A traditional Chinese medicine composition for preventing and treating vaginitis, a preparation method and a traditional Chinese medicine preparation

Abstract

The present application relates to the field of traditional Chinese medicine composition, and specifically discloses a traditional Chinese medicine composition for preventing and treating vaginitis, a preparation method and a traditional Chinese medicine preparation. The traditional Chinese medicine composition comprises the following components in mass fractions: Cassia senna 1-20 parts, Radix et Rhizoma Humuli 1-15 parts, Polygonum hydropiper 1-15 parts, Euphorbia humifusa 1-10 parts, Acmella oleracea 1-5 parts and Prussian blue 1-5 parts. The traditional Chinese medicine composition has a significant therapeutic effect on bacterial vaginitis and mycotic vaginitis through the combined action of the monarch, minister and assistant drugs. The traditional Chinese medicine preparation prepared by using the traditional Chinese medicine composition has the advantages of being less likely to produce drug resistance, having minimal toxic and side effects, being capable of promoting the balance of the vaginal environment and enhancing the immune function of the female body, etc. The present application effectively solves the problems of the prior art, i.e., the western medicine treatment of vaginitis has toxic and side effects, adverse reactions and drug resistance, and the traditional Chinese medicine treatment of vaginitis has limitations and low efficiency.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and specifically discloses a traditional Chinese medicine composition, preparation method and preparation for the prevention and treatment of vaginitis. Background Technology

[0002] Vaginitis is a common gynecological disease with a high incidence rate among women. The main types include trichomonal vaginitis, bacterial vaginitis, and candidiasis (yeast infection). Vaginitis can cause symptoms such as lower abdominal pain and discomfort, vulvar itching and burning, abnormal discharge, scanty and painful urination, and thick vaginal discharge that hinders sperm passage, potentially leading to infertility. It not only causes physical discomfort but can also negatively impact a patient's mental health and quality of life. Therefore, in-depth research into treatment methods for vaginitis is of significant clinical importance.

[0003] Currently, Western medicine primarily uses antibiotics for systemic or local treatment. For example, bacterial vaginosis is often treated with antibiotics such as metronidazole or clindamycin; candidal vaginitis is treated with clotrimazole or nystatin antibiotics. However, antibiotics are synthetic drugs with certain toxic side effects and adverse reactions. They can easily lead to vaginal flora imbalance, causing pathogenic strains to develop drug resistance, resulting in chronic and difficult-to-cure conditions with high recurrence rates.

[0004] Traditional Chinese medicine (TCM) has extensive clinical experience in treating vaginitis. TCM believes that vaginitis is often related to external dampness, internal damp-heat, liver stagnation and spleen deficiency, and kidney yin deficiency. Dampness invading the lower abdomen and accumulating into heat over time, or liver stagnation transforming into fire that scorches yin fluids, or spleen dysfunction leading to internal dampness that descends to the vulva, can all cause vaginitis. TCM emphasizes a holistic approach, adjusting the body's yin-yang balance and organ function. This not only treats local symptoms of vaginitis but also improves the patient's overall constitution, reducing the likelihood of recurrence. Furthermore, most TCM herbs are derived from natural plants, resulting in fewer side effects and less harm to the body compared to chemical drugs. More importantly, TCM has a broad spectrum of activity, effective against various pathogens. However, current TCM treatments for vaginitis still have some shortcomings. For example, TCM emphasizes symptom-based treatment and requires syndrome differentiation, which significantly affects the efficiency of TCM treatment. Therefore, developing a TCM composition that can prevent and treat various types of vaginitis has practical significance for women's physical and mental health. Summary of the Invention

[0005] To address the issues of toxic side effects and adverse reactions, drug resistance, and persistent symptoms associated with existing Western and traditional Chinese medicine treatments for vaginitis, and the limitations and low efficiency of traditional Chinese medicine treatments, this invention provides a traditional Chinese medicine composition, preparation method, and formulation for the prevention and treatment of vaginitis. The formulation prepared using this composition has advantages such as low likelihood of drug resistance, minimal toxic side effects, promotion of vaginal environment balance, and enhancement of female immune function. It exhibits significant efficacy in treating bacterial and fungal vaginitis.

[0006] To solve the above-mentioned technical problems, the technical solution provided by the present invention is as follows:

[0007] The first aspect of the present invention provides a traditional Chinese medicine composition for the prevention and treatment of vaginitis, the traditional Chinese medicine composition comprising the following raw material components in parts by weight: 1-20 parts of Cassia tora, 1-15 parts of Polygonum hydropiper, 1-15 parts of Equisetum hyemale, 1-10 parts of Equisetum arvense, 1-5 parts of Artemisia annua and 1-5 parts of Indigo naturalis.

[0008] This invention uses Cassia tora extract, Gynostemma pentaphyllum and Polygonum hydropiper as principal ingredients, and Equisetum hyemale, Ageratum rubrum and Indigofera tinctoria as assistant ingredients. Among them, *Cassia tora* is cold in nature and bitter in taste, entering the lung, stomach, and large intestine meridians; it has the effects of anti-inflammatory, analgesic, expectorant, thirst-quenching, fever-reducing, and middle-regulating effects; *Gynostemma pentaphyllum* is cool in nature and bitter in taste, entering the liver and lung meridians; it has the effects of clearing heat and detoxifying, promoting blood circulation and removing blood stasis, reducing swelling and relieving pain; *Polygonum hydropiper* is warm in nature and pungent in taste, entering the lung, liver, and large intestine meridians; it has the effects of detoxifying, removing dampness, removing blood stasis, stopping bleeding, inhibiting bacteria and reducing inflammation; *Stemona japonica* is neutral in nature and sweet and bitter in taste, entering the lung and liver meridians; it has the effects of dispelling wind and heat, relieving muscle tension, clearing away pterygium, removing wind-dampness, and dispersing fire evil; *Cirsium japonicum* is neutral in nature and bitter and pungent in taste, entering the lung and heart meridians; it has the effects of dispelling wind and clearing heat, relieving pain, stopping bleeding, detoxifying, reducing swelling, and removing blood stasis; *Indigo naturalis* is cold in nature and salty in taste, entering the liver, lung, and stomach meridians; it has the effects of clearing heat and detoxifying, cooling blood and eliminating spots, purging fire and calming the nerves.

[0009] Preferably, the traditional Chinese medicine composition further includes the following raw material components in parts by weight: 1-10 parts of Sophora flavescens, 1-10 parts of Scutellaria baicalensis, 1-5 parts of Astragalus membranaceus, 1-5 parts of Poria cocos, 1-5 parts of Artemisia argyi, 1-5 parts of Glycyrrhiza uralensis, and 1-5 parts of Menthol.

