Rapid and long-acting gynecological antibacterial gel and preparation method thereof

Abstract

The invention discloses a quick and long-acting gynecological antibacterial gel and a preparation method thereof. According to the formula of the gynecological antibacterial gel, a plurality of key components are selected and combined, and the gynecological antibacterial gel specifically comprises the following components in parts by weight: 5-15 parts of poloxamer, 0.5-1 part of carbomer, 0.5-1 part of N, N-dicarboxymethyl alanine trisodium salt, 0.2-0.1 part of carboxymethyl cellulose and 50-250ppm stable chlorine dioxide powder. The preparation method of the gynecological antibacterial gel comprises the five steps of chlorine dioxide chelating solution preparation, gel matrix preparation, gel forming, pH value adjustment and finished product packaging, all the steps are accurately controlled, and the product quality is ensured. The invention provides a gynecological gel product which is high in initial flowability, can be quickly gelated in vivo and has a quick long-acting antibacterial function, solves the problems of non-ideal antibacterial effect, inconvenience in use, insufficient safety and the like of an existing gynecological nursing product, ensures the safety and stability of the product, overcomes many defects of a traditional product, and has a good application prospect. And a better choice is provided for female reproductive health care.

Description

Technical Field

[0001] The invention relates to the field of gynecological care products, and in particular to a fast and long-acting gynecological antibacterial gel for female private parts care and a preparation method thereof. Background Art

[0002] Gynecological diseases have always been a major category of diseases that trouble women. Cervical erosion is generally treated with miconazole nitrate suppositories, etc. Fuyanjie wash, Baofukang suppositories, Zhimikang suppositories, Kangfuyan capsules, Fuyanjie effervescent tablets, Sanweikang, Minocycline, Doxycycline, Xiaomi suppositories, etc. are drugs for treating vaginal inflammation. Drugs for treating pelvic inflammation include Fuyankang, Fuke Qianjin tablets, Huahong tablets, and pain-relieving and inflammatory capsules. Anti-cervicitis tablets and Gongyankang capsules for cervicitis, as well as Guizhi Fuling capsules for treating uterine fibroids. There are many types of gynecological drugs, mainly using various antibacterial ingredients to make various types of washes, suppositories, and gels. There are many types of female private care products on the market, but all types of products have certain limitations. As one of the common private care products, washes have a relatively superficial mode of action. There are many wrinkles inside the female reproductive tract, and it is difficult for washes to penetrate these parts to exert antibacterial effects. It cannot effectively remove harmful bacteria hidden in the deep layer, thus greatly reducing the overall antibacterial effect. The use of suppositories is relatively inconvenient, and often requires the assistance of others to complete the insertion operation. When used by oneself, the insertion angle is not appropriate, and the suppository will cause friction and compression on the vaginal wall, which will cause pain and damage. In addition, the range of action of the suppository in the vagina is limited, and it is difficult to fully disperse, resulting in its antibacterial components not being able to act evenly on the entire vaginal environment, affecting the inhibitory effect on harmful bacteria. Gel products are due to the complex physiological structure of women, and the vagina has a certain depth and curvature. Gels with too low fluidity cannot smoothly reach the bottom of the vagina under the action of gravity, and cannot fully cover the folds of the vaginal mucosa, allowing some harmful bacteria to hide in them. Gels with too high fluidity are not easy to form an effective protective film on the surface of the vaginal mucosa. On the other hand, they are easy to flow out of the body in a short time, resulting in too short an action time in the vagina, and cannot continue to play an antibacterial role, which ultimately affects the prevention and treatment of gynecological diseases.

[0003] As a highly effective disinfectant, chlorine dioxide has shown excellent performance in sterilization and deodorization. It has strong adsorption and penetration capabilities on cell walls, can penetrate deep into bacteria, release atomic oxygen to oxidize sulfhydryl-containing enzymes in cells, thereby blocking the metabolic process of bacteria and achieving efficient sterilization. In terms of deodorization, it can react with a variety of odorous substances to undergo dehydration, causing the odorous substances to be rapidly oxidized and converted into other harmless substances, effectively eliminating odors. In addition, chlorine dioxide also has the effect of delaying decay. It can prevent methionine from decomposing into ethylene, while destroying the formed ethylene. It does not react with fatty acids in the process of killing microorganisms, and does not damage the food structure, which makes it widely used in fields such as food preservation. However, the chemical properties of chlorine dioxide are extremely unstable, and it is easy to decompose during storage and use, resulting in the loss of its effective ingredients, which largely limits its direct application in some fields. Special means are needed to stabilize its performance in order to better exert its sterilization and deodorization effects. Summary of the invention

[0004] The purpose of the present invention is to provide a gynecological gel with strong initial fluidity, rapid gelation in the body and rapid and long-lasting antibacterial function, so as to solve the problems of existing gynecological care products with unsatisfactory antibacterial effect, inconvenience in use and insufficient safety, while ensuring the safety and stability of the product.

[0005] The invention provides a fast and long-acting gynecological antibacterial gel, the formula of which cleverly integrates multiple ingredients, and aims to provide women with an efficient and long-lasting gynecological care solution; wherein, the temperature-sensitive property of poloxamer enables it to quickly gel according to temperature changes after entering the human body, which not only ensures good initial fluidity so as to penetrate deeply into the vaginal folds, but also allows it to adhere for a long time under the action of body temperature, thereby achieving long-term antibacterial effect; carbomer enhances the viscosity and stability of the gel, and prevents the gel from flowing out of the body too quickly; N,N-dicarboxymethylalanine trisodium salt stabilizes unstable chlorine dioxide, so that it can continuously exert its bactericidal and deodorizing effects, and at the same time, the two synergistically enhance the antibacterial ability; carboxymethyl cellulose adjusts the gelation temperature and viscosity, and optimizes the overall performance of the gel; these ingredients complement each other and are jointly committed to effectively preventing and treating gynecological diseases and maintaining women's reproductive health.

[0006] The invention provides a fast and long-acting gynecological antibacterial gel, which specifically comprises: 5-15 parts of poloxamer, 0.5-1 part of carbomer, 0.5-1 part of N,N-dicarboxymethyl alanine trisodium salt, 0.2-0.1 part of carboxymethyl cellulose and 50-250ppm of stable chlorine dioxide powder.

