Traditional Chinese medicine composition for treating high-risk HPV infection

Abstract

The invention belongs to the field of biological medicine, and relates to a traditional Chinese medicine composition for treating high-risk HPV infection. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: radix sophorae flavescentis, rhizoma smilacis glabrae, fructus cnidii, cyrtomium fortunei, dried alum, pericarpium zanthoxyli, cortex phellodendri and raw radix stemonae.

Description

Technical Field

[0001] This invention belongs to the field of biomedicine and relates to a traditional Chinese medicine composition for treating high-risk HPV infection. Background Technology

[0002] Cervical cancer (CC) is one of the most common malignant tumors among women worldwide, second only to breast cancer in incidence, posing a serious threat to women's reproductive health. The latest epidemiological data shows that approximately 500,000 new cases of cervical cancer are diagnosed globally each year, and it ranks fourth in both incidence and mortality among female malignant tumors. In my country, the incidence and mortality rates of cervical cancer remain high, with 131,500 new cases and at least 53,000 deaths annually. Persistent infection with high-risk human papillomavirus (HR-HPV) is a definite cause of precancerous lesions and cervical cancer. HPV-DNA can be detected in 100% of cervical cancer samples, fully demonstrating the strong correlation between HPV infection and the development of cervical cancer. Recent studies show that the overall HPV infection rate among women worldwide is 15%–20%, with a 21% infection rate of high-risk HPV types (such as HPV16, HPV18, HPV52, and HPV58). HPV infection rates are highest in sexually active women, reaching 30%–50%, with peak infection periods around age 20 and 40–50. These periods are crucial for women's work, studies, and reproductive health. Therefore, proactive prevention and treatment are essential. Infection rates vary significantly across regions and ethnicities, with rates exceeding 35% in women in Africa and Latin America, and 12%–25% in Asia. In my country, the HPV infection rate among women is approximately 16.8%, with high-risk types accounting for 11%–14%, and rates exceeding 80% in cervical inflammation and precancerous lesions. Furthermore, HPV infection rates in men are also on the rise. 90% of genital warts are caused by non-carcinogenic HPV types 16 and 11, commonly occurring on the genitals, urethra, perineum, perianal skin, anus, and scrotum, but can also occur in the conjunctiva, nasal cavity, oral cavity, and larynx. Therefore, HPV infection is a reproductive health challenge faced by both men and women. High morbidity and mortality rates are particularly pronounced in low- and middle-income countries, accounting for over 90% of the global burden. Currently, the main prevention and control measure worldwide is HPV vaccination.

[0003] To implement the "Vaccine Administration Law of the People's Republic of China" and the "Action Plan for Accelerating the Elimination of Cervical Cancer (2023-2030)," and to fully leverage the important role of vaccines in preventing and controlling HPV infection and cervical cancer, HPV vaccines will be included in the National Immunization Program starting November 10, 2025.

[0004] Currently, the main treatments for high-risk HPV infection include chemotherapy, physical therapy, and immunotherapy. Chemotherapy for HPV infection does not include high-risk HPV infection, and its clinical efficacy is uncertain; for example, interferon, imiquimod, and podophyllotoxin are not yet targeted. Physical therapy, such as laser, electrocautery, and cryotherapy, can remove lesions but cannot eradicate latent viruses, resulting in slow wound healing and scarring. Immunotherapy, including preventative vaccination or cytokine therapy, has some effect in prevention, but its efficacy against existing infections is limited, and it suffers from high costs and long treatment cycles; therapeutic vaccines are still in the clinical research stage. Commonly used physical or chemical removal methods can only remove local lesions and cannot fundamentally eliminate the virus, with a high recurrence rate. Therefore, it is essential to find a more targeted, effective, safe, and cost-effective traditional Chinese medicine treatment for high-risk HPV infection. Traditional Chinese medicine (TCM), a treasure of the Chinese nation, has played a vital role in the standardized three-tiered prevention and treatment of cervical cancer. Its principles of "prevention before disease occurs, prevention of disease progression, and prevention of recurrence after recovery," "adapting treatment to the time, place, and individual," and the holistic approach of "treating internal conditions by addressing external ones" utilize syndrome differentiation and treatment to adjust the Yin-Yang balance of the body's organs, thereby enhancing the body's overall and local immune function and improving the local immune microenvironment of the male and female reproductive organs, ultimately blocking persistent infection. Multiple studies have confirmed that TCM has synergistic, toxicity-reducing, and safe effects in the prevention and treatment of high-risk HPV infection and cervical cancer, and its use in both men and women can better reduce recurrence. However, with the deepening of clinical research, the high price and limited efficacy of currently available TCM preparations have led to discontinuation of use. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for the prevention and treatment of HPV infection.

