Traditional Chinese medicine composition for treating pruritus vulvae as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating pruritus vulvae, which is prepared from the following raw material medicines in parts by weight: 200-280 parts of fried fructus xanthii, 100-140 parts of radix sophorae flavescentis, 100-140 parts of cortex phellodendri, 100-140 parts of alum, 100-140 parts of fructus cnidii, 100-140 parts of roasted herba epimedii and 2-6 parts of borneol, and the traditional Chinese medicine composition can effectively treat various pruritus vulvae problems and recover pudendum health.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and particularly to a traditional Chinese medicine composition for treating vulvar pruritus, its preparation method and application. Background Art

[0002] Vulvar pruritus is a disease name in traditional Chinese medicine. It refers to the itching of a woman's vulva, and in severe cases, the itching pain is unbearable, making it difficult to sit or lie still, or accompanied by increased vaginal discharge, etc., which is called "vulvar pruritus", also known as "pruritus of the vaginal orifice". In Western medicine, vulvar pruritus, vulvitis, vaginitis, and vulvar hypopigmentation diseases that present vulvar pruritus symptoms are a type of gynecological disease with a relatively high incidence in clinical practice. In severe cases, the vulva is extremely itchy and even ulcerated, making it difficult to sit or lie still, seriously affecting the patient's life and work. During pregnancy and lactation, due to changes in the vaginal environment, it is more likely to cause vulvar itching; after menopause, elderly women are deficient in blood and the vaginal orifice is not nourished, which is likely to cause itching and burning of the vulva and vagina. Currently, in clinical practice, the main treatment for vulvar pruritus is the application of corresponding antibacterial drugs, but there are problems such as cautious use of drugs in pregnant and lying-in women, long treatment time, and easy recurrence. Moreover, the abuse of antibiotics, unreasonable medication, and excessive cleaning can all lead to the recurrence of the disease. Traditional Chinese medicine believes that vulvar pruritus belongs to the category of leucorrhea in traditional Chinese medicine. The liver meridian passes through the external genitalia, the kidney stores essence and is in charge of reproduction, and the spleen is in charge of transporting and transforming water and dampness. Vulvar pruritus is closely related to the functions of the liver, kidney, and spleen. Liver depression and spleen deficiency lead to the downward flow of damp-heat, which accumulates and stagnates in the genital area.

[0003] In view of the relatively complex pathogenesis of vulvar pruritus, although there are already some prescriptions for its treatment, the treatment effect is not very satisfactory. Therefore, there is an urgent need for an effective traditional Chinese medicine preparation for vulvar pruritus. Summary of the Invention

[0004] Aiming at the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating vulvar pruritus, its preparation method and application, which have the advantages of significant curative effect, safety, and simple preparation, and are applicable to vulvar pruritus problems of various populations and types.

[0005] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating vulvar pruritus, which is made from the following raw materials in parts by weight: stir-fried Xanthium sibiricum Patrin ex Widd. 200 - 280 parts, Sophora flavescens Aiton 100 - 140 parts, Phellodendron amurense Rupr. 100 - 140 parts, Alum 100 - 140 parts, Fructus Cnidii 100 - 140 parts, roasted Epimedium brevicornum Maxim. 100 - 140 parts, and Borneol 2 - 6 parts.

[0006] In some embodiments, the traditional Chinese medicine composition for treating vulvar pruritus is made from the following raw materials in parts by weight: stir-fried Xanthium sibiricum Patrin ex Widd. 220 - 260 parts, Sophora flavescens Aiton 110 - 130 parts, Phellodendron amurense Rupr. 110 - 130 parts, Alum 110 - 130 parts, Fructus Cnidii 110 - 130 parts, roasted Epimedium brevicornum Maxim. 110 - 130 parts, and Borneol 3 - 5 parts.

[0007] In some embodiments, the traditional Chinese medicine composition for treating vulvar pruritus is prepared from the following raw medicinal materials in parts by weight: stir-fried Xanthium sibiricum Patrin ex Widd. 240 parts, Sophora flavescens Aiton 120 parts, Phellodendron amurense Rupr. 120 parts, Alum 120 parts, Fructus Cnidii 120 parts, roasted Epimedium brevicornu Maxim. 120 parts, and Borneol 4 parts.