[0010] This invention also uses Sophora flavescens, Scutellaria baicalensis, Astragalus membranaceus, and Poria cocos as adjuvant herbs, and Artemisia argyi, Glycyrrhiza uralensis, and menthol as guiding herbs. Sophora flavescens is cold in nature and bitter in taste, entering the liver, kidney, large intestine, and small intestine meridians; it has the effects of clearing heat and drying dampness, promoting diuresis and relieving jaundice, dispelling wind, killing parasites and relieving itching, and antibacterial and anti-inflammatory effects. Scutellaria baicalensis is neutral in nature and bitter in taste, entering the lung, gallbladder, spleen, large intestine, and small intestine meridians; it has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding and calming the fetus. Astragalus membranaceus is sweet in taste and warm in nature, entering the lung and spleen meridians; it has the effects of tonifying qi and strengthening the exterior, promoting diuresis and eliminating toxins, draining pus, astringing sores and promoting tissue regeneration, promoting metabolism, and anti-fatigue effects. Poria cocos is neutral in nature... Sweet and bland in taste, it enters the heart, lung, spleen, and kidney meridians, and has the effects of promoting diuresis and removing dampness, strengthening the spleen and calming the mind; Artemisia argyi is warm in nature, bitter and pungent in taste, and enters the spleen, liver, and kidney meridians, and has the effects of regulating menstruation and stopping bleeding, calming the fetus and preventing miscarriage, dispelling cold and dampness, reducing inflammation and regulating qi; Licorice is neutral in nature, sweet in taste, and enters the foot Taiyin and Jueyin meridians, and has the effects of dispelling external cold, removing pathogenic heat, relieving stagnation of vital energy, and nourishing yin and blood; Menthol is warm in nature, pungent and sweet in taste, and has the effects of dispelling wind, regulating qi, relieving pain, preventing decay and killing bacteria, promoting diuresis, and resolving phlegm.

[0011] This invention utilizes the synergistic effects of principal, assistant, adjuvant, and guiding herbs to achieve a significant therapeutic effect on bacterial and fungal vaginitis, with a low recurrence rate, effectively avoiding the toxic side effects and adverse reactions caused by Western medicine. More importantly, the traditional Chinese medicine preparations made using the herbal composition provided by this invention are less prone to drug resistance, have minimal toxic side effects, promote vaginal environment balance, and enhance female immune function, demonstrating significant efficacy in the prevention and treatment of bacterial and fungal vaginitis, providing new ideas and theoretical basis for the treatment of gynecological inflammation.

[0012] More preferably, the traditional Chinese medicine composition comprises the following raw material components in parts by weight: 10-18 parts of Cassia tora, 8-12 parts of Polygonum hydropiper, 8-12 parts of Polygonum hydropiper, 4-8 parts of Equisetum hyemale, 2-4 parts of Ageratum conyzoides, 2-4 parts of Indigo naturalis, 3-8 parts of Sophora flavescens, 3-8 parts of Scutellaria baicalensis, 2-4 parts of Astragalus membranaceus, 2-4 parts of Poria cocos, 2-4 parts of Artemisia argyi, 2-4 parts of Glycyrrhiza uralensis, and 2-4 parts of Menthol.

[0013] A second aspect of the present invention provides a method for preparing the traditional Chinese medicine composition for preventing and treating vaginitis, comprising the following steps:

[0014] Step 1: Dry the Cassia tora at 50℃-60℃, pulverize it to obtain Cassia tora powder; extract the Cassia tora powder by reflux with alcohol solution 3-5 times, combine the extracts to obtain crude Cassia tora extract;

[0015] Step 2: The crude extract of Scutellaria baicalensis is purified and concentrated using macroporous resin to obtain Scutellaria baicalensis extract.

[0016] Step 3: Weigh all components except for the extract of Cassia tora and Scutellaria baicalensis according to the designed ratio, mix them evenly, crush them, and sieve them to obtain the first mixture;

[0017] Step 4: Add the first mixture to deionized water, soak for 2-3 hours, boil, decoct at 75-80℃ for 1-2 hours, filter, and obtain the second mixture and the first medicinal solution.

[0018] Step 5: Add the second mixture to the alcohol solution, soak for 1-2 hours, boil, decoct at 55℃-65℃ for 1-2 hours, filter, discard the filter residue, and obtain the second medicinal solution;

[0019] Step 6: Mix the first medicinal solution, the second medicinal solution, and the extract of Cassia tora and Scutellaria baicalensis evenly, and concentrate at 70℃-90℃ to obtain a traditional Chinese medicine composition for the prevention and treatment of vaginitis.

[0020] Preferably, in step one, the drying time is 1-2 hours.

[0021] Preferably, in step one, the particle size of the crushed Cassia tora powder is 100μm-250μm.

[0022] Preferably, in step one, the alcohol solution is a 65%-70% ethanol solution.

[0023] Preferably, in step one, the mass ratio of the Cassia tora powder to the alcohol solution is 1:15-25.

[0024] Preferably, in step two, the macroporous resin is any one of NHA-9, XDA-1, or XDA-8, and the column diameter-to-height ratio of the macroporous resin is 1:4-1:5.

[0025] Preferably, in step two, the purification includes water washing and elution with a mixed alcohol solvent. The volume of water washing is 4 BV-6 BV, and the flow rate of water washing is 2 BV / h-3 BV / h. The volume of mixed alcohol solvent elution is 3 BV-5 BV, and the flow rate of mixed alcohol solvent elution is 2 BV / h-3 BV / h.

[0026] More preferably, the mixed alcohol solvent is n-butanol and ethanol in a volume ratio of 1:2 to 1:3.

[0027] Preferably, in step two, the concentration temperature is 80℃-95℃ and the concentration time is 30min-100min.

[0028] Preferably, in step three, the particle size of the first mixture is 100μm-200μm.

[0029] Preferably, in step four, the mass-to-volume ratio of the first mixture to deionized water is 1g:5mL-1g:8mL.

[0030] Preferably, in step five, the alcohol solution is a 55%-60% ethanol solution, and the mass-to-volume ratio of the second mixture to the alcohol solution is 1g:4mL-1g:7mL.

[0031] Preferably, in step six, the relative density of the traditional Chinese medicine composition for preventing and treating vaginitis is 1.08-1.10.

[0032] A third aspect of the present invention provides a traditional Chinese medicine preparation for the prevention and treatment of vaginitis, comprising the traditional Chinese medicine composition for the prevention and treatment of vaginitis.

[0033] Preferably, the dosage form of the traditional Chinese medicine preparation is any one of suppositories, gels, capsules, granules, or lotions.

