Traditional Chinese medicine composition for treating gynecological diseases

Abstract

The invention relates to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for treating gynecological diseases, which is prepared from the following components in parts by weight: 300 to 350 grams of cortex phellodendri, 300 to 350 grams of radix scutellariae, 300 to 350 grams of fructus schizandrae, 300 to 350 grams of cuttle bone, 200 to 250 grams of rhizoma coptidis, 110 to 150 grams of radix sophorae flavescentis, 100 to 150 grams of borax, 100 to 120 grams of ha powder, 100 to 120 grams of borneol, 150 to 180 grams of indigo naturalis and 5 to 10 grams of musk. The traditional Chinese medicine composition powder prepared from the traditional Chinese medicine composition through the steps of raw material preparation, crushing, screening and sterilization treatment has the remarkable activity of inhibiting pathogenic microorganisms such as candida albicans, gardnerella and trichomonas vaginalis, and meanwhile, the proliferation activity of human vaginal epithelial cells is remarkably promoted; the traditional Chinese medicine composition has a remarkable treatment effect on mice with qi stagnation and blood stasis type vaginitis.

Description

Technical Field

[0001] The invention belongs to the field of Chinese medicine preparations, and specifically relates to a Chinese medicine composition for treating gynecological diseases. Background Art

[0002] Vaginitis belongs to the category of "leucorrhea" in traditional Chinese medicine theory. Its main symptoms include abnormal leucorrhea, vaginal itching and odor, and are often caused by multiple causes such as damp-heat, spleen and kidney deficiency, qi stagnation and blood stasis. According to the theory of syndrome differentiation in traditional Chinese medicine, vaginitis can be divided into the following main types: damp-heat invasion type: due to the invasion of damp-heat toxic evil, blood stasis in the lower part of the body, it manifests as thick yellow leucorrhea with a fishy smell, accompanied by itching and burning in the genitals; spleen and kidney deficiency type: spleen deficiency and dysfunction of transportation and transformation, endogenous dampness and turbidity; kidney yang deficiency, insufficient essence and qi, manifested as clear and thin leucorrhea with large amount and weakness in the limbs; qi stagnation and blood stasis type: due to emotional distress, qi stagnation, or long-term illness entering the collaterals, blood stasis blocks the uterus, resulting in abnormal leucorrhea, which is often seen in dark red leucorrhea, accompanied by lower abdominal distension and pain, and menstrual irregularities. Among the above categories, qi stagnation and blood stasis type vaginitis is more difficult to treat clinically due to its complex condition, stubborn symptoms, and easy recurrence.

[0003] However, modern medicine usually treats vaginitis with antibiotics, antifungal drugs and anti-trichomonas drugs, such as metronidazole, clotrimazole, etc. These treatments have certain effects on the control of acute infections, but they have the following limitations: drug resistance: the resistance of pathogenic microorganisms (such as Candida albicans and Gardnerella) to antibacterial drugs has increased year by year, resulting in a gradual decline in the treatment effect; microecological damage: antibiotics and antifungal drugs can easily destroy the balance of normal vaginal flora, especially the reduction of lactobacilli, causing the vaginal environment to lose its self-protection ability; lack of targetedness: modern drugs mainly aim at pathogen elimination, lacking overall regulation and targeted treatment of the pathogenesis of qi stagnation and blood stasis type vaginitis.