[0007] Poloxamer is a thermosensitive gel that is liquid at low temperatures, with a gelation temperature of 34-37°C. This property makes the gel almost liquid when it first enters the human body, and it can quickly enter the deep folds inside the vagina. With the effect of body temperature, it can form a gel in a short time, and then adhere to the folds, covering every corner of the vagina, providing a long-term action site for the antibacterial ingredients, and contributing to long-term antibacterial. Poloxamer is non-toxic and non-irritating to the skin and mucous membranes, which makes it very safe in gynecological applications and will not cause adverse effects on the vaginal mucosa, ensuring the safety and comfort of product use.

[0008] Carbomer is used as a suspending agent or thickening agent in the gel system to increase the viscosity of the gel, so that the gel can adhere better in the vagina and is not easy to flow out of the body, thereby extending the residence time of the gel in the vagina and ensuring that the antibacterial ingredients can continue to play a role. At the same time, it helps to maintain the uniform dispersion of other ingredients in the gel system, prevents the precipitation of ingredients, and ensures the stability and effectiveness of product quality.

[0009] Although chlorine dioxide has a good bactericidal effect, it is extremely unstable. As a green chelating agent, N,N-dicarboxymethyl alanine trisodium salt can chelate with chlorine dioxide, so that chlorine dioxide can remain stable at room temperature, avoiding the loss of active ingredients caused by the decomposition of chlorine dioxide during storage, thereby ensuring the effectiveness of the product during storage and use. N,N-dicarboxymethyl alanine trisodium salt itself is a metal ion chelating agent that can chelate metal ions to form a stable soluble complex. It can be widely used in the pH range and produce a synergistic effect with chlorine dioxide bactericides to enhance the bactericidal effect of chlorine dioxide and improve the overall antibacterial performance of the product. At the same time, it has good toxicological safety and is non-irritating to the skin and mucous membranes, which makes it suitable for gynecological gel products and does not cause additional health risks to users.

[0010] Carboxymethyl cellulose is very easy to disperse in water to form a colloidal solution of a certain viscosity. In the present invention, it can reduce the gelation temperature of poloxamer and greatly reduce the amount of poloxamer used. At the same time, it helps to adjust the overall viscosity of the gel, so that the gel can meet the initial fluidity requirements of rapid flow into the deep vagina, and can form a suitable gel state under the action of body temperature, thereby ensuring the stability of the performance of the gel and enabling it to play a better role.

[0011] Stable chlorine dioxide powder Chlorine dioxide has a strong ability to adsorb and penetrate cell walls, and can release atomic oxygen to oxidize sulfhydryl-containing enzymes in cells, thereby playing a bactericidal role. It can effectively kill a variety of microorganisms, including bacterial propagules, hepatitis viruses, bacteriophages and bacterial spores, and has a significant inhibitory and killing effect on common pathogens that cause gynecological diseases, such as Escherichia coli, Staphylococcus aureus, and Candida albicans. It can quickly eliminate harmful bacteria in the vagina and prevent and treat gynecological inflammation. In gynecological applications, it can react with H2S, -SOH, -NH2 and other odor substances in the vagina to dehydrate and rapidly oxidize the odor substances into other substances, thereby eliminating vaginal odor. At the same time, it can prevent methionine from decomposing into ethylene, and can also destroy the ethylene that has been formed, which helps to maintain the health of the vaginal environment to a certain extent and delay the changes in vaginal tissue caused by microbial action.

[0012] The various components of the gynecological antibacterial gel formula of the present invention cooperate with each other and work synergistically, so that the gynecological antibacterial gel has a rapid and long-lasting antibacterial effect, can effectively prevent and treat gynecological diseases, and at the same time ensure the safety and comfort of the product, providing an effective care option for women's reproductive health.

[0013] The invention provides a method for preparing a fast and long-acting gynecological antibacterial gel. The preparation of the chlorine dioxide chelating solution in step S1 ensures that the unstable chlorine dioxide is effectively stabilized, providing a guarantee for the subsequent antibacterial effect; step S2 carefully constructs the gel matrix, so that carbomer and carboxymethyl cellulose work together to provide a good basic performance for the gel; step S3 realizes the uniform mixing of each key component, so that poloxamer and other components are perfectly integrated to form a stable gel system, combining the advantages of each component; step S4 accurately adjusts the pH value to ensure that the gel stability and antibacterial activity are in the best state; the finished product packaging of step S5 is convenient for storage and use, and can keep the product sterile and stable in quality. The whole preparation method is closely linked and synergistic, ensuring that the final product has the advantages of fast and long-acting antibacterial, easy to use, safe and reliable, and provides a high-quality product preparation process basis for female reproductive health care.

[0014] The present invention provides a method for preparing a rapid and long-acting gynecological antibacterial gel, which specifically comprises the following steps: In the preparation of S1 chlorine dioxide chelate solution, although chlorine dioxide has a strong bactericidal effect, it is unstable. N, N-dicarboxymethyl alanine trisodium salt is first dissolved in water to form a solution, and then mixed with stable chlorine dioxide powder and stirred until the color of chlorine dioxide disappears. In this process, N, N-dicarboxymethyl alanine trisodium salt and chlorine dioxide undergo a chelation reaction. Chelation keeps chlorine dioxide stable at room temperature, preventing it from decomposing prematurely, ensuring that the effective ingredients are not lost during the subsequent preparation and storage process, thereby ensuring the final antibacterial effect of the product. Because chlorine dioxide decomposes in the early stage of preparation, it will not only reduce the content of effective bactericidal ingredients in the product, but also produce other harmful substances that affect product quality and safety. After forming a stable chlorine dioxide chelate solution, it can participate in the subsequent mixing process with the gel matrix in a stable state, ensuring that chlorine dioxide is evenly dispersed in the entire gel system, laying the foundation for achieving rapid and long-term antibacterial. When chlorine dioxide is not stably chelated, it will react or escape due to instability when mixed with other ingredients in the subsequent mixing, resulting in uneven distribution of antibacterial ingredients in the gel, affecting product performance.

