External traditional Chinese medicine composition for treating leukoplakia vulvae

Abstract

The invention discloses an external traditional Chinese medicine composition for treating leukoplakia vulvae, which belongs to the technical field of traditional Chinese medicines, and is prepared by taking herba epimedii, fructus cnidii and radix sophorae flavescentis as monarch drugs, taking herba pyrolae, Sinkiang lithospermum and radix angelicae sinensis as ministerial drugs, taking cortex phellodendri chinensis, cortex dictamni and radix stephaniae tetrandrae as adjuvant drugs, and taking herba schizonepetae, vinegar-processed curcuma zedoary, crotalaria sessiliflora and pericarpium zanthoxyli as conductant drugs. The traditional Chinese medicine composition for treating leukoplakia vulvae has the effects of clearing away heat and toxic materials, promoting diuresis, promoting blood circulation to remove blood stasis, nourishing blood, dispelling wind, moistening dryness and relieving itching together, the leukoplakia vulvae is treated according to syndrome differentiation in traditional Chinese medicine, the treatment effect is ideal, the total cure rate reaches 83%, and the total effective rate reaches 98%.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to an external Chinese medicine composition for treating vulvar leukoplakia. Background Art

[0002] Vulvar leukoplakia, also known as vulvar non-neoplastic lesions, is a common chronic disease in which the skin and mucous membranes of the female vulva undergo pigment changes and tissue degeneration. It is mainly manifested by persistent vulvar itching, which is usually more obvious at night. In severe cases, it can affect daily life and physical and mental health. The cause of vulvar leukoplakia is still unclear. The industry generally believes that it may be related to immunity, genetics, endocrine, metabolism, oxidation, local irritation, infection, and the lack of trace elements.

[0003] At present, the treatment options for vulvar leukoplakia mainly include: local drug treatment, including hormone drugs and Chinese medicine preparations, surgical treatment by removing the lesion tissue, and physical therapy. Surgical treatment causes great damage to patients, destroys the normal tissue structure of the vulva, usually leaves scars on the surgical site and has a high recurrence rate. Hormone drugs such as compound dexamethasone cream, hydrocortisone cream, triamcinolone acetate urea cream, etc. can be used externally to treat vulvar leukoplakia. Long-term use may cause side effects such as skin atrophy. Most Chinese medicine preparations are derived from natural plants and are made into medicines after processing. Compared with hormone drugs, they have less toxic side effects and are suitable for long-term use. Patent CN 104758396A provides a Chinese medicine composition for treating vulvar leukoplakia, which is composed of drugs such as epimedium, psoralea corylifolia, and deer mouth grass. The invented pharmaceutical composition can effectively treat vulvar leukoplakia, is easy to use, has a quick onset, has significant efficacy, has no side effects, has a consolidated efficacy, and is easy to carry, but its cure rate is low. Patent CN 108186802B provides a Chinese medicine composition for preventing or treating white lesions of the vulva, which is made of the following raw materials in parts by weight: Rehmannia glutinosa, Lycium barbarum, Astragalus membranaceus, Angelica sinensis, Salvia miltiorrhiza, Kochia scoparia, and Dictamni. The Chinese medicine composition of the invention can be used to prevent or treat white lesions of the vulva. The various medicines in the Chinese medicine composition interact and synergize with each other to achieve the effects of nourishing the kidney and blood, promoting blood circulation and relieving itching, and treating both the symptoms and the root cause. However, its cure rate is only 30-45%, which needs to be further improved.

[0004] Therefore, there is an urgent need in the art for an external Chinese medicine combination for treating vulvar leukoplakia with high cure rate and effectiveness. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicinal composition for external use for treating vulvar leukoplakia, so as to solve the problems existing in the above-mentioned prior art.

[0006] One of the technical solutions provided by the present invention:

[0007] A Chinese medicinal composition for external use for treating vulvar leukoplakia, comprising, by weight, 10-30 parts of epimedium, 10-30 parts of cnidium monnieri, 10-30 parts of sophora flavescens, 10-20 parts of pygmy dactylon, 10-20 parts of lithospermum officinale, 10-20 parts of angelica root, 7-15 parts of phellodendron amurense, 7-15 parts of difficile cortex, 7-15 parts of stephania tetrandra, 8-12 parts of schizonepeta, 8-12 parts of curcuma zedoaria, 8-12 parts of aconite and 8-12 parts of Sichuan pepper.

[0008] Preferably, by weight, the herb comprises equal parts of epimedium, fructus cnidium, sophora flavescens, herba strychnifoliae, lithospermum officinale, angelica root, phellodendron chinense, cortex difficile, fangjiuji, schizonepeta tenuifolia, zedoaria officinalis, atractylodes macrocephala and Sichuan pepper.

