginal discharge and mild lower abdominal distension. She was initially treated with our original prescription, but the progress was slow, so we switched to a new prescription for treatment.

[0225] Treatment Comparison

[0226] Phase 1 (Original Treatment): After taking our original decoction for 1.5 courses (60 doses), the original formula showed some efficacy: the symptoms of leukorrhea were slightly relieved, the discomfort was slightly reduced, HPV16 remained positive, and the overall progress to negative was relatively slow.

[0227] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After one course of treatment (40 doses), the patient felt a significant reduction in symptoms; after continuing to take the medicine until the 68th dose, a follow-up examination showed that HPV16 had turned negative, and the discomfort symptoms had completely disappeared. The patient reported that the effect far exceeded expectations.

[0228] Cycle Analysis

[0229] Although our original prescription, which involved 1.5 courses of treatment (60 doses), had some effect, the virus clearance rate was relatively slow. The new prescription takes effect faster and has a more concentrated effect, which can significantly shorten the overall treatment time and allow patients to get rid of the problem of being positive earlier.

[0230] Case 22: High-risk HPV18+52 mixed infection, new formula accelerates negative conversion and improves abnormal vaginal discharge.

[0231] Patient: Ms. Wei, 42 years old, Zhengzhou, Henan Province, with high-risk mixed infection of HPV18+52, with a course of disease lasting 7 years, accompanied by yellow discharge and vulvar itching. She was initially treated with our original prescription, but the progress was slow, so we switched to the new prescription for treatment.

[0232] Treatment Comparison

[0233] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain effect: the itching was slightly relieved, the abnormal vaginal discharge did not improve, the two viruses remained positive, and the overall progress was slow.

[0234] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After 1.5 courses of treatment (60 doses), a follow-up examination showed that HPV18+52 had turned negative, and the itching and abnormal vaginal discharge had completely disappeared.

[0235] Cycle Analysis

[0236] Although our original prescription had some effect after one course of treatment (40 doses), the speed of virus clearance and symptom improvement was relatively slow. The new prescription is more efficient at clearing dual viruses, achieving complete negative conversion in a shorter time and significantly accelerating the overall recovery pace.

[0237] Case 23: High-risk HPV types 16+33+61 mixed infection, new formula effectively clears multiple viruses.

[0238] Patient: Ms. Ren, 36 years old, from Shijiazhuang, Hebei Province, has a high-risk mixed infection of HPV types 16+33+61. The disease has lasted for 2 years and is accompanied by abnormal discharge and vulvar itching. In the early stage, she was treated with our original prescription, but the progress was slow. She then switched to a new prescription for treatment.

[0239] Treatment Comparison

[0240] Phase 1 (Original Treatment): After taking our original decoction for two courses of treatment (80 doses), the original formula had a certain effect: the itching was slightly relieved, the discharge was not significantly improved, the three viruses remained positive, and the overall progress was slow.

[0241] Phase Two (New Formula Treatment): Given that the original formula did not achieve the expected rate of clearing multiple viruses, we switched to our new formula for continued treatment. After two courses of treatment (80 doses), a follow-up examination showed that all three types of viruses had turned negative, and the discomfort symptoms had completely disappeared.

[0242] Cycle Analysis

[0243] Although our original prescription had some effect after two courses of treatment (80 doses), the speed of clearing multiple viruses was relatively slow. The new prescription is more targeted and can clear multiple types of viruses simultaneously, greatly reducing the time required for patients to recover and the effect is more stable.

[0244] Case 24: High-risk HPV18 single infection with LSIL, new formula reverses lesions and repairs cervix

[0245] Patient: Ms. Shen, 47 years old, from Xi'an, Shaanxi Province, HPV18 high-risk positive, disease course lasting 3 years, accompanied by low-grade cervical lesions, discomfort during intercourse, and dull pain in the lower back and abdomen. She was initially treated with our original prescription, but the progress was slow, so we switched to the new prescription for treatment.

[0246] Treatment Comparison

[0247] Phase 1 (Original Treatment): After taking our original decoction for 1.5 courses (60 doses), the original formula showed certain efficacy: the dull pain was slightly relieved, the lesions did not worsen, HPV18 remained positive, and the overall progression was relatively slow.

[0248] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected results in lesion repair and virus clearance, we switched to our new formula for continued treatment. After 2.5 courses of treatment (100 doses), a follow-up examination showed that HPV18 had turned negative, cervical LSIL had been completely reversed, and the discomfort had disappeared.

