A traditional Chinese medicine composition for treating HPV infection, its preparation and uses.

Abstract

This invention discloses a traditional Chinese medicine composition for treating HPV infection, its preparation, and its uses. The composition comprises the following ingredients in the indicated weight percentages: 10-40 parts of *Hedyotis diffusa*, 10-30 parts of *Smilax glabra*, 10-30 parts of *Hedyotis diffusa*, 10-30 parts of *Paeonia suffruticosa*, 10-40 parts of *Lithospermum erythrorhizon*, 10-30 parts of *Dictamnus dasycarpus*, 10-30 parts of *Radix Paeoniae Rubra*, 10-30 parts of *Cicadae Periostracum*, 10-30 parts of *Astragalus membranaceus*, and 10-30 parts of *Glycyrrhiza uralensis*. It effectively inhibits the replication of human papillomavirus (HPV) nucleic acid, thereby effectively treating cervical HPV infection caused by HPV, as well as infectious skin diseases such as cervical precancerous lesions and condyloma acuminata caused by HPV infection.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and particularly to a traditional Chinese medicine composition for treating HPV infection, a traditional Chinese medicine preparation thereof, and uses thereof. Background Art

[0002] Human papillomavirus (HPV) is an epitheliotropic virus, a member of genus A of the family Papovaviridae. It is a small DNA virus that infects epidermal and mucosal squamous epithelium, with a diameter of 52 - 55 nm, no envelope, an icosahedral structure, 72 capsids on the surface, and its viral genome is a double-stranded circular DNA molecule. It is widely distributed in humans and has a high degree of specificity. More than 100 subtypes of HPV have been discovered so far. Low-risk HPV can cause a variety of benign lesions in the skin and mucosal areas, such as condyloma acuminata and skin warts. High-risk HPV is the primary factor leading to cervical cancer. Cervical cancer is one of the most common gynecological malignancies in developing countries.

[0003] In recent years, the high incidence of cervical cancer is seriously threatening the health and lives of women. Only by effectively clearing HPV can the occurrence of cervical cancer be efficiently prevented. The current preventive measure for cervical HPV infection in modern medicine is to inject vaccines, but the scope is limited, the price is expensive, and repeated injections are required. At present, there is no effective treatment for HPV infection. Injecting interferon has large toxic and side effects, a long treatment course, and a low cure rate, making it difficult to promote.

[0004] Condyloma acuminata (known as "sao you" or "sao hou" in traditional Chinese medicine), verruca vulgaris, etc. are all benign skin tumors caused by human papillomavirus (HPV) infecting through the slightly damaged skin and mucosa of the human body after a 3 - 5-month incubation period. Condyloma acuminata, also known as condyloma acuminata, genital warts, venereal warts, can cause common sexually transmitted diseases characterized by wart-like growths in the genital and anal areas, etc. This disease mostly occurs in the genitals and around the anus of men and women. Generally, it initially appears as only a pinhead-sized papule, light red, dark red or dirty gray, and then develops into papillary elevations, which fuse or overlap with each other, resembling cauliflower, being moist and soft, and often accompanied by varying degrees of itching.

[0005] With the in-depth clinical research, some drugs for treating the diseases caused by human papillomavirus mentioned above have also emerged on the market. Some of the existing drugs only address the symptoms without treating the root cause, some use expensive ingredients, and some are discontinued during application due to uncertain curative effects.

[0006] Therefore, in view of the above problems, it is necessary to provide a traditional Chinese medicine composition with a short treatment course, definite curative effects, good safety, and convenient use for treating the diseases caused by human papillomavirus. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating HPV infection, as well as the traditional Chinese medicine preparation and uses thereof, which has a short treatment course, definite curative effect, good safety and convenient use.

[0008] The technical solution adopted by the present invention to solve the above-mentioned technical problems is to provide a traditional Chinese medicine composition for treating HPV infection, comprising the following ingredients in the indicated weight amounts: 10-40 parts of Oldenlandia diffusa, 10-30 parts of Smilax glabra, 10-30 parts of Clematis armandii, 10-30 parts of Paeonia suffruticosa, 10-40 parts of Lithospermum erythrorhizon, 10-30 parts of Dictamnus dasycarpus, 10-30 parts of Paeonia lactiflora, 10-30 parts of Cicadae periostracum, 10-30 parts of Astragalus membranaceus, and 10-30 parts of Glycyrrhiza uralensis.

