A Chinese medicine composition for treating vulvar leukoplakia and preparation method thereof

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition for treating vulvar leukoplakia and a preparation method thereof. The traditional Chinese medicine composition comprises a monarch drug, a minister drug, an adjuvant drug, and a guiding drug; the monarch drug comprises salvia miltiorrhiza and angelica sinensis; the minister drug comprises thorn bark; the adjuvant drug comprises bezoar; and the guiding drug comprises amber and mother-of-pearl. Preparation method: the components in the above-mentioned traditional Chinese medicine composition are made into powders, and the powders are mixed to obtain the powders. The components in the traditional Chinese medicine composition of the present invention cooperate together, so that it has the effects of clearing away heat and dampness, promoting blood circulation and removing blood stasis, dispelling wind and relieving itching, nourishing and promoting muscle growth, and anti-tumor, and has a good therapeutic effect on vulvar leukoplakia. In addition, the traditional Chinese medicine composition is low in price, easy to use, does not affect the daily life of patients, and has high dependence.

Description

Technical Field

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

[0002] "Vulvar leukoplakia" belongs to the white lesions of the vulva. It is a group of skin diseases characterized by itching, hypopigmentation of the vulvar skin, atrophy and thinning of the skin and mucosa of the vulva and perianal area, and recurrent and chronic development. The disease was once called vulvar leukoplakia, vulvar sclerosing atrophy, vulvar dystrophy, vulvar sclerosing lichen, etc. Vulvar leukoplakia is more common in postmenopausal women and prepubertal girls. Since nearly 10% of patients are asymptomatic, it is easy to be missed or misdiagnosed, and the clinical incidence may be underestimated. The most common clinical symptoms are persistent itching, which is generally more obvious at night, as well as vulvar pain, dysuria, urinary pain, sexual dysfunction, and pain during sexual intercourse and defecation. If not treated in a timely and standardized manner, it may cause stenosis of the vaginal opening or (and) anus, seriously affecting the patient's daily life and sleep. A small number of patients may undergo malignant transformation. The main risk factors are advanced age and the persistence of vulvar skin lesions. Therefore, the disease should be taken seriously and treated as early as possible. Western medicine treatment is currently mainly hormone therapy, which is not effective for depigmentation. Currently, there are very few therapeutic drugs for vulvar leukoplakia on the market. Some hospitals require hospitalization for treatment and are expensive. Other treatments such as HIFU, laser, photodynamic therapy, etc. can cause local mucosal redness, swelling, pain, edema, blisters, etc., requiring multiple treatments, and patient compliance is very poor.

[0003] Clinical observations have found that Chinese medicine can improve itching, pain and depigmentation, is simple to use, does not affect work and study, and is easy to carry. Therefore, providing a Chinese medicine composition for the treatment of vulvar leukoplakia is of great significance. Summary of the invention

[0004] The present invention aims to solve at least one of the technical problems existing in the above-mentioned prior art. To this end, the present invention provides a Chinese medicine composition for treating vulvar leukoplakia, which is low in price, easy to use, does not affect the daily life of patients, has satisfactory efficacy and high dependence.

[0005] The invention also provides a method for preparing the Chinese medicine composition.

[0006] According to one aspect of the present invention, a Chinese medicine composition for treating vulvar leukoplakia is provided, comprising a main drug, a ministerial drug, an adjuvant drug and an assistant drug;

[0007] The monarch medicine includes salvia miltiorrhiza and angelica sinensis;

[0008] The ministerial medicine includes thorn bark;

[0009] The adjuvant includes bezoar;

[0010] The adjuvants include amber and mother of pearl.

[0011] According to a preferred embodiment of the present invention, at least the following beneficial effects are achieved:

[0012] The Chinese medicine composition for treating vulvar leukoplakia of the present invention uses salvia miltiorrhiza and angelica as the main medicines, and has the effects of nourishing blood, activating blood circulation, removing blood stasis and generating blood, replenishing the injured yin blood, and achieving the meaning of "treating wind by first treating blood, and blood circulation and wind extinguishing by itself", and can dredge meridians and relieve pain. The auxiliary medicine, radix scutellariae, has a good effect on vulvar pruritus of damp-heat type. It has good antifungal and anti-tumor effects, has an inhibitory effect on a variety of tumor cells, and can significantly inhibit the malignant transformation of patients with vulvar leukoplakia. The adjuvant medicine, bezoar, has the effect of clearing away heat and detoxicating. The external use of amber and mother-of-pearl can astringe sores and dry dampness, reduce swelling and relieve pain, and amber also has the effect of promoting tissue regeneration. The above components cooperate together, so that the Chinese medicine composition has the effects of clearing heat and drying dampness, activating blood circulation and removing blood stasis, dispelling wind and relieving itching, nourishing tissue regeneration, and anti-tumor, and has a good effect on vulvar leukoplakia.

