Antibacterial gel for regulating micro-ecological balance of female vagina and preparation method of antibacterial gel

Abstract

The invention relates to the field of antibacterial gel, in particular to antibacterial gel for adjusting female vagina micro-ecological balance and a preparation method of the antibacterial gel. The invention discloses antibacterial gel for regulating female vagina micro-ecological balance. The antibacterial gel comprises a component A and a component B, the component A is prepared from the following raw materials in parts by weight: 78 to 82 parts of deionized water, 1 to 2.5 parts of hydroxypropyl methyl cellulose, 4 to 6 parts of glycerol and 4 to 6 parts of propylene glycol; the component B is prepared from the following raw materials in parts by weight: 0.03 to 0.06 part of oligosaccharide sodium hyaluronate, 0.3 to 0.6 part of a preservative, 0.7 to 1.2 parts of tween-20, 0.1 to 0.35 part of a silver ion solution, 1 to 3 parts of a soothing agent, 1 to 3 parts of an ecological nutrient solution and 0.005 to 0.015 part of citric acid. When being applied to the vagina, the vagina antibacterial agent can effectively kill invaded harmful bacteria in the presence of interference of an external environment, so that the micro-ecological balance of the vagina is ensured, and the occurrence of inflammations is inhibited.

Description

Technical Field

[0001] The present application relates to the field of antibacterial gels, and particularly to an antibacterial gel for regulating the microecological balance of the female vagina and a preparation method thereof. Background Art

[0002] The most delicate and vulnerable skin of women is in the private parts, which are delicate and private. A key challenge in the field of gynecology is to maintain the health of the skin in women's private parts. Due to its sensitivity, this part is vulnerable to bacterial invasion, which may lead to gynecological problems such as abnormal leucorrhea, dryness, odor, and itching.

[0003] The root causes of gynecological inflammation and vaginal dryness lie in the imbalance of the probiotic microecology. Under normal conditions, the various flora in the vagina are in a balanced state. In particular, the presence of Lactobacillus plays an important role in maintaining the stability of the host vaginal environment. Lactobacillus binds to specific adhesin receptors on the surface of host cells through adhesins such as proteins and peptidoglycans on the bacterial surface. After colonizing on the surface of vaginal mucosal epithelial cells, it immediately adjusts its gene expression and secretes a large amount of extracellular polysaccharides during the growth and reproduction process to form a biofilm. Lactobacillus also prevents pathogenic microorganisms from adhering to vaginal epithelial cells through a competitive exclusion mechanism. Lactobacillus consumes a large amount of glycogen during its growth and metabolism, occupying a large amount of nutrients in the vagina, and objectively inhibiting the growth of other microorganisms. Therefore, vaginal Lactobacillus is an important bacterial species that maintains the balance of the vaginal microecosystem.

[0004] When the microecological balance of probiotics is damaged, it will become a paradise for harmful bacteria, inducing various inflammatory diseases. Therefore, it is very important to maintain the microecological balance of women's private parts. Summary of the Invention

[0005] In order to ensure the microecological balance of the female vagina, the present application provides an antibacterial gel for regulating the microecological balance of the female vagina and a preparation method thereof.

[0006] In the first aspect, the present application provides an antibacterial gel for regulating the microecological balance of the female vagina, adopting the following technical solution.

[0007] An antibacterial gel for regulating the microecological balance of the female vagina, comprising component A and component B; Component A comprises the following raw materials in parts by weight: 78 - 82 parts of deionized water, 1 - 2.5 parts of hydroxypropyl methylcellulose, 4 - 6 parts of glycerol, and 4 - 6 parts of propylene glycol; Component B comprises the following raw materials in parts by weight: 0.03 - 0.06 parts of oligosaccharide sodium hyaluronate, 0.3 - 0.6 parts of preservative, 0.7 - 1.2 parts of Tween - 20, 0.1 - 0.35 parts of silver ion solution, 1 - 3 parts of soother, 1 - 3 parts of ecological nutrient solution, and 0.005 - 0.015 parts of citric acid.

[0008] By adopting the above technical solution, a protective barrier is constructed, in which the ecological nutrient solution can simply and rapidly promote the growth of saprophytic bacteria but not the growth of pathogenic bacteria, competitively inhibit pathogenic bacteria, reduce the growth of yeasts, and cooperate with the soothing agent to construct a microbial, chemical, physical and immune composite barrier in the vagina.