[0004] Existing research and products for the treatment of vaginitis with traditional Chinese medicine mainly focus on the intervention of damp-heat type and spleen and kidney deficiency type. For example, drugs such as Phellodendron chinense and Sophora flavescens are widely used in clearing heat and drying dampness. However, there is still a lack of targeted Chinese medicine compositions and drugs with significant efficacy for the treatment of qi stagnation and blood stasis type vaginitis. Traditional Chinese medicine believes that qi stagnation and blood stasis type vaginitis requires soothing the liver and relieving depression, promoting blood circulation and removing blood stasis, and unblocking meridians to stop leukorrhea. However, the existing technology is limited to the use of soothing the liver or promoting blood circulation drugs alone, and fails to propose a comprehensive solution for the synergistic effect of qi stagnation and blood stasis, resulting in a high recurrence rate and poor treatment effect of this type of vaginitis. Therefore, the development of a Chinese medicine composition with the functions of soothing the liver and relieving depression, promoting blood circulation and removing blood stasis, and regulating the vaginal microecology has become a technical problem that needs to be solved urgently. Summary of the invention

[0005] In order to solve the above problems, the present invention first provides a Chinese medicine composition for treating vaginitis.

[0006] The purpose of the present invention is to provide a Chinese medicine composition and its application in treating qi stagnation and blood stasis type vaginitis, aiming to solve the technical problem that the prior art has poor therapeutic effect on this type of vaginitis.

[0007] The invention also provides a preparation method of the composition and application of the composition in inhibiting pathogenic bacteria.

[0008] The invention provides a traditional Chinese medicine composition, which is prepared from the following components in parts by weight: 300-350 grams of Phellodendron chinense, 300-350 grams of Scutellaria baicalensis, 300-350 grams of Schisandra chinensis, 300-350 grams of Sepia sepia, 200-250 grams of Coptis chinensis, 110-150 grams of Sophora flavescens, 100-150 grams of Borax, 100-120 grams of Ha powder, 100-120 grams of Borneolum, 150-180 grams of Indigo naturalis and 5-10 grams of Musk.

[0009] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: raw material preparation, crushing and screening, and sterilization treatment steps.

[0010] In one embodiment, the raw material preparation step includes: material selection, cleaning and drying.

[0011] In one embodiment, the crushing and screening steps include: preliminary crushing, ultrafine crushing, and mixed screening.

[0012] The present invention also provides the use of the traditional Chinese medicine composition in preparing a medicine capable of inhibiting Candida albicans, Gardnerella and Trichomonas vaginalis.

[0013] The present invention also provides the use of the traditional Chinese medicine composition in preparing a medicine for treating vaginitis, preferably the vaginitis is qi stagnation and blood stasis type vaginitis.

[0014] The main drug in the prescription is used to treat the main causes and pathogenesis of the disease and plays a core role:

[0015] Phellodendron chinense is bitter, cold and can dry dampness, clear away heat and detoxify. It is a commonly used medicine for clearing heat and drying dampness. It can effectively eliminate damp-heat toxins and improve local damp-heat symptoms in the vagina. It is aimed at the symptoms of vaginitis caused by damp-heat, such as redness, swelling, and fishy secretions.

[0016] Scutellaria baicalensis clears away heat and dampness, purges fire and detoxifies, and has a significant inhibitory effect on inflammatory reactions caused by damp-heat toxic evil; when used together with Phellodendron chinense, it enhances the effects of clearing heat and drying dampness, and inhibits the growth of pathogenic bacteria.

[0017] Schisandra chinensis has the functions of astringency, strengthening the kidney and retaining essence, and also has certain antibacterial effects; it can astringe vaginal secretions, improve the symptoms of excessive leucorrhea, and enhance the local barrier function.

[0018] Cuttlefish bone can astringe and stop bleeding, consolidate semen and stop leukorrhea, neutralize the acidic environment caused by local inflammation, and relieve vaginal mucosal erosion; repair vaginal mucosal tissue, stop leukorrhea and bleeding, and relieve the symptoms of blood stasis caused by qi stagnation and blood stasis.

[0019] Assistant medicine is a medicine that assists the main medicine, strengthens the effect of the main medicine, or treats concomitant symptoms:

[0020] Coptis chinensis is bitter and cold, clears away heat, dries dampness and detoxifies, and has significant antibacterial and anti-inflammatory effects on inflammation of damp-heat type; it works synergistically with Phellodendron chinense and Scutellaria baicalensis to enhance the effects of clearing heat and detoxifying, and inhibit pathogenic microorganisms such as Candida albicans and Gardnerella.