[0006] The traditional Chinese medicine composition of the present invention is prepared from the following traditional Chinese medicine raw materials in parts by weight:

[0007] Sophora flavescens 15-60 parts, Smilax glabra 15-60 parts, Cnidium monnieri 7.5-30 parts, Dryopteris crassirhizoma 7.5-30 parts, Stemona japonica 7.5-30 parts, Phellodendron chinense 5-20 parts, Alum 5-20 parts, Zanthoxylum bungeanum 3-12 parts.

[0008] Preferably, the traditional Chinese medicine composition of the present invention is prepared from the following traditional Chinese medicine raw materials in parts by weight:

[0009] Sophora flavescens 28-32 parts, Smilax glabra 28-32 parts, Cnidium monnieri 14-16 parts, Dryopteris crassirhizoma 14-16 parts, Stemona japonica 14-16 parts, Phellodendron chinense 8-12 parts, Alum 8-12 parts, Zanthoxylum bungeanum 5-7 parts.

[0010] According to one embodiment, the traditional Chinese medicine composition of the present invention is prepared from the following parts by weight of traditional Chinese medicine raw materials:

[0011] 30 parts Sophora flavescens, 30 parts Smilax glabra, 15 parts Cnidium monnieri, 15 parts Dryopteris crassirhizoma, 15 parts Stemona japonica, 10 parts Phellodendron chinense, 10 parts dried alum, and 6 parts Zanthoxylum bungeanum.

[0012] The parts mentioned in this invention are by weight, which are units of weight and can be g or kg.

[0013] Another object of the present invention is to provide a method for preparing a traditional Chinese medicine composition.

[0014] Step 1. Aromatic water extraction: Take Sichuan pepper, and extract the aromatic water of Sichuan pepper by water distillation for 5 hours with 8 times the amount of water. Set aside the collected aromatic water; filter the mother liquor and set aside. Combine the residue with 6 other herbs such as Sophora flavescens and extract with water.

[0015] Step 2. Water extraction: Add 10 times the amount of water to the above-mentioned dregs and 6 other herbs, excluding alum, such as Sophora flavescens, and decoct for 1.5 hours each time, for a total of 2 extractions. Filter the decoction and concentrate it under reduced pressure to a relative density of about 1.25, and combine it with the aromatic water from Step 1.

[0016] Step 3. Dissolve the alum in warm water, add it to the water extract obtained in Step 2, adjust the pH to 7.0, refrigerate for 8-16 hours, centrifuge, collect the centrifuged liquid, finally add 2g of sorbic acid, add water to adjust the volume to 1000ml, mix well, dispense into containers, and the product is ready.

[0017] The pharmaceutical formulations of the present invention can be any pharmaceutically acceptable dosage form, including: oral, topical, and injectable dosage forms, such as: tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, capsules, hard capsules, soft capsules, oral liquids, lozenges, granules, powders, pills, powders, ointments, pills, suspensions, powders, solutions, injections, suppositories, ointments, plasters, creams, sprays, drops, and patches.

[0018] The pharmaceutical formulations of the present invention, when administered orally, may contain commonly used excipients such as binders, fillers, diluents, tableting agents, lubricants, disintegrants, colorants, flavoring agents, and humectants, and the tablets may be coated if necessary.

[0019] Suitable fillers include cellulose, mannitol, lactose, and other similar fillers. Suitable disintegrants include starch, polyvinylpyrrolidone, and starch derivatives, such as sodium glycolate starch. Suitable lubricants include, for example, magnesium stearate. Suitable pharmaceutically acceptable wetting agents include sodium lauryl sulfate.