[0009] Microbial barrier: Improve the quality and diversity of vaginal microorganisms, improve the strain diversity of beneficial bacteria on the vaginal surface, and increase the abundance of staphylococci in the vagina.

[0010] Chemical barrier: Maintain the vagina at a healthy weakly acidic pH.

[0011] Physical barrier: Promote the potential of keratinocyte neogenesis and promote the healing and regeneration of damaged tissues.

[0012] Immune barrier: Inhibit a variety of inflammatory factors and reduce key allergy factors.

[0013] Resist the destruction of the ecological balance in the vagina by external influences through the protective barrier, and timely regulate it when attacked by the outside world, maintain the ecological balance, and reduce the probability of vaginal inflammation.

[0014] Further, the soothing agent comprises the following raw materials in parts by weight: 75 - 80 parts of water, 8 - 13 parts of Lactobacillus / Soybean Fermentation Product Filtrate, 8 - 12 parts of butanediol, and 1 - 3 parts of 1,2 - pentanediol.

[0015] Further, the ecological nutrient solution comprises the following raw materials in parts by weight: 55 - 65 parts of inulin, 20 - 30 parts of water, and 10 - 20 parts of α - glucan oligosaccharide.

[0016] Further, the Lactobacillus includes Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium adolescentis, Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus jensenii, Lactobacillus casei subsp. casei, Lactobacillus gasseri, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, Lactococcus lactis, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus delbrueckii, Enterococcus lactis, Streptococcus thermophilus.

[0017] Further, the preparation method of the Lactobacillus / Soybean Fermentation Product Filtrate is as follows: 1) Soak, pulp, and sterilize soybeans, and add fructooligosaccharide and yeast extract to strengthen nutrition as the fermentation substrate; 2) Yeast activation: Culture and activate Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium adolescentis, Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus jensenii, Lactobacillus casei subsp. casei, Lactobacillus gasseri, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, Lactococcus lactis, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus delbrueckii, Enterococcus lactis, Streptococcus thermophilus. 3) Inoculation and fermentation of the bacterial liquid: The first stage: inoculate Bifidobacterium longum, Bifidobacterium bifidum, and Bifidobacterium adolescentis; the temperature is 37°C ± 0.5°C, the dissolved oxygen is < 0.1 mg / L, and the pH drops naturally; the bacterial liquid is injected in three times; add 0.05% L-cysteine and 0.1% fructooligosaccharide to the culture medium; the first stage totals 12 hours; The second stage: inoculate Lactobacillus acidophilus, Lactobacillus rhamnosus, and Lactobacillus paracasei subsp. paracasei; the temperature rises to 40°C ± 0.5°C, the dissolved oxygen is 0.5 - 1.0 mg / L, and the pH is controlled at 5.8 - 6.0; add 0.2% glucose every 2 hours during the reaction process; add 0.01% CaCl to the culture medium; the second stage totals 12 hours; The third stage: inoculate Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, and Streptococcus thermophilus; the temperature rises to 42°C ± 0.5°C, the dissolved oxygen drops below 0.2 mg / L, and the pH drops freely; the bacterial liquid is balanced at 40°C for 30 minutes before injection; add 0.005% MnSO4 to the culture medium; the third stage totals 12 hours; The fourth stage: inoculate Lactobacillus brevis, Lactobacillus jensenii, and Lactococcus lactis; the temperature is adjusted back to 37°C ± 0.5°C, the dissolved oxygen rises to 1.5 - 2.0 mg / L, and the pH is stabilized at 4.3 - 4.5; add 0.1% whey protein concentrate to the culture medium; the fourth stage totals 12 hours; The fifth stage: inoculate Lactobacillus gasseri, Lactobacillus casei, Lactobacillus delbrueckii, and Enterococcus lactis; the temperature drops to 30°C ± 1°C, the dissolved oxygen is naturally stable, and the pH is naturally stable; the bacterial liquid is treated by microencapsulation, and add 0.02% phytase to the culture medium; the fifth stage totals 12 hours; 4) Sterilize and filter to obtain the filtrate of the Lactobacillus / soybean milk fermentation product.

[0018] Furthermore, the weight ratio of Bifidobacterium longum, Bifidobacterium bifidum, and Bifidobacterium adolescentis in the first stage is 2:1:1; the weight ratio of Lactobacillus acidophilus, Lactobacillus rhamnosus, and Lactobacillus paracasei subsp. paracasei in the second stage is 3:2:1; the weight ratio of Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, and Streptococcus thermophilus in the third stage is 2:1:2; the weight ratio of Lactobacillus brevis, Lactobacillus jensenii, and Lactococcus lactis in the fourth stage is 2:1:3; the weight ratio of Lactobacillus gasseri, Lactobacillus casei, Lactobacillus delbrueckii, and Enterococcus lactis in the fifth stage is 5:3:2:5.

