Use of yihuang granules in the preparation of a medicine for treating bacterial vaginosis

Abstract

This invention discloses the application of Yihuang granules in the preparation of drugs for treating bacterial vaginosis. Through the establishment of a rat model of bacterial vaginosis, this invention demonstrates that Yihuang granules can significantly improve vaginal secretion cleanliness, inhibit sialidase activity, and reduce the number of pathogenic bacteria. This invention provides a new traditional Chinese medicine treatment option for bacterial vaginosis, overcoming the shortcomings of existing antibiotic therapies such as high recurrence rates and easy drug resistance, and has clear clinical translational value.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine pharmaceutical technology, specifically relating to the application of Yihuang granules in the preparation of drugs for treating bacterial vaginosis, and a pharmaceutical composition for treating bacterial vaginosis based on Yihuang granules. Background Technology

[0002] Bacterial vaginosis (BV) is a common vaginal microecological imbalance in women of reproductive age, characterized by a decrease in vaginal lactobacilli and an overgrowth of opportunistic pathogens such as anaerobic bacteria. Clinical manifestations include increased vaginal discharge, which is grayish-white or yellowish-green and has a fishy odor, and may be accompanied by vulvar itching. BV is prone to recurrence, and if not treated promptly and effectively, it can ascend and lead to serious complications such as endometritis, pelvic inflammatory disease, infertility, miscarriage, premature birth, and postpartum infection.

[0003] Currently, Western medicine mainly treats bacterial vaginosis (BV) with topical or systemic antibiotics such as metronidazole and clindamycin. While these can relieve symptoms in the short term, the recurrence rate is high, and long-term use can easily lead to dysbiosis and drug resistance. Traditional Chinese medicine considers BV to fall under the categories of "leukorrhea" and "vaginal itching," with the pathogenesis centered on spleen and kidney deficiency and damp-heat leukorrhea. Yi Huang Tang, originating from Fu Shan's "Fu Qingzhu's Gynecology" in the Qing Dynasty, is composed of stir-fried yam, stir-fried foxnut, phellodendron bark, plantain seed, and ginkgo. It has the effects of strengthening the kidneys, stopping leukorrhea, clearing heat, and removing dampness, and is traditionally used to treat kidney deficiency and damp-heat leukorrhea. However, there is currently no systematic pharmacodynamic evaluation or mechanistic study of Yi Huang Tang or its modern preparations (such as Yi Huang granules) in animal models of bacterial vaginosis, and its specific use in treating BV has not yet been patented. Summary of the Invention

[0004] The purpose of this invention is to provide a new use for Yihuang granules in the preparation of drugs for treating bacterial vaginosis.

[0005] The present invention further provides a pharmaceutical composition for treating bacterial vaginosis, wherein the active ingredient is Yihuang granules.

[0006] This invention systematically evaluates the therapeutic effect of Yihuang granules on bacterial vaginosis (BV) by establishing a rat model of BV (using a mixed bacterial suspension of Staphylococcus aureus and Escherichia coli inoculated vaginally). Experimental results show that Yihuang granules significantly improve the cleanliness of vaginal secretions in BV model rats, inhibit sialidase activity, reduce the number of bacterial colonies in vaginal irrigation fluid, and repair vaginal mucosal tissue lesions, with the effect showing a dose-dependent relationship. These findings indicate that Yihuang granules have a definite therapeutic effect on BV through multiple mechanisms, including regulating the vaginal microecology and repairing the mucosal barrier.

[0007] The beneficial effects of the embodiments of the present invention are: Yihuang granules are a traditional Chinese medicine compound preparation. Compared with antibiotic treatment, it has the advantages of low recurrence rate, low risk of drug resistance, and regulation of the body's immune function.

[0008] This invention fills the gap in the market for traditional Chinese medicine that is not effective in treating bacterial vaginosis. Attached Figure Description

[0009] Figure 1 Morphological observation of the vulva in mice with experimental bacterial vaginosis Figure 2 Microscopic images of vaginal secretions from mice with experimental bacterial vaginosis Figure 3 Vaginal sialidase activity in mice with experimental bacterial vaginosis Detailed Implementation

[0010] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific experimental examples. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention.