[0020] Solid oral compositions can be prepared using common methods such as mixing, filling, and tableting. Repeated mixing allows the active ingredient to be distributed throughout compositions that use a large amount of filler.

[0021] Oral liquid formulations may take the form of aqueous or oily suspensions, solutions, emulsions, syrups, or elixirs, or may be a dry product that can be reconstituted with water or other suitable carriers before use. Such liquid formulations may contain conventional additives such as suspending agents, such as sorbitol, syrups, methylcellulose, gelatin, hydroxyethylcellulose, carboxymethylcellulose, aluminum stearate gel, or hydrogenated edible fats; emulsifiers, such as lecithin, dehydrated sorbitan monooleate, or gum arabic; non-aqueous carriers (which may include edible oils), such as almond oil, fractionated coconut oil, oily esters such as glycerol, propylene glycol, or ethanol; preservatives, such as methylparaben or propylparaben or sorbic acid; and, if desired, conventional flavorings or colorings.

[0022] For injectable formulations, the prepared liquid unit contains the active ingredient of this invention and a sterile carrier. Depending on the carrier and concentration, this compound can be suspended or dissolved. Solution preparation typically involves dissolving the active ingredient in a carrier, filtering and sterilizing it before filling it into a suitable vial or ampoule, and then sealing it. Excipients such as a local anesthetic, preservative, and buffer can also be dissolved in this carrier. To improve its stability, the composition can be frozen after filling into the vial, and water can be removed under vacuum.

[0023] The pharmaceutical formulation of the present invention may selectively incorporate a suitable pharmaceutically acceptable carrier during preparation. The pharmaceutically acceptable carrier is selected from: mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine ​​hydrochloride, thioglycolic acid, methionine, vitamin C, disodium EDTA, sodium calcium EDTA, carbonates, acetates, phosphates or aqueous solutions of monovalent alkali metals, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and its derivatives, alginate, gelatin, polyvinylpyrrolidone, glycerol, Twenty-80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, β-cyclodextrin, phospholipids, kaolin, talc, calcium stearate, magnesium stearate, etc.

[0024] Another object of the present invention is to provide the use of the pharmaceutical composition of the invention in a medicament for preventing and treating HPV infection.

[0025] The application mentioned here is for the treatment of high-risk HPV infection.

[0026] Currently, there are no drugs or products internationally that specifically treat or block persistent HPV infection. To address the limitations of existing treatments, this invention, based on prior real-world clinical trials, drug mechanism studies, and safety research, verifies efficacy and safety, and provides a traditional Chinese medicine composition for treating high-risk HPV infection. This composition possesses the effects of clearing heat and dampness, killing parasites and relieving itching, and promoting tissue regeneration. It is primarily used to treat high-risk human papillomavirus infection with damp-heat syndrome, leukorrhea, vulvar itching, vulvar sores, and urethral caruncle. This invention overcomes the limitations of other formulas that only treat a single type of high-risk HPV infection. Taking a holistic approach, it addresses the root cause, allowing the medication to directly act on the affected area through local application. Absorbed through the mucous membrane, it has a rapid onset of action, directly reaching the lesion. It is characterized by definite efficacy, reliable safety, and good patient compliance, making it suitable for widespread clinical application.