[0019] By adopting the above technical solution, the co-culture of multiple strains is realized, a multi-strain fermentation platform is constructed, and the more strains co-ferment, the better the anti-inflammatory effect of the fermented soybean milk product.

[0020] This application realizes co - culture of multiple strains through staged fermentation. Staged fermentation is a precise control strategy designed based on the physiological characteristics and metabolic laws of microorganisms. Its core advantage lies in achieving efficient cooperation of complex microbial communities through temporal environmental regulation and complementary functions of microbial populations, as follows: There are nutritional competitions (such as for carbon sources and trace elements) and spatial competitions (such as for biofilm formation) when microorganisms are co - cultured. Staged inoculation, through temporal isolation, enables different microbial populations to dominate in different time windows. Bifidobacterium preferentially utilizes indigestible oligosaccharides (raffinose, stachyose) at the initial stage, degrading them into monosaccharides (fructose, glucose), providing easily utilizable carbon sources for subsequent Lactobacillus and avoiding direct competition. The β - galactosidase (EC 3.2.1.23) of Bifidobacterium adolescentis specifically decomposes raffinose, while Lactobacillus lacks this enzyme system.

[0021] There is a precursor - product chain relationship in microbial metabolism. Staged fermentation can directionally control the distribution of metabolic fluxes and avoid feedback inhibition. Bifidobacterium metabolizes to produce acetic acid in the early stage (through the phosphoketolase pathway, PK pathway), reducing the pH to 5.8 - 6.0 and activating the lactate dehydrogenase (LDH, EC 1.1.1.27) of Lactobacillus. During the dominant period of Lactobacillus, lactic acid is rapidly accumulated through homo - fermentation (EMP pathway) (at a rate of 1.5 - 2.0 g / L / h), and the pH drops below 4.5 to inhibit contaminating bacteria. Lactobacillus delbrueckii subsp. bulgaricus activates α - acetolactate synthase (EC 2.2.1.6) at the later high - temperature stage (42°C), converting pyruvate into a precursor of diacetyl. Streptococcus thermophilus generates acetaldehyde through threonine aldolase (EC 4.1.2.5), and cooperates with the acetolactate decarboxylase (EC4.1.1.5) of Lactococcus to complete the synthesis of diacetyl.

[0022] There are significant differences in the requirements of different bacterial species for temperature, pH, and dissolved oxygen (DO). Staged regulation can match the optimal growth windows of each microbial population.

[0023] Metabolic modularization is achieved through the division of labor among microbial populations, covering the entire chain from macromolecule decomposition to end - product synthesis. Staged fermentation can quickly intervene in abnormal operating conditions through modular control. A strictly anaerobic environment in the initial stage inhibits molds / yeasts. A low pH (<4.5) in the middle stage inhibits heat - resistant contaminating bacteria such as Bacillus. Staged sugar supplementation avoids ethanol production caused by excess carbon sources, and the phosphoketolase pathway of Lactobacillus is inhibited. Dynamically regulating DO prevents excessive accumulation of acetic acid, and an acetic acid concentration >8 g / L will inhibit the growth of Lactobacillus.

[0024] Furthermore, in the fifth stage, the bacterial liquid is treated by micro - encapsulation, and sodium alginate - chitosan is used as the capsule shell layer.

[0025] Furthermore, 0.005% N - acetylglucosamine is also added to the culture medium in the fourth stage.

[0026] By adopting the above technical solution, the acid production ability of Lactobacillus jensenii induced by adding an inducer is improved.

[0027] In a second aspect, the present application provides a method for preparing an antibacterial gel for regulating the microecological balance of the female vagina, adopting the following technical solution.

[0028] A method for preparing an antibacterial gel for regulating the microecological balance of the female vagina includes the following steps: S1. Mix the materials in phase A, stir and heat to 90 °C, and stir until all the materials are completely melted; S2. Cool down while stirring. When the temperature drops to 45 °C, add the raw materials in phase B in sequence and stir for 30 min.

