A traditional Chinese medicine composition for treating human papilloma virus (HPV) infection, a preparation method and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating human papillomavirus (HPV) infection, its preparation method, and its application. The composition is made from multiple traditional Chinese medicines, including Polygonum cuspidatum, Polygonatum sibiricum, and Atractylodes macrocephala (fried), in a specific weight ratio. Through processes such as decoction extraction, concentration, and granulation, the composition can be prepared into various pharmaceutically acceptable dosage forms, including decoctions, granules, tablets, capsules, pills, powders, and oral liquids. The traditional Chinese medicine composition of this invention has the effects of "tonifying qi and kidneys, detoxifying and removing dampness, and supporting the body's resistance to pathogens," and can be effectively used to treat human papillomavirus (HPV) infection. The preparation process of this invention is simple, and the efficacy is definite, providing a new medication option for the clinical treatment of HPV infection.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating human papillomavirus (HPV) infection, its preparation method, and its application. Background Technology

[0002] Human papillomavirus (HPV) is a spherical DNA virus resistant to dry environments, with humans as its sole host. More than 150 subtypes have been identified, classified as low-risk and high-risk based on carcinogenic risk. High-risk HPV types (such as HPV16 / 18) are the core cause of cervical cancer—high-risk HPV infection is detected in approximately 90% of cervical cancer tissue samples. Transmission characteristics: The virus can remain latent in the basal cell layer for extended periods, and its protein antigens are difficult for the immune system to recognize, leading to persistent infection and subsequently causing malignant tumors such as anal cancer, penile cancer, and oral cancer.

[0003] Existing treatments have significant limitations: Prevention limitations: HPV vaccines are only effective for uninfected individuals and are ineffective for those already infected; Treatment bottlenecks: Western medicine uses physical therapy (laser / cryotherapy), immunomodulation (interferon), or surgical removal of the warts, but none can eradicate the latent virus in the basal layer, resulting in a clinical recurrence rate exceeding 50%; Drug deficiency: Currently, modern medicine lacks specific drugs for HPV infection. While commonly used drugs such as interferon and Baofukang suppositories have some effect, they suffer from uncertain efficacy, high recurrence rates, and side effects (such as flu-like symptoms). There is currently no Western medicine that can directly eliminate the HPV virus, and the WHO has confirmed the global lack of effective treatments.

[0004] Unmet clinical needs: Because current therapies cannot block the persistent viral infection process, patients face an escalating risk of cancer. Persistent high-risk HPV infection is the leading cause of precancerous lesions and even cervical cancer. Statistics show that women with persistent high-risk HPV infection for more than two years have an 8-10 times higher incidence of cervical intraepithelial neoplasia (CIN). Therefore, developing innovative drugs that can completely eliminate the virus and block the cancer pathway has become an urgent need in the global public health field.

[0005] In Traditional Chinese Medicine (TCM) theory, HPV infection can be categorized under "leukorrhea," "vaginal itching," and "abdominal masses." Its core pathogenesis is primarily spleen and kidney qi deficiency, with damp-heat and blood stasis forming the superficial manifestations. Insufficient vital energy allows damp-heat and toxins to descend into the uterus, combining with blood stasis, resulting in a lingering and difficult-to-cure condition. Current TCM treatments often focus on simply clearing heat and dampness or promoting blood circulation and removing blood stasis, a single approach that fails to thoroughly eliminate toxins deeply embedded in the meridians, leading to limited therapeutic effects and poor stability. Therefore, there is an urgent clinical need for a TCM combination for treating HPV infection that is effective, has a low recurrence rate, and minimal side effects. Summary of the Invention

[0006] Purpose of the Invention: Addressing the shortcomings of existing technologies, the purpose of this invention is to provide a traditional Chinese medicine composition for treating human papillomavirus (HPV) infection. This composition is based on the traditional Chinese medicine theory of "strengthening the body's resistance and eliminating pathogenic factors," deeply exploring the mechanism that "where pathogenic factors gather, the body's Qi must be deficient" in women with high-risk HPV cervical lesions. It establishes the treatment principle of "tonifying Qi and kidneys, detoxifying and eliminating dampness, and strengthening the body's resistance and eliminating pathogenic factors" to effectively treat HPV infection. Furthermore, it aims to prevent long-term recurrence after treatment, provided that the patient maintains a balanced diet, regular lifestyle, and avoids excessive exertion. Another objective of this invention is to provide a method for preparing the aforementioned traditional Chinese medicine composition and its application.