[0013] In some embodiments of the present invention, the ministerial drugs also include Cnidium monnieri, Sophora flavescens, Zanthoxylum bungeanum, and Stemona japonica.

[0014] Specifically, the bitterness of Cnidium monnieri can remove dampness, the spiciness can moisten the kidneys, the warmth can dispel cold, and it can prevent other components from being too cold. Together with Sophora flavescens, Zanthoxylum bungeanum, Stemona bulbus, and Psoralea corylifolia, it can dispel wind, kill insects and relieve itching.

[0015] In some preferred embodiments of the present invention, the bezoar is selected from artificial bezoar.

[0016] In some embodiments of the present invention, the adjuvant also includes coptis root, phellodendron chinense, smilax glabra, difficile bark, and cinnabar.

[0017] Specifically, Coptis chinensis, Phellodendron chinense, Smilax glabra and Dictamni are all heat-clearing and dampness-drying medicines. When used together with bezoar and cinnabar, they can not only clear away heat, dry dampness and relieve itching, but also have the effect of clearing heat and detoxifying.

[0018] In some embodiments of the present invention, the drug further comprises borneol.

[0019] Specifically, amber, mother of pearl and borneol can be used externally to astringe sores, dry dampness, reduce swelling and relieve pain.

[0020] In some embodiments of the present invention, the Chinese medicine composition comprises, by weight:

[0021] Main medicine: 15-20 parts of Salvia miltiorrhiza and 10-15 parts of Angelica sinensis;

[0022] Adjuvant drugs: 10-15 parts of tangerine peel, 20-30 parts of cnidium monnieri, 20-30 parts of sophora flavescens, 3-6 parts of zanthoxylum bungeanum, 10-15 parts of radix stemonae;

[0023] Auxiliary drugs: 10-12 parts of bezoar, 10-15 parts of coptis root, 10-15 parts of phellodendron, 15-20 parts of smilax glabra, 10-15 parts of white peony root, 2-3 parts of cinnabar;

[0024] Adjuvant: 10-20 parts of amber, 20-30 parts of mother of pearl, 10-15 parts of borneol.

[0025] In some preferred embodiments of the present invention, the Chinese medicine composition comprises, by weight:

[0026] Main medicine: 20 parts of Salvia miltiorrhiza and 15 parts of Angelica sinensis;

[0027] Ministerial drugs: 15 parts of thorn bark, 30 parts of cnidium monnieri, 30 parts of sophora flavescens, 6 parts of zanthoxylum bungeanum, 15 parts of radix stemonae;

[0028] Adjuvants: 10 parts of bezoar, 15 parts of coptis root, 10 parts of phellodendron, 20 parts of smilax glabra, 15 parts of white peony root, 2 parts of cinnabar;

[0029] Adjuvant: 15 parts of amber, 30 parts of mother of pearl, 15 parts of borneol.

[0030] In some embodiments of the present invention, the traditional Chinese medicine composition further comprises sesame oil and honey.

[0031] Specifically, the sesame oil and honey can be added appropriately according to the weight of other components, and no specific limitation is made here.

[0032] According to another aspect of the present invention, a method for preparing the above-mentioned Chinese medicine composition is proposed, comprising the following steps: preparing each component in the Chinese medicine composition into powders, and uniformly mixing the powders to obtain the Chinese medicine composition.

[0033] In some embodiments of the present invention, the preparation method comprises the following steps: preparing the Chinese medicine composition into powder according to the following parts by mass: 15-20 parts of Salvia miltiorrhiza, 10-15 parts of Angelica sinensis; 10-15 parts of Cortex quinatae, 20-30 parts of Fructus cnidii, 20-30 parts of Sophora flavescens, 3-6 parts of Zanthoxylum bungeanum, 10-15 parts of Stemona officinalis; 10-12 parts of Calculus bovis, 10-15 parts of Coptis chinensis, 10-15 parts of Phellodendron chinense, 15-20 parts of Smilax glabra, 10-15 parts of Dictamni cortex, 2-3 parts of Cinnabaris; 10-20 parts of Amber, 20-30 parts of Mother of Pearl, and 10-15 parts of Borneol; and then mixing the powders evenly to obtain the Chinese medicine composition.

[0034] In some embodiments of the present invention, the preparation method comprises: first mixing salvia miltiorrhiza, angelica, bark of thorn tree, cnidium monnieri, sophora flavescens, zanthoxylum bungeanum, stemonae, coptis chinensis, phellodendron chinense, smilax glabra, cortex difficile, cinnabar, amber and mother-of-pearl according to the above-mentioned parts by mass and making a mixed powder, then adding powders of bezoar and borneol, and mixing to obtain the traditional Chinese medicine composition.

[0035] In some embodiments of the present invention, when preparing the borneol powder, anhydrous ethanol is first added to the borneol, and then the powder is prepared.

[0036] In some embodiments of the present invention, in the preparation method, after each component in the traditional Chinese medicine composition is made into powder, sesame oil and honey are added and mixed into a paste.