[0015] Therefore, a proper amount of water is measured, 0.5-1 part of N, N-dicarboxymethyl alanine trisodium salt is added to the water, and the mixture is stirred thoroughly to completely dissolve the mixture to obtain a N, N-dicarboxymethyl alanine trisodium salt solution. 50-250 ppm of stable chlorine dioxide powder is slowly added to the solution, and the mixture is continuously stirred until the color of the chlorine dioxide completely disappears and the solution becomes colorless, thereby forming a stable chlorine dioxide chelated solution.

[0016] In the preparation of S2 gel matrix, carboxymethyl cellulose is dissolved in water to form a solution with a certain viscosity, which provides basic viscosity and structural support for the gel. It can make the gel have a certain consistency, preventing the gel from being too thin to effectively adhere and stay in the vagina. At the same time, carbomer is added to the carboxymethyl cellulose solution as a suspending agent or viscosity enhancer and dissolved, further increasing the viscosity and stability of the gel. The two work together to construct the basic skeleton of the gel, so that the gel can maintain a certain shape in the vagina and is not easy to flow and deform, thereby ensuring the action time and coverage of the gel in the vagina, which is conducive to the antibacterial ingredients. The addition of carbomer can also improve the rheological properties of the gel, so that it has appropriate fluidity and plasticity under different temperatures and external forces. When the temperature of the gel is low before use, the gel is not too thin, preventing it from being too deep and difficult to control when introduced into the vagina due to excessive fluidity; and under the action of body temperature, it can work with other ingredients to maintain the stability of the gel, so that the gel forms a uniform and stable covering layer in the vagina, providing a good carrier for the antibacterial ingredients, which helps to improve the convenience and effectiveness of the product.

[0017] Therefore, take another appropriate amount of water, add 0.2-0.1 parts of carboxymethyl cellulose into the water, stir evenly to ensure that the carboxymethyl cellulose is completely dispersed and dissolved to form a carboxymethyl cellulose solution, add 0.5-1 parts of carbomer, and continue stirring until the carbomer is completely dissolved to obtain a mixed solution containing carbomer and carboxymethyl cellulose.

[0018] In the S3 gel forming, the chlorine dioxide chelating solution is slowly added to the mixed solution containing carbomer and carboxymethyl cellulose, and poloxamer is added and stirred evenly. As a thermosensitive gel, poloxamer is fully mixed with other ingredients in this step to form a uniform gel for the entire system. The addition of poloxamer gives the gel a temperature-responsive property, that is, it has good fluidity at a lower temperature when it is just prepared and has not entered the human body, making it easy to deliver the gel into the deep vagina through a drug delivery device; after entering the human body, as the temperature rises to approach the human body temperature, poloxamer quickly gels, allowing the gel to firmly adhere to the folds of the vaginal mucosa, locking the antibacterial ingredients such as chlorine dioxide at the site of action, and achieving long-term antibacterial. At the same time, the uniform mixing of the components ensures the stability and consistency of the gel system, so that each part of the gel has the same antibacterial and physical properties, and improves the reliability of product quality. Through this step, the antibacterial chlorine dioxide chelating solution is perfectly combined with the gel carrier (gel system composed of carbomer, carboxymethyl cellulose and poloxamer), so that the antibacterial ingredients are evenly distributed in the gel, which not only ensures that the antibacterial ingredients can effectively contact the harmful bacteria in the vagina, but also uses the characteristics of the gel to achieve the slow release and long-term effect of the antibacterial ingredients. This integration allows the product to take effect quickly when used (quick drug delivery in the initial dilute gel) and continue to exert an antibacterial effect (long-term coverage after poloxamer gelation), effectively preventing and treating gynecological diseases.

[0019] Therefore, the prepared chlorine dioxide chelating solution is slowly added to the mixed solution containing carbomer and carboxymethyl cellulose, and 5-15 parts of poloxamer are added at the same time and stirred continuously to fully mix the poloxamer and the mixed solution to form a uniform gel system.

[0020] S4 pH value adjustment, the appropriate pH value is crucial for the stability of the gel system. By using a pH meter to measure and adjust the pH value of the gel system to 4.5±0.5, it can ensure that the components in the gel are in a stable state, prevent the components from hydrolyzing, precipitating or chemically reacting due to inappropriate pH value, and thus maintain the physical and chemical stability of the gel. Some components will undergo structural changes in an overly acidic or overly alkaline environment, affecting the viscosity and gelling properties of the gel, and thus affecting the use effect and shelf life of the product. The pH value has a significant effect on the growth and survival of microorganisms, and also affects the activity of antibacterial components. Adjusting the pH value of the gel within the range of 4.5±0.5 creates an environment that is conducive to the best bactericidal activity of the antibacterial component chlorine dioxide, while being unfavorable for the growth and reproduction of harmful bacteria. This pH range allows the antibacterial component to better interact with structures such as bacterial cell membranes, enhance the bactericidal effect, and improve the product's ability to inhibit common gynecological pathogens such as Escherichia coli, Staphylococcus aureus, and Candida albicans, thereby ensuring that the product's antibacterial performance reaches the best state.

[0021] Therefore, using a calibrated precision pH meter, the electrode was completely immersed in the gel, the initial pH value was read, and an appropriate amount of acid or base solution was added according to the measured pH value to adjust the pH value of the gel system to 4.5±0.5.

[0022] In the S5 finished product packaging, the prepared gel is transferred to a gel tube with a dispenser and sealed. This packaging method is convenient for the storage and transportation of the product. The gel tube can protect the gel from external contamination and maintain the sterility of the product. At the same time, the design with the dispenser enables users to apply the gel to the vaginal area conveniently and accurately, ensuring the convenience and hygiene of the product. Users do not need to prepare additional dosing tools, which reduces the risk of contamination during use and improves the practicality and user experience of the product. Good sealed packaging can prevent the evaporation of water, volatilization of components and microbial contamination in the gel, thereby ensuring the stability of the product quality within the validity period. During storage, sealed packaging can prevent the influence of external factors such as light, air, and humidity on the gel, and maintain the physical and chemical properties of the gel unchanged. When in use, the sealed packaging ensures that users use safe and effective products every time, reduces the health risks caused by product deterioration or contamination, and effectively protects women's reproductive health.

[0023] Therefore, the prepared gel is transferred to a gel tube with a dispenser, ensuring that the package is well sealed, thereby obtaining a fast and long-acting gynecological antibacterial gel product.