[0027] Targeting the characteristics of high-risk HPV infection and related lesions, and based on the principles of traditional Chinese medicine (TCM) syndrome differentiation and treatment, this invention selects eight Chinese medicinal herbs—Sophora flavescens, Smilax glabra, Cnidium monnieri, Dryopteris crassirhizoma, Stemona japonica, Phellodendron chinense, Alum, and Zanthoxylum bungeanum—and formulates them according to the principles of principal, assistant, adjuvant, and guiding herbs to create a TCM external wash with the effects of clearing heat and dampness, killing parasites and relieving itching, and promoting tissue regeneration. This invention's formula combines warming and cooling properties, effectively preventing and treating HPV infection by clearing heat and detoxifying, inhibiting viruses, improving the local environment, and regulating the vaginal microecology. Among them, Sophora flavescens is the principal herb, clearing heat and promoting diuresis, killing parasites and relieving itching, and is the core of the whole formula; Smilax glabra is the assistant herb, clearing heat and detoxifying, promoting diuresis and relieving strangury, and is combined with Sophora flavescens to enhance the effect of removing dampness and detoxifying; Cnidium monnieri is pungent and warm, killing parasites and relieving itching, so that cold and warm are balanced; Dryopteris crassirhizoma clears heat and detoxifies, kills parasites, and can prevent damp heat from damaging the collaterals; Stemona japonica is sweet, bitter and slightly warm, killing parasites and relieving itching, and is mild in nature; Phellodendron amurense is bitter and cold, purging fire, clearing heat and promoting diuresis, and strengthening the effect of removing dampness and detoxifying; Alum removes putrefaction and promotes tissue regeneration, astringes and consolidates, so as to stop leukorrhea and soothe the skin; Zanthoxylum bungeanum warms the middle, kills parasites and relieves itching. The whole formula is carefully formulated, taking into account the mutual restraint of cold and warm and the complementary effects, and can act on the key links of HPV infection through multiple targets: on the one hand, it improves the local microenvironment by clearing heat and drying dampness, detoxifying and removing blood stasis, inhibiting HPV replication and infection persistence; on the other hand, it restores normal cervical function by killing parasites and relieving itching, repairing epithelial mucosa, and promoting cervical epithelial regeneration.

[0028] After forty years of clinical trials, more than 200 complete retrospective clinical cases have been identified. In approximately 140 patients with damp-heat syndrome, the traditional Chinese medicine composition significantly alleviated vaginal itching, significantly improved abnormalities in vaginal discharge color, texture, and odor, increased HPV infection seroconversion and pathological reversal rates, and improved TCT results and vaginal microenvironment, indicating that the traditional Chinese medicine composition may have a certain adjuvant therapeutic effect on HPV infection. The traditional Chinese medicine composition of this invention is effective and safe in treating high-risk HPV infection. Furthermore, it restores the cervical barrier function and reproductive regulation after treatment. Simultaneous external washing by both men and women yields better results and is more effective in preventing recurrence. The preparation of this invention is mild and safe for external use; no serious adverse events directly related to the drug have been reported. Patient feedback and medical records show that no skin irritation, allergic reactions, or other systemic adverse reactions occurred after local application at conventional doses. It has good patient compliance and can be used as an adjunct or alternative treatment for HPV-related diseases such as cervicitis. Compared with other existing treatments, it has the characteristics of stable process, low cost, high performance, and can be used by both men and women, and has good prospects for industrial application. Detailed Implementation

[0029] The present invention will be further illustrated by the following examples.

[0030] The product and its preparation method according to the present invention will be further described below with reference to specific embodiments, but the present invention is not limited to the following embodiments. Unless otherwise specified, the methods described are conventional methods. Unless otherwise specified, the raw materials can be obtained from publicly available commercial sources.

[0031] Example 1: The pharmaceutical composition of the present invention

[0032] Weigh out 30 parts of Sophora flavescens, 30 parts of Smilax glabra, 15 parts of Cnidium monnieri, 15 parts of Dryopteris crassirhizoma, 15 parts of Stemona japonica, 10 parts of Phellodendron chinense, 10 parts of dried alum, and 6 parts of Zanthoxylum bungeanum.

[0033] Take Sichuan pepper and extract its aromatic water by water distillation for 5 hours with 8 times the amount of water. Set aside the collected aromatic water. Filter the distillate and set aside. Combine the residue with 6 other herbs including Sophora flavescens for water extraction. Add 10 times the amount of water to the residue and decoct for 1.5 hours each time, for a total of 2 extractions. Filter the decoction and concentrate it under reduced pressure to a relative density of approximately 1.25. Combine this with the Sichuan pepper aromatic water. Dissolve the alum in warm water and combine it with the water extract. Adjust the pH to 7.0, refrigerate for 8–16 hours, centrifuge, collect the centrifuged liquid, add 2g of sorbic acid, adjust the volume to 1000ml with water, mix well, and dispense into containers.

