A traditional Chinese medicine composition for gynecological inflammation, a preparation method thereof and application thereof

Abstract

This invention relates to the field of gynecological medication technology. The invention provides a traditional Chinese medicine composition for gynecological inflammation, its preparation method, and its application. The composition consists of the following raw materials in parts by weight: 25-35 parts of Phellodendron bark, 15-20 parts of Atractylodes lancea, 8-12 parts of Sophora flavescens, 8-12 parts of Cnidium monnieri, 4-6 parts of Scutellaria baicalensis, 4-6 parts of Lonicera japonica, 4-6 parts of Taraxacum mongolicum, 1-3 parts of Poria cocos, 1-3 parts of Atractylodes macrocephala, and 5-7 parts of Dioscorea opposita. The composition of this invention has good adaptability, mild and non-irritating effects, and good antibacterial, anti-inflammatory, dampness-removing, antipruritic, and leukorrhea-regulating effects against various common gynecological inflammations, without easily inducing drug resistance. Excipients can be added according to the formulation requirements to prepare it into dosage forms suitable for gynecological use, such as vulvar washes, suppositories, ointments, and powders, for the treatment of common gynecological inflammations such as bacterial vaginosis, fungal vaginitis, and vulvitis.

Description

Technical Field

[0001] This invention relates to the field of gynecological medicine technology, and in particular to a traditional Chinese medicine composition for gynecological inflammation, its preparation method and application. Background Technology

[0002] Gynecological inflammation is a common disease with an extremely high incidence rate among women, encompassing more than ten types of conditions such as trichomoniasis, yeast infection, bacterial vaginosis, cervicitis, pelvic inflammatory disease, and adnexitis. It not only causes discomfort such as vulvar itching, abnormal vaginal discharge, and lower abdominal pain, but also, if left untreated for a long time, can affect a woman's normal work and life, and even impair fertility. In severe cases, there is a potential risk of malignant transformation of local lesions. Currently, the main clinical treatments for gynecological inflammation are chemical Western medicines, but these have many undeniable shortcomings in practical application and cannot fully meet clinical treatment needs.

[0003] Currently, commonly used Western medicine treatments include clotrimazole suppositories, metronidazole tablets, and fluconazole. These drugs primarily work by directly inhibiting or killing pathogenic microorganisms, offering rapid short-term effects. However, the drawbacks of long-term use are becoming increasingly apparent: Firstly, excessive use of antibiotics easily induces drug resistance in bacteria, leading to a significant decrease in treatment effectiveness after repeated use. The relapse rate remains high even after symptom relief, trapping many patients in a vicious cycle of "improvement with medication, relapse upon discontinuation." Secondly, these Western medicines only target a single type of pathogen and cannot simultaneously regulate the vaginal microecological environment. While killing harmful bacteria, they also disrupt the balance of normal vaginal flora, potentially causing dysbiosis and further increasing the risk of subsequent infections. Some Western medicines also have clear contraindications; patients with specific constitutions are prone to adverse reactions such as local irritation and allergies after use, resulting in poor patient adherence to long-term medication.

[0004] Therefore, it is particularly important to develop a new, more adaptable, and gentler product. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for gynecological inflammation, its preparation method and application, and to develop a traditional Chinese medicine composition for gynecological inflammation that is scientifically formulated, has significant efficacy, low side effects, and can achieve both symptomatic and root-cause treatment.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for gynecological inflammation, the composition comprising the following raw materials in parts by weight: 25-35 parts of Phellodendron bark, 15-20 parts of Atractylodes lancea, 8-12 parts of Sophora flavescens, 8-12 parts of Cnidium monnieri, 4-6 parts of Scutellaria baicalensis, 4-6 parts of Lonicera japonica, 4-6 parts of Taraxacum mongolicum, 1-3 parts of Poria cocos, 1-3 parts of Atractylodes macrocephala, and 5-7 parts of Dioscorea opposita.

[0007] Preferably, the composition consists of the following raw materials in parts by weight: 30 parts of Phellodendron bark, 17-18 parts of Atractylodes lancea, 10 parts of Sophora flavescens, 10 parts of Cnidium monnieri, 5 parts of Scutellaria baicalensis, 5 parts of Lonicera japonica, 5 parts of Taraxacum mongolicum, 2 parts of Poria cocos, 2 parts of Atractylodes macrocephala, and 6 parts of Dioscorea opposita.

