A traditional Chinese medicine composition, gel and preparation method and application for resisting male HPV infection
Anti-HPV gel was prepared by combining a specific herbal composition with a gel matrix, which solved the problem of existing drugs being incompatible with male genitalia. It achieved the effect of effectively inhibiting HPV virus and repairing mucous membranes, filling the gap in traditional Chinese medicine preparations specifically for men.
Patent Information
- Application Number
- CN202611266913.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-08-20
- Publication Date
- 2026-11-06
AI Technical Summary
Existing anti-HPV drugs are not compatible with male genitalia, and have problems such as large trauma, high recurrence rate, strong irritation and poor targeting. In addition, there is a lack of traditional Chinese medicine gel preparations specifically for male external genitalia.
Using Cnidium monnieri, Gallnut, Rhodiola rosea, Indigo naturalis, Dryopteris crassirhizoma, Talc, Polygonum cuspidatum, Chaenomeles speciosa, Borneol, and artificial bezoar as raw materials, the effective components are extracted by water extraction and alcohol precipitation, and then mixed with Carbomer 940 and glycerin to prepare a gel formulation suitable for male reproductive organs. The combination of cold and warm properties works to both attack and nourish, inhibiting HPV virus and repairing mucous membranes.
The prepared herbal gel has a significant inhibitory effect on HPV virus, is easy to use, has low irritation, high clinical efficacy, and low recurrence rate, making it suitable for external intervention for HPV infection of the male genitalia.
Smart Images
Figure SMS_1
Abstract
Description
Technical Field
[0001] This invention relates to the field of traditional Chinese medicine external preparations, and in particular to a traditional Chinese medicine composition, gel, preparation method and application for treating male HPV infection. Background Technology
[0002] Human papillomavirus (HPV) is a type of double-stranded circular DNA virus with high host specificity and tissue tropism. HPV infection in men can not only cause overt lesions such as genital warts and perianal warts, but also lead to subclinical and latent infections. This not only affects male reproductive health but can also be transmitted to partners through sexual contact, increasing the risk of cervical lesions in women. Currently, clinical interventions for male HPV infection are limited. Physical therapies (laser, cryotherapy, electrocautery) are highly invasive and have a high recurrence rate; chemical corrosives are highly irritating and unsuitable for delicate mucous membranes; and Western antiviral drugs are mostly broad-spectrum antivirals with poor specificity and problems such as local allergies and drug resistance.
[0003] Traditional Chinese medicine (TCM) topical preparations have the advantages of being gentle, safe, and addressing both the symptoms and root cause, demonstrating unique potential in antiviral, anti-inflammatory, mucosal repair, and reducing recurrence rates. Existing anti-HPV TCM preparations are mostly designed for the female vaginal environment, with moisturizing and sticky formulations that are not suitable for the dry, breathable needs of the male external genitalia. Furthermore, the formulas often focus on clearing heat and detoxifying, neglecting the characteristics of local mucosal repair, drying and healing sores, and promoting blood circulation and resolving lumps in men. There is a significant lack of TCM gel preparations specifically for male HPV infection.
[0004] Therefore, developing a traditional Chinese medicine gel for fighting HPV that is suitable for male physiological characteristics, has mild medicinal properties, strong antiviral targeting, low mucosal irritation, and is easy to use would fill a gap in clinical medication and have significant clinical value. Summary of the Invention
[0005] In view of this, the present invention provides a traditional Chinese medicine composition, gel, preparation method and application for combating male HPV infection, in order to solve the above problems.
[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution:
[0007] This invention provides a traditional Chinese medicine composition for combating male HPV infection, comprising the following components in parts by weight: 10-20 parts of Cnidium monnieri, 10-20 parts of Gallnut, 10-20 parts of Rhodiola rosea, 25-35 parts of Indigo naturalis, 15-25 parts of Dryopteris crassirhizoma, 10-20 parts of Talc, 15-25 parts of Polygonum cuspidatum, 15-25 parts of Chaenomeles speciosa, 3-7 parts of Borneol, and 2-4 parts of Artificial Calculus Bovis.
[0008] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 15 parts of Cnidium monnieri, 15 parts of Gallnut, 15 parts of Rhodiola rosea, 30 parts of Indigo naturalis, 20 parts of Dryopteris crassirhizoma, 15 parts of Talc, 20 parts of Polygonum cuspidatum, 20 parts of Chaenomeles speciosa, 5 parts of Borneol, and 3 parts of Artificial Calculus Bovis.