[0009] "Ming Yi Bie Lu" records: Epimedium strengthens tendons and bones, eliminates scrofula, red swelling, and lower body sores. It can be washed to remove worms. Epimedium can disperse stagnation, relieve pain, and clear away heat. It also has a certain effect on the treatment of genital sores; Sichuan pepper has the effects of warming the middle and dispersing cold, killing insects and relieving itching; Nongjili has the effect of removing dampness, which helps to eliminate moisture in the body and improve vulvar discomfort caused by heavy moisture; Curcuma zedoaria tastes pungent and bitter, is warm in nature, and enters the liver and spleen meridians. It has the effects of breaking blood and promoting qi, eliminating accumulation and relieving pain, and protecting the liver and kidneys; Deer bite grass is sweet, bitter, warm in nature, and enters the liver and kidney meridians. It has the effects of strengthening bones and tendons, dispelling wind and dampness, and astringing and stopping bleeding; Xinjiang purple Grass has the effects of cooling blood, activating blood circulation, detoxifying and clearing rashes; Cnidium monnieri has the effects of drying dampness and wind, killing insects and relieving itching, warming the kidney and strengthening yang; Sophora flavescens and Phellodendron chinense both have the effects of clearing heat and detoxifying, drying dampness and relieving itching, and are used to relieve the damp-heat and itching symptoms of vulvar leukoplakia, and at the same time prevent the further development of the disease; Schizonepeta tenuifolia can play the role of dispersing wind and relieving exterior symptoms, and clearing rashes; Stephania tetrandra, as an anti-rheumatic drug, has anti-inflammatory and analgesic effects; Dictamni has the effects of clearing heat and detoxifying, drying dampness and relieving itching, and can be used to relieve the itching and damp-heat symptoms of vulvar leukoplakia; Angelica sinensis tail has a certain improvement effect on skin roughness and pigmentation caused by vulvar leukoplakia.

[0010] The second technical solution provided by the present invention is:

[0011] A use of the above-mentioned traditional Chinese medicine composition in preparing a medicine for treating vulvar leukoplakia.

[0012] Preferably, the dosage form of the drug is an ointment or a lotion.

[0013] The third technical solution provided by the present invention is:

[0014] A traditional Chinese medicine ointment for treating vulvar leukoplakia is composed of the external Chinese medicine composition for treating vulvar leukoplakia and pharmaceutically acceptable excipients.

[0015] The fourth technical solution provided by the present invention is:

[0016] A method for preparing a Chinese medicine ointment for treating vulvar leukoplakia, comprising weighing epimedium, Sichuan pepper, Nongjili, Curcuma zedoaria, Herba Lysimachiae, Fructus Cnidii, Sophorae Flavescentis, Phellodendron Amurense, Schizonepeta Tenuifolia, Stephania Tetrandrae, Radix Angelicae Sinensis and Cortex Dictamni according to the above-mentioned external Chinese medicine composition for treating vulvar leukoplakia, mixing and decocting, filtering, concentrating the filtrate into an extract, cooling, adding ethanol, stirring, standing, filtering, recovering ethanol to obtain a Chinese medicine extract, adding the Chinese medicine extract into a mixed solution of glycerin, ethylparaben, distilled water and Tween-80,

[0017] Heat to obtain a water phase; mix stearic acid, paraffin oil, vaseline and monoglyceride, heat and melt,

[0018] The oil phase is obtained, and the oil phase is added into the water phase while stirring, and the traditional Chinese medicine ointment for treating vulvar leukoplakia is prepared after emulsification.

[0019] Preferably, the dosage ratio of the traditional Chinese medicine extract, glycerol, ethylparaben, distilled water and Tween-80 is: (10-15) g: (30-50) g: (1-3) g: (300-500) mL: (20-30) mL.

[0020] Preferably, the usage ratio of stearic acid, paraffin oil, vaseline and monoglyceride is (35-55) g: (10-15) g: (15-20) g: (15-20) g.

[0021] Preferably, the heating temperatures for preparing the water phase and the oil phase are both 70-80°C.