[0037] Specifically, if the above-mentioned powdered Chinese medicine composition is selected, the vulvar lesion site of the patient with vulvar leukoplakia can be washed by decocting the medicine, so that the drug effect can reach the diseased site directly, and a better curative effect can be achieved; if the above-mentioned paste Chinese medicine composition is selected, it is applied to the vulvar lesion site of the patient with vulvar leukoplakia, twice a day, externally applied for 4 hours, and if there is discomfort, it is changed to external application for 2 hours. According to clinical observation, it can relieve itching or completely stop itching in three days. Because the female vulvar mucosa is thin, it can be directly absorbed by external washing or external application, relieve pain and itching, promote blood circulation and remove blood stasis, nourish and regenerate muscles, accelerate local mucosal blood circulation, and restore the lesion site with depigmentation to normal. DETAILED DESCRIPTION

[0038] The following will clearly and completely describe the concept of the present invention and the technical effects produced in combination with the embodiments, so as to fully understand the purpose, characteristics and effects of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, other embodiments obtained by technicians in this field without creative work are all within the scope of protection of the present invention. The test methods used in the embodiments are all conventional methods unless otherwise specified; the materials, reagents, etc. used, unless otherwise specified, can all be reagents and materials obtained from commercial channels.

[0039] The Chinese medicine compositions prepared in the following examples all include monarch medicine, ministerial medicine, adjuvant medicine, and guiding medicine; among them, the components that exert the main effects are as follows:

[0040] The main drugs include Danshen and Angelica;

[0041] The ministerial drugs include the bark of thorn tree;

[0042] Adjuvants include bezoar;

[0043] The remedies include amber and mother of pearl.

[0044] The Chinese medicine compositions prepared in the following examples are based on these components, and then other components with the same, similar or coordinated effects are added. By appropriately adjusting and matching the weight of each component, the Chinese medicine composition can better play its effects of clearing away heat and dampness, promoting blood circulation and removing blood stasis, dispelling wind and relieving itching, nourishing and promoting muscle growth, and anti-tumor, thereby exerting a better therapeutic effect on vulvar leukoplakia. See the following examples for details. Example

[0045] This embodiment prepares a Chinese medicine composition 1 for treating vulvar leukoplakia, which comprises the following components by weight:

[0046] Main medicine: 20 parts of Salvia miltiorrhiza and 15 parts of Angelica sinensis;

[0047] Ministerial drugs: 15 parts of thorn bark, 30 parts of cnidium monnieri, 30 parts of sophora flavescens, 6 parts of zanthoxylum bungeanum, 15 parts of radix stemonae;

[0048] Adjuvants: 10 parts of bezoar, 15 parts of coptis root, 10 parts of phellodendron, 20 parts of smilax glabra, 15 parts of white peony root, 2 parts of cinnabar;

[0049] Adjuvant: 15 parts of amber, 30 parts of mother of pearl, 15 parts of borneol.

[0050] The specific preparation process is:

[0051] The components are prepared according to the above mass fractions, ground into fine powder respectively, and then the fine powders are mixed evenly to obtain the Chinese medicine composition 1. Example

[0052] This embodiment prepares a Chinese medicine composition 2 for treating vulvar leukoplakia, which comprises the following components by weight:

[0053] Main medicine: 15 parts of Salvia miltiorrhiza and 10 parts of Angelica sinensis;

[0054] Ministerial drugs: 10 parts of tangerine peel, 20 parts of cnidium monnieri, 20 parts of sophora flavescens, 3 parts of zanthoxylum bungeanum, 10 parts of radix stemonae;

[0055] Adjuvants: 12 parts of bezoar, 10 parts of coptis root, 15 parts of phellodendron, 15 parts of smilax glabra, 10 parts of white peony root, 3 parts of cinnabar;

[0056] Adjuvant: 10 parts of amber, 20 parts of mother of pearl, 10 parts of borneol.

[0057] The specific preparation process is:

[0058] First, mix salvia miltiorrhiza, angelica, bark of thorn tree, cnidium monnieri, sophora flavescens, zanthoxylum bungeanum, stemonae, coptis chinensis, phellodendron chinense, smilax glabra, cortex difficile, cinnabar, amber and mother of pearl according to the above-mentioned parts by mass and grind into fine powder. Then, add bezoar fine powder and borneol fine powder (first add anhydrous ethanol to borneol and then grind into fine powder), mix well to obtain Chinese medicine composition 2. Example

[0059] This embodiment prepares a Chinese medicine ointment 1 for treating vulvar leukoplakia, and the specific process is as follows:

[0060] Sesame oil and honey were added to the Chinese medicine composition 1 prepared in Example 1, and the mixture was mixed to obtain a Chinese medicine ointment 1. Example

[0061] This embodiment prepares a Chinese medicine ointment 2 for treating vulvar leukoplakia, and the specific process is as follows:

[0062] Sesame oil and honey were added to the Chinese medicine composition 2 prepared in Example 2, and the mixture was mixed to obtain a Chinese medicine ointment 2.