[0021] Sophora flavescens can clear away heat and dampness, kill insects and relieve itching. It has broad-spectrum antibacterial, antifungal and anti-inflammatory effects; it can relieve itching and local inflammation, and is particularly effective for vaginitis caused by Trichomonas vaginalis.

[0022] Borax can be used externally to detoxify, kill insects, clear away heat and dry dampness, and is often used to treat local inflammation such as vaginitis and ulcers; it can regulate the pH value of the vaginal microenvironment, inhibit the growth of pathogens, and promote the healing of local tissues.

[0023] The adjuvant drug assists the principal and ministerial drugs in exerting their therapeutic effects, or harmonizes the medicinal properties:

[0024] Mechanism of action of Ha Powder: Talcum powder ingredients absorb moisture, heal sores, protect mucous membranes, relieve local irritation caused by inflammation; relieve local redness and swelling of the vagina and symptoms of excessive secretions.

[0025] Borneol can invigorate the mind, clear away heat and detoxify, promote drug penetration, enhance local anti-inflammatory and antibacterial effects; reduce local inflammatory stimulation and enhance overall drug efficacy.

[0026] Indigo can clear away heat and detoxify, cool blood and reduce swelling, and has an inhibitory effect on local inflammation and toxic reactions; it can remove damp-heat and toxins and relieve symptoms of vaginal erosion.

[0027] Musk can invigorate blood circulation, relieve swelling and relieve pain, promote local microcirculation and drug absorption; improve blood stasis caused by qi stagnation and blood stasis, and relieve symptoms such as lower abdominal distension and pain.

[0028] Combination of clearing heat and drying dampness with promoting blood circulation and removing blood stasis: The main drugs Phellodendron chinense and Scutellaria baicalensis are combined with the auxiliary drugs Coptis chinensis and Sophora flavescens, focusing on clearing heat and detoxifying, drying dampness and killing insects, targeting the pathogenesis of vaginitis with damp heat and obvious inflammatory reaction. Musk and Indigo naturalis can promote blood circulation and remove blood stasis, dredge the qi of the uterus, target the causes of qi stagnation and blood stasis, and improve the symptoms of local stasis.

[0029] Combination of stopping leukorrhea, astringency and repair: Schisandra chinensis and cuttlefish bone are used together to astringe and stop leukorrhea, replenish essence and Qi, and combined with Hay powder, it can absorb moisture and heal sores, protect the vaginal mucosa, and promote wound healing.

[0030] Combining enhanced efficacy with overall regulation: Borneol and musk promote local blood circulation, enhance drug absorption and penetration, and relieve local swelling and pain by promoting blood circulation and removing blood stasis. Indigo cools blood and reduces swelling, supplementing the overall heat-clearing and detoxifying effects.

[0031] Multi-target synergistic effect: The composition can directly inhibit pathogenic microorganisms such as Candida albicans, Gardnerella and Trichomonas vaginalis through multi-target therapeutic mechanisms such as clearing away heat and dampness, promoting blood circulation and removing blood stasis, killing insects and relieving itching, and can also achieve the purpose of treating both the symptoms and the root causes by regulating the vaginal microecology and repairing the mucosal barrier function.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] The Chinese medicine composition of the present invention is based on the TCM principle of "differentiation and treatment", focuses on the main pathogenesis of qi stagnation and blood stasis type vaginitis, adopts multi-faceted treatment strategies such as clearing away heat and dampness, soothing the liver and relieving depression, promoting blood circulation and removing blood stasis, astringing and stopping leukorrhea, and has a rigorous combination of monarch, minister, adjuvant and envoy ingredients. It can not only significantly improve the symptoms of inflammation, but also reduce recurrence, and has a good therapeutic effect.