[0008] The present invention also provides a method for preparing the traditional Chinese medicine composition, comprising the following steps: (1) Weigh out the following ingredients in proportion: Phellodendron bark, Atractylodes lancea, Sophora flavescens, Cnidium monnieri, Scutellaria baicalensis, Lonicera japonica, Taraxacum mongolicum, Poria cocos, Atractylodes macrocephala, and Dioscorea opposita. After crushing, a mixture is obtained. (2) Soak the mixture in water and then boil it to separate the residue 1 and the filtrate 1. (3) Add water to the filter residue 1 and boil it a second time to separate the filter residue 2 and the filtrate 2; (4) Soak the filter residue 2 in ethanol solution and boil it again, then filter to obtain filtrate 3; (5) Combine filtrate 1, filtrate 2 and filtrate 3 and concentrate to obtain the extract of traditional Chinese medicine composition.

[0009] Preferably, the mass ratio of the mixture to water in step (2) is 1:10~12, the soaking time is 25~35 min, and the decocting time is 30~40 min.

[0010] Preferably, the mass ratio of filter residue 1 to water in step (3) is 1:5~6, and the time for the second decoction is 15~25 min.

[0011] Preferably, in step (4), the mass ratio of the filter residue 2 to the ethanol solution is 1:2~3, the concentration of ethanol in the ethanol solution is 70~80%, the soaking time is 5~10 min, and the second decoction time is 4~8 min.

[0012] Preferably, the ratio of the extract of the traditional Chinese medicine composition in step (5) to the mixture in step (1) is 0.9~1.1mL:1g.

[0013] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating gynecological inflammation.

[0014] This invention provides a traditional Chinese medicine composition for gynecological inflammation, its preparation method, and its application. The composition consists of the following raw materials in parts by weight: 25-35 parts of Phellodendron bark, 15-20 parts of Atractylodes lancea, 8-12 parts of Sophora flavescens, 8-12 parts of Cnidium monnieri, 4-6 parts of Scutellaria baicalensis, 4-6 parts of Lonicera japonica, 4-6 parts of Taraxacum mongolicum, 1-3 parts of Poria cocos, 1-3 parts of Atractylodes macrocephala, and 5-7 parts of Dioscorea opposita. The traditional Chinese medicine composition of this application is composed of Phellodendron bark, Atractylodes lancea, Sophora flavescens, Cnidium monnieri, Scutellaria baicalensis, Lonicera japonica, Taraxacum mongolicum, Poria cocos, Atractylodes macrocephala, and Dioscorea opposita. The composition of this invention has good adaptability, mild and non-irritating effects, and good antibacterial, anti-inflammatory, dampness-removing, antipruritic, and leukorrhea-regulating effects against various common gynecological inflammations, and is not prone to drug resistance. Excipients can be added according to the formulation requirements to prepare dosage forms suitable for gynecological use, such as vulvar washes, suppositories, ointments, and powders, for the treatment of common gynecological inflammations such as bacterial vaginosis, fungal vaginitis, and vulvitis. This application scientifically combines 10 medicinal herbs, which synergistically exert a comprehensive effect of antibacterial and anti-inflammatory properties, dampness-removing and itching-relieving effects, and regulating leukorrhea. While inhibiting bacteria, this application also regulates the spleen and stomach through herbs such as Poria cocos, Atractylodes macrocephala, and Dioscorea opposita, enhancing the body's immunity and achieving a holistic treatment effect. By controlling parameters such as soaking time, decoction time, and the ratio of ingredients to liquid, the effective components in the medicinal herbs are ensured not to be destroyed, thus improving the efficacy of the traditional Chinese medicine composition. Detailed Implementation

[0015] This invention provides a traditional Chinese medicine composition for gynecological inflammation, the composition comprising the following raw materials in parts by weight: 25-35 parts of Phellodendron bark, 15-20 parts of Atractylodes lancea, 8-12 parts of Sophora flavescens, 8-12 parts of Cnidium monnieri, 4-6 parts of Scutellaria baicalensis, 4-6 parts of Lonicera japonica, 4-6 parts of Taraxacum mongolicum, 1-3 parts of Poria cocos, 1-3 parts of Atractylodes macrocephala, and 5-7 parts of Dioscorea opposita.