[0024] In the method for preparing a fast and long-acting gynecological antibacterial gel provided by the present invention, step S1 of preparing a chlorine dioxide chelating solution comprises accurately measuring purified water and dissolving N,N-dicarboxymethylalanine trisodium salt in a specific manner, and controlling the stirring speed at 300-500 rpm and the time at 5-10 minutes to ensure that the trisodium salt is completely dissolved and evenly distributed, thereby providing ideal conditions for a subsequent chelating reaction; slowly adding stable chlorine dioxide powder under continuous stirring and maintaining a stirring speed of 200-300 rpm to effectively prevent the escape of chlorine dioxide or excessive reaction, thereby ensuring that the chelating reaction is safe and fully carried out; and continuing stirring for 10-20 minutes until the color change of the solution is complete, thereby ensuring that the chlorine dioxide is completely chelated to form a stable chelating solution, which not only stabilizes the chlorine dioxide, prevents its decomposition loss, and ensures the antibacterial effect of the product, but also lays a solid foundation for the subsequent mixing with other ingredients to prepare high-quality gynecological antibacterial gel, thereby making the entire preparation process more scientific, reliable, and efficient.

[0025] Preferably, the preparation of the chlorine dioxide chelate solution in step S1 specifically includes the following operations: measuring an appropriate amount of purified water, slowly adding 0.5-1 part of N, N-dicarboxymethyl alanine trisodium salt into the water, turning on the stirring device, setting the stirring speed to 300-500 rpm, and stirring for 5-10 minutes, until the N, N-dicarboxymethyl alanine trisodium salt is completely dissolved to obtain a clear and transparent N, N-dicarboxymethyl alanine trisodium salt solution; taking 50-250ppm of stable chlorine dioxide powder, and slowly adding the chlorine dioxide powder to the N, N-dicarboxymethyl alanine trisodium salt solution while maintaining continuous stirring at a stirring speed of 200-300 rpm; continuing stirring for 10-20 minutes, observing the color change of the solution, until the yellow-green color of the chlorine dioxide completely disappears, the solution becomes colorless and transparent, and a stable chlorine dioxide chelate solution is formed.

[0026] When N,N-dicarboxymethylalanine trisodium salt is dissolved, a high stirring speed of 300-500 rpm can generate strong shear force, prompting N,N-dicarboxymethylalanine trisodium salt particles to quickly disperse in water and accelerate its dissolution process. Slowly adding N,N-dicarboxymethylalanine trisodium salt can prevent it from forming high concentration areas locally, avoiding agglomeration or incomplete dissolution. A stirring time of 5-10 minutes is sufficient to fully dissolve N,N-dicarboxymethylalanine trisodium salt to obtain a clear and transparent solution, ensuring that N,N-dicarboxymethylalanine trisodium salt is evenly distributed in the solution, providing a uniform reaction environment for the subsequent efficient chelation reaction with chlorine dioxide. Uneven dissolution of N,N-dicarboxymethylalanine trisodium salt will lead to incomplete reaction with chlorine dioxide, affecting the chelation effect of chlorine dioxide, and thus reducing the stability and antibacterial properties of the product. After being completely dissolved, the N,N-dicarboxymethylalanine trisodium salt molecules are evenly distributed in the solution, and each molecule can fully expose its active site to effectively collide and react with the chlorine dioxide molecules to be added. This ensures that the chelation reaction is carried out evenly in the entire solution system, so that the chlorine dioxide can be fully chelated, and the stabilization degree of chlorine dioxide is improved, thereby ensuring that chlorine dioxide will not decompose prematurely during the subsequent preparation and storage process, and effectively maintaining the antibacterial activity of the product.

[0027] The role of chlorine dioxide addition and chelation operation is to control the reaction rate and prevent chlorine dioxide from escaping, ensuring complete chelation and solution stability. A stirring speed of 200-300 rpm can ensure that the chlorine dioxide powder is quickly dispersed in the solution, and will not cause chlorine dioxide to escape due to excessive stirring. The slow addition of chlorine dioxide powder is also to avoid excessive local concentration, causing excessive reaction and resulting in loss of chlorine dioxide. Chlorine dioxide is a strong oxidant with high reaction activity. If the addition speed is too fast or the stirring is uneven, chlorine dioxide will react quickly locally to produce gas or heat, causing chlorine dioxide to escape from the solution, reducing the content of effective bactericidal components in the product and affecting product quality. Continue stirring for 10-20 minutes and observe the color change of the solution until the yellow-green color of chlorine dioxide disappears completely and the solution becomes colorless and transparent, indicating that chlorine dioxide has been completely chelated by trisodium salt of N,N-dicarboxymethylalanine to form a stable complex. During this process, continuous stirring allows N,N-dicarboxymethylalanine trisodium salt and chlorine dioxide molecules to have enough time and opportunity to interact, ensuring that all chlorine dioxide can undergo a chelation reaction with N,N-dicarboxymethylalanine trisodium salt. The change in solution color intuitively reflects the progress of the chelation reaction. When the color disappears completely, it means that the chlorine dioxide has been successfully chelated to form a stable chlorine dioxide chelated solution. This stable solution can effectively maintain the stability of chlorine dioxide and prevent its decomposition during subsequent mixing with other ingredients and storage, thereby ensuring that the product has a reliable antibacterial effect when used. If the chelation is incomplete, the unchelated chlorine dioxide will easily decompose in the subsequent process, which will not only reduce the antibacterial effect, but also produce harmful substances that affect product safety.

[0028] In the method for preparing a fast and long-acting gynecological antibacterial gel provided by the present invention, in step S2, in the preparation of the gel matrix, carboxymethyl cellulose is slowly sprinkled into water and the stirring speed is controlled in stages, and the powder is stirred at a low speed first and then at a high speed for a specific length of time, so that the powder can be evenly dispersed to prevent agglomeration and can be ensured to be completely dissolved, thereby obtaining a uniform solution with a suitable viscosity, providing basic viscosity and structural support for the gel, and ensuring its adhesion and stability in the vagina; carbomer is added thereto at a suitable stirring speed and continuously stirred until completely dissolved, so that the two are fully mixed, the rheological properties of the gel are synergistically optimized, and its stability and viscosity are further enhanced; and during the stirring process, the solution temperature is controlled at 40-50° C., which can accelerate the dissolution rate of carbomer and improve production efficiency, and avoid adverse effects on the components due to excessively high temperature, thereby ensuring the quality of the gel matrix, creating a good start for the subsequent preparation of a gynecological antibacterial gel with excellent performance, stability and reliability, and effectively ensuring the use effect and safety of the product.