[0007] Technical Solution: To achieve the above-mentioned objectives, the technical solution adopted by this invention is as follows: A traditional Chinese medicine composition for treating human papillomavirus (HPV) infection is made from twelve kinds of Chinese medicinal herbs: Polygonum cuspidatum, Polygonatum sibiricum, Atractylodes macrocephala (fried), Smilax glabra, Portulaca oleracea, Lithospermum erythrorhizon, Sophora flavescens, Ginseng slices, Phellodendron chinense, Astragalus membranaceus, dried ginger, and Cornus officinalis.

[0008] The preparation method of the traditional Chinese medicine composition of the present invention is simple. The twelve kinds of traditional Chinese medicine slices can be directly decocted and taken orally using traditional methods. To obtain better efficacy and facilitate the preparation of modern drug dosage forms, the preferred drug formulation of the present invention is as follows: Polygonum cuspidatum 5-30 parts, Polygonatum sibiricum 5-30 parts, Atractylodes macrocephala (fried) 5-30 parts, Smilax glabra 10-40 parts, Portulaca oleracea 5-30 parts, Lithospermum erythrorhizon 3-20 parts, Sophora flavescens 5-30 parts, Ginseng slices 3-20 parts, Phellodendron chinense 3-20 parts, Astragalus membranaceus 3-20 parts, Zingiber officinale 3-20 parts, Cornus officinalis 5-30 parts.

[0009] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts Polygonum cuspidatum, 10 parts Polygonatum sibiricum, 10 parts Atractylodes macrocephala (fried), 20 parts Smilax glabra, 10 parts Portulaca oleracea, 6 parts Lithospermum erythrorhizon, 10 parts Sophora flavescens, 6 parts Ginseng slices, 6 parts Phellodendron chinense, 6 parts Astragalus membranaceus, 6 parts Zingiber officinale, and 10 parts Cornus officinalis.

[0010] The preferred preparation method is as follows: Mix the raw materials in the specified weight proportions evenly, soak in water for 30-40 minutes, and add water in an amount 8-10 times the total weight of the medicinal materials. First, bring to a boil over high heat, then reduce to low heat and simmer for 50-60 minutes. Filter and collect the filtrate. Add 5-8 times the amount of water to the dregs again and decoct once more using the same method, then filter. Combine the two filtrates to obtain the decoction of the herbal composition of this invention.

[0011] The traditional Chinese medicine composition can be prepared into any pharmaceutically acceptable dosage form, including but not limited to decoctions, granules, tablets, capsules, pills, powders, or oral liquids.

[0012] The traditional Chinese medicine composition of this invention has been clinically verified over many years and has the effects of "tonifying qi and kidney, detoxifying and removing dampness, and supporting the body's resistance and eliminating pathogens". It is mainly used to treat human papillomavirus (HPV) infection.

[0013] Beneficial Effects: The traditional Chinese medicine composition for treating human papillomavirus (HPV) infection of this invention has the characteristics of good efficacy, short treatment course, thorough cure, and no side effects. The preparation method of the traditional Chinese medicine composition for treating HPV infection is simple, rapid, efficient, and easy to operate. The prepared mixtures, granules, tablets, capsules, pills, powders, or oral liquids are easy to carry and convenient to take.