[0009] The present invention also provides a gel for treating male HPV infection, comprising an extract of the traditional Chinese medicine composition.
[0010] The present invention also provides a method for preparing the gel, comprising the following steps:
[0011] S1. Mix 10-20 parts of Cnidium monnieri, 10-20 parts of Gallnut, 10-20 parts of Rhodiola rosea, 15-25 parts of Dryopteris crassirhizoma, 15-25 parts of Polygonum cuspidatum, and 15-25 parts of Chaenomeles speciosa with water, heat and reflux to extract 2-2 times, and combine the filtrates.
[0012] S2. Concentrate the filtrate under reduced pressure to obtain an extract; mix the extract with an ethanol solution, let it stand, and recover the ethanol to obtain a traditional Chinese medicine extract;
[0013] S3. Grind 25-35 parts of indigo naturalis, 10-20 parts of talc, and 2-4 parts of artificial bezoar into powder and sift; dissolve borneol in ethanol solution;
[0014] S4. Add 4-6 parts of carbomer 940 to water to swell, add 18-22 parts of glycerol and 0.1-0.3 parts of ethylparaben, stir, and obtain a gel matrix;
[0015] S5. Mix the Chinese herbal extract, fine powder and matrix, stir, add borneol ethanol solution dropwise, stir until the ethanol evaporates, add water to 900~1100 parts, homogenize, and the product is obtained; the parts mentioned are mass parts.
[0016] Preferably, the mass-to-volume ratio of the total mass of Cnidium monnieri, Gallnut, Rhodiola rosea, Dryopteris crassirhizoma, Polygonum cuspidatum, and Chaenomeles speciosa to water in S1 is 1g:8~10.
[0017] Preferably, the reflux time for each heating cycle is 80-100 minutes.
[0018] Preferably, the extract is mixed with an ethanol solution to a concentration of 55-65% alcohol, wherein the concentration of the ethanol solution is 93-97%.
[0019] Preferably, the mass-to-volume ratio of the carbomer 940 to water is 1 g: 200 mL.
[0020] Preferably, the stirring speed is 300~500 rpm and the stirring time is 20~30 min.
[0021] Preferably, the homogenization pressure is 25 MPa, the homogenization temperature is 45°C, and the homogenization time is 10-15 min.
[0022] By adopting the above technical solution, the present invention has the following beneficial effects: The traditional Chinese medicine gel of the present invention uses Cnidium monnieri, Galla chinensis, Rhodiola rosea, Indigo naturalis, Dryopteris crassirhizoma, Talcum powder, Polygonum cuspidatum, Chaenomeles speciosa, Borneol, and artificial bezoar as raw materials, formulated in specific weight proportions, and the effective components are extracted by water extraction and alcohol precipitation, supplemented with a gel matrix suitable for male physiological characteristics. The formulation of the present invention is rigorous, possessing the effects of clearing heat and detoxifying, drying dampness and astringing sores, and repairing mucous membranes. It has a significant inhibitory effect on HPV virus. The gel formulation is mild and refreshing, with low irritation and convenient use; the preparation process is controllable and suitable for industrial production, and can be effectively used for external intervention of male genital HPV infection and warts, filling the gap in traditional Chinese medicine preparations specifically for male anti-HPV. Detailed Implementation
[0023] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.
[0024] The formula of this invention follows the traditional Chinese medicine treatment principles of "clearing heat and detoxifying, drying dampness and dispersing nodules, and promoting blood circulation and repairing," and is tailored to the pathogenesis of male HPV infection characterized by damp-heat accumulation and toxic stasis.
[0025] Indigo naturalis, Dryopteris crassirhizoma, and Polygonum cuspidatum are the principal herbs, which clear heat and detoxify, cool the blood and dry dampness, and fight viruses. They directly target the core of the HPV virus, inhibit viral replication, and eliminate local inflammatory reactions.
[0026] Cnidium monnieri, Gallnut, and Talc are used as auxiliary medicines to dry dampness and astringe sores, kill insects and relieve itching, shrink warts, improve the local moist environment in men, destroy the survival conditions of HPV virus, and relieve itching and foreign body sensation.
[0027] Rhodiola rosea and papaya are used as adjuvant herbs to invigorate blood and qi, repair mucous membranes, enhance local resistance, improve local microcirculation, promote the healing of damaged mucous membranes, and reduce the risk of recurrence.
