A traditional Chinese medicine composition for anti-HPV virus and its related applications

Abstract

The present invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for anti-HPV virus and its related applications. As a medicine for the treatment and prevention of HPV infection, the traditional Chinese medicine composition takes clearing heat and detoxifying, expelling toxins outwards, removing stasis and promoting new growth as the main treatment principles, and comprises the following raw materials: indigo naturalis, coptis chinensis, polygonum cuspidatum, talc, astragalus membranaceus, liquorice, saxicola undulata, gleditsia sinensis thorn, bletilla striata, chaenomeles sinensis, dragon's blood and borneol. The composition of the present invention has been clinically used for more than 5 years and is found to have a good effect on clearing high-risk HPV infection in the cervix and vagina. The clearance rate can reach more than 80% after 3 to 6 months of clinical local medication, indicating that the traditional Chinese medicine composition has an anti-HPV virus effect. After being wrapped by nanomaterials, the traditional Chinese medicine composition can effectively protect the active molecule while slowly and continuously exerting its efficacy, effectively clearing the cervix and playing an anti-HPV virus role.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions, and relates to a traditional Chinese medicine composition wrapped with an external nano material, and particularly relates to a traditional Chinese medicine composition for anti-HPV virus and its related applications. Background Art

[0002] Human papillomavirus (HPV) is a type of DNA virus that infects human skin and mucous membranes through direct or indirect contact. Among them, high-risk human papillomavirus infection is the main factor leading to vaginal and cervical precancerous lesions and vaginal and cervical cancers. At present, about more than 160 types of HPV have been identified, of which about 40 types are related to female genital tract infections. 14 high-risk types of HPV have been determined to be related to the incidence of cervical cancer in women. Long-term infection with the same subtype of high-risk HPV can induce cervical intraepithelial lesions or cervical cancer. Cervical cancer is the fourth most common malignant tumor in women globally and ranks second among the fastest-growing malignant tumors, seriously threatening women's health.

[0003] At present, it can be determined that persistent high-risk HPV infection is the direct cause of cervical cancer. Preventing and treating high-risk HPV infection is the key and effective blocking method for preventing and controlling vaginal and cervical lesions, and is also the key content for preventing and controlling cervical cancer.

[0004] At present, there are few drugs for treating HPV infection, and there are no specific drugs or definitely effective methods. Generally, it is local treatment with recombinant interferon and traditional Chinese medicine extracts. However, there are still few drugs for treating high-risk HPV infection in the vagina and cervix, and the curative effect is not good, and it is easy to have recurrence, side effects and drug resistance. For example, some studies have combined recombinant human interferon α-2b vaginal effervescent tablets (RHIα2b-VEC) with Baofukang Suppository to treat cervical precancerous lesions (CIN). The effective rate of HPV clearance is 63.64%, and the comprehensive treatment effective rate is 60.61%. The administration method is local vaginal administration, but the drug needs to be inserted into the posterior fornix of the vagina, which has a certain operation difficulty for patients, and the treatment effective rate is not ideal. There are also other technical solutions that disclose traditional Chinese medicine compositions for treating cervical precancerous lesions. This solution uses a combination of mild drugs, which can not only treat cervical precancerous lesions but also avoid damage to women's health. However, this drug is an oral preparation and needs to be taken for a long time with slow onset, and the clinical effective rate is 76%. Summary of the Invention

[0005] In order to solve the above problems, the present invention provides a traditional Chinese medicine composition for anti-HPV virus and its related applications. To achieve the above object, the present invention provides the following technical solutions:

[0006] The present invention provides a traditional Chinese medicine composition for anti-HPV virus, and the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15-30 parts of indigo naturalis, 5-10 parts of coptis chinensis, 5-15 parts of polygonum cuspidatum, 10-20 parts of talc, 10-20 parts of astragalus membranaceus, 1-5 parts of liquorice, 10-15 parts of saxicola undulata, 5-10 parts of gleditsia sinensis thorn, 5-10 parts of bletilla striata, 5-10 parts of papaya, 1-5 parts of dragon's blood and 1-3 parts of borneol.