[0014] The therapeutic effects of the traditional Chinese medicine composition described in this invention are as follows: Polygonum cuspidatum: promotes blood circulation and removes blood stasis, eliminates dampness and relieves jaundice, clears heat and detoxifies. Polygonatum: Nourishes Yin and moistens the lungs, tonifies the spleen and replenishes Qi, nourishes the kidneys and replenishes essence. Atractylodes macrocephala (fried): Strengthens the spleen and replenishes qi, dries dampness and promotes diuresis. Smilax glabra: Detoxifies, removes dampness, and promotes joint mobility. Purslane: Clears heat and detoxifies, cools blood and stops bleeding. Purple gromwell: Clears heat and cools blood, invigorates blood circulation and detoxifies, promotes rash eruption and eliminates spots. Sophora flavescens: Clears heat and dries dampness, kills parasites, and promotes diuresis. Ginseng slices: Greatly replenish vital energy, restore pulse and prevent collapse, tonify spleen and lungs, promote body fluid and nourish blood, calm the mind and improve intelligence. Phellodendron bark (fried): Clears heat and dries dampness, drains fire and eliminates steaming heat, detoxifies and heals sores. Roasted Astragalus: Tonifies Qi and strengthens the middle Jiao Dried ginger: warms the middle jiao and dispels cold, restores yang and unblocks the meridians, warms the lungs and resolves phlegm. Cornus officinalis: Tonifies the liver and kidneys, astringes and consolidates the body. The formula is exquisitely combined, employing both tonifying and purging methods to treat both the root cause and the symptoms. It works synergistically to "tonify qi and kidneys, detoxify and eliminate dampness, and support the body's resistance to pathogens." It is highly effective in addressing the core pathogenesis of HPV infection, which involves the mutual interaction of "spleen and kidney qi deficiency, damp-heat and blood stasis." Detailed Implementation

[0015] The present invention will be described in detail below through embodiments, but the scope of protection of the present invention includes, but is not limited to, the following embodiments.

[0016] Example 1: Formula of the Traditional Chinese Medicine Composition of the Present Invention This embodiment provides the optimal formulation of the present invention, which consists of the following active pharmaceutical ingredients by weight: 10 parts Polygonum cuspidatum, 10 parts Polygonatum sibiricum, 10 parts Atractylodes macrocephala (fried), 20 parts Smilax glabra, 10 parts Portulaca oleracea, 6 parts Lithospermum erythrorhizon, 10 parts Sophora flavescens, 6 parts Ginseng slices, 6 parts Phellodendron chinense, 6 parts Astragalus membranaceus, 6 parts Zingiber officinale, and 10 parts Cornus officinalis.

[0017] Example 2: Scope of the Traditional Chinese Medicine Composition Formula of the Present Invention This embodiment provides the formulation range of the present invention, which consists of the following parts by weight of active pharmaceutical ingredients: Polygonum cuspidatum 5-30 parts by weight, Polygonatum sibiricum 5-30 parts by weight, Atractylodes macrocephala (fried) 5-30 parts by weight, Smilax glabra 10-40 parts by weight, Portulaca oleracea 5-30 parts by weight, Lithospermum erythrorhizon 3-20 parts by weight, Sophora flavescens 5-30 parts by weight, Ginseng slices 3-20 parts by weight, Phellodendron chinense 3-20 parts by weight, Astragalus membranaceus 3-20 parts by weight, Zingiber officinale 3-20 parts by weight, Cornus officinalis 5-30 parts by weight.

[0018] Example 3: Preparation of decoction Take the raw materials as described in Example 1, mix them evenly, and soak them in water for 30-40 minutes. The amount of water should be 8-10 times the total weight of the medicinal materials. First, bring to a boil over high heat, then reduce to low heat and simmer for 50-60 minutes. Filter and collect the filtrate. Add 5-8 times the amount of water to the dregs again and decoct once more using the same method. Filter again. Combine the two filtrates to obtain the decoction of the herbal composition of this invention.