[0028] Borneol and artificial bezoar are used as guiding drugs to clear heat and relieve pain, open the orifices and penetrate the skin, guide the medicine directly to the affected area, enhance drug permeability, relieve local stinging and redness, and improve the comfort of medication.
[0029] The formula combines warming and cooling properties, as well as attacking and tonifying effects. It effectively inhibits HPV virus and repairs damaged mucous membranes. The medicine is mild and non-irritating, suitable for the delicate mucous membranes of male external genitalia, and has no obvious toxic side effects.
[0030] Example 1
[0031] 1. Pretreatment of raw materials: Weigh out 15g of Cnidium monnieri, 15g of Gallnut, 15g of Rhodiola rosea, 20g of Dryopteris crassirhizoma, 20g of Polygonum cuspidatum, and 20g of Chaenomeles speciosa, wash, dry, and pulverize them, and pass them through a 40-mesh sieve for later use; grind 30g of Indigo naturalis, 15g of Talc powder, and 3g of Artificial Calculus Bovis into a fine powder, pass it through a 100-mesh sieve for later use; dissolve 5g of Borneol in 20mL of 95% ethanol for later use.
[0032] Water extraction and alcohol precipitation extraction: Crushed Cnidium monnieri, Gallnut, Rhodiola rosea, Dryopteris crassirhizoma, Polygonum cuspidatum, and Chaenomeles speciosa are put into an extraction tank, 8-10 times the amount of purified water is added, soaked for 1 hour, and heated under reflux for 1.5 hours each time. The extracts are combined, filtered, and the filtrate is concentrated under reduced pressure to a relative density of 1.10-1.15 (60℃). The extract is cooled, 95% ethanol is added to a concentration of 60%, and the mixture is allowed to stand for 24 hours. The extract is filtered, the ethanol is recovered from the filtrate, and the mixture is concentrated until there is no alcohol odor to obtain the Chinese herbal extract for later use.
[0033] Gel matrix preparation: Take 5g of carbomer 940 (gel matrix), sprinkle it on the surface of 1000 mL of deionized water, and allow it to swell fully for 12 hours until it is free of particles, uniform and transparent. Add 20g of glycerin (humectant) and 0.2g of ethylparaben (preservative), stir well, and adjust the pH value to 6.0 with triethanolamine (suitable for the physiological pH value of male local area) to obtain the gel matrix.
[0034] Mixing and filling: Add the Chinese herbal extract, indigo powder, talc powder, and artificial bezoar powder to the gel matrix and stir at 500 rpm for 20 min; slowly add borneol ethanol solution and continue stirring until the ethanol is completely evaporated; add purified water to 1000 g, homogenize and emulsify at 25 MPa and 45℃ for 10 min, fill, and sterilize to obtain the Chinese herbal composition gel for anti-male HPV infection.
[0035] The herbal composition gel is a dark blue, uniform gel with a pleasant aroma. It spreads well, has no grainy feel, and has a pH of 5.5-6.5, which is within the tolerance range of male local mucosa.
[0036] Example 2. Pharmacological verification of traditional Chinese medicine composition gel
[0037] This study included 60 male patients with persistent high-risk human papillomavirus (HPV) infection. All patients had a history of sexual activity and did not desire fertility during treatment; their ages ranged from 25 to 65 years, and the duration of illness ranged from 6 to 40 months. Based on whether they were infected with high-risk HPV subtypes 16 / 18, all cases were divided into the following two groups:
[0038] Treatment Group 1: The average course of disease was 10.5 months, and the high-risk HPV infection was high-risk type 16 / 18, with a total of 30 cases;
[0039] Treatment group 2: The average course of disease was 11.2 months. The high-risk HPV infection was a high-risk non-16 / 18 type infection, with a total of 30 cases.
[0040] Treatment methods:
[0041] The above-mentioned Chinese herbal medicine composition gel was applied evenly to the surface of the male genitalia once a day. Condoms were used during sexual intercourse. The treatment lasted for 3 months. After 3 months of continuous use, the medication was stopped for 1 month and a follow-up examination of the genital glans secretions was performed to check for HPV.
[0042] 2) Treatment judgment criteria
[0043] Cure: All high-risk HPV types in genital glans discharge have turned negative;
[0044] Effective: High-risk HPV infection types in genital glans penis secretions partially became negative, and the viral load value of HPV genotyping and quantitative detection decreased significantly;
[0045] Relapse: A follow-up examination should be conducted 3 months after stopping medication. If a high-risk HPV reinfection occurs and the HPV viral load is higher than before medication, the relapse should be investigated.