[0007] The present invention also provides a traditional Chinese medicine composition, and the traditional Chinese medicine composition is preferably composed of the following raw materials in parts by weight: 15-25 parts of indigo naturalis, 5-8 parts of coptis chinensis, 5-15 parts of polygonum cuspidatum, 10-15 parts of talc, 10-15 parts of astragalus membranaceus, 1-3 parts of liquorice, 10-13 parts of saxicola undulata, 5-8 parts of gleditsia sinensis thorn, 5-8 parts of bletilla striata, 5-7 parts of papaya, 1-4 parts of dragon's blood and 1-2 parts of borneol. Further, it is composed of the following raw materials in parts by weight: 23 parts of indigo naturalis, 7 parts of coptis chinensis, 15 parts of polygonum cuspidatum, 17 parts of talc, 15 parts of astragalus membranaceus, 3 parts of liquorice, 12 parts of saxicola undulata, 7 parts of gleditsia sinensis thorn, 8 parts of bletilla striata, 7.5 parts of papaya, 3 parts of dragon's blood and 2 parts of borneol.

[0008] In the present invention, the indigo naturalis, talc, astragalus membranaceus, liquorice, bletilla striata, papaya and dragon's blood are preferably common commercially available powders.

[0009] The present invention also provides the application of the above traditional Chinese medicine composition in the preparation of products for anti-HPV virus, and the dosage forms of the products include powders, capsules, suppositories, powders and tablets.

[0010] The present invention provides a preparation for anti-HPV virus, and the preparation includes the above traditional Chinese medicine composition.

[0011] The present invention also provides the application of the above preparation in the preparation of products for anti-HPV virus.

[0012] The present invention provides a preparation method of a preparation for anti-HPV virus, and the preparation method includes the following steps:

[0013] (1) Grab raw materials according to the above description;

[0014] (2) Take indigo naturalis, coptis chinensis, polygonum cuspidatum, astragalus membranaceus, liquorice, salvia chinensis, gleditsia sinensis thorn and papaya from the raw materials. Divide indigo naturalis into two equal parts. After weighing the first part of indigo naturalis, coptis chinensis, polygonum cuspidatum, astragalus membranaceus, liquorice, salvia chinensis, gleditsia sinensis thorn and papaya, add 8 - 10 times the weight of water and boil until boiling, and maintain the boiling state. Boil for 1.5 hours for the first time to obtain a mixture. After the mixture is cooled to room temperature, conduct a second boiling for 1 hour. After the second boiling is completed, filter to remove the residue to obtain a filtrate. After cooling the filtrate to 65°C, add the second part of indigo naturalis, talc, bletilla striata, dragon's blood and borneol and mix evenly to obtain a mixture. The mixture is subjected to a first concentration treatment to obtain an ointment, and the ointment is subjected to a second concentration, evaporation and drying at 50°C - 70°C to obtain a dry extract;

[0015] In the present invention, the dry extract powder can be used as the basic raw material for preparing capsules, suppositories, powders and tablets clinically;

[0016] (3) Grind the dry extract to obtain fine powder; in the present invention, the particle size of the fine powder is 120 - 200 mesh;

[0017] (4) Perform ultrafine comminution on the fine powder to obtain ultrafine powder; in the present invention, the particle size of the ultrafine powder is 400 - 600 mesh;

[0018] (5) Mix the ultrafine powder with the nanomaterial and then conduct freeze-drying treatment to obtain a traditional Chinese medicine composition wrapped by the nanomaterial, namely the preparation for anti-HPV virus; in the present invention, the mass ratio of the ultrafine powder to the nanomaterial is 1:1.

