Gynecological gel with antibacterial function and preparation method thereof

Abstract

The invention provides a gynecological gel with an antibacterial function and a preparation method of the gynecological gel with the antibacterial function. The composition comprises the following components in percentage by weight: 0.5%-5% of hydroxyethyl cellulose, 0.02%-2% of biodefensin, 0.1%-30% of a humectant, 0.02%-8% of a surfactant, 0.05%-7% of sodium alginate, 0.08%-9% of trehalose and 0.01%-6% of a repairing conditioner, wherein the repairing conditioner is a mixture of cysteine accounting for 45%-55% by mass, proline accounting for 35%-45% by mass and lysine accounting for 15%-25% by mass, and the gynecological gel which is safe and effective and has the functions of resisting bacteria and promoting tissue repair is provided. And a safe and effective solution is provided for female reproductive health.

Description

Technical Field

[0001] The invention relates to the field of gynecological products, and in particular to a gynecological gel with antibacterial function and a preparation method thereof. Background Art

[0002] The female vaginal environment is very complex, with a variety of aerobic and anaerobic bacteria and other microorganisms, which are interdependent and mutually restricted, forming a relatively stable microecological environment. Under normal circumstances, the vaginal environment is acidic (pH 3.8 - 4.5) and has self-cleaning properties. However, when pathogenic bacteria invade the vaginal environment, the bacteria will multiply rapidly, destroying the acidic microenvironment of the vagina, leading to symptoms such as itching and fishy odor, which may further cause vaginal diseases such as bacterial vaginitis and yeast infection, and may even cause urinary tract infection.

[0003] Traditional treatments for gynecological inflammation are mainly antibiotics. Antibiotics can often effectively inhibit the growth and reproduction of pathogens in the early stages of treatment, thereby alleviating inflammatory symptoms. However, long-term use of antibiotics can cause many problems: on the one hand, while killing harmful pathogens, antibiotics can also damage the normal flora in the vagina, leading to dysbacteriosis. Once dysbacteriosis occurs, the vagina's self-purification ability will decrease, making it easier for other pathogens to breed, thereby increasing the risk of reinfection and forming a vicious cycle; on the other hand, pathogens will gradually adapt and develop drug resistance during long-term exposure to antibiotics. As drug resistance increases, the therapeutic effect of antibiotics will gradually decrease, which may eventually lead to the failure of conventional antibiotic treatment, making the condition more difficult to control, increasing the difficulty and complexity of treatment, and bringing greater pain and economic burden to patients.

[0004] The prior art also provides various gynecological antibacterial gels. For example, CN113940915A provides an intravaginal gel composed of various active substance carriers, moisturizers, gelling agents, preservatives, and regulators. The intravaginal gel achieves good ductility through the ratio of each component to cover the upper surface of the mucosa, thereby protecting the mucosa. However, in terms of tissue repair, the gynecological gel of this patent solution only focuses on the protection of the mucosal surface, but does not deeply involve the substantial repair and recovery process of the vaginal tissue. After the vaginal tissue is invaded by pathogens or other injuries, a series of complex changes will occur in the internal cell structure, tissue morphology, etc., such as cell degeneration, necrosis, tissue congestion, inflammatory cell infiltration, and abnormal collagen fiber deposition, etc., and the antibacterial gel provided by CN113940915A cannot be designed to repair these deep tissue injuries; in addition, in terms of antibacterial effect, the antibacterial gel provided by CN113940915A only uses active ingredients derived from Chinese herbal medicine for sterilization, and this single sterilization method has many shortcomings. The pathogens in the vagina are numerous and complex, including various bacteria, fungi, viruses, etc. It is difficult to deal with them comprehensively and effectively relying solely on the active ingredients of Chinese herbal medicine. This leads to the fact that in actual applications, the bactericidal effect of the gynecological gel is unsatisfactory, and it is unable to effectively inhibit the growth and reproduction of various pathogens, making it difficult to meet the needs of clinical treatment and prevention of gynecological infections.