[0063] Test example

[0064] In this test example, the Chinese medicine ointment prepared in the example was administered to the patient to test the therapeutic effect of each drug on vulvar leukoplakia. The details are as follows:

[0065] 1. Patient 1, female, 58 years old, married, had recurrent vulvar itching for 1 year, especially at night, which was relieved by the use of lotion. She came to the hospital for treatment on 2022.03.28.

[0066] Examination results: abnormal development of the vulva, loss of skin pigmentation in the folds of the labia majora and minora, keratinization and brittleness. The preliminary diagnosis was vulvar leukoplakia.

[0067] Treatment process: 7 doses of Chinese medicine ointment 1 prepared in Example 3 were applied to the affected area, twice a day, for 4 hours. If there was discomfort, it was changed to 2 hours; follow-up for discomfort. 2022.04.11 The patient reported that after using the above-mentioned Chinese medicine ointment, the symptoms of vulvar itching were alleviated, but it still recurred intermittently at night. Continue to use 10 doses of Chinese medicine ointment 1, follow-up for discomfort, and after the end of the medication, the patient reported that the vulvar itching basically disappeared and there was no attack at night.

[0068] 2. Patient 2, female, 51 years old, married, developed vulvar itching 5 years ago, which recurred intermittently and gradually worsened, especially at night. She used multiple medications but the effect was poor. She came to the hospital for treatment on 2022.02.07.

[0069] Examination results: The vulva was negative, with local depigmentation of the labia majora and minora, local keratinization of the mucosa, and thickening. The preliminary diagnosis was vulvar leukoplakia.

[0070] Treatment process: Use 7 doses of Chinese medicine ointment 1 prepared in Example 3, apply it externally to the affected area, twice a day, for 4 hours, and change to 2 hours if there is any discomfort; follow up for discomfort. 2022.2.14 The patient reported that after using the above-mentioned Chinese medicine ointment, the symptoms of vulvar itching were alleviated, the itching was alleviated during night attacks, and the number of attacks decreased. The gynecological examination was the same as before, and it was further diagnosed as vulvar leukoplakia (vulvar itching, damp heat). Continue to use 7 doses of Chinese medicine ointment 1, and follow up for discomfort. 2022.3.4 The patient reported that there was no obvious discomfort after using the Chinese medicine ointment, the itching symptoms were significantly relieved, the number of attacks decreased, and the gynecological examination was the same as before. Continue to use 7 doses of Chinese medicine ointment 1, follow up for discomfort, and after the end of the medication, the patient reported that the vulvar itching disappeared and there were no more attacks at night.

[0071] 3. Patient 3, female, 29 years old, married, had vulvar itching for half a year, which worsened for 1 week. She used to have regular menstruation, with a 28-day cycle, 3-4 days of menstruation, light quality, red color, no odor, and no dysmenorrhea. The patient reported that she had vulvar itching without obvious causes six months ago, accompanied by increased secretions. After using a vaginal preparation on her own, the symptoms were alleviated. Now the symptoms recur and worsen at night. She was treated on 2023.04.06.

[0072] Examination results: The vulva was of married and parous type, the skin of the labia minora, interlabial groove, and inner side of the labia majora were atrophied and thinned, and the color was pale, the vagina was unobstructed, the amount of secretions was moderate, the color was white, and there was no odor, and the cervix was smooth. The preliminary diagnosis was vulvar leukoplakia.

[0073] Treatment process: oral Chinese medicine decoction, external application of 7 doses of Chinese medicine ointment 1 prepared in Example 3 (twice a day, external application for 4 hours, if there is discomfort, change to external application for 2 hours), follow-up for discomfort. 2023.04.13 The patient reported that the symptoms of vulvar itching were significantly relieved after medication, and the number of nocturnal attacks decreased. The gynecological examination was the same as before, and further diagnosed as vulvar leukoplakia (vulvar itching, liver and kidney deficiency). Continue to use 7 doses of Chinese medicine ointment 1, follow-up for discomfort, after the end of medication, the patient reported that the vulvar itching basically disappeared, and basically no attacks at night.

[0074] 4. Patient 4, female, 82 years old, married, had vulvar itching without obvious cause 2 years ago, which worsened at night. She had used a variety of topical medications but the effect was not good. She was diagnosed on June 11, 2022.

[0075] Examination results: The vulva looked like an elderly woman, with cracks in the folds of the labia majora and minora, depigmentation of the skin, and a small amount of scarring. The preliminary diagnosis was vulvar leukoplakia.