[0034] The Chinese medicine composition of the present invention has significant activity in inhibiting pathogenic microorganisms such as Candida albicans, Gardnerella and Trichomonas vaginalis, and at the same time significantly promotes the proliferation activity of human vaginal epithelial cells, and has a significant therapeutic effect on mice with qi stagnation and blood stasis type vaginitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 The antibacterial activity of the Chinese medicine compositions of Examples 1-2 and Comparative Examples 1-4.

[0036] Figure 2 The activity of the Chinese medicine compositions of Examples 1-2 and Comparative Examples 1-4 in promoting proliferation of human vaginal epithelial cells. DETAILED DESCRIPTION

[0037] In order to make the technical problems, technical solutions and advantages to be solved by the present invention more clear, a detailed description will be given below with reference to the accompanying drawings and specific embodiments.

[0038] Example 1

[0039] This embodiment provides a Chinese medicine composition for preventing and treating vaginitis, and the specific contents are as follows:

[0040] The raw materials for preparing the traditional Chinese medicine composition include the following components in parts by mass: 350 grams of Phellodendron chinense, 350 grams of Scutellaria baicalensis, 300 grams of Schisandra chinensis, 300 grams of Cuttlefish bone, 250 grams of Coptis chinensis, 110 grams of Sophora flavescens, 150 grams of Borax, 120 grams of Ha powder, 120 grams of Borneol, 180 grams of Indigo naturalis, and 5 grams of Musk.

[0041] Example 2

[0042] This embodiment provides a Chinese medicine composition for preventing and treating vaginitis, and the specific contents are as follows:

[0043] The raw materials for preparing the traditional Chinese medicine composition include the following components in parts by mass: 300 grams of Phellodendron chinense, 300 grams of Scutellaria baicalensis, 350 grams of Schisandra chinensis, 350 grams of Cuttlefish bone, 200 grams of Coptis chinensis, 150 grams of Sophora flavescens, 100 grams of Borax, 100 grams of Ha powder, 100 grams of Borneol, 150 grams of Indigo naturalis, and 10 grams of Musk.

[0044] Comparative Example 1

[0045] This comparative example provides a Chinese medicine composition for preventing and treating vaginitis, and the specific contents are as follows:

[0046] The raw materials for preparing the traditional Chinese medicine composition include the following components in parts by weight: 300 grams of scutellaria baicalensis, 350 grams of schisandra chinensis, 350 grams of cuttlefish bone, 200 grams of coptis chinensis, 150 grams of sophora flavescens, 100 grams of borax, 100 grams of ha powder, 100 grams of borneol, 150 grams of indigo naturalis and 10 grams of musk.

[0047] Comparative Example 2

[0048] This comparative example provides a Chinese medicine composition for preventing and treating vaginitis, and the specific contents are as follows:

[0049] The raw materials for preparing the traditional Chinese medicine composition include the following components in parts by mass: 300 grams of Phellodendron chinense, 350 grams of Schisandra chinensis, 350 grams of Sepia bone, 200 grams of Coptis chinensis, 150 grams of Sophora flavescens, 100 grams of Borax, 100 grams of Ha powder, 100 grams of Borneol, 150 grams of Indigo naturalis and 10 grams of Musk.

[0050] Comparative Example 3

[0051] This comparative example provides a Chinese medicine composition for preventing and treating vaginitis, and the specific contents are as follows:

[0052] The raw materials for preparing the traditional Chinese medicine composition include the following components in parts by weight: 350 grams of Phellodendron chinense, 350 grams of Scutellaria baicalensis, 300 grams of Sepia bone, 250 grams of Coptis chinensis, 110 grams of Sophora flavescens, 150 grams of Borax, 120 grams of Ha powder, 120 grams of Borneol, 180 grams of Indigo naturalis and 5 grams of Musk.