[0034] In summary, this invention provides a traditional Chinese medicine composition for the prevention and treatment of vaginitis and its preparation method. Utilizing the principles of traditional Chinese medicine (TCM) principles, it provides rapid and effective treatment for bacterial and fungal vaginitis. Furthermore, the TCM preparation made from the TCM composition of this invention has advantages such as low likelihood of drug resistance, minimal toxicity and side effects, promotion of vaginal environment balance, and enhancement of female immune function, demonstrating significant efficacy in treating bacterial and fungal vaginitis. The technical solution of this invention effectively solves the problems of toxic side effects and adverse reactions, drug resistance, and persistent symptoms associated with existing Western medicine treatments for vaginitis, as well as the limitations and low efficiency of TCM treatments. This invention provides a new approach and theoretical basis for the treatment of gynecological inflammations in women. Detailed Implementation

[0035] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0036] Example 1

[0037] This embodiment provides a traditional Chinese medicine composition for the prevention and treatment of vaginitis, the details of which are as follows:

[0038] The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: 15g of Cassia tora, 10g of Polygonum hydropiper, 10g of Polygonum hydropiper, 5g of Eriocaulon buergerianum, 3g of Artemisia annua and 3g of Indigo naturalis, 5g of Sophora flavescens, 5g of Scutellaria baicalensis, 2g of Astragalus membranaceus, 3g of Poria cocos, 3g of Artemisia argyi, 3g of Glycyrrhiza uralensis and 2g of Menthol.

[0039] The preparation method of the traditional Chinese medicine composition for preventing and treating vaginitis includes the following steps:

[0040] Step 1: Dry 100g of Cassia tora at 55℃ for 2 hours, then pulverize to obtain Cassia tora powder with a particle size of 150μm; extract the Cassia tora powder by reflux with 1800mL of 65% ethanol solution 4 times, combine the extracts to obtain crude Cassia tora extract.

[0041] Step 2: The crude extract of *Cassia tora* was purified using XDA-1 macroporous resin via wet loading at a column diameter-to-height ratio of 1:4. First, deionized water was used to remove impurities at a volume of 5 BV and a flow rate of 2 BV / h. Then, a mixed alcohol solvent of n-butanol and ethanol at a volume ratio of 1:2.5 was used for elution at a volume of 4 BV and a flow rate of 2.5 BV / h. The eluent was concentrated at 85°C for 80 min to obtain the *Cassia tora* extract.

[0042] Step 3: Weigh all components except for the extract of Cassia tora and Scutellaria baicalensis according to the designed ratio, mix them evenly, crush them, and sieve them to obtain a first mixture with a particle size of 150μm.

[0043] Step 4: Add 400 mL of deionized water to the first mixture, soak for 3 hours, boil, decoct at 75°C for 1.5 hours, filter, and obtain the second mixture and the first medicinal solution.

[0044] Step 5: Add 230 mL of 55% ethanol solution to the second mixture, soak for 1 hour, boil, decoct at 65°C for 1 hour, filter, discard the filter residue, and obtain the second medicinal solution.

[0045] Step 6: Mix the first medicinal solution, the second medicinal solution, and the extract of Cassia tora and Scutellaria baicalensis evenly, and concentrate at 80°C to obtain a traditional Chinese medicine composition for the prevention and treatment of vaginitis with a relative density of 1.08.

[0046] Example 2

[0047] This embodiment provides a traditional Chinese medicine composition for the prevention and treatment of vaginitis, the details of which are as follows:

[0048] The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: 12g of Cassia tora, 9g of Gynostemma pentaphyllum, 8g of Polygonum hydropiper, 8g of Eriocaulon buergerianum, 4g of Artemisia annua and 3g of Indigo naturalis, 4g of Sophora flavescens, 6g of Scutellaria baicalensis, 3g of Astragalus membranaceus, 4g of Poria cocos, 4g of Artemisia argyi, 2g of Glycyrrhiza uralensis and 3g of Menthol.

[0049] The preparation method of the traditional Chinese medicine composition for preventing and treating vaginitis includes the following steps:

[0050] Step 1: Dry 100g of Cassia tora at 50℃ for 2 hours, then pulverize to obtain Cassia tora powder with a particle size of 150μm; extract the Cassia tora powder by reflux with 1500mL of 70% ethanol solution 4 times, combine the extracts to obtain crude Cassia tora extract.

[0051] Step 2: The crude extract of *Cassia tora* was purified using XDA-1 macroporous resin via wet loading at a column diameter-to-height ratio of 1:5. First, deionized water was used to remove impurities at a volume of 4 BV and a flow rate of 3 BV / h. Then, a mixed alcohol solvent of n-butanol and ethanol at a volume ratio of 1:2.5 was used for elution at a volume of 5 BV and a flow rate of 3 BV / h. The eluent was concentrated at 85°C for 80 min to obtain the *Cassia tora* extract.

[0052] Step 3: Weigh all components except for the extract of Cassia tora and Scutellaria baicalensis according to the designed ratio, mix them evenly, crush them, and sieve them to obtain a first mixture with a particle size of 150μm;

[0053] Step 4: Add 400 mL of deionized water to the first mixture, soak for 2 hours, boil, decoct at 80°C for 1 hour, filter, and obtain the second mixture and the first medicinal solution.

[0054] Step 5: Add 350 mL of 55% ethanol solution to the second mixture, soak for 1 hour, boil, decoct at 60°C for 1 hour, filter, discard the filter residue, and obtain the second medicinal solution.

[0055] Step 6: Mix the first medicinal solution, the second medicinal solution, and the extract of Cassia tora and Scutellaria baicalensis evenly, and concentrate at 75°C to obtain a traditional Chinese medicine composition for the prevention and treatment of vaginitis with a relative density of 1.09.

[0056] Example 3

[0057] This embodiment provides a traditional Chinese medicine composition for the prevention and treatment of vaginitis, the details of which are as follows:

[0058] The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: 15g of Cassia tora, 12g of Gynostemma pentaphyllum, 8g of Polygonum hydropiper, 6g of Eriocaulon buergerianum, 2g of Artemisia annua, 4g of Indigo naturalis, 8g of Sophora flavescens, 6g of Scutellaria baicalensis, 3g of Astragalus membranaceus, 3g of Poria cocos, 4g of Artemisia argyi, 4g of Glycyrrhiza uralensis, and 2g of Menthol.

[0059] The preparation method of the traditional Chinese medicine composition for preventing and treating vaginitis includes the following steps:

[0060] Step 1: Dry 100g of Cassia tora at 60℃ for 1.5h, then pulverize to obtain Cassia tora powder with a particle size of 180μm; extract the Cassia tora powder by reflux with 2000mL of 65% ethanol solution 4 times, combine the extracts to obtain crude Cassia tora extract.

[0061] Step 2: The crude extract of *Cassia tora* was purified using XDA-1 macroporous resin via wet loading at a column diameter-to-height ratio of 1:5. First, deionized water was used to remove impurities at a volume of 5 BV and a flow rate of 2 BV / h. Then, a mixed alcohol solvent of n-butanol and ethanol at a volume ratio of 1:3 was used for elution at a volume of 5 BV and a flow rate of 2.5 BV / h. The eluent was concentrated at 85°C for 80 min to obtain the *Cassia tora* extract.