[0029] Preferably, the preparation of the gel matrix in step S2 specifically includes the following operations: taking an appropriate amount of purified water in a clean container, slowly sprinkling 0.2-0.1 parts of carboxymethyl cellulose into the water, first stirring at a low speed of 100-200 rpm to evenly disperse the carboxymethyl cellulose powder in the water; gradually increasing the stirring speed to 300-400 rpm, and continuing stirring for 10-15 minutes to ensure that the carboxymethyl cellulose is completely dissolved to obtain a uniform carboxymethyl cellulose solution with a certain viscosity; adding 0.5-1 parts of carbomer to the carboxymethyl cellulose solution, adjusting the stirring speed to 200-300 rpm, and stirring for 15-25 minutes until the carbomer is completely dissolved to form a uniform mixed solution containing carbomer and carboxymethyl cellulose; during the stirring process, the temperature of the heated solution is controlled at 40-50°C.

[0030] The gentle shear force generated by low-speed stirring can make the carboxymethyl cellulose powder dispersed in the water initially and evenly, avoiding powder agglomeration. Because carboxymethyl cellulose powder is directly stirred quickly or added to water in large quantities at one time, it is easy to form lumps that are difficult to disperse, affecting its dissolution rate and the uniformity of the final solution. Through low-speed initial stirring, the carboxymethyl cellulose particles are wetted and dispersed by water one by one, creating good conditions for subsequent rapid dissolution. Gradually increase the stirring speed to 300-400 rpm, and continue stirring for 10-15 minutes to ensure that the carboxymethyl cellulose is completely dissolved and a uniform solution with a certain viscosity is obtained. After increasing the stirring speed, the strong shear force further promotes the full contact and interaction between the carboxymethyl cellulose molecules and the water molecules, accelerating the dissolution process. 10-15 minutes of continuous stirring time can give enough time for the carboxymethyl cellulose to completely dissolve and form a uniform solution system. At this time, the solution has a certain viscosity, and this viscosity characteristic is crucial for the subsequent gel formation and performance. Appropriate viscosity can make the gel have better adhesion in the vagina and not easily flow out of the body too quickly, while ensuring good mixing with other ingredients during the preparation process, laying the foundation for building a stable gel matrix. Incomplete dissolution of carboxymethyl cellulose or inappropriate solution viscosity will lead to unstable gel matrix, affecting the quality and use effect of the entire gel product.

[0031] Add 0.5-1 part of carbomer to the carboxymethyl cellulose solution, adjust the stirring speed to 200-300 rpm, and stir for 15-25 minutes until the carbomer is completely dissolved to form a uniform mixed solution containing carbomer and carboxymethyl cellulose. The stirring speed of 200-300 rpm ensures that the carbomer is evenly dispersed in the solution without introducing too many bubbles due to excessive stirring. Carbomer dissolves relatively slowly in water, and a stirring time of 15-25 minutes can ensure that it is fully dissolved and evenly mixed with the carboxymethyl cellulose solution. As a suspending agent or viscosity increasing agent, carbomer is evenly distributed in the solution and can synergize with carboxymethyl cellulose to further adjust the viscosity and rheological properties of the gel, making the gel matrix more stable and uniform, which is conducive to the subsequent mixing with other ingredients to prepare a gel product with excellent performance. Incomplete dissolution of carbomer or uneven mixing with carboxymethyl cellulose will lead to local performance differences in the gel, affecting the consistency and effectiveness of the product. During the stirring process, the temperature of the heated solution is controlled at 40-50°C. Moderate heating can improve the solubility of carbomer, speed up its dissolution, shorten the preparation time, and improve production efficiency. However, the temperature is controlled at 40-50°C because too high a temperature will have an adverse effect on the chemical structure and properties of carbomer and other ingredients, leading to component degradation and affecting the stability of the gel. By precisely controlling the heating temperature, the stability of each ingredient and the quality of the gel matrix are guaranteed while accelerating the dissolution of carbomer, ensuring that the prepared gel matrix has good performance and providing a stable basic structure for the final gynecological antibacterial gel product.

[0032] In the method for preparing a fast and long-acting gynecological antibacterial gel provided by the present invention, in step S3 of gel forming, a chlorine dioxide chelating solution is slowly added to a mixed solution containing carbomer and carboxymethyl cellulose, and poloxamer is slowly poured in at the same time, and a stirring speed of 200-300 rpm is maintained throughout the process. Such an operation can ensure that the components are fully mixed under mild and stable conditions, and avoid component agglomeration or excessive local concentration due to too fast addition or uneven stirring, thereby ensuring the uniformity of the gel system; after the poloxamer is added, stirring is continued for 20-30 minutes to achieve uniform dispersion of the poloxamer and other components, which is not only conducive to exerting the temperature-sensitive characteristics of the poloxamer, so that it can synergize with other components at different temperatures, and ensure the stability of the gel during storage and use, but also enables the antibacterial components such as chlorine dioxide to be evenly distributed in the gel system, laying a foundation for achieving a fast and long-acting antibacterial effect, and ensuring that the finally prepared gynecological antibacterial gel has stable performance and reliable effect, and meets the needs of female reproductive health care.

[0033] Preferably, the gel forming in step S3 specifically includes the following operations: slowly adding the prepared chlorine dioxide chelating solution to the mixed solution containing carbomer and carboxymethyl cellulose, and slowly pouring 5-15 parts of poloxamer into the mixed system. During the addition process, stirring is continued at a stirring speed of 200-300 rpm; after the poloxamer is added, stirring is continued for 20-30 minutes to uniformly disperse the poloxamer and other ingredients to form a uniform gel system.