[0076] Treatment process: Use 7 doses of Chinese medicine ointment 2 prepared in Example 4, apply externally to the affected area, twice a day, apply externally for 4 hours, and change to external application for 2 hours if there is discomfort; follow up for discomfort. 2022.07.01 The patient reported no obvious discomfort after using the above-mentioned Chinese medicine ointment, and the vulvar itching was relieved, but still felt repeated discomfort at night. Continue to use 7 doses of Chinese medicine ointment 2, keep the vulva dry, smooth emotions, avoid wind and cold, adjust diet, and follow up for discomfort. After the end of the medication, the patient reported that the vulvar itching disappeared and there was no more attack at night.

[0077] 5. Patient 5, female, 39 years old, married, used to have regular menstruation, 28-day menstrual cycle, 5-day menstrual period, red color and normal volume, no dysmenorrhea. One month ago, she developed itching and discomfort in the labia minora without obvious cause, which worsened at night. She did not see significant relief after taking a certain drug on her own. She came to the hospital on 2023.03.17.

[0078] Examination results: The vulva was of married and parous type, the skin of the labia majora on both sides was slightly atrophied and white, and there were no other obvious abnormalities. The preliminary diagnosis was vulvar leukoplakia.

[0079] Treatment process: oral Chinese medicine decoction, external application of 7 doses of Chinese medicine ointment 1 prepared in Example 3 (twice a day, external application for 4 hours, if there is discomfort, change to external application for 2 hours), pay attention to hygiene, avoid wind and cold, adjust diet, smooth emotions, and follow up for discomfort. 2023.03.24 The patient reported that the discomfort of vulvar pruritus improved significantly after medication. The gynecological examination was the same as before, and further diagnosed as vulvar leukoplakia (vulvar pruritus, liver and kidney yin deficiency). Continue to use 7 doses of Chinese medicine ointment 1, and follow up for discomfort. After the end of the medication, the patient reported no more symptoms of vulvar pruritus and no more attacks at night.

[0080] 6. Patient 6, female, 32 years old, married, had increased secretions, yellow color, and odor 2 months ago. She placed "sea buckthorn seed oil suppository" on her own for 1 week, and the symptoms were relieved. Now the itching has worsened, and she sought medical treatment on 2023.05.06.

[0081] Examination results: The vulva was of married and parous type, the skin color of the labia majora on both sides became darker, the skin was slightly atrophied, and there were no other abnormalities. The preliminary diagnosis was vulvar leukoplakia.

[0082] Treatment process: oral Chinese medicine decoction, external application of 7 doses of Chinese medicine ointment 2 prepared in Example 4 (twice a day, external application for 4h, if there is discomfort, change to external application for 2h), avoid wind and cold, smooth emotions, adjust diet, and follow up for discomfort. 2023.05.13 The patient reported that the symptoms of vulvar itching were significantly relieved, and no obvious abnormalities were found in gynecological examination. It was further diagnosed as vulvar leukoplakia. Continue to use 7 doses of Chinese medicine ointment 2, adjust diet, avoid wind and cold, smooth emotions, and follow up for discomfort. After the end of the medication, the patient reported that the vulvar itching disappeared.

[0083] 7. Patient 7, female, 36 years old, married, used to have regular menstruation, 27-day cycle, 3-5 days of menstruation, normal flow, red color, no odor, no dysmenorrhea. The patient reported that she had increased vaginal discharge, yellow color, and odor 1 month ago. She used nifuratel vaginal tablets on her own but the effect was not good, and the itching worsened at night. She came to the hospital on 2023.03.25.

[0084] Examination results: The vulva is of married and parous type, the skin on the outer side of the labia majora is atrophied and white, the vagina is unobstructed, the secretions are moderate, white, sticky, and have no odor, and the cervix is ​​smooth. The preliminary diagnosis is vulvar leukoplakia.

[0085] Treatment process: oral Chinese medicine decoction, external application of 7 doses of Chinese medicine ointment 2 prepared in Example 4 (twice a day, external application for 4 hours, if there is discomfort, change to external application for 2 hours), avoid wind and cold, relieve emotions, and follow up if discomfort occurs. 2023.04.01 The patient reported that the vulvar itching was significantly relieved after medication, the secretions were normal, and the gynecological examination was the same as before. It was further diagnosed as vulvar leukoplakia (vulvar itching, damp heat bet). Continue to use 7 doses of Chinese medicine ointment 2, follow up if discomfort occurs, and the patient reported that the vulvar itching disappeared after the medication, and it did not occur at night.

[0086] 8. Patient 8, female, 56 years old, married, developed vulvar itching without obvious cause 3 years ago, with recurrent attacks, aggravated at night. She was treated in other hospitals many times with poor therapeutic effects. She came to our hospital for treatment on 2022.02.10.

[0087] Examination results: The vulva was normal, the skin in the folds of the labia majora and minora was depigmented, and the local skin keratinization and thickening were preliminarily diagnosed as vulvar leukoplakia.