[0062] Step 3: Weigh all components except for the extract of Cassia tora and Scutellaria baicalensis according to the designed ratio, mix them evenly, crush them, and sieve them to obtain a first mixture with a particle size of 130μm;

[0063] Step 4: Add 400 mL of deionized water to the first mixture, soak for 3 hours, boil, decoct at 75°C for 1.5 hours, filter, and obtain the second mixture and the first medicinal solution;

[0064] Step 5: Add 260 mL of 60% ethanol solution to the second mixture, soak for 1 hour, boil, decoct at 65°C for 1 hour, filter, discard the filter residue, and obtain the second medicinal solution.

[0065] Step 6: Mix the first medicinal solution, the second medicinal solution, and the extract of Cassia tora and Scutellaria baicalensis evenly, and concentrate at 80°C to obtain a traditional Chinese medicine composition for the prevention and treatment of vaginitis with a relative density of 1.10.

[0066] Comparative Example 1

[0067] This comparative example provides a traditional Chinese medicine composition for the prevention and treatment of vaginitis. The extract of *Cassia tora* and *Cynanchum paniculatum* in Example 1 is replaced with an equal amount of dandelion extract, while other components and preparation processes remain unchanged. The specific details are as follows:

[0068] The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: 15g of dandelion, 10g of *Gynostemma pentaphyllum*, 10g of *Polygonum hydropiper*, 5g of *Hedyotis diffusa*, 3g of *Ageratum sibiricum* and 3g of indigo naturalis, 5g of *Sophora flavescens*, 5g of *Scutellaria baicalensis*, 2g of *Astragalus membranaceus*, 3g of *Poria cocos*, 3g of *Artemisia argyi*, 3g of licorice and 2g of menthol.

[0069] The preparation method of the traditional Chinese medicine composition for preventing and treating vaginitis includes the following steps:

[0070] Step 1: Dry 100g of dandelion at 55℃ for 2h, then pulverize it to obtain dandelion powder with a particle size of 150μm; extract the powder of Cassia tora powder by reflux with 1800mL of 65% ethanol solution 4 times, combine the extracts to obtain crude dandelion extract.

[0071] Step 2: The crude dandelion extract was purified using XDA-1 macroporous resin via wet loading at a column diameter-to-height ratio of 1:4. First, deionized water was used to remove impurities at a volume of 5 BV and a flow rate of 2 BV / h. Then, a mixed alcohol solvent of n-butanol and ethanol at a volume ratio of 1:2.5 was used for elution at a volume of 4 BV and a flow rate of 2.5 BV / h. The eluent was concentrated at 85°C for 80 min to obtain the dandelion extract.

[0072] Step 3: Weigh all components except dandelion extract according to the designed ratio, mix them evenly, crush them, and sieve them to obtain a first mixture with a particle size of 150μm;

[0073] Step 4: Add 400 mL of deionized water to the first mixture, soak for 3 hours, boil, decoct at 75°C for 1.5 hours, filter, and obtain the second mixture and the first medicinal solution;

[0074] Step 5: Add 230 mL of 55% ethanol solution to the second mixture, soak for 1 hour, boil, decoct at 65°C for 1 hour, filter, discard the filter residue, and obtain the second medicinal solution.

[0075] Step 6: Mix the first medicinal solution, the second medicinal solution and the dandelion extract evenly, and concentrate at 80°C to obtain a traditional Chinese medicine composition for the prevention and treatment of vaginitis with a relative density of 1.08.

[0076] Comparative Example 2

[0077] This comparative example provides a traditional Chinese medicine composition for the prevention and treatment of vaginitis. The *Hu Zi Qi* in Example 1 is replaced with an equal amount of *Wu Wei Zi*, while other components and preparation processes remain unchanged. The specific details are as follows:

[0078] The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: 15g of Cassia tora, 10g of Schisandra chinensis, 10g of Polygonum hydropiper, 5g of Equisetum hyemale, 3g of Artemisia annua and 3g of Indigo naturalis, 5g of Sophora flavescens, 5g of Scutellaria baicalensis, 2g of Astragalus membranaceus, 3g of Poria cocos, 3g of Artemisia argyi, 3g of Glycyrrhiza uralensis and 2g of Menthol.

[0079] The preparation method of the traditional Chinese medicine composition for preventing and treating vaginitis includes the following steps:

[0080] Step 1: Dry 100g of Cassia tora at 55℃ for 2 hours, then pulverize to obtain Cassia tora powder with a particle size of 150μm; extract the Cassia tora powder by reflux with 1800mL of 65% ethanol solution 4 times, combine the extracts to obtain crude Cassia tora extract.

[0081] Step 2: The crude extract of *Cassia tora* was purified using XDA-1 macroporous resin via wet loading at a column diameter-to-height ratio of 1:4. First, deionized water was used to remove impurities at a volume of 5 BV and a flow rate of 2 BV / h. Then, a mixed alcohol solvent of n-butanol and ethanol at a volume ratio of 1:2.5 was used for elution at a volume of 4 BV and a flow rate of 2.5 BV / h. The eluent was concentrated at 85°C for 80 min to obtain the *Cassia tora* extract.

[0082] Step 3: Weigh all components except for the extract of Cassia tora and Scutellaria baicalensis according to the designed ratio, mix them evenly, crush them, and sieve them to obtain a first mixture with a particle size of 150μm.

[0083] Step 4: Add 400 mL of deionized water to the first mixture, soak for 3 hours, boil, decoct at 75°C for 1.5 hours, filter, and obtain the second mixture and the first medicinal solution.

[0084] Step 5: Add 230 mL of 55% ethanol solution to the second mixture, soak for 1 hour, boil, decoct at 65°C for 1 hour, filter, discard the filter residue, and obtain the second medicinal solution.

[0085] Step 6: Mix the first medicinal solution, the second medicinal solution, and the extract of Cassia tora and Scutellaria baicalensis evenly, and concentrate at 80°C to obtain a traditional Chinese medicine composition for the prevention and treatment of vaginitis with a relative density of 1.08.

[0086] Comparative Example 3

[0087] This comparative example provides a traditional Chinese medicine composition for the prevention and treatment of vaginitis. The Polygonum hydropiper in Example 1 is replaced with an equal amount of Fraxinus chinensis, while other components and preparation processes remain unchanged. The specific details are as follows:

[0088] The raw materials for this traditional Chinese medicine composition include the following components in parts by weight: 15g of Cassia tora, 10g of Schisandra chinensis, 10g of Fraxinus chinensis, 5g of Eriocaulon buergerianum, 3g of Artemisia annua and 3g of Indigo naturalis, 5g of Sophora flavescens, 5g of Scutellaria baicalensis, 2g of Astragalus membranaceus, 3g of Poria cocos, 3g of Artemisia argyi, 3g of Glycyrrhiza uralensis and 2g of Menthol.