[0249] Cycle Analysis

[0250] Although our original prescription, which involved 1.5 courses of treatment (60 doses), had some effect, the reversal of the lesions and the clearance of the virus were relatively slow. The new prescription can simultaneously promote negative conversion and cervical repair, making the reversal of the lesions smoother and the overall treatment process more efficient.

[0251] Case 25: Mixed infection of low-risk HPV6 and high-risk HPV59; new formula clears the virus and enhances immunity.

[0252] Patient: Mr. Zhong, 29 years old, from Taiyuan, Shanxi Province, has a mixed infection of HPV types 6+59, with a disease course lasting 3 years. Small warts are visible in the coronal sulcus and perianal area, accompanied by a foreign body sensation in the genitals and easy fatigue. In the early stage, he was treated with our original prescription, but the progress was slow. He then switched to the new prescription for treatment.

[0253] Treatment Comparison

[0254] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain effect: fatigue was slightly relieved, the foreign body sensation in the lower body was not improved, the warts did not shrink or fall off, the two viruses remained positive, and the overall progress was slow.

[0255] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, our new formula was used for continued treatment. After one course of treatment (40 doses), the warts gradually dried up and shrank; after 1.5 courses of treatment (60 doses), a follow-up examination showed that the warts had completely fallen off, HPV6+59 had both turned negative, discomfort had disappeared, and immunity had significantly improved.

[0256] Cycle Analysis

[0257] Although our original prescription had some effect after one course of treatment (40 doses), the virus clearance speed was relatively slow and the effect on the shrinkage and shedding of warts was not obvious. The new prescription can effectively inhibit the growth of warts and promote their shedding, while taking into account both antiviral and immune enhancement, resulting in faster recovery and being more suitable for the physical characteristics of male infected individuals.

[0258] Case 26: High-risk HPV16+45 mixed infection, new formula quickly relieves itching and achieves negative result.

[0259] Patient: Ms. Jiang, 32 years old, Guangzhou, Guangdong Province, with high-risk mixed infection of HPV16+45, with a course of disease lasting 5 years, accompanied by vulvar itching and yellow discharge. She was initially treated with our original prescription, but the progress was slow, so we switched to the new prescription for treatment.

[0260] Treatment Comparison

[0261] Phase 1 (Original Treatment): After taking our original decoction for 0.5 courses (20 doses), the original formula had a certain effect: the itching was slightly relieved, the vaginal discharge did not improve, the two viruses remained positive, and the overall progress was slow.

[0262] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After 1.6 courses of treatment (64 doses), a follow-up examination showed that HPV16+45 had turned negative, and the itching and abnormal vaginal discharge had completely disappeared.

[0263] Cycle Analysis

[0264] Although our original prescription had some effect after 0.5 courses of treatment (20 doses), the virus clearance speed was relatively slow. The new prescription accelerates the virus clearance from the root cause, allowing the symptoms to improve in sync with the virus, and significantly shortens the overall treatment cycle.

[0265] Case 27: High-risk HPV types 18+56 + low-risk HPV type 43 infection, new treatment completely cleared the mixed infection.

[0266] Patient: Ms. Wen, 41 years old, from Nanning, Guangxi, has a mixed infection of high and low risk HPV types 18+56+43. The disease has lasted for 8 years and is accompanied by excessive discharge and a strong odor. In the early stage, she was treated with our original prescription, but the progress was slow. She was then switched to a new prescription for treatment.

[0267] Treatment Comparison

[0268] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain effect: the odor was slightly relieved, the secretions were not improved, the three viruses remained positive, and the overall progress was slow.

[0269] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected clearance rate of multiple viral types, we switched to our new formula for continued treatment. After two courses of treatment (80 doses), a follow-up examination showed that all three viral types had turned negative, and the symptoms had completely disappeared.

[0270] Cycle Analysis

[0271] Although our original prescription had some effect after one course of treatment (40 doses), the clearance speed of multiple virus types was relatively slow; the new prescription has a stronger comprehensive effect and can clear multiple virus types at once, making the recovery process shorter and more thorough.

[0272] Case 28: Single infection with high-risk HPV31, new treatment accelerated negative conversion and improved abnormal vaginal discharge.

[0273] Patient: Ms. Ruan, 26 years old, from Luoyang, Henan Province, HPV type 31 high-risk positive, course of disease unknown, accompanied by increased vaginal discharge and slight odor. She was initially treated with our original prescription, but the progress was slow, so we switched to the new prescription for treatment.