[0088] Treatment process: Use 7 doses of Chinese medicine ointment 1 prepared in Example 3, apply it externally to the affected area, twice a day, for 4 hours, and change to 2 hours if there is any discomfort; follow up for discomfort. 2022.03.11 The patient reported that after using the above-mentioned Chinese medicine ointment, the vulvar itching still exists at night, but the degree has been alleviated, and the skin of the affected area is smoother than before. Now in order to consolidate the therapeutic effect, he is visiting the doctor again. Continue to use 10 doses of Chinese medicine ointment 1, keep the vulva dry and clean, and follow up for discomfort. 2022.04.01 The patient reported that there was no obvious discomfort after using the Chinese medicine ointment, and the itching was significantly relieved. The gynecological examination was the same as before, and the rest of the examinations were basically normal. It was further diagnosed as vulvar leukoplakia. Continue to use 7 doses of Chinese medicine ointment 1, follow up for discomfort, and after the end of the medication, the patient reported that the vulvar itching basically disappeared, and there was basically no night attack.

[0089] 9. Patient 9, female, 30 years old, married, developed vulvar itching without obvious cause 3 years ago. The symptoms recurred intermittently and gradually worsened, especially at night. Other medications had poor effects, and she sought medical treatment on 2022.04.25.

[0090] Examination results: The vulva was normally developed, the skin in the folds of the labia majora and minora was depigmented, the texture became brittle, and there were a few scratches. The preliminary diagnosis was vulvar leukoplakia.

[0091] Treatment process: Use 7 doses of Chinese medicine ointment 1 prepared in Example 3, apply externally to the affected area, twice a day, for 4 hours, and change to 2 hours if there is discomfort; follow up for discomfort. 2022.05.09 The patient reported that after using the above-mentioned Chinese medicine ointment, the symptoms of vulvar itching were relieved, but there were still intermittent and recurrent itching discomfort at night, so she went to the doctor again to consolidate the therapeutic effect. Continue to apply 10 doses of Chinese medicine ointment 1 externally, keep the vulva clean and dry, and follow up for discomfort. 2022.05.30 The patient reported that the discomfort was significantly alleviated after using the Chinese medicine ointment, the number of attacks decreased, and the gynecological examination was the same as before, and further diagnosed with vulvar leukoplakia. Continue to use 7 doses of Chinese medicine ointment 1, follow up for discomfort, and after the end of the medication, the patient reported that the vulvar itching basically disappeared, and there were no more attacks at night.

[0092] 10. Patient 10, female, 34 years old, married, developed vulvar itching after vaginitis one year ago, which worsened at night. The treatment with metronidazole was ineffective and she sought medical treatment on 2022.02.21.

[0093] Examination results: The vulva was normally developed, the labia majora was partially depigmented, the skin was locally keratinized, brittle, and had scratches. The preliminary diagnosis was vulvar leukoplakia.

[0094] Treatment process: 7 doses of Chinese medicine ointment 2 prepared in Example 4 were applied to the affected area, twice a day, for 4 hours. If there was any discomfort, change to 2 hours; follow-up for discomfort. 2022.03.14 The patient reported that after using the above-mentioned Chinese medicine ointment, the vulvar itching was significantly relieved, but there were still repeated attacks at night, and he visited the doctor again to consolidate the therapeutic effect. Continue to use 10 doses of Chinese medicine ointment 2, and follow up for discomfort. After the end of the medication, the patient reported that the vulvar itching disappeared and there were no more attacks at night.

[0095] 11. Patient 11, female, 49 years old, married, developed vulvar itching without obvious cause 10 years ago, which recurred intermittently and significantly worsened in the past year, especially at night, and she was unable to sleep. She used metronidazole and other drugs for treatment many times, but the effect was poor. She came to the hospital for treatment on 2022.05.27.

[0096] Examination results: The vulva was normally developed, the labia majora and minora were atrophied, the labia majora and minora and perianal skin and mucosa were depigmented, the texture became brittle, and there were many scratches. The preliminary diagnosis was vulvar leukoplakia.

[0097] Treatment process: Use 7 doses of Chinese medicine ointment 1 prepared in Example 3, apply it externally to the affected area, twice a day, for 4 hours. If there is any discomfort, change to external application for 2 hours; follow up for discomfort. 2022.06.10 The patient reported that there was no obvious discomfort after using the above-mentioned Chinese medicine ointment, and the discomfort of vulvar itching was relieved, but it still recurred at night, affecting sleep. In order to consolidate the therapeutic effect, he went to the doctor again. Continue to use 10 doses of Chinese medicine ointment 1, keep the vulva clean and dry, avoid excessive scratching, and follow up for discomfort. 2022.07.01 The patient reported that the symptoms were significantly relieved after using the Chinese medicine ointment, the number of nocturnal itching attacks decreased, and the gynecological examination was the same as before. Continue to use 7 doses of Chinese medicine ointment 1, follow up for discomfort, and after the end of the medication, the patient reported that the vulvar itching basically disappeared, and there was no attack at night.