[0019] The traditional Chinese medicine composition provided by the present invention takes clearing heat and detoxifying, expelling toxins outward, removing stasis and promoting new growth as the main treatment principles, and the effects of each component are as follows:

[0020] Indigo naturalis: cold in nature, having the effects of clearing heat and purging fire, cooling blood and detoxifying, treating ulcers, anti-tumor, etc., insoluble in water, and directly using the powder clinically;

[0021] Coptis chinensis: bitter and cold, having the effects of clearing heat and drying dampness, purging fire and detoxifying, and the main active ingredient is berberine, having antibacterial and antiviral effects;

[0022] Polygonum cuspidatum: slightly bitter and cold, having the effect of promoting blood circulation to remove stasis and relieve pain, and modern research shows that it has antiviral and anti-tumor effects;

[0023] Salvia chinensis (also known as purple ginseng): slightly bitter and pungent, having the effects of clearing heat and promoting diuresis, detoxifying and detumescence, and modern research shows that it has anti-tumor effects;

[0024] Astragalus membranaceus: sweet and warm, having the effects of replenishing qi and consolidating the exterior, expelling toxins and promoting granulation, and modern research shows that it has the effect of promoting wound healing;

[0025] Bletilla striata: bitter and astringent, having the effects of arresting bleeding by astringents, detumescence and promoting granulation, and modern research shows that it can promote the healing of rotten wounds;

[0026] Talcum: sweet and bland, with the efficacy of clearing heat and detoxifying, removing dampness and astringing sores, and promoting diuresis and draining turbidity;

[0027] Gleditsia spine: pungent and warm, with the efficacy of detumescence and discharging toxins, and draining pus to conduct medicine to the affected area of sores;

[0028] Chaenomeles fruit: sour and warm, with the efficacy of relaxing tendons and activating collaterals. Modern research shows that it has anti-tumor and antibacterial effects;

[0029] Dragon's blood: sweet and flat, with the efficacy of promoting blood circulation to remove stasis, stopping bleeding and promoting granulation;

[0030] Borneol: pungent and cold, with the efficacy of clearing heat and relieving pain, and dispersing fire and detumescence;

[0031] Licorice root: sweet and flat, with the efficacy of clearing heat and detoxifying, and coordinating various medicines;

[0032] The preparation for anti-HPV virus provided by the present invention involves using a nanomaterial of methoxypolyethylene glycol of polycaprolactone. The nanomaterial is an amphiphilic polymer, and the polyethylene glycol segment in it is not easy to fall off. In an aqueous environment, it can cover the surface of the nanoparticles, enhance the hydrophilicity of the nanoparticles, reduce the rate and degree of uptake by the reticuloendothelial system, prolong the circulation time in the body, improve the bioavailability, and further improve the blood-activating, anti-inflammatory and antibacterial properties, especially improving the anti-inflammatory and antibacterial properties of the composition.

[0033] At the same time, the present invention discovers that loading the traditional Chinese medicine composition powder with the nanomaterial can prevent the active factors from being lost during the transmission process; by utilizing the molecular polar structure characteristics, after contacting the skin, the loaded traditional Chinese medicine composition powder is replaced by skin lipids and is slowly and continuously released to penetrate into the lower part of the skin epidermis. The progressive release mechanism significantly improves the absorption rate of the skin epidermis to the traditional Chinese medicine composition powder, and the active function of the traditional Chinese medicine composition powder can be exerted for a long time, and acting on the vagina can effectively improve the antibacterial property.

[0034] Beneficial effects: According to the data of the examples, the total effective rate of the traditional Chinese medicine composition provided by the present invention is 90%, the cure rate is 80%, the recurrence rate is less than 5%, and it has the advantages of being convenient to prepare, taking both into account and being inexpensive, having no drug resistance, and being easy to use. Using the powder to apply medicine locally to the HPV-infected parts such as the vagina and cervix has the advantages of wide coverage, long action time, good local absorption, and strong antiviral effect. Detailed implementation manners

[0035] For the reagents or instruments involved in the following text without specifying the specific technology or conditions, they shall be carried out according to the conventional experimental conditions. For those without clearly stating the reagent company's instructions, they shall be carried out according to the conditions recommended by the instructions. For the reagents or instruments without indicating the manufacturer, they are all conventional products that can be obtained through commercial purchase.

[0036] The present invention will be further described below in conjunction with clinical trials.