[0016] In this invention, the composition is preferably composed of the following raw materials in parts by weight: 30 parts of Phellodendron bark, 17-18 parts of Atractylodes lancea, 10 parts of Sophora flavescens, 10 parts of Cnidium monnieri, 5 parts of Scutellaria baicalensis, 5 parts of Lonicera japonica, 5 parts of Taraxacum mongolicum, 2 parts of Poria cocos, 2 parts of Atractylodes macrocephala, and 6 parts of Dioscorea opposita.

[0017] The present invention also provides a method for preparing the traditional Chinese medicine composition, comprising the following steps: (1) Weigh out the following ingredients in proportion: Phellodendron bark, Atractylodes lancea, Sophora flavescens, Cnidium monnieri, Scutellaria baicalensis, Lonicera japonica, Taraxacum mongolicum, Poria cocos, Atractylodes macrocephala, and Dioscorea opposita. After crushing, a mixture is obtained. (2) Soak the mixture in water and then boil it to separate the residue 1 and the filtrate 1. (3) Add water to the filter residue 1 and boil it a second time to separate the filter residue 2 and the filtrate 2; (4) Soak the filter residue 2 in ethanol solution and boil it again, then filter to obtain filtrate 3; (5) Combine filtrate 1, filtrate 2 and filtrate 3 and concentrate to obtain the extract of traditional Chinese medicine composition.

[0018] In this invention, the mass ratio of the mixture to water in step (2) is preferably 1:10~12, more preferably 1:11, the soaking time is preferably 25~35min, more preferably 30min, and the decocting time is preferably 30~40min, more preferably 35min.

[0019] In this invention, the mass ratio of filter residue 1 to water in step (3) is preferably 1:5~6, more preferably 1:5.5, and the time for the second decoction is preferably 15~25 min, more preferably 20 min.

[0020] In this invention, the mass ratio of the filter residue 2 and the ethanol solution in step (4) is preferably 1:2~3, more preferably 1:2.5, the concentration of ethanol in the ethanol solution is 70~80%, more preferably 75%, the soaking time is preferably 5~10min, more preferably 7~8min, and the second boiling time is preferably 4~8min, more preferably 6min.

[0021] In this invention, the ratio of the extract of the traditional Chinese medicine composition in step (5) to the mixture in step (1) is preferably 0.9~1.1mL:1g, and more preferably 1mL:1g.

[0022] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating gynecological inflammation.

[0023] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0024] Example 1

[0025] A method for preparing a traditional Chinese medicine composition for gynecological inflammation includes the following steps: (1) Weigh the raw materials according to the mass ratio of 25 parts of Phellodendron bark, 15 parts of Atractylodes lancea, 12 parts of Sophora flavescens, 12 parts of Cnidium monnieri, 4 parts of Scutellaria baicalensis, 6 parts of Lonicera japonica, 4 parts of Taraxacum mongolicum, 1 part of Poria cocos, 3 parts of Atractylodes macrocephala, and 5 parts of Dioscorea opposita. After crushing, a mixture is obtained. (2) Soak the mixture in 10 times its weight of water for 35 minutes and then boil for 30 minutes to separate the residue 1 and the filtrate 1. (3) Add 6 times the mass of water to the filter residue 1 and boil it for 15 minutes to separate the filter residue 2 and the filtrate 2. (4) Soak the filter residue 2 in 3 times its mass of 70% ethanol solution for 10 minutes, then boil it again for 4 minutes, and filter to obtain filtrate 3; (5) Combine filtrate 1, filtrate 2 and filtrate 3 and concentrate to obtain the extract of traditional Chinese medicine composition.

[0026] Note: The ratio of the extract of the traditional Chinese medicine composition to the mixture in step (1) is 1.1 mL: 1 g.