[0029] In summary, the present application has the following beneficial effects: The present application constructs a microbial, chemical, physical and immune composite barrier in the vagina through the synergistic effect of the ecological nutrient solution and the soothing agent. When it is applied to the vagina, it can effectively kill the invading harmful bacteria in the face of external environmental interference, ensure the microecological balance of the vagina, and inhibit the occurrence of inflammation. And it can effectively treat cervical erosion. The treatment effective rate for patients with mild cervical erosion can reach 100%, the treatment effective rate for patients with moderate cervical erosion can reach 97.5%, and the treatment effective rate for patients with severe cervical erosion can reach 90%. Specific embodiments

[0030] The following further elaborates on the present application with reference to examples.

[0031] Preparation examples of raw materials and intermediates Raw materials The raw materials in the examples of the present application can all be obtained commercially and all comply with the "Technical Specifications for Cosmetic Safety": Hydroxypropyl methylcellulose, analytical pure; Glycerol, analytical pure; Propylene glycol, analytical pure; Oligosaccharide sodium hyaluronate, analytical pure; Silver ion solution, with a silver powder volume content of 0.5% and a water volume content of 99.5%; Citric acid, analytical pure; Butylene glycol, analytical pure; 1,2-Pentanediol, analytical pure; Inulin, cosmetic grade; α-Glucan oligosaccharide, analytical pure; Culture medium, standard MRS culture medium; Sodium alginate, Chitosan, food grade, viscosity ≥200 mPa·s, concentration 2.5% w / v; Chitosan, degree of deacetylation ≥85%, molecular weight 50 kDa, concentration 1.2% w / v, dissolved in 0.1 M acetic acid; Calcium chloride, 0.1 M solution, pH 6.0; Preservative, Chlorhexidine Digluconate Preservative, SAMP CDH-G.

[0032] Preparation Example Preparation Example 1 A microcapsule containing bacterial liquid wrapped in sodium alginate-chitosan, the preparation method of which is as follows: 1) Inner layer sodium alginate embedding Lactobacillus gasseri, Lactobacillus casei, Lactobacillus delbrueckii, and Enterococcus lactis were concentrated to 1×10¹ 0 CFU / mL, suspended in a protective solution containing 5% skim milk to obtain a bacterial suspension; The bacterial suspension was mixed with 2.5% sodium alginate solution at a volume ratio of 1:3, 0.05% Tween-80 was added, and the mixture was stirred magnetically (300 rpm, 20°C) for 30 min to remove air bubbles; the nuclear layer bacterial suspension was obtained; The nuclear layer bacterial solution was dropped into 0.1M CaCl2 solution, pre-cooled to 4°C, solidified with magnetic stirring (150 rpm) for 20 min, and formed into microspheres in an electrostatic microcapsule generator; The solution was filtered through a 500 μm pore size mesh, washed three times with normal saline, and stored at 4°C to obtain sodium alginate microspheres; 2) Outer chitosan coating The 1.2% chitosan solution was adjusted to pH 5.5 with 0.1 M NaOH, 5% glycerol was added, and activated in a 50°C water bath for 30 min to obtain a chitosan reaction solution; The sodium alginate microspheres obtained in step 1) were immersed in the chitosan reaction solution at a solid-liquid ratio of 1:10, and the mixture was shaken at 35°C (120 rpm) for 30 min. The coated microspheres were collected by centrifugation. The collected coated microspheres were immersed in 0.05% CaCl2 solution (containing 0.1% sodium alginate) for 10 min to form microcapsules of bacterial solution wrapped in sodium alginate-chitosan.

[0033] Preparation Example 2 A microcapsule containing bacterial liquid encapsulated in sodium alginate, the preparation method of which is as follows: Lactobacillus gasseri, Lactobacillus casei, Lactobacillus delbrueckii, and Enterococcus lactis were concentrated to 1×10¹ 0 CFU / mL, suspended in a protective solution containing 5% skim milk to obtain a bacterial suspension; Mix the bacterial suspension with 2.5% sodium alginate solution at a volume ratio of 1:3, add 0.05% Tween-80, and stir magnetically (300 rpm, 20 °C) for 30 min to remove air bubbles; obtain the core layer bacterial solution; Drop the core layer bacterial solution into 0.1 M CaCl2 solution, pre-cool to 4 °C, and stir magnetically (150 rpm) for 20 min to solidify, and form microspheres in an electrostatic microcapsule generator; Filter with a sieve with a pore size of 500 μm, then wash 3 times with physiological saline, and store at 4 °C to obtain sodium alginate microspheres; Immerse the collected coated microspheres in 0.05% CaCl2 solution (containing 0.1% sodium alginate) for 10 min; form microcapsules with sodium alginate-wrapped bacterial solution.