[0022] Compared with the prior art, the present invention has the following advantages and technical effects:

[0023] The invention uses herba epimedii, fructus cnidii and sophorae flavescentis as main drugs, herba pyrifera, lithospermum officinale and angelica root as assistant drugs, phellodendron chinense, cortex difficile and tetrandra as adjuvant drugs, and herba schizonepetae, zedoariae curcumae, gypsophila oleracea and prickly ash as guiding drugs. The components are used together to achieve the effects of clearing away heat, detoxicating and removing dampness, promoting blood circulation and removing blood stasis, nourishing blood and dispelling wind, moistening dryness and relieving itching. The invention treats vulvar leukoplakia with traditional Chinese medicine differentiation of symptoms, has an ideal treatment effect, and the total cure rate reaches 83%. The invention provides a new effective formula for treating vulvar leukoplakia, and the total effective rate reaches 98%. DETAILED DESCRIPTION

[0024] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but should be understood as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0025] It should be understood that the terms described in the present invention are only for describing special embodiments and are not intended to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the scope is also specifically disclosed. Each smaller range between the intermediate value in any stated value or stated range and any other stated value or intermediate value in the described range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0026] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0027] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to those skilled in the art. The present application description and examples are exemplary only.

[0028] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0029] The topical Chinese medicine composition for treating vulvar leukoplakia provided by the present invention can be used to prepare both an ointment and a lotion. The preparation method of the lotion is the same as the preparation method of the Chinese medicine extract, and a sitting bath is used for at least 15 minutes each time. However, the lotion is inconvenient to use, and the drug action time is insufficient. The present invention has been found through clinical experiments that the therapeutic effect is not as good as the ointment, so the embodiment focuses on the ointment as an example to examine its therapeutic effect.

[0030] Example 1 A method for preparing a Chinese medicine ointment for treating vulvar leukoplakia

[0031] Weigh 10g of Epimedium, 10g of Cnidium, 10g of Sophora flavescens, 10g of Herba Lycopodii, 10g of Lithospermum officinale, 10g of Angelica sinensis, 10g of Phellodendron chinense, 10g of Dictamni, 10g of Stephania tetrandra, 10g of Schizonepeta tenuifolia, 10g of Curcuma zedoaria, 10g of Nongjili and 10g of Sichuan pepper, mix and boil with water, filter, and concentrate the filtrate into an extract (the water content of the extract is 20±5%). After cooling, add ethanol (80%, v / v) to make the ethanol content reach 70% (v / v), stir, let stand, filter, and recover ethanol to obtain a traditional Chinese medicine extract. 15 g of the liquid is added to a mixed solution of glycerol, ethylparaben, distilled water and Tween-80 (wherein the amount ratio of glycerol, ethylparaben, distilled water and Tween-80 is 50 g: 2 g: 300 mL: 25 mL), and heated (75° C., keep warm for 1 h) to obtain an aqueous phase; 35 g of stearic acid, 15 g of paraffin oil, 20 g of vaseline and 15 g of monoglyceride are mixed, and heated to melt (75° C.) to obtain an oil phase, and the oil phase is added to the aqueous phase while stirring, and the Chinese medicine ointment for treating vulvar leukoplakia is prepared after emulsification.

[0032] Example 2 A method for preparing a Chinese medicine ointment for treating vulvar leukoplakia

[0033] Weigh 30g of Epimedium, 15g of Cnidium, 15g of Sophora flavescens, 20g of Herba Luzi, 15g of Lithospermum chinense, 20g of Radix Angelicae Sinensis, 7g of Cortex Phellodendri, 15g of Dictamni, 7g of Stephania tetrandra, 8g of Schizonepeta tenuifolia, 12g of Curcuma zedoaria, 8g of Nongjili and 8g of Sichuan pepper, mix and boil, filter, concentrate the filtrate into an extract (the water content of the extract is 20±5%), cool, add ethanol (80%, v / v) to make the ethanol content reach 70% (v / v), stir, let stand, filter, recover ethanol, obtain a Chinese medicine extract, and the Chinese medicine extract 12g is added to a mixed solution of glycerol, ethylparaben, distilled water and Tween-80 (wherein the amount ratio of glycerol, ethylparaben, distilled water and Tween-80 is 40g:2g:500mL:30mL), heated (80°C, keep warm for 1h) to obtain an aqueous phase; 40g of stearic acid, 10g of paraffin oil, 15g of vaseline and 20g of monoglyceride are mixed, heated to melt (80°C) to obtain an oil phase, the oil phase is added to the aqueous phase, stirring while adding, and the traditional Chinese medicine ointment for treating vulvar leukoplakia is prepared after emulsification.