[0008] In a second aspect, the present invention provides a traditional Chinese medicine preparation for treating vulvar pruritus, which is prepared from the traditional Chinese medicine composition described in the first aspect and pharmaceutically acceptable excipients.

[0009] Preferably, the traditional Chinese medicine preparation is an external preparation.

[0010] More preferably, the traditional Chinese medicine preparation is an ointment, a plaster, a powder, a lotion, a tincture, a suppository, a film, a lozenge or a paste.

[0011] Most preferably, the traditional Chinese medicine preparation is a lotion.

[0012] In some embodiments, the pharmaceutically acceptable excipients include solvents, solubilizers, pH regulators, preservatives, humectants, surfactants, buffers, disinfectants, etc.

[0013] Preferably, the pharmaceutically acceptable excipient is bromogeramine.

[0014] More preferably, the parts by weight of bromogeramine are 2 - 8 parts, and the concentration of bromogeramine can be 0.3% - 1.2%, preferably the concentration is 0.4%.

[0015] In a third aspect, the present invention provides a preparation method of the traditional Chinese medicine preparation for treating vulvar pruritus described in the second aspect, and the preparation method includes the following steps:

[0016] 1) Select, screen and identify the authenticity of each traditional Chinese medicine decoction piece contained in the prescription, and weigh the decoction pieces according to the prescription amount;

[0017] 2) Wash the stir-fried Xanthium sibiricum Patrin ex Widd., Sophora flavescens Aiton, Phellodendron amurense Rupr., Fructus Cnidii and roasted Epimedium brevicornu Maxim. decoction pieces twice with running water, put the clean decoction pieces and Alum into a multi-functional traditional Chinese medicine extractor, add about 8 - 12 times the weight of the crude drugs in the prescription of water, soak for at least 4 hours, decoct twice, each time for 1 hour, and combine the decoction liquid;

[0018] 3) Concentrate the filtrate, precipitate for 24 hours, pour out the supernatant, add Borneol, add pharmaceutically acceptable excipients, and mix to prepare a traditional Chinese medicine preparation.

[0019] Preferably, the traditional Chinese medicine preparation is a lotion.

[0020] In a fourth aspect, the present invention provides the application of the traditional Chinese medicine composition for treating vulvar pruritus described in the first aspect, or the traditional Chinese medicine preparation described in the second aspect, or the traditional Chinese medicine preparation prepared by the preparation method described in the third aspect in the preparation of drugs for treating vulvar pruritus.

[0021] Advantages of the present invention:

[0022] (1) The present invention has carried out targeted and reasonable formula medication for the etiology and pathogenesis of vulvar pruritus:

[0023] Traditional Chinese medicine believes that the pathogenesis of vulvar pruritus has two aspects: deficiency and excess. Those caused by deficiency of liver and kidney yin, depletion of essence and blood, and loss of nourishment of the vulva belong to deficiency syndromes; those caused by dampness-heat in the liver meridian, transformation of liver depression into heat, hyperactivity of wood insulting earth, and spleen deficiency with excessive dampness, resulting in the combination of dampness and heat, flowing downward to the lower energizer and invading the vulva, belong to excess syndromes. When the body gets sick, pain occurs due to obstruction or lack of nourishment. Due to deficiency of essence and blood, the vulvar skin lacks nourishment and causes itching. In addition, unclean vulva, or living in a damp and shady place for a long time, can breed damp insects, which erode the vagina and cause vulvar pruritus. Those with yang deficiency of the constitution or deficiency of liver and kidney are susceptible populations under these two circumstances. Clinically, women have itching in the vulva and vagina, and the itching sensation can even affect the anus, with unbearable itching and pain around the anus, and they like to scratch. In severe cases, they can't sit or lie still, seriously affecting personal normal life.