[0005] In summary, there is currently a lack of gynecological gels on the market that can effectively repair vaginal tissue and have strong and extensive antibacterial functions. Summary of the invention

[0006] The purpose of the present invention is to provide a gynecological gel with antibacterial function and a preparation method thereof, to provide a safe and effective gynecological gel with antibacterial and tissue repair promoting functions, and to provide a safe and effective solution for women's reproductive health.

[0007] To achieve the above objectives, the present technical solution provides a gynecological gel with antibacterial function, comprising: by weight percentage, 0.5%-5% hydroxyethyl cellulose, 0.02%-2% biodefensin, 0.1%-30% moisturizer, 0.02%-8% surfactant, 0.05%-7% sodium alginate, 0.08%-9% trehalose and 0.01%-6% repair conditioner, wherein the repair conditioner is a mixture of 45%-55% cysteine, 35%-45% proline and 15%-25% lysine.

[0008] The antibacterial gynecological gel provided in this scheme is compounded with multiple functional ingredients, among which biodefensins as the core antibacterial ingredients specifically act on the cell membrane of pathogens. This unique antibacterial mechanism is different from the common sterilization method that relies solely on Chinese herbal medicine or ordinary active ingredients; the various amino acids in the repair conditioner synergistically provide nutrients for cell growth, regulate signal pathways and promote epithelial cell proliferation and differentiation. This combination and mode of action jointly achieve antibacterial and tissue repair functions. For example, hydroxyethyl cellulose, sodium alginate, etc. jointly construct a suitable gel environment that is conducive to the function of the ingredients. The synergistic effect of biodefensins and repair conditioners also enables the antibacterial gynecological gel to repair tissue loss while being antibacterial, and also optimizes the antibacterial environment to enhance the activity of biodefensins and accelerate healing.

[0009] In some embodiments, the biodefensin of the present embodiment is selected as biodefensin KY23, which specifically acts on the cell membrane of pathogens to inhibit their growth and reproduction, thereby achieving a bactericidal effect.

[0010] Unlike other biological environments, there are many pathogens in the complex microecological environment of the vagina, including bacteria, fungi, etc. The biodefensin KY23 provided in this solution can accurately identify specific targets on the pathogen cell membrane, thereby interfering with the normal function of the pathogen cell membrane, destroying the integrity of the cell membrane, causing leakage of intracellular substances, and then inhibiting the growth and reproduction of pathogens, and ultimately achieving an efficient bactericidal effect. This specific targeting effect is fundamentally different from the antibiotics or ordinary antibacterial agents widely used in traditional gynecological antibacterial products. Since the biodefensin KY23 only acts on the pathogen cell membrane, while effectively killing harmful pathogens, it minimizes interference with the normal vaginal flora and helps maintain the balance of the vaginal microecology.

[0011] In addition, the antibacterial activity of biodefensin KY23 is highly selective. It can distinguish between pathogens and beneficial symbiotic bacteria in the vagina and will not have similar destructive effects on the cell membranes of beneficial bacteria. This feature allows the use of this gynecological gel to treat or prevent vaginal infections. While inhibiting harmful pathogens, it can protect the normal growth and function of beneficial flora in the vagina, avoiding secondary flora imbalance problems caused by treatment, and providing more accurate and safer protection for vaginal health.

[0012] In addition, the repair conditioner of the present solution contains compounded cysteine, proline and lysine, preferably, the ratio of cysteine, proline and lysine is 52%, 33% and 15% respectively. The repair conditioner provided by the present solution can be used as a repair conditioner, which can not only provide the nutrients required for cell growth, but also promote the proliferation and differentiation of epithelial cells by regulating cell signaling pathways, thereby accelerating the repair of damaged tissues.