[0034] Preparation Example 3 A filtrate of Lactobacillus / soy milk fermentation product, and its preparation method is as follows: 1) Select non-genetically modified soybeans with a protein content of ≥ 38%, and remove mildewed and insect-eaten grains; Soak the soybeans: the ratio of soybeans to water is 1:3, add 0.5% NaHCO3 solution, soak at a constant temperature of 30 °C for 10 ± 0.5 hours, change water every 2 hours until the inner surface of the soybean cotyledon is sunken ≤ 1 / 2 and the hardness ≤ 3.5 kg / cm²; Make pulp: Pulping parameters: the ratio of soybeans to water is 1:8, the gap of the colloid mill is 50 μm, and grind twice; Cooking conditions: dynamic boiling at 105 °C for 8 minutes, steam pressure 0.15 MPa; Homogenization treatment: pressure 35 MPa, temperature 65 °C, circulate 3 times.

[0035] Sterilization treatment: UHT sterilization: 137 °C ± 1 °C, keep for 4 seconds, and quickly cool to 40 °C; and add 0.2% fructooligosaccharide + 0.1% yeast extract to strengthen nutrition as the fermentation substrate; 2) Yeast activation: Culture and activate Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium adolescentis, Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus jensenii, Lactobacillus paracasei subsp. paracasei, Lactobacillus gasseri, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, Lactococcus lactis, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus delbrueckii, Enterococcus lactis, Streptococcus thermophilus in standard MRS medium; 3) Inoculate the bacterial solution for fermentation: The first stage (0 - 12 h): inoculate Bifidobacterium longum, Bifidobacterium bifidum, and Bifidobacterium adolescentis; inoculation amount: 2% of the mother culture solution, and the weight ratio of Bifidobacterium longum, Bifidobacterium bifidum, and Bifidobacterium adolescentis is 2:1:1; temperature 37°C ± 0.5°C, dissolved oxygen < 0.1 mg / L, pH decreases naturally; the culture solution is injected in three times (0 h, 2 h, 4 h); add 0.05% L-cysteine and 0.1% fructooligosaccharide to the culture medium; The second stage (12 - 24 h): inoculate Lactobacillus acidophilus, Lactobacillus rhamnosus, and Lactobacillus paracasei subsp. paracasei; inoculation amount: 2% of the mother culture solution, and the weight ratio of Lactobacillus acidophilus, Lactobacillus rhamnosus, and Lactobacillus paracasei subsp. paracasei is 3:2:1; temperature rises to 40°C ± 0.5°C, dissolved oxygen 0.5 - 1.0 mg / L, pH is controlled at 5.8 - 6.0; add 0.2% glucose every 2 h during the reaction process; add 0.01% CaCl to the culture medium; The third stage (24 - 36 h): inoculate Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, and Streptococcus thermophilus; inoculation amount: 2% of the mother culture solution, and the weight ratio of Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, and Streptococcus thermophilus is 2:1:2; temperature rises to 42°C ± 0.5°C, dissolved oxygen drops below 0.2 mg / L, pH decreases freely; the culture solution is equilibrated at 40°C for 30 min before injection; add 0.005% MnSO4 to the culture medium; The fourth stage (36 - 48 h): inoculate Lactobacillus brevis, Lactobacillus jensenii, and Lactococcus lactis; inoculation amount: 2% of the mother culture solution, and the weight ratio of Lactobacillus brevis, Lactobacillus jensenii, and Lactococcus lactis is 2:1:3; temperature is adjusted back to 37°C ± 0.5°C, dissolved oxygen rises to 1.5 - 2.0 mg / L, pH is stabilized at 4.3 - 4.5; add 0.1% whey protein concentrate to the culture medium; The fifth stage (48 - 60 h): inoculate Lactobacillus gasseri, Lactobacillus casei, Lactobacillus delbrueckii, and Enterococcus faecium; inoculation amount: 2% of the mother culture solution, and the weight ratio of Lactobacillus gasseri, Lactobacillus casei, Lactobacillus delbrueckii, and Enterococcus faecium is 5:3:2:·5; temperature drops to 30°C ± 1°C, dissolved oxygen is naturally stabilized, pH is naturally stabilized; the culture solution is microencapsulated according to the method of Preparation Example 1, and add 0.02% phytase to the culture medium; 4) Sterilization: flash sterilization at 85°C / 15 s; filter, and then perform cold storage stabilization treatment at 4°C for 24 h to obtain the filtrate of the Lactobacillus / soy milk fermentation product.