[0034] Example 2: The pharmaceutical composition of the present invention

[0035] Weigh out 28 parts of Sophora flavescens, 28 parts of Smilax glabra, 14 parts of Cnidium monnieri, 14 parts of Dryopteris crassirhizoma, 14 parts of Stemona japonica, 8 parts of Phellodendron chinense, 8 parts of dried alum, and 5 parts of Zanthoxylum bungeanum.

[0036] Take Sichuan pepper and extract its aromatic water by water distillation for 5 hours with 8 times the amount of water. Set aside the collected aromatic water. Filter the distillate and set aside. Combine the residue with 6 other herbs including Sophora flavescens for water extraction. Add 10 times the amount of water to the residue and decoct for 1.5 hours each time, for a total of 2 extractions. Filter the decoction and concentrate it under reduced pressure to a relative density of approximately 1.25. Combine this with the Sichuan pepper aromatic water. Dissolve the alum in warm water and combine it with the water extract. Adjust the pH to 7.0, refrigerate for 8–16 hours, centrifuge, collect the centrifuged liquid, add 2g of sorbic acid, adjust the volume to 1000ml with water, mix well, and dispense into containers.

[0037] Example 3: The pharmaceutical composition of the present invention

[0038] Weigh out 32 parts of Sophora flavescens, 32 parts of Smilax glabra, 16 parts of Cnidium monnieri, 16 parts of Dryopteris crassirhizoma, 16 parts of Stemona japonica, 12 parts of Phellodendron chinense, 12 parts of dried alum, and 7 parts of Zanthoxylum bungeanum.

[0039] Example 4: Evaluation of the efficacy of treatment for HPV infection

[0040] The efficacy experiment was conducted on the traditional Chinese medicine external wash prepared in Example 1 of this invention. HPV-infected patients were divided into two groups, with the sample size allocated in a 2:1 ratio. There were 60 cases in the experimental group and 30 cases in the blank control group. The age range was 22-45 years. The method of use was as follows: (1) Experimental group: After washing the vulva with clean water, 1000ml of medicine solution (200ml of concentrated medicine solution plus 800ml of boiling water, placed in a special measuring container) was selected at a temperature of about 38-40℃ or a temperature that suited the individual's requirements. (The temperature sensor patch was attached to the outside of the sitz bath device (the device that can correctly sense the temperature patch), ensuring that it was attached tightly. The color change of the temperature sensor patch was observed. When the water temperature was displayed as 40℃, it indicated that the temperature was suitable.) The vulva was fumigated for 3-5 minutes. The sitz bath should not exceed 5 minutes. The treatment was carried out once in the morning and once in the evening. The medicine solution was for single use and could not be reused. The sitz bath device should be used separately. (2) Control group: The subjects in the blank control group did not receive any drug treatment and were observed for 3 months. Discontinue medication during menstruation and observe for one course of treatment (each course of treatment for menstruating patients is 3 menstrual cycles; each course of treatment for postmenopausal or non-menstrual patients is 3 months). According to the menstrual cycle, 14 days is used as one visit point. During medication, sexual intercourse should be conducted correctly using contraception. The standards for diagnosis and treatment efficacy of diseases and syndromes in traditional Chinese medicine and the revised standards of the Third Academic Conference of the Gynecology Professional Committee of the Chinese Association of Integrated Traditional and Western Medicine were formulated. Clinical treatment is divided into total effective rate of clinical treatment and cure, effectiveness and ineffectiveness for statistical analysis. (1) Evaluation of total effective rate of clinical treatment: Total effective rate (%) = (cure + effectiveness) / total number of people x 100% (2) Evaluation of cure, effectiveness and ineffectiveness based on the main efficacy indicator of HPV negative conversion.

[0041] Criteria for determining HPV seroconversion: Negative HPV DNA test result;

[0042] Cured: All HPV infections have turned negative;

[0043] Effective: At least one HPV subtype among all infected HPV subtypes becomes negative;

[0044] Ineffective: No significant improvement was observed in HPV infection.

[0045] HPV seroconversion rate = (Number of HPV seroconversion cases / Total number of cases) × 100%.