[0013] Specifically, cysteine ​​can enhance the antioxidant capacity of cells by participating in the synthesis of glutathione in the vaginal microenvironment, protecting vaginal epithelial cells from damage by harmful substances such as free radicals. The sulfhydryl groups it contains can also play a key role in maintaining the stability of intracellular protein structure and function; proline helps to enhance the flexibility and stability of vaginal epithelial cells, so that cells can better maintain their own structural integrity when facing pathogen invasion and inflammatory stimulation, and reduce the risk of cell damage and death; lysine actively promotes the proliferation and differentiation of vaginal epithelial cells, accelerates the repair and regeneration of damaged tissues, and helps to restore the normal tissue structure and barrier function of the vaginal mucosa. The three amino acids are compounded in an optimal proportion to form a synergistic repair conditioner that can maximize the nutritional support and repair promotion of vaginal epithelial cells. In addition, cysteine, proline and lysine are used to regulate the mitogen-activated protein kinase (MAPK) signaling pathway that affects cell growth, proliferation and differentiation. By activating or inhibiting key kinases in this pathway, they regulate the growth and repair process of epithelial cells. At the same time, they are also involved in regulating the nuclear factor κB (NF-κB) signaling pathway, controlling the expression of genes related to inflammatory response, reducing the damage of vaginal inflammation to tissues, and promoting tissue repair. In addition, these amino acids also interact with components in the extracellular matrix, regulate integrin-mediated signaling pathways, and affect the adhesion, migration and tissue remodeling processes between cells and the matrix, thereby accelerating the repair and healing of damaged vaginal tissues and restoring the balance of the vaginal microecology.

[0014] In some embodiments, the ratio between the biodefensin and the repair conditioning agent is 1:10. The compound synergistic biodefensin and the repair conditioning agent in the gynecological gel of this scheme can enhance the inhibitory effect of the biodefensin on pathogens. Specifically, the biodefensin will specifically act on the pathogen cell membrane when exerting its powerful antibacterial function. Although this process effectively inhibits the growth and reproduction of pathogens, it may also cause a certain degree of collateral effects on the vaginal tissue. For example, while destroying the pathogen cell membrane, it may cause a local inflammatory response, release some reactive oxygen species and inflammatory mediators, and produce certain oxidative stress and inflammatory damage to the vaginal epithelial cells, resulting in slight changes in cell structure and function and a temporary imbalance in the tissue environment. At this time, the repair conditioning agent in the antibacterial gel can repair the potential damage to the vaginal tissue caused by the biodefensin during the action of the biodefensin, and also optimize the vaginal microenvironment and enhance the barrier function of the vaginal epithelial cells, which makes the vaginal tissue more solid and powerful when resisting the invasion of pathogens again, and also provides a stable internal environment support for the biodefensin to continue to effectively exert its antibacterial effect.

[0015] In a preferred embodiment, the gynecological gel with antibacterial function includes: by weight percentage, 3% hydroxyethyl cellulose, 1% biodefensin, 14% moisturizer, 7% surfactant, 8% sodium alginate, 7% trehalose and 2% repair conditioner, wherein the repair conditioner is a mixture of 52% cysteine, 33% proline and 15% lysine.

[0016] Other functional ingredients of this gynecological gel: The moisturizer is used to increase the moisture content of the gynecological gel, keep the vaginal environment moist, relieve dryness and discomfort, and improve user comfort. In some embodiments, the moisturizer is glycerin, which can also be used as a stabilizer to prevent the decomposition of the components in the gynecological gel, thereby extending the shelf life of the product and ensuring product quality.

[0017] Surfactants are used to enhance the uniformity and stability of the gynecological gel and ensure that the components are evenly distributed so that other functional components can penetrate better and the active components can more easily contact the vaginal tissue. In some embodiments, the surfactant is Tween 80.

[0018] Hydroxyethylcellulose is used as a gel mechanism to provide appropriate viscosity and stability. The appropriate viscosity ensures that the gel can be effectively adhered to the vagina and will not flow easily, allowing the active ingredients to stay on the surface of the vaginal mucosa for a sufficient time.

[0019] Sodium alginate is used to enhance the adhesion and biocompatibility of gynecological gels. Together with glycerol as a stabilizer, it enables the gel to fit closely to the vaginal wall and prolong its residence time in the vagina, just like installing a "strong suction cup" on the gel, increasing the contact time between the active ingredients and the vaginal tissue, thereby enhancing the drug's effect.

[0020] Trehalose is used to provide moisturizing and cell protection, and as a stabilizer to help maintain the stability and activity of the gynecological gel.