[0036] Preparation Example 4 Different from Preparation Example 2, in the fourth stage of Preparation Example 3, 0.005% N-acetylglucosamine is also added to the culture medium.

[0037] Preparation Example 5 Different from Preparation Example 2, in Preparation Example 4, the bacterial liquid in the fifth stage was subjected to microencapsulation treatment according to the method of Preparation Example 2.

[0038] Example Examples 1 - 3 An antibacterial gel for regulating the microecological balance of the female vagina, and its preparation method is as follows: S1. According to the raw material ratio in Table 1, mix the materials in Phase A, stir and heat to 90°C, and stir until all materials are completely melted; S2. Cool down while stirring. When the temperature drops to 45°C, add the raw materials in Phase B in sequence and stir for 30 min.

[0039] Table 1 Raw material ratio table of Examples 1 - 3 (10 g)

[0040] Among them, the soothing agent refers to Example 1 in Table 2, and the ecological nutrient solution refers to Example 1 in Table 3.

[0041] Table 2 Soothing agent ratio table (10 g)

[0042] Among them, the filtrate of Lactobacillus / soybean milk fermentation product comes from Preparation Example 3.

[0043] Table 3 Ecological nutrient solution ratio table (10 g)

[0044] Examples 4 - 5 Different from Example 2, the ratio of the soothing agent in Examples 4 - 5 is shown in Table 2.

[0045] Examples 6 - 7 Different from Example 4, the ratio of the ecological nutrient solution in Examples 6 - 7 is shown in Table 3.

[0046] Examples 8 - 9 Different from Example 6, the filtrate of Lactobacillus / soybean milk fermentation product in Examples 8 - 9 comes from Preparation Examples 4 - 5 respectively.

[0047] Example 10 Different from Example 6, the Lactobacillus in the filtrate of Lactobacillus / soybean milk fermentation product in Example 10 includes Bifidobacterium longum, Lactobacillus rhamnosus, Lactobacillus helveticus, Lactobacillus brevis, and Lactobacillus gasseri.

[0048] Comparative Example Comparative Example 1 Different from Example 1, in Comparative Example 1, the ecological nutrient solution was replaced with an equal amount of soothing agent.

[0049] Comparative Example 2 Different from Example 1, in Comparative Example 2, the soothing agent was replaced with an equal amount of ecological nutrient solution.

[0050] Performance Detection The antibacterial gels obtained in the examples and comparative examples were subjected to the following performance detections: I. Antibacterial Detection: 1. Bacterial strain activation: Transfer Escherichia coli, Staphylococcus aureus, and Lactobacillus stored in a 4°C refrigerator to a fresh nutrient agar slant and culture at 37°C for 24 h; 2. Preparation of bacterial suspension: Wash the bacterial growth on the slant twice with 10 mL of sterilized physiological saline into a conical flask containing glass beads, place it on a shaker and shake at 200 r / min for 10 min, and adjust the concentration of the bacterial suspension to 106 cfu / ml; 3. Preparation of antibacterial plates: Dispense 20 ml of melted nutrient agar medium into each test tube, add a rubber stopper, bundle 7 tubes together and sterilize at 121°C for 20 min. After sterilization and cooling, keep it in a 50°C constant temperature water bath for heat preservation. In a laminar flow hood, first add 1 mL of bacterial suspension to each sterilized petri dish, pour 20 mL into the petri dish, mix well, blow dry the condensed water, and wait for it to solidify; 4. Oxford cup method: Use sterile forceps to pick out the sterilized Oxford cup, quickly pass it over the flame of an alcohol lamp first, and then place it vertically on the surface of the culture medium and gently press it so that there is no gap between the bottom of the cup and the culture medium. Place 5 Oxford cups on each plate, inject 200 uL of gel into each Oxford cup, use physiological saline as a control in the middle, and the gel should not overflow; make 3 replicates for each type of gel, culture at 37°C for 24 hours, observe, measure and record the diameter of the antibacterial zone, and the test results are shown in Table 4.