[0089] The preparation method of the traditional Chinese medicine composition for preventing and treating vaginitis includes the following steps:

[0090] Step 1: Dry 100g of Cassia tora at 55℃ for 2 hours, then pulverize to obtain Cassia tora powder with a particle size of 150μm; extract the Cassia tora powder by reflux with 1800mL of 65% ethanol solution 4 times, combine the extracts to obtain crude Cassia tora extract.

[0091] Step 2: The crude extract of *Cassia tora* was purified using XDA-1 macroporous resin via wet loading at a column diameter-to-height ratio of 1:4. First, deionized water was used to remove impurities at a volume of 5 BV and a flow rate of 2 BV / h. Then, a mixed alcohol solvent of n-butanol and ethanol at a volume ratio of 1:2.5 was used for elution at a volume of 4 BV and a flow rate of 2.5 BV / h. The eluent was concentrated at 85°C for 80 min to obtain the *Cassia tora* extract.

[0092] Step 3: Weigh all components except for the extract of Cassia tora and Scutellaria baicalensis according to the designed ratio, mix them evenly, crush them, and sieve them to obtain a first mixture with a particle size of 150μm.

[0093] Step 4: Add 400 mL of deionized water to the first mixture, soak for 3 hours, boil, decoct at 75°C for 1.5 hours, filter, and obtain the second mixture and the first medicinal solution.

[0094] Step 5: Add 230 mL of 55% ethanol solution to the second mixture, soak for 1 hour, boil, decoct at 65°C for 1 hour, filter, discard the filter residue, and obtain the second medicinal solution.

[0095] Step 6: Mix the first medicinal solution, the second medicinal solution, and the extract of Cassia tora and Scutellaria baicalensis evenly, and concentrate at 80°C to obtain a traditional Chinese medicine composition for the prevention and treatment of vaginitis with a relative density of 1.08.

[0096] Comparative Example 4

[0097] This comparative example provides a commercially available metronidazole-chlorhexidine wash for treating bacterial vaginosis.

[0098] Comparative Example 5

[0099] This comparative example provides a commercially available antifungal wash, Fuyanjie, for treating fungal vaginitis.

[0100] Experimental Example 1

[0101] This experimental example provides a traditional Chinese medicine suppository for the prevention and treatment of vaginitis, using the traditional Chinese medicine composition provided in Example 1, specifically including the following steps:

[0102] Add 60g of glycerin and 55g of polyethylene glycol to 10g of the traditional Chinese medicine composition obtained in Example 1, heat in a water bath to melt, add to a suppository mold, cool and solidify, and package to obtain a traditional Chinese medicine suppository for the prevention and treatment of vaginitis.

[0103] Experimental Example 2

[0104] This experimental example provides a traditional Chinese medicine wash for the prevention and treatment of vaginitis, using the traditional Chinese medicine composition provided in Example 1, specifically including the following steps:

[0105] Add 1L of deionized water to 100g of the traditional Chinese medicine composition obtained in Example 1, then add 30g of polysorbate-80 and 5g of sodium benzoate, mix well and dispense to obtain a traditional Chinese medicine wash for preventing and treating vaginitis.

[0106] Experimental Example 3

[0107] This experimental example provides a traditional Chinese medicine gel for the prevention and treatment of vaginitis, using the traditional Chinese medicine composition provided in Example 1, specifically including the following steps:

[0108] Add 50g of glycerin and 20g of azone to 150g of the traditional Chinese medicine composition obtained in Example 1, mix well, add to the prepared gel matrix, add 1000mL of purified water, add triethanolamine to adjust the pH to 6.2, stir and mix well, dispense into a container, and obtain the traditional Chinese medicine gel for the prevention and treatment of vaginitis.

[0109] Test Example 4

[0110] This experimental example provides a traditional Chinese medicine granule for the prevention and treatment of vaginitis, using the traditional Chinese medicine composition provided in Example 1, specifically including the following steps:

[0111] Add 30g of medicinal starch, 0.5g of sodium carboxymethyl cellulose, and 0.3g of β-cyclodextrin to 10g of the traditional Chinese medicine composition obtained in Example 1, mix well, and granulate to obtain traditional Chinese medicine granules for the prevention and treatment of vaginitis.

[0112] The traditional Chinese medicine compositions obtained in Examples 2-3 and Comparative Examples 1-3 can also be used to prepare traditional Chinese medicine preparations of relevant dosage forms through experimental methods, which will not be elaborated here.

[0113] To demonstrate the technical effects of the present invention, the drugs obtained in Examples 1-3 and Comparative Examples 1-5 were tested as follows:

[0114] 1.1 Toxicity Test

[0115] 1.1.1 Long-term toxicity test: The traditional Chinese medicine compositions for preventing and treating vaginitis obtained in Examples 1-3 and Comparative Examples 1-3 of this invention were prepared into granules. Kunming female mice were divided into 6 groups of 10 mice each. The mice were administered the medicine according to the group (Group 1: granules prepared using the traditional Chinese medicine composition obtained in Example 1; Group 2: granules prepared using the traditional Chinese medicine composition obtained in Example 2; Group 3: granules prepared using the traditional Chinese medicine composition obtained in Example 3; Group 4: granules prepared using the traditional Chinese medicine composition obtained in Comparative Example 1; Group 5: granules prepared using the traditional Chinese medicine composition obtained in Comparative Example 2; Group 6: granules prepared using the traditional Chinese medicine composition obtained in Comparative Example 3) at a dosage of 0.005 g / kg, for 10 consecutive weeks, twice a day, with normal diet during the treatment period. Four weeks after drug withdrawal, the mice in each group were tested for indicators such as hair, behavior, urination and defecation, body weight, organ weight, blood count, liver and kidney function, blood glucose, and blood lipids. Pathological anatomical tests were performed on the organs. The results are shown in Table 1.

[0116] Table 1 Results of Long-Term Toxicity Tests

[0117]

[0118] 1.1.2 Acute toxicity test:

[0119] The traditional Chinese medicine compositions for preventing and treating vaginitis obtained in Examples 1-3 and Comparative Examples 1-3 of this invention were prepared into granules and dissolved in distilled water. Kunming female mice were divided into 6 groups of 10 mice each. The granules were prepared according to the following groups: Group 1: granules prepared using the traditional Chinese medicine composition obtained in Example 1; Group 2: granules prepared using the traditional Chinese medicine composition obtained in Example 2; Group 3: granules prepared using the traditional Chinese medicine composition obtained in Example 3; Group 4: granules prepared using the traditional Chinese medicine composition obtained in Comparative Example 1; Group 5: granules prepared using the traditional Chinese medicine composition obtained in Comparative Example 2. The obtained traditional Chinese medicine composition was used to prepare traditional Chinese medicine granules; Group 6: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition obtained in Comparative Example 3 were administered to mice. The initial dose was 0.005 g / kg. Mice were then administered the medicine at 100, 140, 160, 180, 200, and 220 times the clinical daily dose, respectively. The mice were observed for 7 days. The hair, behavior, urination and defecation, body weight, organ weight, blood count, liver and kidney function, blood glucose, and blood lipids of each group of mice were tested. Pathological anatomical tests were performed on the organs. No toxic reactions were observed in any of the results.