[0034] Example 3 Preparation method of a Chinese medicine ointment for treating vulvar leukoplakia

[0035] Weigh 20g of Epimedium, 30g of Cnidium, 30g of Sophora flavescens, 15g of Herba Luzi, 20g of Lithospermum chinense, 15g of Angelica sinensis, 15g of Phellodendron chinense, 7g of Dictamni, 15g of Stephania tetrandra, 12g of Schizonepeta tenuifolia, 8g of Curcuma zedoaria, 12g of Nongjili and 12g of Sichuan pepper, mix and boil with water, filter, concentrate the filtrate into an extract (the water content of the extract is 20±5%), cool, add ethanol (80%, v / v) to make the ethanol content reach 70% (v / v), stir, let stand, filter, recover ethanol, obtain a Chinese medicine extract, and extract the Chinese medicine 10g of the liquid is added to a mixed solution of glycerol, ethylparaben, distilled water and Tween-80 (wherein the amount ratio of glycerol, ethylparaben, distilled water and Tween-80 is 32g:1g:400mL:20mL), and heated (70°C, keep warm for 1h) to obtain an aqueous phase; 55g of stearic acid, 12g of paraffin oil, 20g of vaseline and 15g of monoglyceride are mixed, heated to melt (70°C) to obtain an oil phase, and the oil phase is added to the aqueous phase while stirring, and the Chinese medicine ointment for treating vulvar leukoplakia is prepared after emulsification.

[0036] Comparative Examples 1-10

[0037] The preparation method is the same as that of Example 1, except that different raw material components are added, as shown in Table 1 for details.

[0038] Table 1

[0039]

[0040]

[0041] 1. Animal Experiments

[0042] 1.1 Tissue repair experiment:

[0043] 150 male Kunming mice were randomly divided into 15 groups, 10 mice in each group, and depilated with a depilatory agent, with the depilatory area being 10% of the total body surface area, and the mouse skin was damaged by rubbing with sandpaper until bleeding spots appeared. The positive drug control group was given 1 mL of 1.5 mg / mL Yunnan Baiyao, and the experimental drug group was given the Chinese medicine ointment prepared by Examples 1-3 and Comparative Examples 1-10, which was applied topically once a day. The damage control group was not treated in any way to investigate the healing effect of the experimental drugs. The experimental results are shown in Table 2-3.

[0044] Table 2

[0045]

[0046] Table 3

[0047]

[0048] 1.2 Twisting experiment

[0049] 150 male Kunming mice were randomly divided into 15 groups, 10 mice in each group, namely normal control group, positive drug group, and test drug group. The hair removal method and area were the same as those in 1.1 tissue repair experiment.

[0050] Topical administration: the normal control group was coated with 1 mL of physiological saline, the positive drug group was coated with 1 mL of 1 mg / mL Yunnan Baiyao solution, and the test drug was given the Chinese medicine ointment prepared by Examples 1-3 and Comparative Examples 1-10, and applied topically for 3 consecutive days. 30 minutes after the third day of medication, 2% acetic acid (0.2 mL / mouse) was injected intraperitoneally, and the mice were observed for 15 minutes. The time to start twisting and the number of twisting within 15 minutes were calculated. The number of twisting times of mice in each group was averaged to investigate the analgesic effect of the experimental drugs. The experimental results are shown in Tables 4-5.

[0051] Table 4

[0052]

[0053] Table 5

[0054]

[0055] 1.3 Antipruritic experiment

[0056] 150 male Kunming mice were randomly divided into 15 groups, 10 mice in each group, namely normal control group, positive drug group and test drug group. The hair removal method and hair removal area were the same as those in 1.1 tissue repair experiment.

[0057] The medication method was the same as the writhing test in 1.2, and the medication was used continuously for 3 days. 40 minutes after the last medication, 0.01% 4-aminopyridine was given to the hair removal area to induce itching. After 10 seconds, the number of times the mice licked the body within 10 minutes was recorded. The number of times the mice licked the body in each group was averaged to determine the antipruritic efficacy of the drug. The experimental results are shown in Tables 6-7.

[0058] Table 6

[0059]

[0060] Table 7

[0061]

[0062] It can be seen from the above animal experiments and Tables 2-7 that the Chinese medicine ointment prepared from the external Chinese medicine composition for treating vulvar leukoplakia provided by the present invention has good repairing, analgesic and antipruritic effects.

[0063] Clinical Trials

[0064] A total of 140 patients were diagnosed based on medical history, clinical manifestations, gynecological examination and biopsy, including 60 cases of hyperplastic type, 60 cases of mixed type and 20 cases of atrophic type. All patients signed informed consent.

[0065] It can be seen from the animal experiments that the Chinese medicine ointment prepared in Example 1 is more effective than that in Examples 2 and 3 for treating vulvar leukoplakia. The Chinese medicine ointment prepared in Example 1 was used for clinical experiments.