[0021] The antibacterial gynecological gel provided in this solution is a gel dosage form, which is easy to apply, comfortable for patients to use, and improves treatment compliance. In addition, each component in the antibacterial gel of this solution is natural or pharmaceutical grade raw materials, ensuring the safety and stability of gynecological vaginal use.

[0022] In a second aspect, the present invention provides a method for preparing a gynecological gel with antibacterial function, comprising the following steps: Add 0.5% to 5% by weight of hydroxyethyl cellulose into water and heat to dissolve to obtain a gel base solution; Sequentially adding 0.1%-30% by weight of a moisturizer, 0.02%-8% by weight of a surfactant, 0.05%-7% by weight of sodium alginate, 0.08%-9% by weight of trehalose, and 0.01%-6% by weight of a repair conditioner to a gel base solution, heating and dissolving to obtain a mixed solution, wherein the repair conditioner is a mixture of 45%-55% by weight of cysteine, 35%-45% by weight of proline, and 15%-25% by weight of lysine; After the mixed solution is cooled to room temperature, 0.02%-2% by weight of biodefensins are added, and the mixture is slowly stirred to dissolve to obtain a gynecological gel.

[0023] The biodefensins in this scheme are the main active substances for sterilization and are relatively sensitive to environmental factors. In order to avoid the influence of high temperature or long-term stirring on the activity of the biodefensins, this scheme adds the biodefensins at the end of the production process, which can minimize the time they are exposed to conditions that may lead to reduced activity, ensuring that they can maintain a high antibacterial activity in the final product.

[0024] In some embodiments, the heating temperature for adding hydroxyethyl cellulose into water is 25°C-95°C; the heating temperature for adding each functional component into the gel base liquid is 25°C-70°C.

[0025] Compared with the prior art, this technical solution has the following characteristics and beneficial effects: 1. Significant antibacterial advantages The gynecological gel provided in this program uses biodefensins as the core antibacterial ingredient. Its antibacterial mechanism is unique. Unlike the common method of sterilizing by relying solely on Chinese herbal medicine or common active ingredients, it specifically acts on the cell membrane of pathogens. For example, biodefensin KY23 can accurately identify and destroy the integrity of pathogen cell membranes, causing leakage of intracellular substances, effectively inhibiting the growth and reproduction of pathogens, and achieving efficient sterilization; and its antibacterial activity is highly selective, which can distinguish pathogens from beneficial symbiotic bacteria, maintain the balance of vaginal microecology while sterilizing, reduce interference with normal flora, and avoid secondary flora imbalance.

[0026] 2. Promote effective tissue repair The repair conditioner of the gynecological gel provided in this program contains cysteine, proline and lysine. They work together to provide nutrition for cell growth. For example, cysteine ​​can enhance cell antioxidant capacity and stabilize protein structure; proline enhances epithelial cell flexibility and stability; lysine promotes cell proliferation and differentiation. At the same time, these amino acids can regulate multiple signal pathways and interact with extracellular matrix components, thereby accelerating the repair and healing of damaged vaginal tissue and restoring microecological balance.

[0027] 3. Other comprehensive benefits are outstanding In addition to antibacterial and repair functions, other components of the gel also play an important role. Moisturizers can increase moisture, relieve dryness, improve comfort, and can also be used as stabilizers to extend the shelf life. Surfactants enhance the uniformity and stability of the gel, which is conducive to the penetration of ingredients. Hydroxyethyl cellulose provides suitable viscosity and stability for easy gel adhesion. Sodium alginate enhances adhesion and biocompatibility and prolongs residence time. Trehalose moisturizes and protects cells and helps maintain stability. All ingredients are natural or pharmaceutical grade raw materials, ensuring the safety and stability of gynecological vaginal use. The gel dosage form is also easy to apply, which improves patient treatment compliance. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a schematic diagram of the cervical mucosa of a normal rat under an optical microscope according to an embodiment of the present invention.

[0029] Figure 2 It is a schematic diagram of the cervical mucosa of rats in the blank group under an optical microscope according to an embodiment of the present invention.

[0030] Figure 3 This is a schematic diagram of the cervical mucosa of rats in the NO1 group under an optical microscope according to an embodiment of the present invention.