[0120] 1.2 In vitro antibacterial test

[0121] Test drugs: Traditional Chinese medicine washes prepared from the traditional Chinese medicine compositions obtained in Examples 1-3 and Comparative Examples 1-3, respectively.

[0122] Experimental group: Group 1: Traditional Chinese medicine washes prepared using the traditional Chinese medicine composition obtained in Example 1;

[0123] Group 2: Herbal washes prepared using the herbal composition obtained in Example 2; Group 3: Herbal washes prepared using the herbal composition obtained in Example 3; Group 4: Herbal washes prepared using the herbal composition obtained in Comparative Example 1; Group 5: Herbal washes prepared using the herbal composition obtained in Comparative Example 2; Group 6: Herbal washes prepared using the herbal composition obtained in Comparative Example 3.

[0124] Experimental procedure: Staphylococcus aureus was inoculated into LB liquid medium, Candida albicans was inoculated into Sabouraud liquid medium, and Gardnerella vaginalis was inoculated into HTM liquid medium;

[0125] The LB liquid culture medium is prepared as follows: 10g of tryptic peptone, 5g of yeast extract, and 10g of sodium chloride are mixed evenly and dissolved in 950mL of ultrapure water. The pH is adjusted to 7.0 with 1mol / L sodium hydroxide solution, and the volume is brought to 1L. The medium is then autoclaved at 121℃ for 20min.

[0126] The preparation method of Sabouraud dextrose liquid culture medium is as follows: Weigh 30g of purchased Sabouraud dextrose liquid culture medium powder, add 1L of deionized water, stir and heat to boiling until completely dissolved, dispense into Erlenmeyer flasks, sterilize at 121℃ for 15 minutes, and set aside.

[0127] The preparation method of the HTM liquid culture medium is as follows: Weigh 43g of purchased HTM culture medium powder, add deionized water to 1L, adjust the pH to 7.2, heat to boiling to completely dissolve, sterilize at 121℃ for 15min, and set aside.

[0128] The test drug was added to 10 mL test tubes containing 2 mL of the corresponding liquid culture medium. The final drug concentrations were 128 mg / mL, 64 mg / mL, 32 mg / mL, 16 mg / mL, 8 mg / mL, 4 mg / mL, 3 mg / L, 2.5 mg / L, 2 mg / mL, 1.5 mg / L, 1 mg / mL, 0.5 mg / mL, 0.25 mg / mL, 0.125 mg / mL, and 0 mg / mL, respectively. The drug concentration in the blank control was 0 mg / mL. The bacterial suspension was then inoculated at a ratio of 5% of the total volume. The tubes were then incubated at 37℃ and 200 rpm for 20 h, and the results were observed visually. Compared with the blank control, the lowest drug concentration that completely inhibits bacterial growth was defined as the minimum inhibitory concentration (MIC) (mg / mL). Due to the influence of drug color and crude extract turbidity, the liquid in the corresponding tube was thoroughly dipped into the corresponding agar medium using a sterile inoculation loop and transferred to the corresponding agar medium. After incubation at 37°C overnight for 12 hours, the absence of bacterial growth at the streaked area was determined as the minimum inhibitory concentration (mg / mL) of the extracted drug. The specific test results are shown in Table 2.

[0129] Table 2 Results of in vitro antibacterial test

[0130]

[0131] As can be seen from Table 2, the traditional Chinese medicine preparations made from the traditional Chinese medicine compositions provided in Examples 1-3 of this invention have a significant inhibitory effect on the growth of Gardnerella vaginalis, Staphylococcus aureus and Candida albicans.

[0132] 1.3 Therapeutic effect on bacterial vaginosis

[0133] Experimental animals: Kunming female rats, acclimatized for one week before the experiment; 10 rats per group.

[0134] Test drugs: Traditional Chinese medicine wash solutions prepared from the traditional Chinese medicine compositions obtained in Examples 1-3 and Comparative Examples 1-3, and metronidazole-chlorhexidine wash solution provided in Comparative Example 4.

[0135] Dosage: 0.05 mL / kg, vaginal administration, once daily.

[0136] Experimental groups: Group 1: Traditional Chinese medicine wash obtained in Example 1; Group 2: Traditional Chinese medicine wash obtained in Example 2; Group 3: Traditional Chinese medicine wash obtained in Example 3; Group 4: Traditional Chinese medicine wash obtained in Comparative Example 1; Group 5: Traditional Chinese medicine wash obtained in Comparative Example 2; Group 6: Traditional Chinese medicine wash obtained in Comparative Example 3; Group 7: Metronidazole and chlorhexidine wash provided in Comparative Example 4; Group 8: Sterile physiological saline.

[0137] Modeling method: Gardnerella vaginalis (BNCC354890) and Staphylococcus aureus (BNCC186158) were resuscitated and passaged using standard methods, and then prepared with sterile physiological saline to a concentration of 1.5 × 10⁻⁶. 9 CFU / mL bacterial suspension was mixed at a 1:1 ratio to prepare the infectious bacterial solution. Female mice in groups 1 through 7 were treated as follows: The vaginas of the female mice were first rinsed three times with sterile PBS, with a 5-minute interval between each rinse. Then, a No. 5 scalp vein needle coated with sterile paraffin oil was slowly inserted into the rat's vagina approximately 1.5 cm deep. Each rat was injected with 0.025 mL / 100 g of bacteria once daily. After inoculation, the vaginal lesions of the female mice were observed daily, and vaginal secretions were collected for microscopic examination.

[0138] When female mice exhibit typical symptoms of bacterial vaginosis (significant vaginal congestion, redness and swelling accompanied by a large amount of purulent discharge, and microscopic examination of smears of the discharge reveals a large number of infectious bacteria and necrotic cells), it indicates that the bacterial vaginosis model in female mice has been successfully established.

[0139] According to the experimental design, each group was given drug treatment. The wash solution was diluted with 10 mL of physiological saline and administered by rinsing the vagina. The administration was carried out continuously for 14 days. After 2 days of observation, local X-rays of the vagina of female mice were taken, and vaginal swab smears were stained for microscopic examination and pathological examination.

[0140] The criteria for healing are as follows:

[0141] Cure: The vaginal appearance shows no congestion or redness, no purulent discharge, and microscopic examination reveals no infectious bacteria or necrotic cells. The vaginal tissue section shows an intact mucosa and basically normal submucosal tissue, and there is no recurrence within 60 days.