[0274] Treatment Comparison

[0275] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula has a certain therapeutic effect: the leukorrhea is slightly relieved, the physical condition is slightly improved, HPV31 is still positive, and the overall progress is slow.

[0276] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After 1.5 courses of treatment (60 doses), a follow-up examination showed that HPV31 had turned negative, and the vaginal discharge and odor had completely disappeared.

[0277] Cycle Analysis

[0278] Although our original prescription had some effect after one course of treatment (40 doses), the virus clearance speed was relatively slow; the new prescription takes effect more quickly and can achieve complete negative conversion in a shorter course of treatment, reducing the psychological and time costs for patients.

[0279] Case 29: High-risk HPV16+68 mixed infection with chronic cervicitis, new formula for cervical repair.

[0280] Patient: Ms. Xiang, 39 years old, from Handan, Hebei Province, has a high-risk mixed infection of HPV16 and 68, with a disease course of 6 years, accompanied by chronic cervicitis and lower back and abdominal pain. She was initially treated with our original prescription, but the progress was slow, so we switched to a new prescription for treatment.

[0281] Treatment Comparison

[0282] Phase 1 (Original Treatment): After taking our original decoction for 1.5 courses (60 doses), the original formula showed some efficacy: the soreness was slightly relieved, the inflammation was stabilized, the two viruses remained positive, and the overall progress was slow.

[0283] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected speed of virus clearance and inflammation repair, we switched to our new formula for continued treatment. After two courses of treatment (80 doses), a follow-up examination showed that HPV16+68 had both turned negative, cervical inflammation had been repaired, and the pain had disappeared.

[0284] Cycle Analysis

[0285] Although our original prescription, which involved 1.5 courses of treatment (60 doses), had some effect, the speed of virus clearance and inflammation repair was relatively slow. The new prescription can clear the virus and repair the cervix at the same time, making the overall recovery cycle more compact and the effect more solid.

[0286] Case 30: Persistent infection with high-risk HPV18, a new approach breaks the deadlock of positive results.

[0287] Patient: Mr. Lu, 34 years old, from Qingdao, Shandong Province, tested positive for HPV18 high-risk, with a disease course lasting 2 years. Scattered small warts were visible in the perianal and vulvar areas. He had low immunity. He was initially treated with our original formula, but the progression was slow. He was then switched to a new formula for treatment.

[0288] Treatment Comparison

[0289] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula showed certain efficacy: physical strength improved slightly, mental state improved, the warts did not increase significantly in size, but did not shrink or fall off significantly, HPV18 remained positive, and the overall progress was slow.

[0290] Phase Two (New Formula Treatment): Given that the original treatment failed to clear the infection as expected, we switched to our new formula for continued treatment. After one course of treatment (40 doses), the warts gradually dried up and shrank; after continuing treatment for 1.8 courses (72 doses), a follow-up examination showed that the warts had completely fallen off, HPV18 had turned negative, and there were no discomforts.

[0291] Cycle Analysis

[0292] Although our original prescription had some effect after one course of treatment (40 doses), the rate of clearing persistent infection was relatively slow, and its effect on shrinking and falling off warts was limited. The new prescription can quickly inhibit the virus, promote the drying and falling off of warts, directly target stubborn infections, significantly accelerate the rate of negative conversion, and help male patients recover to normal more quickly.

[0293] Case 31: Mixed infection of high-risk HPV58 and low-risk HPV11, treated with a new formula to clear the virus and prevent warts.

[0294] Patient: Ms. Tong, 44 years old, from Weinan, Shaanxi Province, has a mixed infection of HPV types 58 and 11, with a course of illness lasting 3 years. She also experiences vulvar discomfort and fatigue. She initially used our original formula for treatment, but the progress was slow. We then switched to a new formula for treatment.

[0295] Treatment Comparison

[0296] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain therapeutic effect: fatigue was slightly relieved, vulvar discomfort was not improved, both viruses remained positive, and the overall progress was slow.

[0297] Phase Two (New Formula Treatment): Given that the original formula did not clear the mixed virus as expected, we switched to our new formula for continued treatment. After 1.5 courses of treatment (60 doses), a follow-up examination showed that HPV 58+11 had all turned negative, the discomfort disappeared, and the energy was restored.