[0019] Example 4: Preparation of Granules Take the raw materials as described in Example 1, add water and decoct 2-3 times, each time adding 8-12 times the total weight of the medicinal materials, decoct for 1-2 hours each time, combine all the decoction liquids, and filter through a 100-200 mesh sieve to obtain a refined filtrate. Concentrate the filtrate under reduced pressure at 60-70℃ and -0.05 to -0.10 MPa to a thick paste with a relative density of 1.10-1.25 (measured at 60℃). Add 1-2 times the weight of dextrin and 0.5-1 times the weight of lactose as excipients to the thick paste, mix well, and granulate with ethanol. Dry the wet granules at 60-80℃, granulate, and package to obtain the granules of the traditional Chinese medicine composition of this invention.

[0020] Example 5: Preparation of tablets A thick paste was prepared according to the method described in Example 4. The thick paste was then mixed evenly with an appropriate amount of pharmaceutical excipients (including fillers such as starch, disintegrants such as sodium carboxymethyl starch, and lubricants such as magnesium stearate) to form a dry paste powder. Granulation was performed using wet granulation or dry granulation processes, followed by tableting. The tablets were then coated with a film or left uncoated to obtain the tablets of the traditional Chinese medicine composition of the present invention.

[0021] Example 6: Preparation of Capsules Take the dry powder obtained in Example 5 and fill it directly into No. 0 hydroxypropyl methylcellulose (HPMC) capsule shells, with each capsule containing 0.4g, to obtain the capsule form of the traditional Chinese medicine composition of the present invention.

[0022] Example 7: Preparation of pills Take the raw materials as described in Example 1, mix them evenly, pulverize them into a fine powder, and pass them through a 100-200 mesh sieve to obtain a fine powder of medicinal materials. Mix the fine powder of medicinal materials with an appropriate amount of refined honey (honey that has been refined), with the weight ratio of honey to powder being 1:1 to 1.5:1, to form a plastic soft material. Roll the mixture into strips, form into pills, and dry them at 60-80℃ to obtain the honey pills of the traditional Chinese medicine composition of this invention. Alternatively, mix the medicinal extract with the powder of medicinal materials, and use water or ethanol as a wetting agent to form water pills or concentrated pills.

[0023] Example 8: Preparation of Powder Take the raw materials in the proportions described in Example 1, dry them, mix them evenly, pulverize them into fine powder using a pulverizer, pass them through an 80-120 mesh sieve, mix them evenly, and package them to obtain the powder of the traditional Chinese medicine composition of the present invention.

[0024] Example 9: Preparation of oral liquid Take the raw materials prepared according to the proportions described in Example 1, soak them in water for 30-40 minutes, and add water in an amount 8-10 times the total weight of the medicinal materials (equivalent to the weight ratio of the prescription). First, bring to a boil over high heat, then reduce to low heat and simmer for 50-60 minutes. Filter and collect the filtrate. Add 6-8 times the amount of water to the dregs again and decoct once more using the same method, then filter. Combine the two filtrates, concentrate the filtrate under reduced pressure to a relative density of 1.05-1.25 g / ml (60℃) to obtain an extract, add ethanol to a concentration of 70%, let stand for 18 hours, collect the supernatant, recover the ethanol until there is no alcohol odor, concentrate to an appropriate volume, add water to an appropriate volume, stir well, dispense, and sterilize by moist heat to obtain the final product.

[0025] Example 10: Typical case.

[0026] Ms. Lin, 29 years old, had high-risk HPV (positive for 6, 43, and 51, and weakly positive for 68). She came for treatment on December 31, 2024, and took the above-mentioned prescription decoction for 30 days. On February 11, 2025, all her test results turned negative.

[0027] Ms. Tang, female, 28 years old, tested positive for high-risk HPV68 on November 20, 2024. She came to see a doctor on December 4, 2024 and took the above-mentioned prescription decoction for 39 days. On January 24, 2025, all test results turned negative.

[0028] Ms. Wang, 25 years old, tested positive for high-risk HPV (16, 18, 42, 52, 66, 81) on February 29, 2024. She came to see a doctor on December 7, 2024, and took the above-mentioned prescription decoction for 30 days. On January 21, 2025, all test results turned negative.