[0037] Example

[0038] (1) Preparation of raw materials

[0039] By mass, take 23 parts of indigo naturalis powder, 7 parts of coptis root, 15 parts of polygonum cuspidatum, 17 parts of talc powder, 15 parts of astragalus membranaceus, 3 parts of licorice root, 12 parts of saxicola undulata, 7 parts of gleditsia sinensis thorn, 8 parts of bletilla striata powder, 7.5 parts of papaya, 3 parts of dragon's blood powder, 2 parts of borneol and 119.5 parts of methoxypolyethylene glycol of polycaprolactone as the nanomaterial.

[0040] (2) Preparation of the preparation

[0041] 1) According to 23 parts of indigo naturalis powder (divided into two equal parts), 7 parts of coptis root, 15 parts of polygonum cuspidatum, 17 parts of talc powder, 15 parts of astragalus membranaceus, 3 parts of licorice root, 12 parts of saxicola undulata, 7 parts of gleditsia sinensis thorn, 8 parts of bletilla striata powder, 7.5 parts of papaya, 3 parts of dragon's blood powder, 2 parts of borneol. Weigh the Chinese medicinal materials according to the weight ratio of the raw materials and take them after purification.

[0042] 2) The first part of indigo naturalis, coptis root, polygonum cuspidatum, astragalus membranaceus, licorice root, saxicola undulata, gleditsia sinensis thorn, and papaya are decocted with 8 - 10 times the amount of water until boiling twice, 1.5 hours for the first time and 1 hour for the second time, filtered to remove the residue to obtain the filtrate. After cooling to 65°C, add the second part of indigo naturalis powder, talc powder, bletilla striata powder, dragon's blood powder, and borneol, stir well, concentrate to form an ointment, and further concentrate and evaporate to dryness at 50 - 70°C to form a dry extract.

[0043] 3) Grind the dry extract further to make fine powder with a particle size of about 120 - 200 mesh. Further, perform ultrafine grinding on the fine powder (particle size of about 400 - 600 mesh). Mix the ultrafinely ground traditional Chinese medicine composition with the nanomaterial, freeze-dry, and make a traditional Chinese medicine composition wrapped with the nanomaterial for standby.

[0044] (4) Treatment

[0045] 120 patients with persistent high-risk HPV infection in the cervix were enrolled. They all had sexual intercourse, had no fertility requirements during the treatment period, and were aged 20 - 70 years. Among them, the disease course was 6 - 60 months. According to whether they were infected with high-risk HPV16 / 18 types, they were divided into the following 2 groups:

[0046] Treatment group 1: The average disease course was 14.2 months, and the high-risk HPV infection was high-risk type 16 / 18 infection, with a total of 60 cases;

[0047] Treatment group 2: The average disease course was 15.3 months, and the high-risk HPV infection was high-risk type 16 / 18 infection, with a total of 60 cases.

[0048] 1) Treatment method: Use a sterile vaginal medication device to load the traditional Chinese medicine composition wrapped in the above-mentioned nanomaterials, and perform local vaginal and cervical medication treatment, 3 times a week. Stop taking the medicine during menstruation. Strict contraception should be used during the medication period. Use a condom during sexual intercourse. The treatment lasts for 3 months in total. After continuous medication for 3 months, stop taking the medicine for 1 month and then recheck the cervical HPV.

[0049] 2) Treatment judgment criteria

[0050] Cure: All high-risk HPV in the cervix turn negative.

[0051] Effective: Some types of high-risk HPV infections in the cervix turn negative, and the viral load value detected by HPV genotyping and quantification significantly decreases.

[0052] Recurrence situation: Recheck 3 months after stopping the medicine. If there is a recurrence of high-risk HPV infection and the HPV viral load increases compared to before taking the medicine.