[0298] Cycle Analysis

[0299] Although our original prescription had some effect after one course of treatment (40 doses), the clearance speed of mixed high- and low-risk viruses was relatively slow. The new prescription has a stronger clearing effect on both high- and low-risk viruses, and the overall recovery efficiency is significantly improved, resulting in a more thorough recovery.

[0300] Case 32: High-risk HPV16+59 mixed infection, new formula quickly relieves lower abdominal discomfort

[0301] Patient: Ms. Yin, 31 years old, from Datong, Shanxi Province, with high-risk mixed infection of HPV16 and 59, course of illness unknown, accompanied by lower abdominal pain and mild menstrual abnormalities. She was initially treated with our original prescription, but the progress was slow, so we switched to a new prescription for treatment.

[0302] Treatment Comparison

[0303] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain effect: mild relief of dull pain, no improvement during menstruation, both viruses remained positive, and the overall progress was slow.

[0304] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After 1.5 courses of treatment (60 doses), a follow-up examination showed that HPV16+59 had turned negative, the dull pain disappeared, and menstruation returned to normal.

[0305] Cycle Analysis

[0306] Although our original prescription had some effect after one course of treatment (40 doses), the speed of virus clearance and symptom improvement was relatively slow. The new prescription achieves simultaneous improvement in symptoms and seroconversion, making the treatment more efficient and the patient more comfortable.

[0307] Case 33: High-risk HPV18+39 mixed infection; new formula improves dryness and enhances immunity.

[0308] Patient: Ms. Li, 46 years old, from Shenzhen, Guangdong Province, has a high-risk mixed infection of HPV types 18 and 39. The disease has lasted for 3 years and is accompanied by vaginal dryness, fatigue, and poor sleep. She was initially treated with our original formula, but the progress was slow. She then switched to the new formula for treatment.

[0309] Treatment Comparison

[0310] Phase 1 (Original Treatment): After taking our original decoction for 1.5 courses (60 doses), the original formula showed some efficacy: sleep improved slightly, dryness was not relieved, both viruses remained positive, and the overall progress was slow.

[0311] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected speed of virus clearance and symptom improvement, we switched to our new formula for continued treatment. After 2.5 courses of treatment (100 doses), a follow-up examination showed that HPV18+39 had both turned negative, dryness had disappeared, and sleep and energy had significantly improved.

[0312] Cycle Analysis

[0313] Although our original prescription, which involved 1.5 courses of treatment (60 doses), had some effect, the virus clearance and improvement of systemic symptoms were relatively slow. The new prescription takes into account both local rehabilitation and overall immunity, allowing the seroconversion and physical recovery to be accelerated simultaneously, making it more efficient overall.

[0314] Case 34: Single infection with high-risk HPV16 accompanied by mild inflammation; rapid negative conversion with new treatment.

[0315] Patient: Ms. Hong, 24 years old, from Liuzhou, Guangxi, HPV16 high-risk positive, disease course lasted for 2 years, accompanied by mild gynecological inflammation. In the early stage, she was treated with our original prescription, but the progress was slow. She then switched to the new prescription for treatment.

[0316] Treatment Comparison

[0317] Phase 1 (Original Treatment): After taking our original decoction for 0.5 courses (20 doses), the original formula showed some efficacy: the inflammatory state tended to stabilize and the body improved slightly, but HPV16 remained positive, and the overall progress was slow.

[0318] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After 1.5 courses of treatment (60 doses), a follow-up examination showed that HPV16 had turned negative and the inflammation had completely subsided.

[0319] Cycle Analysis

[0320] Although our original prescription, with 0.5 courses of treatment (20 doses), had some effect, the virus clearance rate was relatively slow; the new prescription has a more direct effect, significantly accelerates the conversion to negative, and helps young patients recover their health earlier.

[0321] Case 35: High-risk HPV18+66+low-risk HPV42 infection, new treatment completely clears the mixed infection.

[0322] Patient: Ms. Zhu, 37 years old, from Xinxiang, Henan Province, has a mixed infection of high and low risk HPV types 18+66+42. The disease has lasted for 3 years and is accompanied by abnormal vaginal discharge and vulvar itching. In the early stage, she was treated with our original prescription, but the progress was slow. She then switched to the new prescription for treatment.

[0323] Treatment Comparison

[0324] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain effect: the itching was slightly relieved, the vaginal discharge did not improve, the three viruses remained positive, and the overall progress was slow.