[0031] Figure 4 This is a schematic diagram of the cervical mucosa of rats in the NO2 group under an optical microscope according to an embodiment of the present invention. DETAILED DESCRIPTION

[0032] The following will be combined with the accompanying drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field belong to the scope of protection of the present invention.

[0033] It is to be understood that the term "one" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element may be one, while in another embodiment, the number of the element may be multiple, and the term "one" should not be understood as a limitation on the quantity.

[0034] 1. Inactivation effect on HPV type 16 virus: 1.1 Design implementation example: Take 1.5g of hydroxyethyl cellulose and add it to 100g of purified water, heat it until it is completely dissolved to form a gel base solution, and then add 1g of glycerol, 0.3g of Tween 80, 0.05g of sodium alginate, 0.2g of trehalose, 0.1g of cysteine, 0.2g of proline, and 0.5g of lysine in sequence while stirring, and continue to heat until it is completely dissolved, and keep mixing evenly. After the solution is cooled to an appropriate temperature, add 0.1g of biodefensin and stir slowly until it is completely dissolved to obtain a gynecological gel.

[0035] 1.2 Experimental materials: The gynecological gel, 293FT cells, human papillomavirus 16 pseudovirus (HPV16pp), DMEM culture medium, fetal bovine serum and other reagents prepared in the embodiment.

[0036] 1.3 Experiment: 293FT cells were inoculated in a 96-well cell culture plate and set aside after the cells adhered to the wall; 10µl of HPV16 pseudovirus solution was added to 90µl of sample or 90µIPBS, stirred and mixed, incubated at room temperature for 30 minutes, and then diluted in 900ul culture medium as the first concentration, and then 10-fold and 3-fold gradient dilutions were performed. 100µl of gradient diluted virus solution was added to the cells to determine the residual virus titer. Six wells were set for each concentration gradient and cultured in a CO2 incubator at 37°C. After 72h of culture, the number of fluorescent cells was counted using a fluorescence microscope, and the FFU of the virus was calculated.

[0037] 1.4 Test data: The test data obtained by using gynecological gel as the medical gynecological antibacterial gel sample group and using virus as the virus control group are shown in Table 1 below: Table 1 Inactivation effect of gynecological gel on HPV16pp

[0038] Note: “+” indicates the presence of fluorescent spots, “-” indicates the absence of fluorescent spots, and the numerical value indicates the number of fluorescent spots in each well.

[0039] The test results show that the virus titer of the antibacterial gel of this solution is less than 1.67*10 2 FFU / ml, compared with the virus control group, the inactivation rate of the antibacterial gel of this scheme against HPV16 pseudovirus is greater than 99.9988%.

[0040] 2. Inactivation effect on HPV type 18 virus: 2.1 Design implementation example: Take 1.5g of hydroxyethyl cellulose and add it to 100g of purified water, heat it until it is completely dissolved to form a gel base solution, and then add 1g of glycerol, 0.3g of Tween 80, 0.05g of sodium alginate, 0.2g of trehalose, 0.1g of cysteine, 0.2g of proline, and 0.5g of lysine in sequence while stirring, and continue to heat until it is completely dissolved, and keep mixing evenly. After the solution is cooled to an appropriate temperature, add 0.1g of biodefensin and stir slowly until it is completely dissolved to obtain a gynecological gel.

[0041] 2.2 Experimental Materials: The gynecological gel, 293FT cells, human papillomavirus 18 pseudovirus (HPV16pp), DMEM culture medium, fetal bovine serum and other reagents prepared in the embodiment.

[0042] 2.3 Experiments: 293FT cells were inoculated in a 96-well cell culture plate and set aside after the cells adhered to the wall; 10µl of HPV18 pseudovirus solution was added to 90µl of sample or 90µIPBS, stirred and mixed, incubated at room temperature for 30 minutes, and then diluted in 900ul culture medium as the first concentration, and then 10-fold and 3-fold gradient dilutions were performed. 100µl of gradient diluted virus solution was added to the cells to determine the residual virus titer. Six wells were set for each concentration gradient and cultured in a CO2 incubator at 37°C. After 72h of culture, the number of fluorescent cells was counted using a fluorescence microscope, and the FFU of the virus was calculated.