[0034] Slowly adding each component can avoid excessive local concentration due to too fast addition speed, causing component agglomeration or uneven distribution. The moderate shear force generated by continuous stirring at 200-300 rpm enables the components to fully contact and mix, ensuring that the chlorine dioxide chelate solution, carbomer, carboxymethyl cellulose and poloxamer are evenly dispersed in the mixed system. Uniform mixing is crucial to the stability and performance of the gel system. Only when the components are evenly distributed can the gel have consistent physical and chemical properties, viscosity, gelation temperature, antibacterial effect, etc. in subsequent use. Uneven mixing will lead to performance differences in some areas of the gel, affecting the overall quality and use effect of the product, too much or too little local antibacterial components, affecting the antibacterial effect; inconsistent local gelation characteristics affect the adhesion and action time of the gel in the vagina, etc. Continuous stirring during the addition process can also prevent chemical reactions caused by local accumulation of components. If the chlorine dioxide chelate solution is too high in local concentration, it will react abnormally with other components, resulting in the loss of active ingredients or the production of unwanted by-products. By slowly adding and continuously stirring, the ingredients are gradually and evenly mixed in the entire mixing system, avoiding the occurrence of local reactions, ensuring the integrity and effectiveness of each ingredient, and thus ensuring the quality and safety of the product.

[0035] After adding poloxamer, continue stirring for 20-30 minutes to allow poloxamer and other ingredients to be fully mixed and uniform to form a uniform gel system. This process allows poloxamer molecules to be evenly dispersed throughout the mixed system and fully interact with other ingredients. As a thermosensitive gel, the uniform dispersion of poloxamer is the key to ensuring the stable performance of the gel at different temperatures. At lower temperatures during preparation and storage, poloxamer can maintain good fluidity and form a liquid state that is easy to operate and store with other ingredients; when entering the human body, under the action of body temperature, poloxamer can quickly and evenly gel to form a stable gel structure, covering the surface of the vaginal mucosa, effectively locking the antibacterial ingredients at the site of action, and achieving long-term antibacterial effect. Uneven dispersion of poloxamer will lead to inconsistent gelation process, with some areas gelling too early and affecting operation, and some areas gelling too late and affecting the antibacterial effect and adhesion time in the vagina. Through continuous stirring, the components interact with each other to form a stable gel system structure. The viscosity and structural support provided by carbomer and carboxymethyl cellulose are combined with the thermosensitive gel properties of poloxamer to jointly construct a stable three-dimensional network structure. In this structure, the chlorine dioxide chelate solution is evenly distributed. When the gel is used in the vagina, this structure can ensure that the gel slowly releases antibacterial ingredients in the vaginal environment while maintaining the integrity of the gel, which is not easily washed away by vaginal secretions, prolonging the gel's action time in the vagina and improving the product's antibacterial effect and ease of use. The stable gel system structure can also ensure the stability of the product's physical and chemical properties during storage and extend the product's shelf life.

[0036] In the method for preparing the fast and long-acting gynecological antibacterial gel provided by the present invention, the finished product packaging in step S5 adopts aseptic operation technology and transfers the gel to a pre-sterilized gel tube with a dispenser with the help of aseptic tools. This process can effectively prevent microorganisms from contaminating the gel, ensure the sterility of the product in the packaging link, avoid the invasion of external pathogens such as bacteria and fungi to affect the product quality and safety, and reduce the risk of infection for users; the gel tube is sealed by heat sealing or screwing the cap, on the one hand, the moisture content and component stability of the gel can be maintained, and its volatilization, oxidation or moisture deterioration can be prevented, thereby extending the shelf life of the product; on the other hand, the combination of the sealed packaging and the design of the dispenser is convenient for the storage, transportation and preservation of the product, and it is convenient for the user to accurately and hygienically apply the gel to the vaginal area, thereby enhancing the practicality and convenience of the product, ensuring that the fast and long-acting antibacterial properties of the gel can be effectively exerted in actual use, and providing a reliable product guarantee for women's reproductive health care.

[0037] Preferably, the finished product packaging in step S5 specifically includes the following operations: using aseptic operation technology, the prepared gel is transferred to a pre-sterilized gel tube with a dispenser through a sterile funnel or syringe and the like, and the gel tube is sealed by heat sealing or screw-on sealing to obtain a fast and long-acting gynecological antibacterial gel product.

[0038] Aseptic operation is a key link to ensure product quality and safety. During the transfer process, strictly prevent external microorganisms such as bacteria, fungi, and viruses from entering the gel to avoid product contamination. The gel is contaminated by microorganisms during the packaging process, and harmful microorganisms will be introduced into the vagina during use, causing new infections or aggravating the original condition, seriously affecting the use effect of the product and the health of the user. Through aseptic operation, the gel is always in a sterile environment during the packaging process, ensuring the sterility of the product and providing users with safe and reliable products. Using tools such as sterile funnels or syringes for transfer can accurately control the transfer amount of gel and ensure that the gel dosage in each gel tube is accurate and consistent. At the same time, these tools can avoid the loss and leakage of gel during the transfer process and ensure the integrity of the product. Accurate dosage is crucial to the effectiveness of the product. Users use the gel according to the prescribed dosage to ensure the expected antibacterial effect. Inaccurate dosage will lead to insufficient antibacterial effect or excessive use, bringing other potential risks. In addition, ensuring product integrity can prevent the gel from being contaminated by external factors such as dust and impurities before packaging, further ensuring product quality.

[0039] The gel tube is sealed by heat sealing or screw cap sealing to effectively prevent the evaporation of water in the gel, the volatilization of ingredients, and contact with the outside air. The evaporation of water will cause the gel to dry and harden, affecting its physical properties and performance; the volatilization of ingredients will reduce the effective antibacterial ingredients and reduce the antibacterial effect of the product. Contact with the outside air will also introduce substances such as oxygen, accelerate the oxidation and deterioration of certain ingredients, and shorten the shelf life of the product. Good sealed packaging can create a stable storage environment for the gel, maintain the stability of the physical and chemical properties of the gel, extend the shelf life of the product, and ensure that the product always maintains good performance and effectiveness during the validity period. The sealed gel tube is easy to store and transport, and protects the gel from external physical factors such as squeezing and collision. During storage, the sealed packaging can prevent the gel tube from being damaged, ensuring that the product quality is not affected. For users, the well-sealed gel tube is easy to store, easy to carry, and available at any time. At the same time, the design with a dispenser combined with the sealed packaging makes the product more convenient and hygienic to use. Users do not need to prepare additional drug delivery tools. They only need to open the package and use the applicator to accurately apply the gel to the vaginal area, reducing the risk of contamination during use and improving the product's practicality and user experience.