[0009] Preferably, the ingredients are composed of the following components in the indicated weight percentages: 30 parts Oldenlandia diffusa, 15 parts Smilax glabra, 10 parts Paeonia suffruticosa, 15 parts Clematis armandii, 10 parts Lithospermum erythrorhizon, 10 parts Dictamnus dasycarpus, 10 parts Paeonia lactiflora, 15 parts Cicadae periostracum, 15 parts Astragalus membranaceus, and 15 parts Glycyrrhiza uralensis.

[0010] Preferably, it also includes 15-30 parts of Anoectochilus roxburghii.

[0011] Preferably, it also includes 15-30 parts of yew.

[0012] To address the aforementioned technical problems, this invention also provides a traditional Chinese medicine preparation for treating HPV infection, the preparation comprising the aforementioned traditional Chinese medicine composition.

[0013] Preferably, the dosage form of the traditional Chinese medicine preparation includes decoction, pill, powder, paste, granule, oral liquid, capsule or tablet.

[0014] To solve the above-mentioned technical problems, the present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of drugs for the prevention and / or treatment of cervical HPV infection and cervical precancerous lesions caused by HPV infection.

[0015] To solve the above-mentioned technical problems, the present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for the prevention and / or treatment of condyloma acuminata.

[0016] Compared with existing technologies, this invention has the following beneficial effects: The traditional Chinese medicine composition, its preparation, and uses provided by this invention for treating HPV infection exhibit synergistic effects among its components. In particular, the addition of *Hypericum perforatum* (a type of medicinal herb) greatly enhances the ability to inhibit HPV viral replication, thereby strengthening the inhibition or elimination of HPV. It can effectively inhibit the replication of human papillomavirus nucleic acid, thus effectively treating cervical HPV infection caused by human papillomavirus and infectious skin diseases such as cervical precancerous lesions and condyloma acuminata caused by HPV infection from the source. Furthermore, it has significant advantages such as simple preparation method, convenient use (suitable for home use), definite efficacy, good safety, and short treatment course, especially with the treatment course shortened to one week, which is significantly more effective than similar products that often require several months of treatment. Detailed Implementation

[0017] The present invention will be further described in detail below through specific embodiments, but it should not be construed as limiting the scope of the present invention to the following embodiments.

[0018] The traditional Chinese medicine composition for treating HPV infection provided by this invention comprises the following ingredients in the indicated weight percentages: 10-40 parts of Hedyotis diffusa, 10-30 parts of Smilax glabra, 10-30 parts of Paeonia suffruticosa, 10-40 parts of Lithospermum erythrorhizon, 10-30 parts of Dictamnus dasycarpus, 10-30 parts of Paeonia lactiflora, 10-30 parts of Cicadae periostracum, 10-30 parts of Astragalus membranaceus, 10-30 parts of Glycyrrhiza uralensis, and 10-30 parts of Leonurus japonicus. Further, it also includes 15-30 parts of Taxus chinensis and 15-30 parts of Anoectochilus roxburghii.

[0019] The traditional Chinese medicine composition provided in this embodiment can be further formulated into traditional Chinese medicine preparations. The dosage forms of the traditional Chinese medicine preparations include decoctions, pills, powders, ointments, granules, oral liquids, capsules, or tablets, etc. Those skilled in the art can prepare various dosage forms for patients to use as needed.

[0020] The term "principal, assistant, adjuvant, and guide" refers to the different functions of each herb in a traditional Chinese medicine prescription. In the above-mentioned traditional Chinese medicine composition, the specific functions of each component are as follows:

[0021] Principal drug (the drug that plays a major therapeutic role against the primary disease or symptom):

[0022] Oldenlandia diffusa has a bitter and bland taste, and is cold in nature. Its main functions are clearing heat and detoxifying, relieving pain and dissipating nodules, and promoting diuresis and removing dampness. It is especially effective in treating various types of inflammation.

[0023] Smilax glabra (Tufuling) is sweet and bland in taste, and neutral in nature. It has the effects of detoxifying, removing dampness, and promoting joint mobility. It is mainly used for limb contractures and muscle and bone pain caused by syphilis and mercury poisoning; damp-heat urinary tract infections, leukorrhea, carbuncles, scrofula, and scabies.