[0024] In the formula of the present invention, Sophora flavescens and Phellodendron amurense are bitter and cold, which are good at clearing dampness-heat in the lower energizer and purging deficiency-fire of the kidney. The combination of the two can clear heat and dry dampness, kill insects and relieve itching, and is used as the monarch drug for the main pathogenesis of vulvar pruritus. Cnidium monnieri is pungent, dispersing, bitter and drying, which can dry dampness, expel wind, kill insects and relieve itching. It is used in combination with the monarch drug Sophora flavescens and is a commonly used drug for syndromes such as damp itching of the female genitals. Alum is bitter and cold, which can clear heat and dry dampness, purge fire and remove steaming, and detoxify and treat sores; Borneol can detoxify and kill insects, dry dampness and relieve itching, clear heat and reduce swelling; The above three drugs can clear heat and transform dampness, expel wind and detoxify, kill insects and relieve itching, clear heat and reduce swelling to assist the monarch drug, and are used as ministerial drugs. Epimedium brevicornum can tonify kidney yang, strengthen tendons and bones, dispel wind and dampness, and can enhance the function of removing dampness and reducing leucorrhea. Modern research shows that Epimedium brevicornum also has estrogen-like effects, which can protect the vaginal mucosa, strengthen nutrition, and improve disease resistance; Xanthium sibiricum can disperse wind and remove dampness, and has anti-inflammatory and analgesic effects. The above two drugs can clear heat and remove dampness, expel wind, relieve itching and pain, and are used as assistant drugs together.

[0025] The combination of various drugs can attack and tonify simultaneously, treat both the principal and secondary aspects of a disease, and together achieve the effects of clearing heat and drying dampness, killing insects and relieving itching, expelling wind and detoxifying, and tonifying the kidney and removing dampness, and can effectively treat vulvar pruritus.

[0026] (2) At the same time, the traditional Chinese medicine preparation of the present invention adds benzalkonium bromide as an adjuvant, which has functions such as antioxidant, bactericidal and bacteriostatic, promoting wound healing, good biocompatibility and biodegradability, and can improve the overall curative effect of the preparation.

[0027] (3) The present invention is an external preparation, which can directly act on the affected area. Compared with oral preparations, the drug effect is more direct and safer.

[0028] (4) The traditional Chinese medicine preparation of the present invention is simple to prepare and has low production cost. Detailed implementation mode

[0029] The preferred embodiments of the present invention will be described in detail below in conjunction with the embodiments. It should be understood that the following embodiments are given only for the purpose of illustration and are not used to limit the scope of the present invention. Those skilled in the art can make various modifications and substitutions to the present invention without departing from the purpose and spirit of the present invention.

[0030] Unless otherwise specified, the experimental methods used in the following examples are all conventional methods.

[0031] Unless otherwise specified, the materials, reagents, etc. used in the following examples can all be obtained from commercial channels.

[0032] Example 1 Preparation of the Traditional Chinese Medicine Preparation for Treating Vulvar Pruritus of the Present Invention

[0033] The dosages of each raw material and auxiliary material are as follows:

[0034] Raw medicinal materials: stir-fried Xanthium sibiricum 240 g, Sophora flavescens 120 g, Phellodendron amurense 120 g, Alum 120 g, Cnidium monnieri 120 g, roasted Epimedium brevicornum 120 g, and Borneol 4 g; Auxiliary materials: 4 g of benzalkonium bromide with a concentration of 0.4%.

[0035] Preparation process:

[0036] 1) Select, screen, and identify the authenticity of each traditional Chinese medicine decoction piece contained in the prescription, and weigh the decoction pieces according to the prescription amount;

[0037] 2) Wash the stir-fried Xanthium sibiricum, Sophora flavescens, Phellodendron amurense, Cnidium monnieri, and roasted Epimedium brevicornum decoction pieces twice with running water. Put the clean decoction pieces and Alum into a multi-functional traditional Chinese medicine extractor, add about 8 - 12 times the weight of the raw medicine in the prescription of water, soak for at least 4 hours, decoct twice, each time for 1 hour, and combine the decoction liquid;

[0038] 3) Concentrate the filtrate, precipitate for 24 hours, pour out the supernatant, add Borneol, and add benzalkonium bromide to obtain the traditional Chinese medicine lotion.