[0043] 2.4 Test data: The test data obtained by using gynecological gel as the medical gynecological antibacterial gel sample group and using virus as the virus control group are shown in Table 2 below: Table 2 Inactivation effect of gynecological gel on HPV16pp

[0044] Note: “+” indicates the presence of fluorescent spots, “-” indicates the absence of fluorescent spots, and the numerical value indicates the number of fluorescent spots in each well.

[0045] The test results show that the virus titer of the antibacterial gel of this solution is less than 1.67*10 2 FFU / ml, compared with the virus control group, the inactivation rate of the antibacterial gel in this scheme against HPV18 pseudovirus is greater than 99.9999%.

[0046] 3. Vaginal stimulation experiment: 3.1 Design implementation example: Take 1.5g of hydroxyethyl cellulose and add it to 100g of purified water, heat it until it is completely dissolved to form a gel base solution, and then add 1g of glycerol, 0.3g of Tween 80, 0.05g of sodium alginate, 0.2g of trehalose, 0.1g of cysteine, 0.2g of proline, and 0.5g of lysine in sequence while stirring, and continue to heat until it is completely dissolved, and keep mixing evenly. After the solution is cooled to an appropriate temperature, add 0.1g of biodefensin and stir slowly until it is completely dissolved to obtain a gynecological gel.

[0047] 3.2 Experimental Materials: Negative control: 0.9% sodium chloride injection; Experimental animals: 6 nulliparous and non-pregnant female New Zealand rabbits of the normal grade, with a body weight range of 2.22kg-2.45kg.

[0048] 3.3 Experimental methods: Before each test operation, check the animals for vaginal discharge, edema and other signs of infection, irritation and / or injury. The vagina should also be checked during the estrus period to avoid false positive reactions due to physiological changes in the vagina. Fix the rabbit on its back to expose the perineum and vaginal opening. Wet the catheter (disposable urinary catheter with a length of about 6 cm connected to a 2 mL disposable sterile syringe) and gently insert it into the vagina (4 cm) and slowly inject 1 mL of the test substance with a syringe, and withdraw the catheter. The control group animals were treated in the same way with 0.9% sodium chloride injection. Repeat the above steps every 24 hours for 5 consecutive days. 5.3 Observe and record the signs of discharge, erythema and edema at the vaginal opening and perineum 24 hours after the first contact and before each test operation. 24 hours after the last contact, the animals were killed by gas embolism, and the intact vagina was removed by laparotomy. The vagina was opened longitudinally to check for signs of irritation, injury and necrosis of the epithelial tissue layer. Then the samples were fixed in 10% formalin solution for 48 hours, and tissues from the two ends and three central parts of the vagina were selected for preparation and HE staining for histopathological examination.

[0049] 3.4 Test standards: The results of histopathological examination were scored for vaginal mucosal irritation reaction according to the scoring table shown in Table 3. The irritation reaction scores of the three sites of the three animals in the experimental group were added together and then divided by the total number of observations (number of animals*3) to obtain the average score of vaginal mucosal irritation reaction in the experimental group. The maximum score was 16. The scoring method of the control group was the same.

[0050] Table 3 Rating table

[0051] After the stimulation index is obtained by subtracting the average score of the control group from the average score of the test group, it is graded according to the reaction degree grading table in Table 4: Table 4 Reaction degree classification table

[0052] 3.5 Test results: The results of visual observation of the irritation reaction of the vaginal mucosa of rabbits in the experimental group and the control group are shown in Table 5: Table 5 Results of naked eye observation

[0053] The X in the table means that no congestion or edema is visible to the naked eye.

[0054] The reaction score summary table of the rabbit vaginal mucosal irritation reaction of the test group and the control group is shown in Table 6, where the average score is the quotient of the sum of the irritation reaction scores of 3 parts of 3 animals and the total number of observations, and the irritation index is the difference between the average score of the test group and the average score of the negative control group: Table 6 Summary of reaction scores

[0055] From the data in Table 6, it can be seen that the gynecological gel of this scheme has little irritation to the vagina.