[0024] Golden silk grass, also known as small lung grass, is bitter and sweet, and neutral in nature. Its main functions are clearing the lungs, resolving phlegm, relieving cough, promoting blood circulation, and killing parasites. It is primarily used to treat cough with hemoptysis, whooping cough, asthma, lung abscess, carbuncle, intestinal bleeding, insufficient lactation in women, amenorrhea, infantile malnutrition, and ascariasis. Small lung grass grows in shady, damp places in mountainous areas. Its leaves are slender and soft, and its roots contain numerous grains the size of wheat grains.

[0025] The addition of golden silk grass (small lung grass) to this formula greatly enhances its ability to inhibit HPV virus replication, thus strengthening the inhibition or elimination of HPV.

[0026] Assistant drugs (drugs that assist the principal drug in enhancing its therapeutic effect on the primary disease or symptom):

[0027] Moutan bark is pungent, sweet, and slightly cold. It clears heat and cools the blood, invigorates blood circulation, and removes blood stasis. It is used for febrile diseases with rashes, hematemesis, epistaxis, night fever with morning chills, steaming bone fever without sweating, amenorrhea, dysmenorrhea, carbuncles, boils, and injuries from falls.

[0028] Red purplish herb, sweet and cold in nature. It cools the blood and promotes blood circulation, detoxifies, and promotes rash eruption. It is used for sores, eczema, vulvar itching, malignant sores, tinea, and rashes and pox.

[0029] Dictamnus dasycarpus root bark, bitter and cold. It clears heat and detoxifies, eliminates dampness and relieves itching. It is used for damp-heat herpes, skin ulcers, itchy skin, swelling and pain in the vulva in women, and treats all kinds of heat-toxin wind, aggravated wind, wind sores, scabies, and red, festering sores.

[0030] Golden Thread Orchid (Anoectochilus roxburghii) has a neutral and sweet taste. It has the effects of clearing heat and cooling blood, dispelling wind and dampness, detoxifying, relieving pain, and suppressing cough. It is mainly used to treat hemoptysis, bronchitis, nephritis, cystitis, diabetes, hematuria, rheumatoid arthritis, tumors, and other difficult and complicated diseases.

[0031] Yew is bland and neutral in nature. It can be used to treat leukemia, nephritis, diabetes, and polycystic kidney disease. Paclitaxel in yew can be used to treat advanced breast cancer, lung cancer, ovarian cancer, head and neck cancer, soft tissue cancer, and digestive tract cancer.

[0032] Adding Anoectochilus roxburghii and Taxus chinensis can further enhance the ability to inhibit HPV virus replication and clear HPV.

[0033] Adjuvant drugs (drugs used in conjunction with principal and assistant drugs to enhance therapeutic effects or directly treat secondary or concurrent symptoms):

[0034] Red medicine, bitter and slightly cold. Clears heat and cools the blood, removes blood stasis and relieves pain. Used for treating painful swelling and toxicity.

[0035] Cicada slough, sweet and cold in nature. It dispels wind-heat, promotes rash eruption, improves eyesight and removes corneal opacity, and relieves wind-heat and pain. It is used for wind-heat syndrome, itchy skin, boils and carbuncles, and swelling of the genitals.

[0036] Astragalus membranaceus is sweet and slightly warm. It tonifies qi and raises yang, strengthens the defensive qi and consolidates the exterior, promotes tissue regeneration and detoxification, and promotes diuresis and reduces swelling. It is used for carbuncles and boils caused by qi and blood deficiency, especially those that do not ulcerate or have ulcers that are slow to heal.

[0037] Guiding herbs (metaphorical drugs, harmonizing herbs):

[0038] Licorice root is sweet and pungent. It tonifies the spleen and replenishes qi, and moderates the properties of other herbs. It is used for carbuncles, boils, and other skin infections, and to harmonize the effects of other medications.

[0039] The formula contains a total of 12 herbs, with clear distinctions between principal, assistant, adjuvant, and guide herbs, working synergistically to enhance efficacy.