[0011] Example 1: Preparation of Yihuang Granules Weigh out 3730 g of stir-fried yam, 3730 g of stir-fried foxnut, 746 g of stir-fried phellodendron bark (with salt water), 373 g of stir-fried plantain seed (with wine), and 1000 g of crushed ginkgo. Add 10 times the amount of water and decoct for 1.5 hours, then filter. Add 8 times the amount of water to the dregs and decoct for another hour, then filter. Combine the two filtrates and concentrate under reduced pressure to a thick paste with a relative density of 1.10~1.15 (60℃). Add an appropriate amount of dextrin, spray dry to granulate, and sieve through a 14-mesh sieve to obtain Yihuang granules. Each gram of granules is equivalent to 5.987 g of raw herbs.

[0012] Example 2: Animal experimental verification of Yihuang granules in the treatment of bacterial vaginosis 2.1 Establishment of experimental animals and models Eighty SPF-grade unmated female SD rats, weighing 180-220 g, were acclimatized for 7 days. Except for the control group, the remaining rats were subcutaneously injected with estradiol benzoate 0.3 mL / kg to establish a pseudoestrus cycle, once every 2 days for a total of 3 times. Subsequently, the vagina was inoculated daily with 0.25 mL of a mixed bacterial suspension (Staphylococcus aureus: Escherichia coli = 1:1, concentration 3 × 10^8 CFU / mL) for 4 consecutive days to establish a bacterial vaginosis (BV) model. Successful modeling criteria included vaginal congestion and swelling, copious purulent discharge, and the presence of clue cells and numerous infectious bacteria in smears.

[0013] 2.2 Grouping and Administration After successful model establishment, patients were randomly divided into 5 groups (n=10): model group (physiological saline, 10 mL / kg), low-dose Yihuang granules group (10 g crude drug / kg), medium-dose group (20 g crude drug / kg), high-dose group (40 g crude drug / kg), and positive control group (metronidazole vaginal gel, 1 g / kg). A normal control group (physiological saline, 10 mL / kg) was also included. All groups were administered the medication by gavage (the positive control group received vaginal administration) once daily for 7 consecutive days.

[0014] 2.3 Results The results are attached. Figure 1 The results showed that the vulva of rats in the model group was red and swollen, but the redness and swelling disappeared after administration of the positive control drug and Yihuang granules. Further microscopic examination showed that the vaginal secretion smears in the model group contained a large number of bacteria; while the smears after administration of the positive control drug or Yihuang granules were cleaner, close to the normal group (see attached image). Figure 2 ).

[0015] Normally, lactobacilli dominate the vagina, and sialidase activity is low. When bacterial vaginosis (BV) occurs, harmful bacteria (such as Gardnerella vaginalis) proliferate, secreting sialidase to break down sialic acid in vaginal mucus, leading to a significant increase in enzyme activity. After administration of positive control drugs or Yihuang granules, sialidase activity was significantly reduced compared to the model group (see attached). Figure 3 ).

[0016] 2.4 Conclusion Yihuang granules have a clear therapeutic effect on a rat model of bacterial vaginosis.

[0017] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. Application of Yihuang Granules in the preparation of drugs for treating bacterial vaginosis.

2. The application according to claim 1, characterized in that, The Yihuang granules are made from the following Chinese medicinal materials in parts by weight: 37.30 parts of stir-fried yam, 37.30 parts of stir-fried foxnut, 7.46 parts of stir-fried phellodendron bark (with salt water), 3.73 parts of stir-fried plantain seed (with wine), and 10.00 parts of crushed ginkgo.

3. The application according to claim 1 or 2, characterized in that, The preparation method of the Yihuang granules includes: decocting the above-mentioned Chinese herbal raw materials with water, filtering, concentrating, and granulating.

4. The application according to claim 1, characterized in that, Bacterial vaginosis is characterized by vaginal microecological imbalance, elevated inflammatory factors, enhanced oxidative stress, and vaginal mucosal damage.

5. A pharmaceutical composition for treating bacterial vaginosis, characterized in that, The active ingredient is the Yihuang granules as described in claim 1 or 2, and it contains pharmaceutically acceptable excipients.

6. The pharmaceutical composition according to claim 5, characterized in that, Its dosage forms include granules, capsules, tablets, or oral liquids.

7. The application according to claim 1, characterized in that, The Yihuang granules treat bacterial vaginosis through the following mechanisms: inhibiting sialidase activity and reducing the pathogenic bacterial load.

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