[0027] Example 2

[0028] A method for preparing a traditional Chinese medicine composition for gynecological inflammation includes the following steps: (1) Weigh the raw materials according to the mass ratio of 35 parts of Phellodendron bark, 20 parts of Atractylodes lancea, 8 parts of Sophora flavescens, 8 parts of Cnidium monnieri, 6 parts of Scutellaria baicalensis, 4 parts of Lonicera japonica, 6 parts of Taraxacum mongolicum, 3 parts of Poria cocos, 1 part of Atractylodes macrocephala, and 7 parts of Dioscorea opposita. After crushing, a mixture is obtained. (2) Soak the mixture in 12 times its weight of water for 25 minutes and then boil for 40 minutes to separate the residue 1 and the filtrate 1. (3) Add 5 times the mass of water to the filter residue 1 and boil it for 25 minutes to separate the filter residue 2 and the filtrate 2. (4) Soak the filter residue 2 in 2 times its mass of 80% ethanol solution for 5 minutes, then boil it again for 8 minutes, and filter to obtain filtrate 3; (5) Combine filtrate 1, filtrate 2 and filtrate 3 and concentrate to obtain the extract of traditional Chinese medicine composition.

[0029] Note: The ratio of the extract of the Chinese herbal medicine composition to the mixture in step (1) is 0.9 mL: 1 g.

[0030] Example 3

[0031] A method for preparing a traditional Chinese medicine composition for gynecological inflammation includes the following steps: (1) Weigh the raw materials according to the mass ratio of 30 parts of Phellodendron bark, 17 parts of Atractylodes lancea, 10 parts of Sophora flavescens, 10 parts of Cnidium monnieri, 5 parts of Scutellaria baicalensis, 5 parts of Lonicera japonica, 5 parts of Taraxacum mongolicum, 2 parts of Poria cocos, 2 parts of Atractylodes macrocephala, and 6 parts of Dioscorea opposita. After crushing, a mixture is obtained. (2) Soak the mixture in 11 times its weight of water for 30 minutes, then boil for 30-40 minutes to separate the residue 1 and the filtrate 1. (3) Add 5.5 times the mass of water to the filter residue 1 and boil it for 20 minutes to separate the filter residue 2 and the filtrate 2. (4) Soak the filter residue 2 in 2.5 times its mass of 75% ethanol solution for 8 minutes, then boil it again for 6 minutes, and filter to obtain filtrate 3; (5) Combine filtrate 1, filtrate 2 and filtrate 3 and concentrate to obtain the extract of traditional Chinese medicine composition.

[0032] Note: The ratio of the extract of the Chinese herbal medicine composition to the mixture in step (1) is 1 mL: 1 g.

[0033] Test case

[0034] 1. Antibacterial test

[0035] (1) Preparation of drug-containing plates: Take 1 mL of the extract of the traditional Chinese medicine composition prepared in Example 1 and 9 mL of Columbia blood agar medium (Cida (Guangzhou) Biotechnology Co., Ltd.), mix well and pour into a plate, which is labeled as sample plate 1. Then prepare drug-containing plates for Example 2 and Example 3 in the same way, which are labeled as sample plate 2 and sample plate 3 respectively; Preparation of blank plates: Take 10 mL of Columbia blood agar medium (Cida (Guangzhou) Biotechnology Co., Ltd.), pour it into a plate, and label it a blank plate.

[0036] Gardnerella vaginalis was collected, and the bacterial concentration in the bacterial solution was adjusted to 1×10⁻⁶. 7 The adjusted Gardnerella vaginalis was added to sample plates 1-3 and blank plates, with 0.1 mL added to each plate. Ten plates were used for each group, with the blank plate as a control. The plates were incubated at 37℃ and 5% CO2 for 48 h. After incubation, Gardnerella vaginalis in each sample plate was counted. The average value of the 10 plates in each group was taken and the difference in bacterial count was statistically analyzed.

[0037] The results showed that, compared with the bacteria in blank plate 1, the number of bacteria in sample plate 1 was reduced by 94.97%, the number of bacteria in sample plate 2 was reduced by 93.55%, and the number of bacteria in sample plate 3 was reduced by 95.62%.

[0038] 2. Safety test

[0039] (1) Preparation of medicinal solution: Take the extract of the traditional Chinese medicine composition prepared in Example 1 and deionized water, mix them in a volume ratio of 1:4 to obtain medicinal solution 1; then prepare the medicinal solutions of Example 2 and Example 3d respectively in the same way, and number them as medicinal solution 2 and medicinal solution 3.