[0053] Table 1 Clinical experimental results of the traditional Chinese medicine composition wrapped in nanomaterials against HPV virus

[0054]

[0055] The data in Table 1 show that the traditional Chinese medicine composition wrapped in nanomaterials provided by the present invention can effectively treat HPV virus infection, with a total effective rate of 94.2%, a total cure rate of 80.0%, and a recurrence rate less than 5% during the recheck 3 months after treatment. Compared with the traditional Chinese medicine compositions for treating cervical pre-cancerous lesions disclosed in the prior art, the traditional Chinese medicine composition wrapped in nanomaterials of the present invention has a high clinical treatment effective rate, high safety, small toxic and side effects, and strong ability to treat HPV virus.

[0056] The above are only the preferred embodiments of the present invention. It should be noted that for the inventors of the present invention, without departing from the principle of the present invention, several improvements and refinements can still be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A traditional Chinese medicine preparation for anti-HPV virus, characterized in that, The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 15-30 parts of indigo naturalis, 5-10 parts of coptis chinensis, 5-15 parts of polygonum cuspidatum, 10-20 parts of talc, 10-20 parts of astragalus membranaceus, 1-5 parts of liquorice root, 10-15 parts of saxicolae herba, 5-10 parts of gleditsiae spina, 5-10 parts of bletilla striata, 5-10 parts of chaenomeles sinensis, 1-5 parts of dragon's blood, and 1-3 parts of borneol; The traditional Chinese medicine preparation is wrapped by nanomaterials, and the nanomaterials are methoxypolyethylene glycol of polycaprolactone. The mass ratio of the traditional Chinese medicine preparation to the nanomaterials is 1:1; The preparation method of the traditional Chinese medicine preparation comprises the following steps: (1) Grab raw materials; (2) Take indigo naturalis, coptis chinensis, polygonum cuspidatum, astragalus membranaceus, liquorice root, saxicolae herba, gleditsiae spina, and chaenomeles sinensis from the raw materials. Divide the indigo naturalis into two equal parts. After weighing the weights of the first part of indigo naturalis, coptis chinensis, polygonum cuspidatum, astragalus membranaceus, liquorice root, saxicolae herba, gleditsiae spina, and chaenomeles sinensis, add 8-10 times the weight of water and boil until boiling, and maintain the boiling state. Boil for 1.5 hours for the first time to obtain a mixture. After the mixture is cooled to room temperature, boil for 1 hour for the second time. After the second boiling, filter to remove the residue to obtain a filtrate. After the filtrate is cooled to 65°C, add the second part of indigo naturalis, talc, bletilla striata, dragon's blood, and borneol and mix evenly to obtain a mixture. The mixture is subjected to a first concentration treatment to obtain an ointment, and the ointment is subjected to a second concentration evaporation drying at 50°C-70°C to obtain a dry extract; (3) Grind the dry extract to obtain fine powder; (4) Perform ultrafine comminution treatment on the fine powder to obtain ultrafine powder; (5) Mix the ultrafine powder with the nanomaterials and then perform freeze-drying treatment to obtain a preparation for anti-HPV virus; The HPV virus is HPV16 and / or HPV18.

2. The traditional Chinese medicine preparation according to claim 1, wherein The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 15-25 parts of indigo naturalis, 5-8 parts of coptis chinensis, 5-15 parts of polygonum cuspidatum, 10-15 parts of talc, 10-15 parts of astragalus membranaceus, 1-3 parts of liquorice root, 10-13 parts of saxicolae herba, 5-8 parts of gleditsiae spina, 5-8 parts of bletilla striata, 5-7 parts of chaenomeles sinensis, 1-4 parts of dragon's blood, and 1-2 parts of borneol.

3. The traditional Chinese medicine preparation for resisting HPV virus according to claim 1, wherein, The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 23 parts of indigo naturalis, 7 parts of coptis chinensis, 15 parts of polygonum cuspidatum, 17 parts of talc, 15 parts of astragalus membranaceus, 3 parts of liquorice root, 12 parts of saxicolae herba, 7 parts of gleditsiae spina, 8 parts of bletilla striata, 7.5 parts of chaenomeles sinensis, 3 parts of dragon's blood, and 2 parts of borneol.

4. Use of the traditional Chinese medicine preparation according to any one of claims 1-3 in the preparation of a drug for anti-HPV virus.

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