[0053] Comparative Example 4:

[0054] This comparative example provides a Chinese medicine composition for preventing and treating vaginitis, and the specific contents are as follows:

[0055] The raw materials for preparing the traditional Chinese medicine composition include the following components in parts by mass: 350 grams of Phellodendron chinense, 350 grams of Scutellaria baicalensis, 300 grams of Schisandra chinensis, 250 grams of Coptis chinensis, 110 grams of Sophora flavescens, 150 grams of Borax, 120 grams of Ha powder, 120 grams of Borneol, 180 grams of Indigo naturalis and 5 grams of Musk.

[0056] The formula of the Chinese medicine composition for preventing and treating vaginitis was prepared using the raw materials of Examples 1-2 and Comparative Examples 1-4 of the present application, and the preparation was carried out according to the following method:

[0057] (1) Raw material preparation

[0058] Material selection: strictly select Chinese medicinal materials that meet the pharmacopoeia standards to ensure the quality of the medicinal materials, free of mildew, insect infestation and impurities, and weigh each medicinal material strictly according to the raw material formula ratio of Examples 1-2 and Comparative Examples 1-4;

[0059] Cleaning: Use clean water to rinse the rhizomes of Phellodendron chinense, Scutellaria baicalensis, Coptis chinensis, and Sophora flavescens, and ensure that there is no sand on the surface. Use a dry cloth to wipe the dust off the surface of Schisandra chinensis seeds. Borax, Indigo naturalis, Ha powder, Borneol, and Musk do not need to be washed with water, and should be kept dry for later use.

[0060] Drying: After washing, the medicinal materials are dried in a dryer at low temperature (40-60℃) to avoid loss of medicinal properties, until the moisture content is less than 8%-10%. Hygroscopic or volatile medicinal materials (borneol, musk) are stored separately at low temperature to ensure a dry environment. The rhizomes of Phellodendron chinense, Scutellaria baicalensis, Coptis chinensis, and Sophora flavescens are cut into thin slices of 1-3 mm thickness, and the hard medicinal materials of cuttlefish bone are initially crushed into small pieces of 5-10 mm. The above processed raw materials are set aside.

[0061] (2) Crushing and screening

[0062] Initial crushing: Use a coarse powder machine to process the sliced ​​medicinal materials into 20-40 mesh coarse powder, which is convenient for the next step of ultra-fine crushing. Be careful to avoid overheating during crushing, and it can be processed in batches.

[0063] Ultrafine grinding: Use air flow mill, the temperature is controlled at 10-15℃, to avoid high temperature caused by friction and affect the active ingredients of medicinal materials. The grinding fineness is controlled below 500 mesh (about 25μm), borneol, musk and other volatile medicinal materials should be added last, mixed with the main drug powder and then ground at low temperature for a short time to prevent volatilization.

[0064] Mixing: Use a V-type mixer or a three-dimensional mixer to add the crushed single medicinal materials in proportion and mix for more than 30 minutes to ensure uniformity. When mixing, pay attention to adding materials in batches to prevent uneven mixing of powders of different densities.

[0065] Sieving: Use a 500-mesh standard sieve to sieve the mixed powder. The coarse particles that fail to pass can be crushed again and remixed. Keep a dry environment during sieving to prevent the powder from absorbing moisture and agglomerating.

[0066] (3) Sterilization

[0067] Low-temperature irradiation sterilization or ethylene oxide sterilization is adopted to ensure the hygienic safety of the medicine powder and obtain the final Chinese medicine composition powder.