[0029] Ms. Zhang, female, 39 years old, tested positive for high-risk HPV58 on April 11, 2024. She came to see a doctor on January 10, 2025 and took the above-mentioned prescription decoction for 30 days. On February 14, 2025, all test results turned negative.

[0030] Ms. Zhu, 26 years old, tested positive for high-risk HPV (61,68 positive) on April 11, 2024. She came for treatment on December 24, 2024 and took the above-mentioned prescription decoction for 21 days. She came for a follow-up visit on February 15, 2025 and took the above-mentioned prescription decoction for another 9 days. On January 21, 2025, all test results turned negative.

[0031] Example 11: Clinical efficacy observation: From May 2018 to February 2025, more than 100 patients diagnosed with persistent high-risk HPV infection were treated. The patients took the decoction prepared in Example 3 of this invention orally, one dose per day, divided into three warm doses, for 30 consecutive days as one course of treatment. Results: HPV-DNA was retested 30 days after treatment. The results showed that among more than 100 patients, 68 had negative HPV results, and no obvious adverse reactions occurred during the treatment. A few patients were unwilling to provide test reports or cooperate with the registration of test report information. Conclusion: The traditional Chinese medicine composition provided by this invention has a definite curative effect and high safety in treating HPV infection, and can significantly improve the HPV seroconversion rate.

[0032] The above embodiments are only for the purpose of helping to understand the core content of the present invention. Those skilled in the art can make appropriate adjustments to the dosage form and preparation parameters within the scope of the principles and formulations of the present invention, and these adjustments should also be considered to fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating human papillomavirus (HPV) infection, characterized in that: According to the weight ratio, it consists of: 5-30 parts of Polygonum cuspidatum, 5-30 parts of Polygonatum sibiricum, 5-30 parts of Atractylodes macrocephala (fried), 10-40 parts of Smilax glabra, 5-30 parts of Portulaca oleracea, 3-20 parts of Lithospermum erythrorhizon, 5-30 parts of Sophora flavescens, 3-20 parts of Panax ginseng slices, 3-20 parts of Phellodendron chinense, 3-20 parts of Astragalus membranaceus, 3-20 parts of Zingiber officinale (dried), and 5-30 parts of Cornus officinalis. The weight of the above components is calculated based on the raw herbs.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The basic formula is as follows: 10 parts Polygonum cuspidatum, 10 parts Polygonatum sibiricum, 10 parts Atractylodes macrocephala (fried), 20 parts Smilax glabra, 10 parts Portulaca oleracea, 6 parts Lithospermum erythrorhizon, 10 parts Sophora flavescens, 6 parts Panax ginseng slices, 6 parts Phellodendron chinense, 6 parts Astragalus membranaceus, 6 parts dried ginger, and 10 parts Cornus officinalis.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The composition is prepared into a pharmaceutically acceptable dosage form, including but not limited to decoctions, granules, tablets, capsules, pills, powders, or oral liquids.

4. A method for preparing the traditional Chinese medicine composition according to claim 3, characterized in that, The method includes the step of extracting the raw drug by decoction.

5. The method according to claim 4, characterized in that, The water decoction extraction step includes decocting 2-3 times.

6. The method according to claim 4 or 5, characterized in that, The method also includes the steps of filtering and concentrating the water-based extract.

7. The method according to claim 6, characterized in that, The concentration is performed under reduced pressure to obtain a thick paste or extract.

8. The method according to claim 7, characterized in that, It also includes the step of mixing the paste or extract with pharmaceutically acceptable excipients to form granules, tablets or capsules.

9. A method for preparing the powder or pills according to claim 3, characterized in that, This includes the step of pulverizing the active pharmaceutical ingredient into a fine powder.

10. The traditional Chinese medicine composition prepared by the method according to any one of claims 4-9, characterized in that, The prepared drug also contains pharmaceutical excipients or carriers permitted by the formulation.

11. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating human papillomavirus (HPV) infection.