[0325] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected clearance rate of multiple viral types, we switched to our new formula for continued treatment. After two courses of treatment (80 doses), a follow-up examination showed that all three viral types had turned negative, and the symptoms had completely disappeared.

[0326] Cycle Analysis

[0327] Although our original prescription had some effect after one course of treatment (40 doses), the clearance speed of multiple virus types was relatively slow; the new prescription has a stronger comprehensive clearance ability, can quickly straighten out the treatment rhythm, and make the negative conversion more stable and faster.

[0328] Case 36: Single infection with high-risk HPV35, improved vaginal discharge and rapid negative result with a new treatment.

[0329] Patient: Ms. Ge, 42 years old, from Baoding, Hebei Province, HPV type 35 high-risk positive, course of disease unknown, accompanied by yellowish vaginal discharge with a slight odor. She was initially treated with our original prescription, but the progress was slow, so we switched to the new prescription for treatment.

[0330] Treatment Comparison

[0331] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain effect: the odor was slightly relieved, the vaginal discharge did not improve, HPV35 remained positive, and the overall progress was slow.

[0332] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After 1.6 courses of treatment (64 doses), a follow-up examination showed that HPV35 had turned negative, and the vaginal discharge and odor had completely disappeared.

[0333] Cycle Analysis

[0334] The original formula resulted in a steady but slow rate of negative clearance, taking a considerable amount of time overall; the new formula significantly accelerates the clearance process, allowing patients to recover to normal in a shorter time and providing a better recovery experience.

[0335] Case 37: High-risk HPV16+51 mixed infection, new formula relieves vulvar discomfort and quickly clears the virus.

[0336] Patient: Ms. Wen, 35 years old, from Yantai, Shandong Province, has a high-risk mixed infection of HPV16 and 51. The disease has lasted for 3 years and is accompanied by vulvar discomfort and increased discharge. She was initially treated with our original prescription, but the progress was slow. She then switched to a new prescription for treatment.

[0337] Treatment Comparison

[0338] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain effect: the discharge was slightly reduced, the vulvar discomfort was not improved, the two viruses remained positive, and the overall progress was slow.

[0339] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After 1.5 courses of treatment (60 doses), a follow-up examination showed that HPV16+51 had all turned negative, and the discomfort had completely disappeared.

[0340] Cycle Analysis

[0341] Although our original prescription had some effect after one course of treatment (40 doses), the virus clearance speed was relatively slow; the new prescription achieves dual simultaneous improvement, the treatment rhythm is more compact, and the overall effect is better.

[0342] Case 38: Single infection with high-risk HPV18 accompanied by mucosal fragility; new treatment to repair mucosa and achieve negative result.

[0343] Patient: Ms. Chang, 49 years old, from Yulin, Shaanxi Province, tested positive for HPV18 high-risk, with a disease course of 5 years, accompanied by easily damaged mucous membranes and recurrent discomfort. She was initially treated with our original formula, but the progress was slow, so we switched to the new formula for treatment.

[0344] Treatment Comparison

[0345] Phase 1 (Original Treatment): After taking our original decoction for 1.5 courses (60 doses), the original formula showed some efficacy: discomfort was slightly relieved, but there was no significant repair of the mucous membranes, HPV18 remained positive, and the overall progress was slow.

[0346] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected results in virus clearance and mucosal repair, we switched to our new formula for continued treatment. After three courses of treatment (120 doses), a follow-up examination showed that HPV18 had turned negative, the mucosal repair was complete, and the discomfort had completely disappeared.

[0347] Cycle Analysis

[0348] The original formula struggled to simultaneously address mucosal repair and viral clearance, significantly prolonging the recovery period; the new formula promotes repair and negative conversion simultaneously, enabling even complex cases to recover steadily and efficiently.

[0349] Case 39: Mixed infection of high-risk HPV53 and low-risk HPV6; new formula to boost immunity and clear the virus.

[0350] Patient: Ms. Xi, 30 years old, from Jinzhong, Shanxi Province, has a mixed infection of HPV 53+6, which is of high and low risk. The disease has lasted for 4 years and is accompanied by mild foreign body sensation and easy fatigue. In the early stage, she was treated with our original prescription, but the progress was slow. She was then switched to a new prescription for treatment.

[0351] Treatment Comparison

[0352] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain therapeutic effect: fatigue was slightly relieved, the foreign body sensation was not improved, the two viruses remained positive, and the overall progress was slow.