[0051] II. Vaginal mucosa irritation experiment: The experimental subjects were healthy female white rats, divided into groups of 3 each. For the experimental groups of the examples and comparative examples, inject 20 uL of the corresponding antibacterial gel into the vaginas of the white rats respectively, and inject 20 uL of physiological saline into the control group. The injection interval is 24 hours each time, and the injection is continuous for 3 times. After 6 days, take out the vaginas of the corresponding white rats, cut them longitudinally, and observe the physiological conditions of the vaginal cross-sections under a microscope to observe whether there are abnormal irritation phenomena such as fluid overflow and erythema. The results are shown in Table 5.

[0052] III. Clinical effect observation: The gel obtained in Example 8 was used for the experiment. During the period from March 2023 to November 2024, the applicant collected a total of 100 cases of patients with cervical erosion (mild, moderate, and severe cervical erosion) for clinical experiments.

[0053] The treatment subjects were applied once a day. After 12 days of treatment for mild erosion and 30 days of treatment for moderate and severe erosion, colposcopy was performed again to determine the treatment effect.

[0054] Efficacy criteria: Recovery: Symptoms disappear, erosion surface disappears, and the cervix is smooth; Effective: Symptoms are significantly improved, the erosion surface shrinks by more than 50%, severe degree turns into moderate degree or moderate degree turns into mild degree, or papillary type turns into granular type, granular type turns into simple type; Ineffective: Neither symptoms nor erosion surface shows obvious improvement. The effective rate is calculated based on the number of recovery and marked effective cases. The results are shown in Table 6.

[0055] Table 4 Detection Results of Bacteriostatic Effect Performance

[0056] Combined with Examples 1 - 10 and Comparative Examples 1 - 2, and with reference to Table 4, it can be seen that the gels in Examples 1 - 10 have better bacteriostatic effects on Escherichia coli and Staphylococcus aureus than Comparative Examples 1 - 2, and the gels in Examples 1 - 10 have weaker bacteriostatic effects on Lactobacillus than Comparative Examples 1 - 2. This shows that the bacteriostatic gel obtained in this application can effectively inhibit harmful bacteria, while having a weak inhibitory effect on beneficial bacteria. When applied to the vagina, it can effectively kill the invading harmful bacteria in the face of external environmental interference, ensure the microecological balance of the vagina, and inhibit the occurrence of inflammation.

[0057] Table 5 Results of Vaginal Mucosa Irritation Experiment

[0058] It can be seen that the bacteriostatic gel of this application has no irritation to the vaginal mucosa of white rats.

[0059] Table 5 Clinical Experiment Results

[0060] It can be seen that the gel obtained in this application has good therapeutic effects on cervical erosions of different degrees. Among them, the treatment effective rate for mild patients can reach 100%, and the treatment effective rate for severe patients can reach 90%.

[0061] This specific embodiment is only an explanation of this application, and it is not a limitation of this application. Those skilled in the art can make modifications without creative contributions to this embodiment according to needs after reading this specification, but as long as it is within the scope of the claims of this application, it is protected by the patent law.

Claims

1. An antibacterial gel for regulating the microecological balance of the female vagina, characterized in that, It includes Component A and Component B; Component A includes the following raw materials in parts by weight: 78 - 82 parts of deionized water, 1 - 2.5 parts of hydroxypropyl methylcellulose, 4 - 6 parts of glycerol, and 4 - 6 parts of propylene glycol; Component B includes the following raw materials in parts by weight: 0.03 - 0.06 parts of oligosaccharide sodium hyaluronate, 0.3 - 0.6 parts of preservative, 0.7 - 1.2 parts of Tween - 20, 0.1 - 0.35 parts of silver ion solution, 1 - 3 parts of soothing agent, 1 - 3 parts of ecological nutrient solution, and 0.005 - 0.015 parts of citric acid.

2. The antibacterial gel for regulating the microecological balance of the female vagina according to claim 1, characterized in that, The soothing agent includes the following raw materials in parts by weight: 75 - 80 parts of water, 8 - 13 parts of Lactobacillus / soybean fermentation product filtrate, 8 - 12 parts of butanediol, and 1 - 3 parts of 1,2 - pentanediol.

3. The antibacterial gel for regulating the microecological balance of the female vagina according to claim 1, characterized in that, The ecological nutrient solution includes the following raw materials in parts by weight: 55 - 65 parts of inulin, 20 - 30 parts of water, and 10 - 20 parts of α - glucan oligosaccharide.

4. The antibacterial gel for regulating the microecological balance of the female vagina according to claim 2, characterized in that, The Lactobacillus includes Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium adolescentis, Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus jensenii, Lactobacillus paracasei subsp. paracasei, Lactobacillus gasseri, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, Lactococcus lactis, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus delbrueckii, Enterococcus lactis, Streptococcus thermophilus.