[0039] Example 2 Efficacy Verification of the Traditional Chinese Medicine Preparation for Treating Vulvar Pruritus of the Present Invention

[0040] Clinical experiment

[0041] 1. Data and methods

[0042] 1.1 Clinical Data The research subjects were 200 female patients with vaginal itching and sexual life who visited Shijiazhuang Fourth Hospital from July 2024 to December 2024, including pregnant women, parturients, the elderly and other patients. All patients underwent strict examination and diagnosis, had no contraindications to this medication and met the relevant diagnostic criteria: Results ① The patient's vagina had more or less abnormal secretions, and there was pain and burning sensation, and itching symptoms appeared in the vulva, such as insect-like, even extremely itchy, and sexual intercourse pain occurred during normal sexual intercourse; ② The patient's vagina had abnormal secretions and was accompanied by an unpleasant fishy smell.

[0043] 1.2 Diagnostic criteria

[0044] All patients have undergone rigorous examination and diagnosis, have no contraindications to this medication, and meet the relevant diagnostic criteria. ① Medical history: bad hygiene habits, heavy vaginal discharge, long-term irritation of the vulva, or a history of vulvar and vaginitis; ② Clinical manifestations: occasional vaginal itching, even unbearable, restless, and can also affect the area around the anus or the inner thigh; ③ Gynecological examination: normal vulva, normal leucorrhea or yellow-green, accompanied by pain and burning sensation; ④ Laboratory examination: normal leucorrhea microscopy or occasional positive Candida, Trichomonas, bacterial vaginosis, etc.

[0045] 1.3 Inclusion criteria

[0046] ①Women aged between 18 and 74 years old; ②Complaint of increased discharge with odor or accompanied by vulvar itching or burning pain;

[0047] ③ Meet the diagnostic criteria for vulvovaginitis or vaginitis through clinical and laboratory examinations; ④ No serious systemic or chronic diseases; ⑤ Understand the purpose of this study and sign the informed consent.

[0048] 1.4 Exclusion criteria

[0049] ① Women who are menstruating; ② Patients with diabetes or other serious chronic diseases in acute attack; ③ Those who cannot be followed up; ④ Patients with vaginal inflammation caused by sexually transmitted diseases such as mycoplasma, chlamydia, and gonococci; ⑤ Patients with vulvar leukoplakia.

[0050] 2. Treatment Methods

[0051] Patients use the Chinese medicine lotion described in the embodiment. Take 80ml of the lotion for treatment, add warm water at a ratio of 1:1, and perform vulvar and vaginal washing once a day; add warm water to the medicine, fumigate first and then wash, once a day; 1 week is 1 course of treatment. Other drugs are prohibited during treatment, and sexual intercourse is prohibited.

[0052] 3. Efficacy criteria

[0053] Marked effect means that all the clinical symptoms of the patient have disappeared; effective means that the clinical symptoms of the patient have basically disappeared; ineffective means that none of the above indicators have been achieved. The total effective rate = (marked effect + effective) / total number of cases × 100%. Compare the vaginal health and inflammation scores of the patients before and after. Among them, the vaginal inflammation score can be divided into 0-8 points. The higher the score, the more severe the inflammation. 0-3 points is mild, 4-6 points is moderate, and 7-8 points is severe. In the vaginal health score, the total score is 24 points. The higher the score, the higher the health level. Among them, 0-8 points means lower health, 9-16 points means medium health, and >16 points means good health.

[0054] 4. Statistical methods

[0055] The data were processed using SPSS 26.0 statistical software. The data were expressed as mean ± standard deviation (x±s) and analyzed by t-test; the count data were expressed as rate (%) and analyzed by x2-test. P<0.05 was considered statistically significant.

[0056] 5. The clinical trial results are shown in Tables 1-3.