[0353] Phase Two (New Formula Treatment): Given that the original formula did not clear the mixed virus as expected, we switched to our new formula for continued treatment. After 1.5 courses of treatment (60 doses), a follow-up examination showed that HPV53+6 had turned negative, the discomfort disappeared, and immunity improved.

[0354] Cycle Analysis

[0355] Although our original prescription had some effect after one course of treatment (40 doses), the speed of clearing mixed viruses was relatively slow. The new prescription works in two ways, clearing the virus and strengthening the body, resulting in a faster and more stable overall recovery.

[0356] Case 40: High-risk HPV types 16+35+59 infection, new formula overcomes stubborn multiple infections

[0357] Patient: Ms. Lou, 45 years old, from Dongguan, Guangdong Province, has a high-risk mixed infection of HPV types 16, 35, and 59. The disease has lasted for 6 years and is accompanied by abnormal vaginal discharge, lower abdominal discomfort, and fatigue. The condition is stubborn. In the early stage, we used the original formula to regulate her condition, but the progress was slow. We then switched to the new formula for treatment.

[0358] Treatment Comparison

[0359] Phase 1 (Original Treatment): After taking our original decoction for two courses of treatment (80 doses), the original formula had a certain therapeutic effect: fatigue was slightly relieved, discomfort was not improved, the three viruses remained positive, and the overall progress was slow.

[0360] Phase Two (New Formula Treatment): Given that the original treatment failed to clear the stubborn infection as expected, we switched to our new formula for continued treatment. After three courses of treatment (120 doses), a follow-up examination showed that all three types of viruses had turned negative, and the discomfort had completely disappeared.

[0361] Cycle Analysis

[0362] Although our original prescription had some effect after two courses of treatment (80 doses), the clearance speed of stubborn and multi-type infections was relatively slow. The new prescription specifically strengthens the clearance ability, and can steadily accelerate even complex and stubborn infections, eventually achieving complete negative conversion.

[0363] Case 41: High-risk HPV 18+45 mixed infection, new formula improves menstrual cycle and quickly clears negative.

[0364] Patient: Ms. Hui, 38 years old, from Guigang, Guangxi, has a high-risk mixed infection of HPV types 18 and 45. The disease has lasted for 3 years and is accompanied by menstrual disorders and lower abdominal discomfort. She was initially treated with our original prescription, but the progress was slow. She then switched to a new prescription for treatment.

[0365] Treatment Comparison

[0366] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula showed some efficacy: menstrual periods were slightly stable, lower abdominal discomfort did not improve, both viruses remained positive, and overall progress was slow.

[0367] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected results in clearing the virus and regulating menstruation, we switched to our new formula for continued treatment. After 1.7 courses of treatment (68 doses), a follow-up examination showed that HPV 18+45 had turned negative, and menstruation returned to normal.

[0368] Cycle Analysis

[0369] Although our original prescription had some effect after one course of treatment (40 doses), the speed of virus clearance and menstrual regulation was relatively slow. The new prescription regulates the endocrine system and clears the virus simultaneously, allowing the negative result and physiological state to recover at the same time, making it more efficient overall.

[0370] Case 42: Co-infection with multiple high-risk HPV types; new formula effectively clears the virus and relieves symptoms.

[0371] Patient: Ms. Qian, from Rizhao, Shandong Province, 45 years old, with mixed infection of multiple high-risk HPV types 18, 39, and 59. She reported having been infected for many years with a stubborn condition; the specific course of the disease is unknown. She also experienced symptoms such as vulvar itching and yellow vaginal discharge. Initially, she used our original formula for treatment, which had some effect but progressed slowly, so she switched to a new formula.

[0372] Treatment Comparison

[0373] Phase 1 (Original Treatment): After taking our original decoction for one course of treatment (40 doses), the original formula had a certain effect: the vulvar itching and yellow discharge were slightly relieved, and the condition did not worsen further. However, multiple viruses remained positive, and the overall progress was slow.

[0374] Phase Two (New Formula Treatment): Given that the original treatment did not achieve the expected virus clearance speed, we switched to our new formula for continued treatment. After one course of treatment (40 doses), the patient felt significantly less unwell; after continuing treatment for 1.5 courses (60 doses), a follow-up examination showed that HPV18 and 39 subtypes had all turned negative, while HPV59 subtype remained positive. The patient is currently continuing consolidation treatment, and it is hoped that a complete negative result will be achieved in the future.