[0142] Effective: The vaginal appearance shows mild congestion and mild redness and swelling, with a small amount of purulent discharge. Microscopic examination reveals a small number of infectious bacteria and necrotic cells. Vaginal tissue sections show mucosal defects, a small number of capillary dilations in the submucosal tissue, increased red blood cells, and a small number of neutrophil infiltrations.

[0143] Invalid: The vaginal appearance shows obvious congestion and swelling, with a large amount of purulent discharge. Microscopic examination reveals a large number of infectious bacteria and necrotic cells. Vaginal tissue sections show severe mucosal defects, a large number of capillary dilations in the submucosal tissue, increased red blood cells, and a large number of neutrophil infiltrations.

[0144] The treatment effects were statistically analyzed based on the drug administration in each group, as shown in Table 3.

[0145] Table 3. Statistical analysis of treatment effects for bacterial vaginosis

[0146]

[0147] As can be seen from Table 3, compared with the blank control group, the medicines provided in Examples 1-3 and Comparative Examples 1-4 of the present invention can all treat bacterial vaginosis. In particular, the traditional Chinese medicine suppositories provided in Examples 1-3 of the present invention have a cure rate of up to 90%-100% for bacterial vaginosis, which is comparable to or even better than the treatment effect of existing Western medicines. However, the recurrence rate of Western medicines is as high as 40%, while the traditional Chinese medicine preparations provided in the examples of the present invention have not shown any recurrence.

[0148] 1.4 Therapeutic effect on fungal vaginitis

[0149] Experimental animals: Kunming female rats, acclimatized for one week before the experiment; 10 rats per group.

[0150] Test drugs: Traditional Chinese medicine wash solutions prepared from the traditional Chinese medicine compositions obtained in Examples 1-3 and Comparative Examples 1-3, and Fuyanjie antifungal wash solution provided in Comparative Example 5.

[0151] Dosage: 0.05 mL / kg, vaginal administration, once daily.

[0152] Experimental groups: Group 1: Traditional Chinese medicine wash obtained in Example 1; Group 2: Traditional Chinese medicine wash obtained in Example 2; Group 3: Traditional Chinese medicine wash obtained in Example 3; Group 4: Traditional Chinese medicine wash obtained in Comparative Example 1; Group 5: Traditional Chinese medicine wash obtained in Comparative Example 2; Group 6: Traditional Chinese medicine wash obtained in Comparative Example 3; Group 7: Metronidazole and chlorhexidine wash provided in Comparative Example 4; Group 8: Sterile physiological saline.

[0153] Modeling method: Candida albicans (BNCC263676) was revived and passaged using standard methods, and then prepared with sterile physiological saline to a concentration of 1.0 × 10⁻⁶. 8 CFU / mL bacterial solution. Female mice in groups 1 to 7 were treated as follows: The vagina of the female mice was first rinsed with sterile PBS 3 times, with an interval of 5 minutes each time. Then, a silicone tube of a No. 5 scalp needle coated with sterile paraffin oil was slowly inserted into the vagina of the rat about 1.5 cm. The amount of bacteria injected into each rat was 0.025 mL / 100 g, once a day. After inoculation, the vaginal lesions of the female mice were observed daily, and vaginal secretions were collected for microscopic examination.

[0154] When female mice exhibit typical symptoms of bacterial vaginosis (vulvar itching, burning, increased vaginal discharge, painful urination, congestion of the vaginal or cervical mucosa, increased curd-like or cottage cheese-like discharge, and microscopic examination reveals a large number of exfoliated cells and obvious hyphae, with the hyphae exhibiting typical Candida albicans characteristics), it indicates that the female mouse model of fungal vaginitis has been successfully established.

[0155] Each group was given drug treatment according to the experimental design. The wash solution was diluted with 10 mL of physiological saline and administered by rinsing the vagina. The administration was carried out continuously for 14 days. After 2 days of observation, local X-rays of the vagina of female mice were taken, and vaginal swab smears were stained and examined under a microscope.

[0156] The criteria for healing are as follows:

[0157] Cure: The vaginal appearance shows no redness or swelling, no cottage cheese-like or curd-like discharge, and microscopic examination reveals no exfoliated cells or Candida albicans hyphae, with no recurrence within 90 days.

[0158] Effective: The vaginal appearance shows mild redness and swelling, with a small amount of cottage cheese-like or curd-like discharge. Microscopic examination reveals a small number of exfoliated cells and Candida albicans hyphae.

[0159] Ineffective: The vaginal appearance is obviously red and swollen, with a large amount of cottage cheese-like or curd-like discharge, and microscopic examination reveals a large number of exfoliated cells and Candida albicans hyphae.

[0160] The treatment effects were statistically analyzed based on the drug administration in each group, as shown in Table 4.

[0161] Table 4. Statistical analysis of treatment effects for fungal vaginitis

[0162]

[0163] As can be seen from Table 4, compared with the blank control group, the medicines provided in Examples 1-3 and Comparative Examples 1-4 of the present invention can all treat bacterial vaginosis. In particular, the traditional Chinese medicine suppositories provided in Examples 1-3 of the present invention have a cure rate of up to 100% for treating fungal vaginitis, which is comparable to or even better than the treatment effect of existing Western medicines. However, the recurrence rate of Western medicines is as high as 60%, while the traditional Chinese medicine preparations provided in the examples of the present invention have not shown any recurrence.

[0164] 1.5 Vaginal mucosal irritation test

[0165] The traditional Chinese medicine compositions obtained in Examples 1-3 and Comparative Examples 1-3 were prepared into traditional Chinese medicine gel preparations. Thirty-five female Kunming mice were divided into seven groups of five mice each. The traditional Chinese medicine gel preparation obtained in Example 1 was injected into the vagina of the female mice in the first group, the traditional Chinese medicine gel preparation obtained in Example 2 was injected into the vagina of the female mice in the second group, the traditional Chinese medicine gel preparation obtained in Example 3 was injected into the vagina of the female mice in the third group, the traditional Chinese medicine gel preparation obtained in Comparative Example 1 was injected into the vagina of the female mice in the fourth group, the traditional Chinese medicine gel preparation obtained in Comparative Example 2 was injected into the vagina of the female mice in the fifth group, the traditional Chinese medicine gel preparation obtained in Comparative Example 3 was injected into the vagina of the female mice in the sixth group, and physiological saline (blank control group) was injected into the vagina of the female mice in the seventh group. The drugs were administered at a dosage of 0.005 g / kg, once a day, for 7 consecutive days. On the 8th day, the physiological condition of the vaginal section of the female mice was observed to see if any abnormal irritation phenomena such as erythema, swelling, or discharge occurred.