[0046] Group Number of cases cure efficient invalid Cure rate + effectiveness rate (%) experimental group 60 18 36 4 93.3% Blank control group 30 0 0 30 0

[0047] Example 5:

[0048] Case 1, General Information: Liu, female, 28 years old, initial visit: December 3, 2024.

[0049] Chief complaint: HPV infection was discovered during a physical examination 1 year ago.

[0050] Present Illness: One year ago, screening revealed 12 types of high-risk HPV (+), TCT: ASCUS, colposcopy, pathology report: cervix: HSIL / CIN2. LMP: November 18th, 5 days of discharge, moderate amount, dark in color, dysmenorrhea (-), blood clots (+). Gynecological Examination: Vulva unobstructed, cervical contact bleeding, copious yellow discharge with an odor, no abnormalities found in the uterus and adnexa. Current Symptoms: Occasional fatigue, copious yellow vaginal discharge, occasional itching, dry mouth with thirst, normal sleep, easily awakened, difficulty falling back asleep, normal appetite, poor digestion, bowel movements every 2-3 days, normal urination, dark red tongue with thin yellow coating, and a thready, slippery pulse.

[0051] Diagnosis: Traditional Chinese Medicine diagnosis: Leukorrhea; Western Medicine diagnosis: High-risk HPV infection; High-grade squamous intraepithelial lesion of the cervix;

[0052] Treatment: Clear heat and promote diuresis, kill parasites and relieve itching, remove necrotic tissue and promote tissue regeneration.

[0053] Prescription: Example 1.

[0054] 28 doses, one dose per day, each dose decocted twice, for a total of 2000ml, divided into 1000ml for external washing in the morning and evening.

[0055] After rinsing the vulva with clean water, add 1000ml of the medicated solution (200ml of concentrated medicated solution to 800ml of boiling water, placed in a dedicated measuring container) to a temperature of approximately 38-40℃ or as desired by the individual. (Attach the temperature sensor to the outside of the sitz bath device (the device should be able to accurately detect the temperature), ensuring a tight fit. Observe the color change of the temperature sensor; when the water temperature shows 40℃, the temperature is suitable.) Soak the vulva for 3-5 minutes. The sitz bath should not exceed 5 minutes, twice a day, morning and evening. The medicated solution is for single use only and cannot be reused. The sitz bath device must be used separately.

[0056] Second consultation: The patient reported that the amount of vaginal discharge had decreased significantly, the dry mouth had been relieved, and all symptoms had been significantly relieved. The prescription was deemed effective and would not be changed.

[0057] Third visit: The patient returned for a follow-up visit at the outpatient clinic. He reported that after 3 months of external washing with traditional Chinese medicine, his HPV and TCT tests were normal. The patient was advised to avoid overexertion, maintain a happy mood, exercise appropriately, strengthen his physique, and have regular check-ups.

[0058] Case 2: Ms. Wang, female, 36 years old, initial consultation date: May 24, 2022

[0059] Chief complaint: Recurrent vaginal discharge for 1 year, HPV18 positive for 1 year.

[0060] Present Illness: One year ago, a physical examination revealed HPV 18 (+), TCT (-), LMP: May 14th, 5 days of discharge, moderate amount, dark in color, no dysmenorrhea, blood clots (+). The patient routinely experiences recurrent, profuse, yellow, thick vaginal discharge, occasional vaginal itching, bleeding after intercourse, lower abdominal distension, sticky stools, and frequent urination. The tongue is red with a yellow, greasy coating, and the pulse is wiry and slippery. Gynecological examination: Cervical hypertrophy with mild erosion-like changes and contact bleeding.

[0061] Diagnosis: Traditional Chinese medicine diagnosis: leukorrhea; Western medicine diagnosis: high-risk HPV infection.

[0062] Treatment: Clear heat and promote diuresis, kill parasites and relieve itching, remove necrotic tissue and promote tissue regeneration.

[0063] Prescription: Example 1.

[0064] 28 doses, one dose per day, each dose decocted twice, for a total of 2000ml, divided into 1000ml for external washing in the morning and evening.