[0066] The Chinese medicine ointment prepared in Example 1 was applied to the affected area of ​​the patient with a cotton swab, 2-3 times a day for 15-25 consecutive days, and the patient's symptom relief, exudation disappearance, wound healing, and pigmentation time were followed up.

[0067] The cure criteria are as follows: cured: no vulvar itching, repair of vulvar skin lesions, improvement of skin color and elasticity, and no clinical symptoms or signs; markedly effective: itching obviously disappeared or improved significantly, lesion skin was scattered with color, and skin elasticity basically returned to normal; effective: vulvar itching was alleviated, skin chapped skin was improved, and skin color changed; ineffective: symptoms and signs were unchanged from before treatment. The clinical trial results are shown in Table 8.

[0068] Table 8

[0069]

[0070] It can be seen from Table 8 that the Chinese medicine ointment prepared from the external Chinese medicine composition for treating vulvar leukoplakia provided by the present invention is effective for common types of vulvar leukoplakia lesions, with a total effective rate of 98% and a total cure rate of 83%.

[0071] The above are only preferred specific implementations of the present application, but the protection scope of the present application is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed in the present application should be included in the protection scope of the present application. Therefore, the protection scope of the present application should be based on the protection scope of the claims.

Claims

1. A Chinese medicine composition for external use for treating vulvar leukoplakia, characterized in that: Measured by weight, the composition includes 10-30 parts of epimedium, 10-30 parts of cnidium monnieri, 10-30 parts of sophora flavescens, 10-20 parts of deer tongue grass, 10-20 parts of lithospermum officinale, 10-20 parts of angelica root, 7-15 parts of phellodendron chinense, 7-15 parts of divaricate cortex, 7-15 parts of stephania tetrandra, 8-12 parts of schizonepeta, 8-12 parts of curcuma zedoaria, 8-12 parts of aconite and 8-12 parts of Sichuan pepper.

2. The external Chinese medicine composition for treating vulvar leukoplakia according to claim 1, characterized in that: Calculated by weight, it includes equal parts of epimedium, cnidium monnieri, sophora flavescens, herba pygmyes, lithospermum officinale, angelica root, phellodendron chinense, cortex difficile, stephania tetrandra, schizonepeta tenuifolia, curcuma zedoaria, atractylodes and Sichuan pepper.

3. Use of the Chinese medicine composition as claimed in claim 1 or 2 in the preparation of a medicament for treating vulvar leukoplakia.

4. The use according to claim 3, characterized in that: The dosage form of the medicine is ointment or lotion.

5. A Chinese medicinal ointment for treating vulvar leukoplakia, characterized in that: The external Chinese medicine composition for treating vulvar leukoplakia according to any one of claims 1 to 2 and pharmaceutically acceptable excipients are prepared.

6. A method for preparing a traditional Chinese medicine ointment for treating vulvar leukoplakia, characterized in that: According to the external Chinese medicine composition for treating vulvar leukoplakia according to any one of claims 1-2, epimedium, cnidium monnieri, sophora flavescens, pygmy spatholobi, radix scutellariae, radix lithospermi, angelica root, phellodendron chinense, cortex dasyphyllae, radix fangji, schizonepeta, curcuma zedoariae, rhizoma atractylodis macrocephalae and Sichuan pepper are weighed, mixed and decocted, and filtered; the filtrate is concentrated into an extract, cooled, ethanol is added, stirred, allowed to stand, filtered, and ethanol is recovered to obtain a Chinese medicine extract; the Chinese medicine extract is added to a mixed solution of glycerol, ethyl paraben, distilled water and Tween-80, and heated to obtain an aqueous phase; stearic acid, paraffin oil, vaseline and monoglyceride are mixed, heated and melted to obtain an oil phase, the oil phase is added to the aqueous phase, stirred while adding, and the Chinese medicine ointment for treating vulvar leukoplakia is prepared after emulsification.

7. The method for preparing the Chinese medicinal ointment for treating vulvar leukoplakia according to claim 6, characterized in that: The dosage ratio of the traditional Chinese medicine extract, glycerol, ethyl paraben, distilled water and Tween-80 is: (10-15) g: (30-50) g: (1-3) g: (300-500) mL: (20-30) mL.

8. The method for preparing the Chinese medicinal ointment for treating vulvar leukoplakia according to claim 7, characterized in that: The usage ratio of stearic acid, paraffin oil, vaseline and monoglyceride is (35-55) g: (10-15) g: (15-20) g: (15-20) g.

9. The method for preparing the Chinese medicinal ointment for treating vulvar leukoplakia according to claim 8, characterized in that: The heating temperature when preparing the water phase and the oil phase is 70-80°C.

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