[0098] 12. Patient 12, female, 68 years old, married, felt vulvar itching 2 months ago, which worsened at night and was sometimes mild and sometimes severe. She bought ointment for external use on her own, and the effect was acceptable. Now she feels a burning sensation in the vulva and came to the hospital for treatment on 2023.05.01.

[0099] Examination results: The vulva was of married and parous type, the inner folds of the labia majora on both sides became lighter and whiter, the vagina was unobstructed, the secretion was moderate, white in color, without odor, the cervix was smooth, and there was no pain when raising it. The preliminary diagnosis was vulvar leukoplakia and liver and kidney yin deficiency.

[0100] Treatment process: oral Chinese medicine decoction, external application of Chinese medicine ointment 2 prepared in Example 4 (twice a day, external application for 4 hours, if there is discomfort, change to external application for 2 hours), emotional relief, avoid wind and cold, adjust diet, and follow up for discomfort. 2023.05.08 The patient reported that the symptoms of vulvar itching were alleviated and the burning sensation of the vulva disappeared. The gynecological examination was the same as before, and the above symptoms were further confirmed. Continue to use 7 doses of Chinese medicine ointment 2, follow up for discomfort, and after the end of the medication, the patient reported that the vulvar itching disappeared and did not occur at night.

[0101] 13. Patient 13, female, 28 years old, married, felt vulvar itching 1 year ago, which worsened at night. There was no obvious improvement after washing. The secretions increased but had no odor. The symptoms are now worsening. She sought medical treatment on 2023.05.12.

[0102] Examination results: The vulva was of the married but nulliparous type, with the skin of the labia majora on both sides atrophied and thinned, whitish in color, with a moderate amount of secretion, white in color, pink in texture, and no odor. There were no other abnormalities. The preliminary diagnosis was vulvar leukoplakia.

[0103] Treatment process: oral Chinese medicine decoction, external application of Chinese medicine ointment 1 prepared in Example 3 (twice a day, external application for 4h, if there is discomfort, change to external application for 2h), emotional relief, avoid wind and cold, adjust diet, follow up for discomfort. 2023.05.19 The patient reported that the symptoms of vulvar pruritus were alleviated after using the medicine, and the number of nocturnal attacks decreased. The gynecological examination was the same as before, and further diagnosed as vulvar leukoplakia. Continue to use 7 doses of Chinese medicine ointment 1, emotional relief, avoid wind and cold, adjust diet, follow up for discomfort. After the end of the medication, the patient reported that the vulvar pruritus disappeared and there was no attack at night.

[0104] 14. Patient 14, female, 51 years old, married, menopausal at the age of 49, has had intermittent itching and discomfort in the vulva for one year, which was sometimes mild and sometimes severe. She used Fuyanjie to clean it on her own, but the effect was not good and the condition worsened at night. She came to the hospital for treatment on 2023.03.12.

[0105] Examination results: The vulva was of married and parous type, with the skin of the labia minora, interlabial groove, inner labia majora, and clitoris atrophied and thinned, and pale in color. The vagina was unobstructed, with a small amount of white secretions without odor, and the cervix was smooth. The preliminary diagnosis was vulvar leukoplakia.

[0106] Treatment process: oral Chinese medicine decoction, external application of Chinese medicine ointment 1 prepared in Example 3 (twice a day, external application for 4 hours, if there is discomfort, change to external application for 2 hours), keep the vulva dry and hygienic, avoid wind and cold, and follow up for discomfort. 2023.03.19 The patient reported that the symptoms of vulvar itching improved significantly after medication, and the number of nocturnal attacks decreased. The gynecological examination was the same as before, and further diagnosed as vulvar leukoplakia (vulvar itching, damp heat). Continue to use 7 doses of Chinese medicine ointment 1, follow up for discomfort, and after the end of the medication, the patient reported that the vulvar itching basically disappeared and basically did not occur at night.

[0107] 15. Patient 15, female, 38 years old, married, with moderate menstrual quality, light quality, red color, and no dysmenorrhea. The patient felt that there was no obvious cause one month ago, with swelling and pain in the vulva, no red color, no high skin temperature, and no abnormal secretions. She was treated on 2023.04.26.

[0108] Examination results: The vulva was of married and parous type, with slightly atrophied skin of mons pubis, clitoris and anterior symphysis of labia, with a pale color, unobstructed vagina, moderate amount of discharge, white color, sticky texture and no odor, hypertrophy of the cervix, and mild outward migration of the columnar epithelium. The preliminary diagnosis was vulvar leukoplakia and liver and kidney deficiency.

[0109] Treatment process: oral Chinese medicine decoction, external application of 15 doses of Chinese medicine ointment 2 prepared in Example 4 (twice a day, external application for 4 hours, if there is discomfort, change to external application for 2 hours), emotional relief, diet adjustment, avoid wind and cold, follow-up for discomfort. 2023.07.03 The patient reported that the swelling and pain of the vulva disappeared, and no obvious abnormalities were found in the gynecological examination. There was no obvious change compared with the previous one, and there was no abnormality in the secretions. It was further diagnosed as vulvar leukoplakia and liver and kidney deficiency. Continue to use 7 doses of Chinese medicine ointment 2, follow-up for discomfort, and the patient reported that the swelling and pain of the vulva disappeared after the end of the medication.