[0065] After rinsing the vulva with clean water, add 1000ml of the medicated solution (200ml of concentrated medicated solution to 800ml of boiling water, placed in a dedicated measuring container) to a temperature of approximately 38-40℃ or as desired by the individual. (Attach the temperature sensor to the outside of the sitz bath device (the device should be able to accurately detect the temperature), ensuring a tight fit. Observe the color change of the temperature sensor; when the water temperature shows 40℃, the temperature is suitable.) Soak the vulva for 3-5 minutes. The sitz bath should not exceed 5 minutes, twice a day, morning and evening. The medicated solution is for single use only and cannot be reused. The sitz bath device must be used separately.

[0066] Second visit: The patient reported that the above symptoms were relieved after taking the medication, the amount of vaginal discharge was normal, there was no bleeding after intercourse in this menstrual cycle, the tongue was pale red and the coating was thin and yellow, so the previous treatment was continued.

[0067] Third visit: After three months of external washing with traditional Chinese medicine, the patient's symptoms disappeared. Follow-up gynecological examination: Cervical hypertrophy, surface still smooth, no active bleeding or abnormal growths observed. HPV had turned negative. The traditional Chinese medicine was discontinued, and the patient was instructed to pay attention to vulvar hygiene, regulate emotions, maintain a light diet, and attend follow-up examinations as scheduled.

[0068] Case 3: Ms. Dong, female, 33 years old, initial consultation date: September 16, 2023

[0069] Chief complaint: Tested positive for HPV16 more than one year ago.

[0070] Present Illness: HPV 16 (+) was detected during a physical examination in 2022. TCT (-), LMP: September 8th, 5 days postpartum, moderate amount, red color, dysmenorrhea (-), blood clots (+). Gynecological Examination: Vulva unobstructed, cervical contact bleeding, copious yellow discharge with odor, thickened bilateral adnexa. Patient reports copious yellow, thin, odorless vaginal discharge and vaginal itching. Other symptoms include aversion to cold, fatigue, poor appetite, normal sleep, lower back pain and coldness, lower abdominal pain, yellow urine, normal bowel movements, red tongue with petechiae, yellow and greasy tongue coating, and slippery pulse.

[0071] Diagnosis: Traditional Chinese medicine diagnosis: leukorrhea; Western medicine diagnosis: high-risk HPV infection.

[0072] Treatment: Clear heat and promote diuresis, kill parasites and relieve itching, remove necrotic tissue and promote tissue regeneration.

[0073] Prescription: Example 1.

[0074] 28 doses, one dose per day, each dose decocted twice, for a total of 2000ml, divided into 1000ml for external washing in the morning and evening.

[0075] After rinsing the vulva with clean water, add 1000ml of the medicated solution (200ml of concentrated medicated solution to 800ml of boiling water, placed in a dedicated measuring container) to a temperature of approximately 38-40℃ or as desired by the individual. (Attach the temperature sensor to the outside of the sitz bath device (the device should be able to accurately detect the temperature), ensuring a tight fit. Observe the color change of the temperature sensor; when the water temperature shows 40℃, the temperature is suitable.) Soak the vulva for 3-5 minutes. The sitz bath should not exceed 5 minutes, twice a day, morning and evening. The medicated solution is for single use only and cannot be reused. The sitz bath device must be used separately.

[0076] Second visit: The lower abdominal pain has subsided, and the amount of vaginal discharge has decreased compared to before. Occasional vaginal itching, yellowish-white in color, is still present. Continue using the above external application. The patient was advised to maintain a regular sleep schedule, eat a balanced diet, increase exercise, and keep a cheerful mood.

[0077] Third visit: After 3 months of external application of traditional Chinese medicine, the patient reported that all symptoms had disappeared, and a follow-up HPV test was negative.

[0078] Example 6: The traditional Chinese medicine composition of the present invention

[0079] Sophora flavescens 15 parts, Smilax glabra 15 parts, Cnidium monnieri 7.5 parts, Dryopteris crassirhizoma 7.5 parts, dried alum 5 parts, Zanthoxylum bungeanum 3 parts, Phellodendron chinense 5 parts, Stemona japonica 7.5 parts.