[0057] Table 1 Treatment effects (n, %)

[0058] n Marked effect Effective Ineffective Effective rate Pregnant women group 50 30 14 6 88％ Puerpera group 50 33 12 5 90％ Elderly group 50 35 10 5 90％ Other female group 50 38 8 4 92％

[0059] Table 2 Comparison of vaginal health scores of patients before and after treatment

[0060] Before treatment After treatment Pregnant women group 9.62±1.20 18.22±2.35* Puerpera group 9.34±1.61 18.90±3.02* Elderly group 8.96±1.94 17.94±3.20* Other female group 10.90±2.03 19.06±2.47*

[0061] Comparison before and after treatment, *P<0.05

[0062] Table 3 Comparison of vaginal inflammation scores of patients before and after treatment

[0063] Before treatment After treatment Pregnant women group 5.04±1.25 1.16±0.30* Puerpera group 5.10±0.62 1.04±0.46* Elderly group 5.28±0.50 1.80±0.63* Other female group 5.12±0.54 1.22±0.55*

[0064] Typical cases

[0065] Typical case 1

[0066] Jia XX, female, 32 years old, from Shijiazhuang. Pregnant for 28 weeks. In the past week, she has had unbearable itching in the vulva, a heavy feeling in the body, yellow urine, a slightly red tongue, yellow and greasy tongue coating, and a slippery pulse. Obstetric examination: The vulva is normal, with a small amount of yellowish-green discharge. Vaginal microecological examination: Cleanliness III, epithelial cells ++, white blood cells ++++, leukocyte esterase (+), pH value 5.4, no mold, trichomonas, or miscellaneous bacteria detected. Traditional Chinese medicine diagnosis: Yin itching, internal accumulation of insect toxins and downward flow of damp-heat. Western medicine diagnosis: Vaginitis. The traditional Chinese medicine preparation in Example 1 of the present invention was used externally. 80 ml of the lotion was taken, and warm water was added at a ratio of 1:1 for vulva and vagina irrigation, once a day, for 1 week as a course of treatment. After one course of external washing, the symptoms completely disappeared, the disease was cured, and there was no recurrence during the follow-up one month after stopping the medicine.

[0067] Typical Case 2

[0068] Zhang XX, female, 38 years old, from Shijiazhuang. Postpartum vulvar pruritus was unbearable for more than a month. The vulva was washed with warm water at home, but the symptoms did not improve. The gynecological doctor examined the vulva, which was normal and had little secretions. Vaginal microenvironment detection: cleanliness II, epithelial cells ++, white blood cells ++, leukocyte esterase (+), pH value 4.9, mold, trichomonas, miscellaneous bacteria, etc. were not detected. The Chinese medicine diagnosis was: vulvar itch, internal insect poison, and burns to the vaginal fluid. Western medicine diagnosis: vaginitis. For external use of the Chinese medicine preparation of Example 1 of the present invention, take 80ml of the washing liquid, add warm water at a ratio of 1:1, and wash the vulva and vagina once a day, 1 week as a course of treatment, and the symptoms completely disappear after one course of external washing, and the disease is cured. There is no recurrence in the follow-up one month after drug withdrawal.

[0069] Typical Case 3

[0070] Zhou XX, 45 years old, suffered from candidal vaginitis for 3 years. Itching of vulva was unbearable during attack. Treatment with Daconin suppository and the like improved. But recurred after menstruation, and medication improved again. Gynecological examination showed vulvar flushing, and the patient felt itchy. Vaginal microenvironment detection: cleanliness III, epithelial cells ++, leukocytes +++, leukocyte esterase ++, pH value 4.1, mold, trichomonas, miscellaneous bacteria, etc. were not detected. External use of the Chinese medicine preparation of the embodiment of the present invention 1, the medicine was rinsed for 14 days, and the subjective symptoms were significantly alleviated. In addition to continuing to rinse, each menstrual period uses a medicated sanitary napkin, and the medicine is rinsed immediately after the period to prevent recurrence. After the symptoms disappear, the patient insisted on rinsing with medicine for one month, and there was no recurrence after two months of follow-up.