[0056] IV. Vaginal repair ability test: In order to verify the efficacy of the gynecological gel with antibacterial function of the present invention, the present application team designed a comparative example without adding a repair conditioner and an example with adding a repair conditioner, and used a rat cervicitis model to verify the antibacterial and mucosal repair functions of the gynecological gel with antibacterial function of the present invention. The specific experiments are as follows: 4.1 Example: Take 1.5g of hydroxyethyl cellulose and add it to 100g of purified water, heat it until it is completely dissolved to form a gel base solution, and then add 1g of glycerol, 0.3g of Tween 80, 0.05g of sodium alginate, 0.2g of trehalose, 0.1g of cysteine, 0.2g of proline, and 0.5g of lysine in sequence while stirring, and continue to heat until it is completely dissolved, and keep mixing evenly. After the solution is cooled to an appropriate temperature, add 0.1g of biodefensin and stir slowly until it is completely dissolved to obtain a gynecological gel.

[0057] 4.2 Comparative Example: Take 1.5g of hydroxyethyl cellulose and add it to 100g of purified water, heat it until it is completely dissolved to form a gel base solution. Under stirring, add 1g of glycerol, 0.3g of Tween 80, 0.05g of sodium alginate, and 0.2g of trehalose in sequence, continue to heat until it is completely dissolved, and keep mixing evenly. After the solution is cooled to an appropriate temperature, add 0.1g of biodefensin and stir slowly until it is completely dissolved to obtain a gynecological gel.

[0058] 4.3 Construction of rat cervicitis model: Thirty SPF-grade healthy, sexually mature, unmated Sprague-Dawley (SD) female rats weighing 180-220 g were selected for the experiment. The feeding conditions were as follows: temperature 18-22°C, relative humidity 40%-60%, and noise below 85 decibels. The 30 SD rats were divided into three groups, 10 in each group, namely, blank group, model group NO1, and model group NO2.

[0059] 4.4 Modeling: Rats were anesthetized with isoflurane, and a No. 12 rat gavage needle was gently inserted into the rat's vagina about 2 cm deep, and 0.25 mL of 25% phenol glue was injected. The vaginal opening was fixed with a cotton ball, and the rat was kept in an inverted position for 2 min. The drug was given once every other day for a total of 5 times. The changes in the vagina were observed during the modeling process. After 5 times of administration of phenol glue, the rat's vaginal opening was red and swollen, and purulent discharge occurred, indicating that the modeling was successful.

[0060] 4.5 Testing: The SD rats in the blank group were not treated in any way and were fed normally. The other two groups were used as model group N01 and model group N02 corresponding to the antibacterial gel of the corresponding proportion and the example, respectively.

[0061] After successful modeling, group treatment began the next day. Model groups N01 and N02 were treated with 0.25 g of gel. The drug was administered once a day, and the rats' body weight, swelling of the vulva, and purulent secretions at the vaginal opening were recorded. After 10 consecutive administrations, the rats were anesthetized and killed for tissue sampling.

[0062] The study observed and recorded the swelling and purulent discharge of the vulva of SD rats in the model group before and after treatment. It was found that the rats in the model groups N01 and N02 had swelling and purulent discharge at the vaginal opening. The N01 and N02 groups had significant therapeutic effects, and the N02 group had a better therapeutic effect. The results showed that the N01 and N02 groups had significant therapeutic effects on the rat cervicitis model, and could significantly reverse the swelling and purulent discharge of the vagina in the model group.

[0063] Normal rat cervical mucosa Figure 1 As shown in Figure 2, the cervical mucosa of rats under an optical microscope was composed of stratified squamous epithelial tissue, and no obvious abnormal changes were observed in the tissue. A small number of small blood vessels were observed in the epithelial tissue, and a large number of collagen fibers were deposited and arranged in an orderly manner. Compared with normal rats, the cervical mucosa of rats in the blank group was Figure 2 As shown, some squamous epithelial tissues of rat cervical tissues were damaged, with cell degeneration, necrosis and shedding. Inflammatory cell infiltration was observed in the epithelial layer, congestion and a large number of inflammatory cells infiltrated the mucosa and submucosal lamina propria, and glandular hyperplasia and squamous epithelialization to varying degrees. Submucosal congestion and inflammatory cell infiltration occurred in the vaginal tissue, and a large number of neutrophils infiltrated under the epithelium. Only a very small amount of collagen fiber deposition was observed in the model group.