[0068] Experimental Example 3: Antibacterial activity of Chinese medicine composition

[0069] The antibacterial activity of the Chinese medicine composition against Candida albicans, Gardnerella vaginalis, Trichomonas vaginalis and Lactobacillus was determined by agar diffusion method (Kirby-Bauer method) to evaluate its potential for treating vaginitis and its effect on normal flora Lactobacillus. spp.) to a standard concentration (about 1×106 CFU / mL), and nutrient agar (NA) for Candida albicans, anaerobic blood agar for Gardnerella, TYG medium for Trichomonas vaginalis, and MRS agar for Lactobacillus were prepared; the powder of the Chinese medicine composition of Examples 1-2 and Comparative Examples 1-4 was prepared into a 50 mg / mL aqueous solution with clean water; the bacterial suspension was evenly coated on the surface of the corresponding culture medium (different culture mediums were selected for each microorganism); the water containing the powder of the Chinese medicine composition of Examples 1-2 and Comparative Examples 1-4 was placed on the surface of the agar. The filter paper of the solution was set up with a positive control group (nystatin, metronidazole, levofloxacin) and a negative control group (drug-free filter paper), wherein nystatin is an antifungal drug, which is used to control Candida albicans; metronidazole is an antiprotozoal drug, which is used to control Trichomonas vaginalis; levofloxacin is an antibacterial drug, which is used to control Gardnerella; then Candida albicans and Lactobacillus were cultured aerobically at 37°C for 24 hours; Gardnerella was cultured anaerobically at 37°C for 48 hours; Trichomonas vaginalis was cultured on TYG medium at 37°C for 48 hours. After the culture was completed, the diameter of the antibacterial ring around the filter paper was measured with a vernier caliper (unit: mm), see Figure 1 .

[0070] Figure 1 The results show that the Chinese medicine composition of Example 1-2 has significant antibacterial activity compared with the Chinese medicine composition of Comparative Examples 1-4, and the effect of the Chinese medicine composition of Example 1-2 in inhibiting Candida albicans is close to that of the positive control nystatin; the Chinese medicine composition of Example 1-2 has a significant antibacterial effect on Gardnerella, but the effect is weaker than levofloxacin; the Chinese medicine composition of Example 1-2 has a weaker antibacterial effect on Trichomonas, which is lower than metronidazole; the Chinese medicine compositions of Example 1-2 and Comparative Examples 1-4 have little effect on Lactobacillus, indicating that the inhibitory effect of the Chinese medicine composition on normal flora is limited.

[0071] Figure 1The results showed that the Chinese medicine composition of Example 1-2 exhibited good antibacterial activity against Candida albicans and Gardnerella, had a certain inhibitory effect on Trichomonas vaginalis, and had a weaker inhibitory effect on Lactobacillus, indicating that it may have the advantage of selective antibacterial activity in the treatment of vaginitis.

[0072] Experimental Example 4: Cell experiment of Chinese medicine composition

[0073] Human vaginal epithelial cell line VK2 / E6E7 was inoculated into a 96-well plate, with 5×10 3 Cells were added with 200 μL of culture medium; the cells were cultured at 37°C and 5% CO2 for 24 hours and divided into 10 groups and treated as follows:

[0074] Example 1-2 group: adding an aqueous solution of the powdered Chinese medicine composition of Example 1-2 to the cell culture medium to a concentration of 50 mg / mL;

[0075] Comparative Example 1-4 Group: Add the aqueous solution of the Chinese medicine composition powder of Comparative Example 1-4 to the cell culture medium, and prepare the concentration to be 50 mg / mL;

[0076] Positive control group: EGF (20 ng / mL) was added;

[0077] Negative control group: medium without drug.

[0078] Three replicate wells were set up for each group. Cell proliferation was detected at 24 hours, 48 ​​hours, 72 hours, 48 ​​hours and 96 hours after drug action. 20 μL MTT solution (5 mg / mL) was added at each time point and incubated for another 4 hours. The culture medium was carefully aspirated and 150 μL dimethyl sulfoxide (DMSO) was added to dissolve the purple crystals. The absorbance value (OD value) at 450 nm was measured with an ELISA instrument to reflect the cell proliferation. Figure 2 .