[0375] Cycle Analysis

[0376] While the original formula had some effect after one course of treatment (40 doses), the clearance speed of multiple stubborn infections was relatively slow. The new formula achieved the negative conversion of two high-risk HPV subtypes in only 1.5 courses of treatment (60 doses), significantly relieved discomfort symptoms, and the virus clearance efficiency and symptom improvement speed were both superior to the original formula. It effectively broke the deadlock of stubborn infection and laid a solid foundation for subsequent full negative conversion.

[0377] Summarize

[0378] The above cases, from different perspectives (simple infection, with lesions, mixed infection, infection with other complications, long-term infection, etc.), consistently demonstrate that, based on the effectiveness of the original treatment approach, a new formula with optimized combination of purslane (enhancing heat-clearing, detoxifying, and blood-cooling properties) and dioscorea hypoglauca (strengthening diuresis and turbidity removal) can: 1. Accelerate the virus clearance process and shorten the time required to achieve virological negativity; 2. Accelerate the reversal and repair of cervical lesions; 3. More rapidly improves clinical symptoms related to damp-heat accumulation.

[0379] Its core mechanism lies in the fact that the new formula targets the pathogenesis of "damp-heat toxin" more precisely and effectively. Through the synergistic enhancement of the two major pathways of "clearing heat" and "eliminating dampness," it rapidly improves the microenvironment for viral survival while supporting the body's vital energy, thereby enhancing overall treatment efficiency and shortening the course of treatment. This provides strong clinical evidence for this prescription optimization.

[0380] The above description of the embodiments is provided to enable those skilled in the art to understand and use the invention. It will be apparent to those skilled in the art that various modifications can be made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present invention is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the invention should be within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition, wherein, The traditional Chinese medicine composition comprises the following components by weight: Codonopsis pilosula 15-45 parts, Atractylodes macrocephala 7-25 parts, Astragalus membranaceus 20-60 parts, Pseudostellaria heterophylla 7-25 parts, Ophiopogon japonicus 7-25 parts, Rehmannia glutinosa 10-30 parts, Trametes versicolor 15-45 parts, Ganoderma lucidum 15-45 parts, Smilax glabra 20-60 parts, Hedyotis diffusa 15-35 parts, Taraxacum mongolicum 15-35 parts, Morus alba 20-40 parts, Coix lacryma-jobi 15-35 parts, Gardenia jasminoides 7-25 parts, Salvia miltiorrhiza 10-30 parts, Portulaca oleracea 15-45 parts, Poria cocos 10-30 parts, Isatis indigotica 10-30 parts, Dendrobium nobile 7-25 parts, Schisandra chinensis 7-25 parts, Glycyrrhiza uralensis 10-20 parts, and Dioscorea hypoglauca 15-35 parts.

2. The traditional Chinese medicine composition according to claim 1, wherein, The traditional Chinese medicine composition comprises the following components by weight: Codonopsis pilosula 25-35 parts, Atractylodes macrocephala 10-20 parts, Astragalus membranaceus 35-45 parts, Pseudostellaria heterophylla 10-20 parts, Ophiopogon japonicus 10-20 parts, Rehmannia glutinosa 15-25 parts, Trametes versicolor 25-35 parts, Ganoderma lucidum 25-35 parts, Smilax glabra 35-45 parts, Hedyotis diffusa 20-30 parts, Taraxacum mongolicum 20-30 parts, Morus alba 25-35 parts, Coix lacryma-jobi 20-30 parts, Gardenia jasminoides 10-20 parts, Salvia miltiorrhiza 15-25 parts, Portulaca oleracea 25-35 parts, Poria cocos 15-25 parts, Isatis indigotica 13-23 parts, Dendrobium nobile 10-20 parts, Schisandra chinensis 10-20 parts, Glycyrrhiza uralensis 10-20 parts, and Dioscorea hypoglauca 20-30 parts; Preferably, the traditional Chinese medicine composition comprises the following components by weight: Codonopsis pilosula 30 parts, Atractylodes macrocephala 15 parts, Astragalus membranaceus 40 parts, Pseudostellaria heterophylla 15 parts, Ophiopogon japonicus 15 parts, Rehmannia glutinosa 20 parts, Ganoderma lucidum 30 parts, Ganoderma lucidum 30 parts, Smilax glabra 40 parts, Hedyotis diffusa 25 parts, Taraxacum mongolicum 25 parts, Morus alba 30 parts, Coix lacryma-jobi 25 parts, Gardenia jasminoides 15 parts, Salvia miltiorrhiza 20 parts, Portulaca oleracea 30 parts, Poria cocos 20 parts, Isatis indigotica 18 parts, Dendrobium nobile 15 parts, Schisandra chinensis 15 parts, Glycyrrhiza uralensis 15 parts, and Dioscorea hypoglauca 25 parts.