[0040] The method for using the fast and long-acting gynecological antibacterial gel provided by the present invention is closely related to the efficacy of the product and the experience and health of the user in each step of the operation; the applicator is inserted to a specific depth along the posterior wall of the vagina, which can not only reduce the stimulation and damage to the vaginal tissue, but also ensure that the gel is accurately delivered to the deep part of the vagina, so that the antibacterial components can effectively act on the key parts where bacteria are prone to breed; the push rod is slowly pushed to evenly push the gel, which helps the gel to be fully and evenly distributed in the vagina, fully contact the vaginal mucosa, and maximize the antibacterial effect, without missing any corner where bacteria are hidden; and after the gel is pushed, the supine or semi-recumbent position is maintained for rest, and the principle of gravity is used to make the gel stay in the vagina for a longer time, reduce outflow, and allow the effective ingredients in the gel to have sufficient time to exert their fast and long-acting antibacterial effect, thereby providing a strong guarantee for the prevention and treatment of gynecological diseases, effectively maintaining women's reproductive health, and at the same time improving the safety and effectiveness of product use and improving user compliance.

[0041] Preferably, the applicator in step S5 includes a gel tube, the bottom end of the gel tube is provided with a discharge port, the top end of the gel tube is provided with a medicine groove, and the inner wall of the medicine groove is provided with a sliding card push plate; it is characterized in that it also includes a front shell, a rear shell and two groups of semicircular fixed rings, the gel tube is arranged in multiple groups, the front shell is clamped with the rear shell through a clamping assembly, the inner ends of the front shell and the rear shell are respectively provided with multiple groups of medicine tube grooves and multiple groups of guide grooves, the multiple groups of gel tubes are respectively clamped with the multiple groups of medicine tube grooves, the multiple groups of medicine tube grooves are respectively connected with the multiple groups of guide grooves, the bottom ends of the front shell and the rear shell are respectively connected with the semicircular fixed rings, the two groups of semicircular fixed rings are connected to form a guide ring, and the guide The flow ring is connected to the mixing tube head assembly, and multiple groups of guide grooves are connected to the guide ring. Insertion assemblies are arranged at the bottom ends of the front shell and the rear shell, and sliding pusher assemblies are respectively arranged on the front shell and the rear shell; the mixing tube head assembly includes a fixed cover, a support block and a double helical blade, and a first thread is respectively arranged on the outer wall of the guide ring, a discharge pipe is arranged at the bottom end of the fixed cover, and a second thread is arranged at the inner end of the fixed cover. The fixed cover is threadedly connected to the guide ring, and the bottom end of the support block is connected to the double helical blades. Two groups of feed through holes are arranged at the top of the support block, and the top of the support block is tightly attached to the front shell and the rear shell. The support block is clamped on the guide ring, and the double helical blades are inserted into the discharge pipe.

[0042] The fast and long-acting gynecological antibacterial gel described in the present invention specifically includes the following operations: inserting the front slender part of the applicator into the vagina along the posterior wall of the vagina to a depth of 7-10 cm, slowly pushing the push rod of the applicator to evenly push the gel into the vagina so that the gel can fully contact the vaginal mucosa, and after the gel is pushed, resting in a supine or semi-recumbent position for 2-3 minutes.

[0043] Insert the front slender part of the applicator into the vagina along the posterior wall of the vagina to a depth of 7-10 cm. This depth range is set to enable the gel to reach the key parts deep in the vagina. The posterior wall of the vagina is relatively smooth, which causes less stimulation to the vaginal tissue during insertion. At the same time, it can guide the applicator to reach the vaginal vault and other parts more accurately, where harmful bacteria are easy to hide and reproduce. The depth of 7-10 cm can ensure that the gel is distributed more evenly in the vagina, and can fully contact various areas of the vaginal mucosa, especially the folds, so that the antibacterial ingredients can effectively act on the existing harmful bacteria and improve the antibacterial effect. If the insertion depth is too shallow, the gel cannot reach the deep vagina, affecting the inhibitory effect on deep pathogens; while inserting too deep will cause discomfort or even damage the vaginal tissue or cervix. Slowly inserting the applicator along the posterior wall of the vagina can minimize friction and irritation to the vaginal mucosa and reduce the user's discomfort. The correct insertion direction and slow operation speed can help avoid the risk of vaginal wall scratches, bleeding and other injuries caused by improper force or wrong insertion angle. This discreet insertion method can make the drug delivery process safer and more comfortable, improve user compliance, and ensure that users can use the product correctly to treat or prevent gynecological diseases.

[0044] Slowly push the push rod of the applicator to push the gel evenly into the vagina. The purpose of this operation is to form a uniform covering layer of gel in the vagina. The evenly distributed gel can maximize the contact area with the vaginal mucosa, so that the antibacterial ingredients can fully play their role. The vaginal mucosa is the main site of bacterial infection. The full contact between the gel and the mucosa can ensure that the antibacterial ingredients directly act on harmful bacteria, quickly inhibit their growth and reproduction, and thus effectively prevent and treat diseases such as gynecological inflammation. Uneven gel push leads to gel accumulation in some areas, while other areas are not covered enough, affecting the comprehensiveness and stability of the antibacterial effect. Slowly pushing the gel helps to avoid the impact force caused by the gel being pushed too fast, and prevents the gel from being quickly squeezed out of the body before it is fully attached to the vaginal mucosa. Through slow and steady pushing, the gel can gradually fill and adhere to the mucosal surface in the vagina, prolonging the residence time of the gel in the vagina and ensuring that the antibacterial ingredients have enough time to play their role. The length of time the gel acts in the vagina directly affects its antibacterial effect. If the gel flows out too quickly, the purpose of long-term antibacterial cannot be achieved, reducing the use value of the product.