[0064] The cervical mucosa of rats in group N01 Figure 3 As shown in Figure 2, the tissue morphology of rats was slightly improved. The squamous epithelium of the cervical mucosa of rats showed hyperplasia, repair and slight thickening. A large number of inflammatory cell infiltrations, inflammatory exudates and a small amount of necrotic tissue were observed, and local deposition of collagen fibers was observed. The cervical mucosa of rats in group N02 was as follows: Figure 4 As shown, very small amounts of inflammatory cell infiltration were observed in the local tissues, and there was no obvious degeneration and necrosis of the epithelium. There were more collagen deposition and orderly collagen fiber bundles, which were closer to the natural tissue state of the normal group rats, and the therapeutic effect was better than that of the N01 group.

[0065] By comparing the antibacterial effect and vaginal tissue repair of the two embodiments, it can be seen that the embodiment is superior to the control example in terms of antibacterial effect and vaginal tissue repair, which fully proves the effect that the addition of the repair conditioner can bring and improves the therapeutic effect of the product.

[0066] The present invention is not limited to the above-mentioned optimal implementation mode. Anyone can derive other various forms of products under the inspiration of the present invention. However, no matter what changes are made in the shape or structure, all technical solutions that are the same or similar to those of the present application fall within the protection scope of the present invention.

Claims

1. A gynecological gel with antibacterial function, characterized in that: include: In terms of mass percentage, the invention comprises 0.5%-5% hydroxyethyl cellulose, 0.02%-2% biodefensins, 0.1%-30% moisturizers, 0.02%-8% surfactants, 0.05%-7% sodium alginate, 0.08%-9% trehalose and 0.01%-6% repair conditioners, wherein the repair conditioner is a mixture of 45%-55% cysteine, 35%-45% proline and 15%-25% lysine.

2. The gynecological gel with antibacterial function according to claim 1, characterized in that: The biodefensin selected was biodefensin KY23.

3. The gynecological gel with antibacterial function according to claim 1, characterized in that: The ratios of cysteine, proline and lysine are 52%, 33% and 15% respectively.

4. The gynecological gel with bacterial function according to claim 1, characterized in that: The ratio between biodefensins and repair conditioners is 1:

10.

5. The gynecological gel with antibacterial function according to claim 1, characterized in that: The humectant selected was glycerin and the surfactant selected was Tween 80.

6. The gynecological gel with antibacterial function according to claim 1, characterized in that: The dosage form is gel type.

7. A method for preparing a gynecological gel with antibacterial function, characterized in that: The following steps are involved: Add 0.5% to 5% by weight of hydroxyethyl cellulose into water and heat to dissolve to obtain a gel base solution; Sequentially adding 0.1%-30% by weight of a moisturizer, 0.02%-8% by weight of a surfactant, 0.05%-7% by weight of sodium alginate, 0.08%-9% by weight of trehalose, and 0.01%-6% by weight of a repair conditioner to a gel base solution, heating and dissolving to obtain a mixed solution, wherein the repair conditioner is a mixture of 45%-55% by weight of cysteine, 35%-45% by weight of proline, and 15%-25% by weight of lysine; After the mixed solution is cooled to room temperature, 0.02%-2% by weight of biodefensins are added, and the mixture is slowly stirred to dissolve to obtain a gynecological gel.

8. The method for preparing the gynecological gel with antibacterial function according to claim 7, characterized in that: The heating temperature for adding hydroxyethyl cellulose into water and heating it is 25°C-95°C; the heating temperature for adding each functional component into the gel base liquid and heating it is 25°C-70°C.

9. The method for preparing the gynecological gel with antibacterial function according to claim 7, characterized in that: The biodefensin selected was biodefensin KY23.

10. The method for preparing the gynecological gel with antibacterial function according to claim 7, characterized in that: The ratio between biodefensins and repair conditioners is 1:10, and the ratios of cysteine, proline, and lysine are 52%, 33%, and 15%, respectively.

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