[0110] For the increasing number of patients with vulvar leukoplakia, the widespread popularization of Western medicine treatment guidelines has improved the initial treatment efficacy, but the recurrence rate and long-term efficacy stability are still very low. How to improve the long-term efficacy of patients with vulvar leukoplakia has become the focus of current research. Modern medicine has not yet fully elucidated the pathogenesis of vulvar leukoplakia. In combination with the traditional Chinese medicine ointment prepared in the embodiment of the present invention, 80 people were clinically observed (the above test examples list the treatment conditions of 15 patients out of 80 cases, all of whom received effective treatment). It was found that the treatment effect on patients was more significant and would not relapse, that is, the long-term efficacy was better.

[0111] In summary, because the female vulvar mucosa is thin, the Chinese medicine ointment for treating vulvar leukoplakia of the present invention can be directly absorbed by external application, relieves pain and itching, promotes blood circulation and removes blood stasis, nourishes and regenerates muscles, accelerates local mucosal blood circulation, and restores the lesion site with depigmentation to normal. In addition, the Chinese medicine ointment prepared by the present invention is low in price, easy to use, does not affect the daily life of patients, has satisfactory efficacy, and has high dependence.

[0112] The above is a detailed description of the embodiments of the present invention, but the present invention is not limited to the above embodiments. Various changes can be made within the knowledge of ordinary technicians in the relevant technical field without departing from the purpose of the present invention. In addition, the embodiments of the present invention and the features in the embodiments can be combined with each other without conflict.

Claims

1. A Chinese medicine composition for external use in treating vulvar leukoplakia, characterized in that: The Chinese medicine composition is composed of a main drug, a secondary drug, an adjuvant drug and an assistant drug; By weight: Main medicine: 15-20 parts of Salvia miltiorrhiza and 10-15 parts of Angelica sinensis; Adjuvant drugs: 10-15 parts of tangerine peel, 20-30 parts of cnidium monnieri, 20-30 parts of sophora flavescens, 3-6 parts of zanthoxylum bungeanum, 10-15 parts of radix stemonae; Auxiliary drugs: 10-12 parts of bezoar, 10-15 parts of coptis root, 10-15 parts of phellodendron, 15-20 parts of smilax glabra, 10-15 parts of white peony root, 2-3 parts of cinnabar; Adjuvant: 10-20 parts of amber, 20-30 parts of mother of pearl, 10-15 parts of borneol.

2. The Chinese medicine composition according to claim 1, characterized in that: By weight, Main medicine: 20 parts of Salvia miltiorrhiza and 15 parts of Angelica sinensis; Ministerial drugs: 15 parts of thorn bark, 30 parts of cnidium monnieri, 30 parts of sophora flavescens, 6 parts of zanthoxylum bungeanum, 15 parts of radix stemonae; Adjuvants: 10 parts of bezoar, 15 parts of coptis root, 10 parts of phellodendron, 20 parts of smilax glabra, 15 parts of white peony root, 2 parts of cinnabar; Adjuvant: 15 parts of amber, 30 parts of mother of pearl, 15 parts of borneol.

3. A Chinese medicine composition for external use in treating vulvar leukoplakia, characterized in that: The Chinese medicine composition is composed of a main drug, a secondary drug, an adjuvant drug, a guiding drug, sesame oil and honey; By weight: Main medicine: 15-20 parts of Salvia miltiorrhiza and 10-15 parts of Angelica sinensis; Adjuvant drugs: 10-15 parts of tangerine peel, 20-30 parts of cnidium monnieri, 20-30 parts of sophora flavescens, 3-6 parts of zanthoxylum bungeanum, 10-15 parts of radix stemonae; Auxiliary drugs: 10-12 parts of bezoar, 10-15 parts of coptis root, 10-15 parts of phellodendron, 15-20 parts of smilax glabra, 10-15 parts of white peony root, 2-3 parts of cinnabar; Adjuvant: 10-20 parts of amber, 20-30 parts of mother of pearl, 10-15 parts of borneol.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 2, characterized in that: The following steps are involved: The components in the traditional Chinese medicine composition are made into powders, and the powders are mixed to obtain the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that: The preparation method comprises: firstly mixing salvia miltiorrhiza, angelica, bark of thorn tree, cnidium monnieri, sophora flavescens, zanthoxylum bungeanum, stemonae, coptis root, phellodendron chinense, smilax glabra, cortex difficile, cinnabaris, amber and mother-of-pearl to prepare a mixed powder, then adding powders of bezoar and borneol, and mixing to obtain the traditional Chinese medicine composition.

6. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: After each component in the traditional Chinese medicine composition is made into powder, sesame oil and honey are added and mixed to form a paste.