[0080] Example 7: The traditional Chinese medicine composition of the present invention

[0081] 60 parts of Sophora flavescens, 60 parts of Smilax glabra, 30 parts of Cnidium monnieri, 30 parts of Dryopteris crassirhizoma, 20 parts of dried alum, 12 parts of Zanthoxylum bungeanum, 20 parts of Phellodendron chinense, and 30 parts of Stemona japonica.

[0082] Other embodiments of the present invention can also achieve the same or similar therapeutic effects as Embodiment 1, and will not be described in detail here for the sake of saving space.

[0083] The above description is merely a preferred embodiment of the present invention. It should be noted that the embodiments of the present invention are not limited to the described embodiments. Various changes, modifications, substitutions, combinations, and simplifications can be made without departing from the principle of the present invention, and all such substitutions should be considered equivalent replacements and should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for preventing and treating HPV virus infection, characterized in that, It is prepared from the following weight parts of traditional Chinese medicine raw materials: Sophora flavescens 15-60 parts, Smilax glabra 15-60 parts, Cnidium 7.5-30 parts, Cyrtomium fortunei 7.5-30 parts, Radix Stachyuri 7.5-30 parts, Phellodendron amurense 5-20 parts, Nitril 5-20 parts, Zanthoxylum bungeanum 3-12 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is prepared from the following weight parts of traditional Chinese medicine raw materials: Sophora flavescens 28-32 parts, Smilax glabra 28-32 parts, Cnidium 14-16 parts, Cyrtomium fortunei 14-16 parts, Radix Stachyuri 14-16 parts, Phellodendron amurense 8-12 parts, Nitril 8-12 parts, Zanthoxylum bungeanum 5-7 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, It is prepared from the following weight parts of traditional Chinese medicine raw materials Sophora flavescens 30 parts, Smilax glabra 30 parts, Cnidium 15 parts, Cyrtomium fortunei 15 parts, Radix Stachyuri 15 parts, Phellodendron amurense 10 parts, Nitril 10 parts, Zanthoxylum bungeanum 6 parts.

4. The traditional Chinese medicine composition of any one of claims 1-3, characterized in that, It can be any pharmaceutically acceptable dosage form, including: oral, external use, injection dosage form, tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, capsules, hard capsules, soft capsules, oral liquids, oral, granules, infusion, pills, powders, pastes, pills, suspensions, powders, solutions, injections, suppositories, ointments, plasters, creams, sprays, drops, patches.

5. The traditional Chinese medicine composition of claim 4, characterized in that, In the preparation of medicine, the appropriate pharmaceutically acceptable carrier can be optionally added, which is selected from the following: mannitol, sorbitol, sodium pyrosulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, mercaptoacetic acid, methionine, vitamin C, disodium EDTA, calcium sodium EDTA, monovalent alkali metal carbonate, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and its derivatives, alginate, gelatin, polyvinylpyrrolidone, glycerol, Tween 80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, β-cyclodextrin, phospholipid material, kaolin, talc, calcium stearate, magnesium stearate.

6. The preparation method of the traditional Chinese medicine composition of claim 1, comprising the following steps: Step 1. Aromatic water extraction: take Zanthoxylum bungeanum, steam distillation extraction of Zanthoxylum bungeanum aromatic water under 8 times the amount of water for 5 hours, and the collected aromatic water is prepared for use; filter the distillation mother liquor for use, and the residue is combined with Sophora flavescens and other 6 kinds of medicine for water extraction; Step 2. Water extraction part: the above residue and Sophora flavescens and other 6 kinds of medicine except Nitril are added with 10 times the amount of water, and decocted for 1.5 hours each time, a total of 2 times, the filtrate is filtered, concentrated to a relative density of about 1.25 under reduced pressure, and combined with the aromatic water in step 1; Step 3. Warm water is used to melt Nitril, which is added to the water extraction part obtained in step 2, the PH is adjusted to 7.0, and the mixture is refrigerated for 8-16 hours, centrifuged, and the centrifugal liquid is taken, finally 2g of sorbic acid is added, the volume is adjusted to 1000ml with water, mixed uniformly, and then divided into portions to obtain the product.

7. The application of the traditional Chinese medicine composition of claim 1 in the preparation of a medicine for preventing and / or treating HPV virus infection.

8. The use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicament for preventing and / or treating high-risk HPV virus infection.