[0040] In the first embodiment, the traditional Chinese medicine composition consists of the following ingredients in the indicated weight proportions: 30 parts of Hedyotis diffusa, 15 parts of Smilax glabra, 15 parts of Clematis armandii (small lung grass), 10 parts of Paeonia suffruticosa, 10 parts of Lithospermum erythrorhizon, 10 parts of Dictamnus dasycarpus, 10 parts of Paeonia lactiflora, 15 parts of Cicadae periostracum, 15 parts of Astragalus membranaceus, and 15 parts of Glycyrrhiza uralensis.

[0041] In the second embodiment, the traditional Chinese medicine composition consists of the following ingredients in the indicated weight percentages: 30 parts of Hedyotis diffusa, 15 parts of Smilax glabra, 15 parts of Clematis armandii (small lung grass), 10 parts of Paeonia suffruticosa, 10 parts of Lithospermum erythrorhizon, 10 parts of Dictamnus dasycarpus, 10 parts of Paeonia lactiflora, 15 parts of Cicadae periostracum, 15 parts of Astragalus membranaceus, 15 parts of Glycyrrhiza uralensis, 20 parts of Taxus chinensis, and 20 parts of Anoectochilus roxburghii.

[0042] Example 1

[0043] Using the traditional Chinese medicine composition provided in this embodiment, a pharmaceutical preparation for the prevention and / or treatment of cervical HPV infection and precancerous lesions of the cervix caused by HPV infection is prepared.

[0044] The following are case studies of the use of the traditional Chinese medicine preparation provided in this embodiment in the treatment of cervical HPV infection and cervical intraepithelial neoplasia caused by HPV infection:

[0045] 1. Select a hospital outpatient clinic for confirmation. If the pathological results are confirmed to be one of the following through liquid-based thin-film test (TCT), colposcopy, and histopathological examination: cervical HPV positive, cervical intraepithelial neoplasia (CIN1, CIN2).

[0046] 2 Treatment methods

[0047] All patients were treated outside of their menstrual period. The herbal composition preparation described in this example was applied to the cervix before bedtime, and the discharge was natural upon waking the next morning. Treatment was administered once daily for 7 consecutive days. A follow-up examination was conducted 3 months after discontinuation of treatment.

[0048] 3. Criteria for Evaluating Therapeutic Effect

[0049] 3.1 HPV infection

[0050] (1) Cured: HPV DNA retest result is negative.

[0051] (2) Invalid: HPV DNA retest result is positive.

[0052] 3.2 CIN Healing:

[0053] (1) Both TCT and HPV tests are negative. A colposcopy is performed. If no abnormalities are found under the colposcopy or a biopsy confirms the absence of CIN, the result is considered valid.

[0054] (2) Invalid: The pathological diagnosis of CIN1 or CIN2 remains unchanged after biopsy.

[0055] 3.3 Statistical analysis was performed using the χ² test. P < 0.05 was considered statistically significant.

[0056] 4. Results

[0057] Table 1. The effects of the traditional Chinese medicine composition provided in the first embodiment on cervical HPV infection and cervical intraepithelial neoplasia.

[0058]

[0059] One case that was still positive was tested negative after another 7 days of testing and 3 months later.

[0060] Conclusion: The traditional Chinese medicine preparation provided in the first embodiment has a significant effect on treating cervical HPV infection and cervical intraepithelial neoplasia caused by HPV infection.

[0061] Table 2. The effects of the traditional Chinese medicine composition provided in the second embodiment on cervical HPV infection and cervical intraepithelial neoplasia.

[0062]

[0063] The two cases that were still positive were tested negative after another 7 days of testing and 3 months later.

[0064] Conclusion: The traditional Chinese medicine preparation provided in the second embodiment is more effective than that in the first embodiment in treating cervical HPV infection and cervical intraepithelial neoplasia caused by HPV infection. The synergistic effect of the added Taxus chinensis, Anoectochilus roxburghii and other components further enhances the ability to inhibit HPV virus replication and the effect of clearing HPV virus.

[0065] Example 2

[0066] The traditional Chinese medicine composition provided by this invention is used to prepare a traditional Chinese medicine preparation for the prevention and / or treatment of condyloma acuminata.

[0067] The following is a case study of the use of the traditional Chinese medicine preparation provided in this embodiment in the treatment of condyloma acuminata:

[0068] 1. Select cases of condyloma acuminata on the external genitalia of men and women aged 18-65 years: the diameter of a single wart is <0.5cm, the number of warts is <5 (the diameter of the wart mass is <1cm), and the warts are located on the external genitalia or perianal area. They are divided into an experimental group and a control group, with 15 people in each group. The experimental group uses the traditional Chinese medicine composition prepared in the first embodiment of this application, and the control group uses imiquimod cream.