5. The antibacterial gel for regulating the microecological balance of the female vagina according to claim 4, characterized in that, The preparation method of the Lactobacillus / soybean fermentation product filtrate is as follows: 1) Soak, make pulp, and sterilize soybeans, and add fructooligosaccharide and yeast extract to strengthen nutrition as the fermentation substrate; 2) Yeast activation: Culture and activate Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium adolescentis, Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus jensenii, Lactobacillus paracasei subsp. paracasei, Lactobacillus gasseri, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, Lactococcus lactis, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus delbrueckii, Enterococcus lactis, Streptococcus thermophilus; 3) Bacterial liquid inoculation and fermentation: The first stage: Inoculate Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium adolescentis; temperature 37°C ± 0.5°C, dissolved oxygen < 0.1 mg / L, pH decreases naturally; the bacterial liquid is injected in three times; add 0.05% L - cysteine and 0.1% fructooligosaccharide to the culture medium; the first stage totals 12h; The second stage: Inoculate Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus paracasei subsp. paracasei; raise the temperature to 40°C ± 0.5°C, dissolved oxygen 0.5 - 1.0 mg / L, control pH at 5.8 - 6.0; add 0.2% glucose every 2h during the reaction process; add 0.01% CaCl to the culture medium; the second stage totals 12h; The third stage: Inoculate Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, Streptococcus thermophilus; raise the temperature to 42°C ± 0.5°C, lower the dissolved oxygen to below 0.2 mg / L, pH decreases freely; among them, the bacterial liquid is balanced at 40°C for 30 min before injection; add 0.005% MnSO4 to the culture medium; the third stage totals 12h; The fourth stage: inoculate *Lactobacillus brevis*, *Lactobacillus jensenii*, *Lactococcus lactis*; adjust the temperature back to 37°C ± 0.5°C, increase the dissolved oxygen to 1.5 - 2.0 mg / L, and keep the pH stable at 4.3 - 4.5; add 0.1% whey protein concentrate to the culture medium; the fourth stage lasts for 12 hours in total; The fifth stage: inoculate *Lactobacillus gasseri*, *Lactobacillus casei subsp. casei*, *Lactobacillus delbrueckii subsp. bulgaricus*, *Enterococcus lactis*; lower the temperature to 30°C ± 1°C, keep the dissolved oxygen stable naturally, and keep the pH stable naturally; the bacterial liquid is treated by microencapsulation, and 0.02% phytase is added to the culture medium; the fifth stage lasts for 12 hours in total; 4) Sterilize and filter to obtain the filtrate of the lactic acid bacteria / soybean milk fermentation product.

6. The antibacterial gel for regulating the microecological balance of the female vagina according to claim 5, characterized in that, The weight ratio of *Bifidobacterium longum*, *Bifidobacterium bifidum*, *Bifidobacterium adolescentis* in the first stage is 2:1:1; the weight ratio of *Lactobacillus acidophilus*, *Lactobacillus rhamnosus*, *Lactobacillus paracasei subsp. paracasei* in the second stage is 3:2:1; the weight ratio of *Lactobacillus delbrueckii subsp. bulgaricus*, *Lactobacillus helveticus*, *Streptococcus thermophilus* in the third stage is 2:1:2; the weight ratio of *Lactobacillus brevis*, *Lactobacillus jensenii*, *Lactococcus lactis* in the fourth stage is 2:1:3; the weight ratio of *Lactobacillus gasseri*, *Lactobacillus casei*, *Lactobacillus delbrueckii subsp. bulgaricus*, *Enterococcus lactis* in the fifth stage is 5:3:2:

5.

7. An antibacterial gel for regulating the microecological balance of the female vagina according to claim 5, characterized in that, In the fifth stage, the bacterial liquid is treated by microencapsulation, and sodium alginate-chitosan is used as the capsule shell layer.

8. An antibacterial gel for regulating the microecological balance of the female vagina according to claim 5, characterized in that, In the fourth stage, 0.005% N-acetylglucosamine is also added to the culture medium.

9. A preparation method of the antibacterial gel for regulating the microecological balance of the female vagina according to any one of claims 1-8, characterized in that, It includes the following steps: S1. Mix the raw materials of phase A, stir and heat to 90°C, and stir until all the raw materials are completely melted; S2. Cool down while stirring, when the temperature drops to 45°C, add the raw materials of phase B in sequence, and stir for 30 minutes.

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