3. A traditional Chinese medicine preparation, which is prepared from the traditional Chinese medicine composition according to claim 1 or 2.

4. The traditional Chinese medicine preparation according to claim 3, wherein, The traditional Chinese medicine preparation comprises the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

5. The traditional Chinese medicine preparation according to claim 3, wherein, The traditional Chinese medicine preparations mentioned are selected from at least one of the following: decoctions, mixtures, powders, pills, teas, gels, pastes, wines, tinctures, elixirs, granules, capsules, tablets, and fermented preparations. Preferably, the compound preparation includes an oral liquid; Preferably, the pills are selected from at least one of honey pills, water pills, concentrated pills, and drop pills; Preferably, the tea preparation includes tea bags; Preferably, the capsule is selected from at least one of soft capsules, hard capsules, and enteric-coated capsules; Preferably, the tablets are selected from at least one of ordinary tablets, lozenges, effervescent tablets, and dispersible tablets.

6. The use of the traditional Chinese medicine composition according to claim 1 or 2, or the traditional Chinese medicine preparation according to any one of claims 3 to 5, in the preparation of a preparation for inhibiting human papillomavirus infection, or a medicament for treating or preventing diseases caused by human papillomavirus infection.

7. The application according to claim 6, wherein, The diseases caused by human papillomavirus infection are selected from at least one of the following: skin warts caused by cutaneous HPV infection, diseases caused by mucosal HPV infection in the anogenital region, malignant tumors, and diseases caused by other mucosal HPV infections; Preferably, the skin warts are selected from at least one of common warts, flat warts, and plantar warts; Preferably, the disease caused by HPV infection of the anorectal mucosa is selected from at least one of benign proliferative diseases, precancerous lesions, and malignant tumors. Preferably, the benign proliferative disease includes condyloma acuminata. Preferably, the precancerous lesion is selected from at least one of cervical intraepithelial neoplasia, vaginal intraepithelial neoplasia, vulvar intraepithelial neoplasia, anal intraepithelial neoplasia, and penile intraepithelial neoplasia. Preferably, the malignant tumor is selected from at least one of cervical cancer, vaginal cancer, vulvar cancer, anal cancer, and penile cancer. Preferably, the disease caused by other mucosal HPV infections is selected from at least one of oropharyngeal cancer, oral cancer, and laryngeal papilloma. Preferably, the oral cavity includes oral squamous cell carcinoma.

8. The application according to claim 6, wherein, The human papillomavirus mentioned is selected from at least one of the following: low-risk cutaneous human papillomavirus, high-risk cutaneous human papillomavirus, low-risk mucosal human papillomavirus, and high-risk mucosal human papillomavirus. Preferably, the low-risk human papillomavirus for cutaneous use is selected from at least one of HPV3, HPV5, HPV7, HPV10, HPV43, HPV44, and HPV61; Preferably, the high-risk human papillomavirus for skin is selected from at least one of HPV16, HPV18, and HPV35; Preferably, the mucosal low-risk human papillomavirus is selected from at least one of HPV6, HPV11, and HPV42; Preferably, the mucosal high-risk human papillomavirus is selected from at least one of the following: high-risk HPV types, including HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, and HPV59; and possibly high-risk HPV types, including HPV53, HPV66, HPV68, and HPV73.

9. The application according to claim 6, wherein, The human papillomavirus (HPV) infection is selected from at least one of HPV simple infection, HPV infection with lesions, and HPV mixed infection.

10. The application according to claim 6, wherein, The aforementioned Chinese medicine composition or preparation can accelerate the reduction of human papillomavirus (HPV) load, improve cervical squamous epithelial lesions, enhance the body's immunity, improve menstrual abnormalities, prevent the formation of HPV-related warts, or improve cervical-related abnormal symptoms. Preferably, the cervical-related abnormal symptoms are selected from at least one of abnormal vaginal discharge, abnormal leukorrhea, and cervical injury; Preferably, the cervical-related abnormal symptoms are selected from at least one of lower abdominal discomfort, vaginal dryness, and vulvar discomfort.

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