[0040] (2) Slug mucosal stimulation test

[0041] Terrestrial slugs were selected as experimental subjects. At the beginning of the experiment, the slugs were placed in petri dishes, and 0.3 mL of drug solution 1 was added to their bodies. Subsequently, the same treatment method was used to conduct experiments with drug solutions 2 and 3 respectively. Five slugs were used in each group; the slugs in the control group were treated with deionized water. After the contact, all the mucus secreted by the slugs was collected.

[0042] The results showed that, compared with the control group, the amount of mucus secreted by slugs treated with the drug solutions 1-3 was comparable to that of the control group, with no significant difference, indicating that the drug solutions 1-3 had good safety.

[0043] As can be seen from the above embodiments, the present invention provides a traditional Chinese medicine composition for gynecological inflammation, its preparation method, and its application. The composition consists of the following raw materials in parts by weight: 25-35 parts of Phellodendron bark, 15-20 parts of Atractylodes lancea, 8-12 parts of Sophora flavescens, 8-12 parts of Cnidium monnieri, 4-6 parts of Scutellaria baicalensis, 4-6 parts of Lonicera japonica, 4-6 parts of Taraxacum mongolicum, 1-3 parts of Poria cocos, 1-3 parts of Atractylodes macrocephala, and 5-7 parts of Dioscorea opposita. The composition of the present invention has good adaptability, mild and non-irritating effects, and good antibacterial, anti-inflammatory, dampness-removing, antipruritic, and leukorrhea-regulating effects against various common gynecological inflammations. It is not prone to drug resistance. Excipients can be added according to the preparation requirements to prepare it into dosage forms suitable for gynecological use, such as vulvar wash, suppositories, ointments, and powders, for the treatment of common gynecological inflammations such as bacterial vaginosis, fungal vaginitis, and vulvitis.

[0044] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for gynecological inflammation, characterized in that, The composition comprises the following raw materials in parts by weight: 25-35 parts of Phellodendron bark, 15-20 parts of Atractylodes lancea, 8-12 parts of Sophora flavescens, 8-12 parts of Cnidium monnieri, 4-6 parts of Scutellaria baicalensis, 4-6 parts of Lonicera japonica, 4-6 parts of Taraxacum mongolicum, 1-3 parts of Poria cocos, 1-3 parts of Atractylodes macrocephala, and 5-7 parts of Dioscorea opposita.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The composition consists of the following raw materials in parts by weight: 30 parts of Phellodendron bark, 17-18 parts of Atractylodes lancea, 10 parts of Sophora flavescens, 10 parts of Cnidium monnieri, 5 parts of Scutellaria baicalensis, 5 parts of Lonicera japonica, 5 parts of Taraxacum mongolicum, 2 parts of Poria cocos, 2 parts of Atractylodes macrocephala, and 6 parts of Dioscorea opposita.

3. The method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: (1) Weigh out the following ingredients in proportion: Phellodendron bark, Atractylodes lancea, Sophora flavescens, Cnidium monnieri, Scutellaria baicalensis, Lonicera japonica, Taraxacum mongolicum, Poria cocos, Atractylodes macrocephala, and Dioscorea opposita. After crushing, a mixture is obtained. (2) Soak the mixture in water and then boil it to separate the residue 1 and the filtrate 1. (3) Add water to the filter residue 1 and boil it a second time to separate the filter residue 2 and the filtrate 2; (4) Soak the filter residue 2 in ethanol solution and boil it again, then filter to obtain filtrate 3; (5) Combine filtrate 1, filtrate 2 and filtrate 3 and concentrate to obtain the extract of traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that, The mass ratio of the mixture to water in step (2) is 1:10~12, the soaking time is 25~35min, and the decocting time is 30~40min.

5. The preparation method according to claim 4, characterized in that, The mass ratio of filter residue 1 to water in step (3) is 1:5~6, and the second decoction time is 15~25min.

6. The preparation method according to claim 5, characterized in that, In step (4), the mass ratio of filter residue 2 to ethanol solution is 1:2~3, the concentration of ethanol in the ethanol solution is 70~80%, the soaking time is 5~10 min, and the second decoction time is 4~8 min.

7. The preparation method according to claim 6, characterized in that, The ratio of the extract of the traditional Chinese medicine composition in step (5) to the mixture in step (1) is 0.9~1.1mL:1g.

8. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating gynecological inflammation.