[0079] Figure 2 The results showed that the Chinese medicine composition of Examples 1-2 had a significant effect on promoting the proliferation of human vaginal epithelial cells compared with Comparative Examples 1-4, which increased with time, and the proliferation effect was most significant at 96 hours; the proliferation promoting effect of Examples 1-2 was equivalent to that of EGF, which indicates that the Chinese medicine composition of Examples 1-2 may improve the vaginal barrier function by repairing vaginal epithelial cells, providing experimental support for its application in the treatment of vaginitis.

[0080] Experimental Example 5: Study on the Effect of Chinese Medicine Composition on the Model Mice of Qi Stagnation and Blood Stasis Vaginitis

[0081] Modeling method of mice with qi stagnation and blood stasis vaginitis: estrogen ointment was applied to the vagina for 2 days to induce vaginal epithelial hyperplasia. Mixed pathogenic bacteria suspension, including Candida albicans, Gardnerella and anaerobic bacteria (1×10 8 CFU / mL). Adrenaline (0.1 mg / kg) was injected into the tail vein and the vaginal wall was mechanically stimulated to induce qi stagnation and blood stasis. After modeling, the clinical symptoms of the mice were observed, including vaginal discharge, congestion, and swelling. Local vaginal irrigation: once a day, 50 μL each time, for 7 consecutive days.

[0082] Healthy adult female mice (6–8 weeks old, weighing 18–22 g) were prepared and randomly divided into 5 groups, with 10 mice in each group:

[0083] Normal control group: No model was established, and the rats were irrigated with normal saline.

[0084] Model group: The model of qi stagnation and blood stasis vaginitis was given normal saline irrigation.

[0085] Positive control group: Qi stagnation and blood stasis type vaginitis model, using metronidazole (topical administration).

[0086] Example 1-2 Group: The model of qi stagnation and blood stasis type vaginitis was given by intragastric administration of an aqueous solution (100 mg / mL) of the powdered Chinese medicine composition.

[0087] Comparative Example 1-4 Group: Qi stagnation and blood stasis type vaginitis model, administered intragastricly with an aqueous solution (100 mg / mL) of the Chinese medicine composition powder.

[0088] 1. Clinical symptom scoring

[0089] The amount of vaginal discharge, color / odor, and degree of vaginal inflammation are scored on a scale of 0–10:

[0090] Amount of secretion:

[0091] 0 points: no secretion;

[0092] 1 point: slight secretion;

[0093] 2 points: moderate secretion;

[0094] 3 points: A lot of secretions.

[0095] Color and smell:

[0096] 0 points: no abnormality;

[0097] 1 point: slight discoloration / odor;

[0098] 2 points: obvious different color / odor;

[0099] 3 points: Severe discoloration / odor.

[0100] Inflammation degree (redness / erosion):

[0101] 0 points: no inflammation;

[0102] 1 point: slight congestion;

[0103] 2 points: moderate redness and swelling;

[0104] 3 points: severe redness, swelling and erosion.

[0105] Table 1 Clinical symptom scores

[0106] Group Secretion volume score Color / Odor Rating Inflammation severity score Overall rating Normal control group 0 0 0 0 Model Group 2.8+0.32 2.6+0.26 2.9+0.32 8.3 Positive control group <![CDATA[0.8+0.16 a ]]> <![CDATA[0.7+0.27 a ]]> <![CDATA[0.9+0.17 b ]]> 2.4 Example 1 <![CDATA[0.6+0.12 a ]]> <![CDATA[0.7+0.22 b ]]> <![CDATA[0.8+0.27 b ]]> 2.1 Example 2 <![CDATA[0.8+0.22 b ]]> <![CDATA[0.6+0.17 a ]]> <![CDATA[0.8+0.32 b ]]> 2.2 Comparative Example 1 <![CDATA[2.4+0.15 c ]]> <![CDATA[1.8+0.20 c ]]> <![CDATA[2.2+0.12 d ]]> 6.4 Comparative Example 2 <![CDATA[1.5+0.27 da ]]> <![CDATA[2.1+0.18 da ]]> <![CDATA[1.6+0.13 ca ]]> 5.2 Comparative Example 3 <![CDATA[1.2+0.12 cb ]]> <![CDATA[1.4+0.18 d ]]> <![CDATA[2.3+0.31 c ]]> 4.9 Comparative Example 4 <![CDATA[1.5+0.21 c ]]> <![CDATA[2.2+0.24 cb ]]> <![CDATA[1.1+0.13 cb ]]> 4.8