[0069] Exclusion criteria: Patients with skin diseases that would affect the evaluation; patients with severe liver or kidney dysfunction; patients allergic to imiquimod cream; patients who have received antiviral treatment.

[0070] 2. Test methods:

[0071] Experimental group: The traditional Chinese medicine preparation prepared in the first embodiment was applied directly to the wart and the surrounding 2cm area. It was applied twice daily for 7 consecutive days as one course of treatment. If the warts did not completely fall off after one course of treatment, a second course could be used, up to a maximum of two courses.

[0072] Control group: 5% imiquimod cream was applied to the wart and a 2cm area around it with a cotton swab three times a week, every other day, for 8 weeks.

[0073] Both groups of patients had follow-up visits once a week for a total of 3 weeks to observe the therapeutic effect.

[0074] 3. Results

[0075] A total of 30 subjects were actually enrolled, with 15 in the experimental group and 15 in the control group.

[0076] 3.1 Complete wart removal rate in the first course of treatment

[0077] Table 3: Comparison of complete wart removal rate in the first course of treatment with two different drugs

[0078]

[0079] 3.2: Statistics on Recurrence

[0080] The patients were examined weekly. After three weeks, no relapse cases were observed in the experimental group, while some patients in the control group were still on medication.

[0081] Conclusion: Statistical analysis of the complete wart shedding and recurrence rate in the experimental and control groups after different drug treatments showed that the traditional Chinese medicine preparation provided in the first embodiment was significantly effective in treating condyloma acuminata, with a short treatment course (within 7 days), complete wart shedding within one week, and a low recurrence rate.

[0082] In summary, the traditional Chinese medicine composition provided by this invention exhibits synergistic effects among its components. In particular, the addition of *Hypericum perforatum* (small lungwort) significantly enhances its ability to inhibit HPV viral replication, thereby strengthening the inhibition or elimination of HPV. It effectively inhibits human papillomavirus nucleic acid replication, thus treating cervical HPV infection caused by human papillomavirus and infectious skin diseases such as cervical precancerous lesions and condyloma acuminata caused by HPV infection at the source. Furthermore, it boasts significant advantages such as simple preparation method, convenient use (suitable for home use), definite efficacy, good safety, and short treatment course, especially with the treatment course shortened to one week, compared to similar products that often require several months of treatment, demonstrating remarkable efficacy.

[0083] Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications and improvements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be defined by the claims.

Claims

1. A traditional Chinese medicine composition for treating HPV infection, characterized in that, It is composed of the following ingredients in the indicated weight percentages: 10-40 parts Oldenlandia diffusa, 10-30 parts Smilax glabra, 10-30 parts Lungwort, 10-30 parts Paeonia suffruticosa, 10-40 parts Lithospermum erythrorhizon, 10-30 parts Dictamnus dasycarpus, 10-30 parts Paeonia lactiflora, 10-30 parts Cicadae periostracum, 10-30 parts Astragalus membranaceus, and 10-30 parts Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, It is composed of the following ingredients in the indicated weight percentages: 30 parts Oldenlandia diffusa, 15 parts Smilax glabra, 15 parts Lungwort, 10 parts Paeonia suffruticosa, 10 parts Lithospermum erythrorhizon, 10 parts Dictamnus dasycarpus, 10 parts Paeonia lactiflora, 15 parts Cicadae periostracum, 15 parts Astragalus membranaceus, and 15 parts Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, It also includes 15-30 doses of Anoectochilus roxburghii.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, It also includes 15-30 portions of yew.

5. A traditional Chinese medicine preparation for treating HPV infection, characterized in that, The traditional Chinese medicine preparation includes the traditional Chinese medicine composition according to any one of claims 1-4.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, The dosage forms of the traditional Chinese medicine preparations include decoctions, pills, powders, ointments, granules, oral liquids, capsules, or tablets.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a drug for the prevention and / or treatment of cervical HPV infection and cervical precancerous lesions caused by HPV infection.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicament for the prevention and / or treatment of condyloma acuminata.

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