[0071] Typical Case 4

[0072] Mao XX, 65 years old, was restless due to symptoms such as vulvar burning pain and itching, and the patient had dry vagina, few secretions, accompanied by symptoms such as dysuria and frequent urination. Patients were routinely examined to find that the vaginal mucosa was congested, and smear examination of vaginal secretions showed that fungi (+) trichomonas, miscellaneous bacteria, etc. were not detected, and the vaginal microenvironment cleanliness was III, epithelial cells ++, leukocytes +++, leukocyte esterase ++, and pH value 4.1. External use of the Chinese medicine preparation of the embodiment of the present invention 1 was rinsed voluntarily, twice a day, and rinsed for 5 days, and the subjective symptoms were significantly alleviated. Adhere to medication flushing for one month, and follow up a case by regular visits to no recurrence after two months.

[0073] Finally, it should be noted that the above embodiments are only used to illustrate rather than limit the technical solutions of the present invention. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that the present invention can still be modified or replaced by equivalents. Any modification or partial replacement that does not depart from the spirit and scope of the present invention should be included in the scope of the claims of the present invention.

Claims

1. A Chinese medicine composition for treating vaginal itching, characterized in that: The drug is prepared from the following raw materials in parts by weight: 200-280 parts of stir-fried Xanthium sibiricum fruit, 100-140 parts of Sophora flavescens, 100-140 parts of Phellodendron amurense, 100-140 parts of Alum, 100-140 parts of Cnidium monnieri fruit, 100-140 parts of roasted Epimedium brevicornum and 2-6 parts of Borneol.

2. The Chinese medicine composition for treating vaginal itching according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 220-260 parts of stir-fried Xanthium sibiricum fruit, 110-130 parts of Sophora flavescens, 110-130 parts of Phellodendron amurense, 110-130 parts of Alum, 110-130 parts of Cnidium monnieri, 110-130 parts of roasted Epimedium and 3-5 parts of Borneol.

3. The Chinese medicine composition for treating vaginal itching according to claim 2, characterized in that: The invention is prepared from the following raw materials in parts by weight: 240 parts of stir-fried Xanthium sibiricum fruit, 120 parts of Sophora flavescens, 120 parts of Phellodendron amurense, 120 parts of Alum, 120 parts of Cnidium monnieri, 120 parts of roasted Epimedium brevicornum and 4 parts of Borneol.

4. A Chinese medicine preparation for treating vaginal itching, characterized in that: The traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

5. The Chinese medicine preparation according to claim 4, characterized in that: The Chinese medicine preparation is an external preparation.

6. The Chinese medicine preparation according to claim 4 or 5, characterized in that: The Chinese medicine preparation is an ointment, a plaster, a powder, a lotion, a tincture, a suppository, a film, a lozenge or a paste.

7. The Chinese medicine preparation according to claim 6, characterized in that: The Chinese medicine preparation is a lotion.

8. The Chinese medicine preparation according to claim 7, characterized in that: The pharmaceutically acceptable excipients in the lotion include chlorhexidine.

9. The method for preparing the Chinese medicine preparation according to any one of claims 4 to 8, characterized in that: The preparation method comprises the following steps: 1) Select, screen, and identify the authenticity of each Chinese herbal medicine slice, and weigh the slice; 2) Wash the fried Xanthium sibiricum, Sophora flavescens, Phellodendron chinense, Cnidium monnieri, and Epimedium brevicornum slices twice with running water, put the clean slices and alum into a multifunctional Chinese medicine extractor, add water about 8 to 12 times the weight of the raw medicine in the prescription, soak for at least 4 hours, decoct twice, each time for 1 hour, and combine the decoctions; 3) Concentrating the filtrate and settling for 24 hours, decanting the supernatant, adding borneol and pharmaceutically acceptable excipients, and mixing to prepare the Chinese medicine preparation.

10. Use of the Chinese medicine composition according to any one of claims 1 to 3, the Chinese medicine preparation according to any one of claims 4 to 8, or the Chinese medicine preparation prepared by the preparation method according to claim 9 in the preparation of drugs for treating vaginal itching.