[0107] Note: Compared with the model group, P a <0.01, P b <0.05; compared with Example 1 / 2 group, P c <0.01, P d <0.05The results in Table 1 show that the Chinese medicine compositions of Examples 1-2 and Comparative Examples 1-4 can significantly improve the symptoms of qi stagnation and blood stasis type vaginitis, among which the effect of Example 1-2 group is close to that of the positive control group, that is, the Chinese medicine composition of Example 1-2 shows significant therapeutic effect on mice with qi stagnation and blood stasis type vaginitis.

[0108] 2. Pathogen elimination rate

[0109] Vaginal smear culture:

[0110] Colony counts of Candida albicans, Gardnerella, and anaerobic bacteria.

[0111] Calculate the clearance rate: Clearance rate (%) = (reduction in colony count after treatment\colony count before treatment) × 100%

[0112] Table 2 Pathogen removal rate

[0113]

[0114]

[0115] The results in Table 2 show that the Chinese medicine compositions of Examples 1-2 and Comparative Examples 1-4 can significantly and effectively eliminate Candida albicans, Gardnerella and anaerobic bacteria, among which the pathogen elimination rate of the Example 1-2 group is more than 90%; that is, the Chinese medicine composition of Examples 1-2 shows a significant therapeutic effect on mice with qi stagnation and blood stasis type vaginitis.

[0116] 3. Improvement of vaginal microecological balance

[0117] Detect the proportion of lactobacilli in the vagina.

[0118] Methods: Vaginal secretions were isolated and selectively cultured for lactobacillus colony count.

[0119] Microecological balance index (L / B):

[0120]

[0121] Table 3 Improvement of vaginal microecological balance

[0122]

[0123]

[0124] Note: Compared with the model group, P a <0.01, P b <0.05; compared with Example 1 / 2 group, P c <0.01, P d <0.05.

[0125] The results in Table 3 show that the Chinese medicine compositions of Examples 1-2 and Comparative Examples 1-4 can significantly increase the number of lactobacilli and restore the L / B index in the vagina, that is, the Chinese medicine compositions show significant therapeutic effects on mice with qi stagnation and blood stasis type vaginitis.

[0126] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating gynecological diseases, characterized in that: The preparation method is prepared from the following components in parts by weight: 300-350 grams of Phellodendron chinense, 300-350 grams of Scutellaria baicalensis, 300-350 grams of Schisandra chinensis, 300-350 grams of Cuttlefish bone, 200-250 grams of Coptis chinensis, 110-150 grams of Sophora flavescens, 100-150 grams of Borax, 100-120 grams of Ha powder, 100-120 grams of Borneol, 150-180 grams of Indigo naturalis and 5-10 grams of Musk.

2. Use of the Chinese medicine composition according to claim 1 in preparing a medicine for treating vaginitis.

3. The use according to claim 2, characterized in that: The vaginitis is of the qi stagnation and blood stasis type.

4. The use according to claim 2, characterized in that: The preparation method of the traditional Chinese medicine composition comprises the steps of raw material preparation, crushing and screening, and sterilization treatment in sequence.

5. The use according to claim 4, characterized in that: The raw material preparation step includes: material selection, cleaning and drying; the crushing and screening steps include: preliminary crushing, ultrafine crushing, and mixed screening.

6. Use of the Chinese medicine composition according to claim 1 in preparing a medicament for inhibiting Candida albicans, Gardnerella and Trichomonas vaginalis.

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