[0046] Table 1. Clinical trial results of the traditional Chinese medicine composition gel for treating male HPV.
[0047]
[0048] The data in Table 1 show that the traditional Chinese medicine composition gel for men provided by this invention can effectively treat HPV infection, with a total effective rate of 91.7% and a total cure rate of 70.0%, and a recurrence rate of less than 5% after 3 months of treatment. Compared with the traditional Chinese medicine compositions for treating male HPV disclosed in the prior art, the traditional Chinese medicine composition gel of this invention has a higher clinical efficacy, higher safety, fewer toxic side effects, and stronger ability to treat HPV.
[0049] As can be seen from the above embodiments, the present invention provides a traditional Chinese medicine composition, gel, preparation method and application for anti-male HPV infection. The traditional Chinese medicine gel of the present invention can be effectively used for external intervention of male genital HPV infection and warts, filling the gap in traditional Chinese medicine preparations for male anti-HPV.
[0050] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.
Claims
1. A traditional Chinese medicine composition for treating male HPV infection, characterized in that, The product contains the following components in parts by weight: 10-20 parts of Cnidium monnieri, 10-20 parts of Gallnut, 10-20 parts of Rhodiola rosea, 25-35 parts of Indigo naturalis, 15-25 parts of Dryopteris crassirhizoma, 10-20 parts of Talc, 15-25 parts of Polygonum cuspidatum, 15-25 parts of Chaenomeles speciosa, 3-7 parts of Borneol, and 2-4 parts of Artificial Calculus Bovis.
2. The traditional Chinese medicine composition according to claim 1, characterized in that, The product contains the following components in parts by weight: 15 parts of Cnidium monnieri, 15 parts of Gallnut, 15 parts of Rhodiola rosea, 30 parts of Indigo naturalis, 20 parts of Dryopteris crassirhizoma, 15 parts of Talc, 20 parts of Polygonum cuspidatum, 20 parts of Chaenomeles speciosa, 5 parts of Borneol, and 3 parts of Artificial Calculus Bovis.
3. A gel for treating male HPV infection, characterized in that, An extract comprising the traditional Chinese medicine composition of claim 1 or 2.
4. The method for preparing the gel according to claim 3, characterized in that, Includes the following steps: S1. Mix 10-20 parts of Cnidium monnieri, 10-20 parts of Gallnut, 10-20 parts of Rhodiola rosea, 15-25 parts of Dryopteris crassirhizoma, 15-25 parts of Polygonum cuspidatum, and 15-25 parts of Chaenomeles speciosa with water, heat and reflux to extract, and combine the filtrates. S2. Concentrate the filtrate under reduced pressure to obtain an extract; mix the extract with an ethanol solution, let it stand, and recover the ethanol to obtain a traditional Chinese medicine extract; S3. Grind 25-35 parts of indigo naturalis, 10-20 parts of talc, and 2-4 parts of artificial bezoar into powder and sift; dissolve borneol in ethanol solution; S4. Add 4-6 parts of carbomer 940 to water to swell, add 18-22 parts of glycerol and 0.1-0.3 parts of ethylparaben, stir, and obtain a gel matrix; S5. Mix the Chinese herbal extract, fine powder and matrix, stir, add borneol ethanol solution dropwise, stir until the ethanol evaporates, add water to 900~1100 parts, homogenize, and the product is obtained; the parts mentioned are mass parts.
5. The preparation method according to claim 4, characterized in that, The mass-to-volume ratio of the total mass of Cnidium monnieri, Gallnut, Rhodiola rosea, Dryopteris crassirhizoma, Polygonum cuspidatum, and Chaenomeles speciosa to water in S1 is 1g:8~10.
6. The preparation method according to claim 4, characterized in that, Extract by heating and reflux twice, with each heating and reflux time being 80~100min.
7. The preparation method according to claim 4, characterized in that, The extract is mixed with an ethanol solution to a concentration of 55-65% alcohol, wherein the concentration of the ethanol solution is 93-97%.
8. The preparation method according to claim 4, characterized in that, The mass-to-volume ratio of the carbomer 940 to water is 1 g: 200 mL.
9. The preparation method according to claim 4, characterized in that, The stirring speed is 300~500 rpm, and the stirring time is 20~30 min.
10. The preparation method according to claim 4, characterized in that, The homogenization pressure is 25 MPa, the homogenization temperature is 45°C, and the homogenization time is 10-15 min.