[0166] Observations showed that the vaginas of the female mice in each group were in good condition and no vaginal irritation was observed, indicating that the traditional Chinese medicine preparations provided in the embodiments and comparative examples of this invention will not cause abnormal irritation to the vagina.

[0167] 1.6 Clinical Trials

[0168] Subjects: A total of 60 women aged 25-35 years were diagnosed with bacterial vaginosis or fungal vaginitis. The test was conducted outside of menstruation and pregnancy. Each group consisted of 10 women.

[0169] Test drug: Traditional Chinese medicine suppositories prepared from the traditional Chinese medicine compositions obtained in Examples 1-3 and Comparative Examples 1-3.

[0170] Dosage: 0.5g, one capsule daily for 14 consecutive days.

[0171] Therapeutic effect evaluation:

[0172] Cure: Clinical symptoms disappear, vaginal discharge is normal, microscopic examination shows no pathogens or necrotic exfoliated cells, and there is no recurrence within 90 days.

[0173] Effective: Most clinical symptoms disappear, vaginal discharge is basically normal, and microscopic examination reveals a small number of pathogenic bacteria and necrotic exfoliated cells.

[0174] Ineffective: Clinical symptoms do not improve, vaginal discharge remains purulent, curd-like, or cottage cheese-like, and microscopic examination reveals a large number of pathogenic bacteria and necrotic exfoliated cells.

[0175] The experimental results are shown in Table 5.

[0176] Table 5 Clinical trial results

[0177]

[0178] As can be seen from Table 5, the traditional Chinese medicine suppositories prepared from the traditional Chinese medicine compositions for preventing and treating vaginitis provided in Examples 1-3 of the present invention can effectively treat bacterial vaginitis or fungal vaginitis, and will not recur for a long time.

[0179] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for the prevention and treatment of vaginitis, characterized in that: The traditional Chinese medicine composition comprises the following raw material components in parts by weight: 1-20 parts of Cassia tora, 1-15 parts of Polygonum hydropiper, 1-15 parts of Equisetum hyemale, 1-10 parts of Artemisia annua, 1-5 parts of Artemisia argyi, 1-5 parts of Indigo naturalis, 1-10 parts of Sophora flavescens, 1-10 parts of Scutellaria baicalensis, 1-5 parts of Astragalus membranaceus, 1-5 parts of Poria cocos, 1-5 parts of Artemisia argyi, 1-5 parts of Glycyrrhiza uralensis, and 1-5 parts of Menthol.

2. The traditional Chinese medicine composition for preventing and treating vaginitis as described in claim 1, characterized in that: The traditional Chinese medicine composition comprises the following raw material components in parts by weight: 10-18 parts of Cassia tora, 8-12 parts of Polygonum hydropiper, 8-12 parts of Polygonum hydropiper, 4-8 parts of Equisetum hyemale, 2-4 parts of Ageratum conyzoides, 2-4 parts of Indigo naturalis, 3-8 parts of Sophora flavescens, 3-8 parts of Scutellaria baicalensis, 2-4 parts of Astragalus membranaceus, 2-4 parts of Poria cocos, 2-4 parts of Artemisia argyi, 2-4 parts of Glycyrrhiza uralensis, and 2-4 parts of Menthol.

3. A method for preparing a traditional Chinese medicine composition for preventing and treating vaginitis as described in any one of claims 1 or 2, characterized in that: Includes the following steps: Step 1: Dry the Cassia tora at 50℃-60℃, pulverize it to obtain Cassia tora powder; extract the Cassia tora powder by reflux with alcohol solution 3-5 times, combine the extracts to obtain crude Cassia tora extract; Step 2: The crude extract of Scutellaria baicalensis is purified and concentrated using macroporous resin to obtain Scutellaria baicalensis extract. Step 3: Weigh all components except for the extract of Cassia tora and Scutellaria baicalensis according to the designed ratio, mix them evenly, crush them, and sieve them to obtain the first mixture; Step 4: Add the first mixture to deionized water, soak for 2-3 hours, boil, decoct at 75-80℃ for 1-2 hours, filter, and obtain the second mixture and the first medicinal solution. Step 5: Add the second mixture to the alcohol solution, soak for 1-2 hours, boil, decoct at 55℃-65℃ for 1-2 hours, filter, discard the residue, and obtain the second medicinal solution; Step 6: Mix the first medicinal solution, the second medicinal solution, and the extract of Cassia tora and Scutellaria baicalensis evenly, and concentrate at 70℃-90℃ to obtain a traditional Chinese medicine composition for the prevention and treatment of vaginitis.

4. The method for preparing the traditional Chinese medicine composition for preventing and treating vaginitis as described in claim 3, characterized in that: In step one, the drying time is 1-2 hours; and / or In step one, the particle size of the pulverized Cassia tora powder is 100μm-250μm; and / or In step one, the alcohol solution is a 65%-70% ethanol solution; and / or In step one, the mass ratio of the Cassia tora powder to the alcohol solution is 1:15-25.

5. The method for preparing the traditional Chinese medicine composition for preventing and treating vaginitis as described in claim 3, characterized in that: In step two, the macroporous resin is any one of NHA-9, XDA-1, or XDA-8, and the column diameter-to-height ratio of the macroporous resin is 1:4-1:5; and / or In step two, the purification includes water washing and elution with a mixed alcohol solvent. The volume of water washing is 4 BV-6 BV, and the flow rate is 2 BV / h-3 BV / h. The volume of the mixed alcohol solvent elution is 3 BV-5 BV, and the flow rate is 2 BV / h-3 BV / h. And / or In step two, the concentration temperature is 80℃-95℃, and the concentration time is 30min-100min.

6. The method for preparing the traditional Chinese medicine composition for preventing and treating vaginitis as described in claim 5, characterized in that: The mixed alcohol solvent is n-butanol and ethanol in a volume ratio of 1:2 to 1:

3.

7. The method for preparing the traditional Chinese medicine composition for preventing and treating vaginitis as described in claim 3, characterized in that: In step three, the particle size of the first mixture is 100 μm-200 μm; and / or In step four, the mass-to-volume ratio of the first mixture to deionized water is 1g:5mL to 1g:8mL; and / or In step five, the alcohol solution is a 55%-60% ethanol solution, and the mass-to-volume ratio of the second mixture to the alcohol solution is 1g:4mL-1g:7mL; and / or In step six, the relative density of the traditional Chinese medicine composition for preventing and treating vaginitis is 1.08-1.

10.

8. A traditional Chinese medicine preparation for the prevention and treatment of vaginitis, characterized in that: The traditional Chinese medicine composition for preventing and treating vaginitis as described in claim 1 or 2.

9. The traditional Chinese medicine preparation as described in claim 8, characterized in that: The dosage form of the traditional Chinese medicine preparation is any one of suppositories, gels, capsules, granules, or lotions.

Images