[0045] After pushing the gel, keep lying in a supine or semi-recumbent position for 2-3 minutes. This measure mainly uses gravity to reduce the possibility of gel flowing out of the vagina. During the rest period, the gel will tend to stay in the vagina under the action of gravity, further increasing the contact time with the vaginal mucosa, allowing the antibacterial ingredients to continue to play a role and improve the antibacterial effect. If the user gets up and moves immediately after pushing the gel, the gel will easily flow out of the vagina quickly under the influence of gravity and body movement, resulting in the inability of the effective ingredients to fully play a role, affecting the treatment or prevention effect. Maintaining a resting position can also give the gel more time to be naturally distributed and diffused in the vagina, better fill the vaginal folds and gaps, and allow the antibacterial ingredients to cover the inner surface of the vagina more comprehensively. At the same time, the relatively static state is conducive to the absorption of the active ingredients in the gel by the vaginal mucosa, allowing the antibacterial ingredients to enter the vaginal tissue and cells faster, exerting their bactericidal and anti-inflammatory effects, thereby improving the use effect of the product and providing better protection for women's reproductive health.

[0046] In summary, the present invention has the following beneficial effects: 1. Compared with the defect that conventional traditional formulas on the market are difficult to take into account multiple performance requirements, the gynecological antibacterial gel formula of the present invention selects and combines multiple key ingredients to achieve multi-faceted performance optimization; the temperature-sensitive property of poloxamer brings unique advantages to the product, and it exhibits good fluidity when not in use, making it easy to enter the deep vagina. This property effectively solves the problem that traditional gel products have poor fluidity in the vagina and are difficult to fully cover the mucosal folds. After entering the human body, it quickly gels and adheres to the vaginal mucosa for a long time, achieving long-term antibacterial effect and overcoming the defect of short action time of traditional products; the synergistic effect of carbomer and carboxymethyl cellulose accurately Adjust the viscosity and stability of the gel so that the gel can maintain good adhesion in the vagina and not easily flow out, and can maintain a suitable physical state at different stages (storage, before use and during use), which is difficult to achieve with traditional formulas; the stabilization and synergistic effect of N,N-dicarboxymethylalanine trisodium salt on unstable chlorine dioxide improves the antibacterial ability. Compared with the single antibacterial ingredient in traditional formulas, the antibacterial effect is more significant and lasting; the powerful bactericidal and deodorizing function of stable chlorine dioxide powder itself provides a more effective solution to common gynecological pathogens and odor problems, and is superior to the antibacterial and deodorizing effects of traditional formulas; 2. The product of the present invention has strong initial fluidity, can quickly gel in the body, and has the characteristics of rapid and long-term antibacterial effect, which is different from many traditional products. Traditional lotion products have a superficial effect and cannot penetrate into the folds inside the vagina, while this gel can penetrate into the folds with good initial fluidity and reach areas that traditional lotions cannot reach for antibacterial effect; traditional suppositories are inconvenient to use and are unevenly dispersed in the vagina, while this gel can be evenly distributed and fully contact the mucosa; traditional gel products cannot meet the requirements of rapid initial flow and long-term adhesion in the later stage at the same time. The temperature-sensitive characteristics of this product perfectly solve this problem. After entering the human body, it quickly turns into a gel state, locks the antibacterial ingredients at the site of action, achieves rapid onset and continuous antibacterial effect, fills the performance gap of traditional products in this regard, and provides a better choice for women's reproductive health care; 3. The preparation method of the present invention is significantly different from the traditional process, and this difference ensures the excellent quality of the product. In the preparation step of the chlorine dioxide chelating solution, the traditional process cannot effectively stabilize the chlorine dioxide, which makes it easy to decompose during the preparation and storage process, affecting the antibacterial effect. The present invention ensures the stable chelation of chlorine dioxide by accurately controlling the dissolution conditions of N, N-dicarboxymethylalanine trisodium salt and the addition method and stirring parameters of chlorine dioxide, providing a solid guarantee for the subsequent antibacterial effect; in the gel matrix preparation step, the traditional process cannot accurately control the dissolution process of carboxymethyl cellulose and carbomer, affecting the performance of the gel matrix; the invention controls the stirring speed, heating temperature, etc. in stages, so that the two are fully dissolved and synergistic, and a stable and high-performance gel matrix is ​​constructed; in the gel forming step, the traditional process cannot ensure uniformity when the components are mixed, resulting in unstable gel performance. The slow addition and continuous stirring operation of the present invention ensures that the components are evenly mixed to form a stable gel system; in the pH adjustment step and the finished product packaging step, the precise control and aseptic operation technology of the present invention ensure the stability, sterility and quality reliability of the product, which is different from the traditional antibacterial agent preparation process. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1 It is a schematic diagram of the connection structure of the drug delivery device of the present invention; Figure 2 It is a schematic diagram of the connection structure between the cover plate and the clamping slide rod of the drug dispensing device of the present invention; Figure 3 It is a schematic diagram of the connection structure between the cover plate and the clamping rod of the drug dispensing device of the present invention; Figure 4 It is a schematic diagram of the front shell structure of the drug delivery device of the present invention; Figure 5 It is a schematic diagram of the enlarged structure of a part of the drug delivery device of the present invention; Markings in the attached drawings: 1. gel tube; 2. push plate; 3. front shell; 4. rear shell; 5. semicircular fixing ring; 6. fixing cover; 7. discharge pipe; 8. support block; 9. double helical blades. DETAILED DESCRIPTION

[0048] This specific embodiment is merely an explanation of the present invention and is not a limitation of the present invention. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed. However, as long as they are within the scope of the claims of the present invention, they are protected by the patent law.

[0049] 1. Experimental Methods 1.1 Preparation of gynecological antibacterial gel products.

[0050] Example 1

[0051] S1 Preparation of chlorine dioxide chelate solution: Measure an appropriate amount of water, add 0.5 parts of N, N-dicarboxymethyl alanine trisodium salt into the water, stir thoroughly to dissolve it completely, and obtain N, N-dicarboxymethyl alanine trisodium salt solution. Slowly add 50ppm of stable chlorine dioxide powder into the solution, and continue stirring until the color of chlorine dioxide completely disappears and the solution becomes colorless, thereby forming a stable chlorine dioxide chelate solution; Preparation of S2 gel matrix: Take an appropriate amount of water, add 0.2 parts of carboxymethyl cellulose into the water, stir evenly to ensure that the molecules are completely dispersed and dissolved to form a carboxymethyl cellulose solution, add 0.5 parts of carbomer, and continue stirring until the carbomer is completely dissolved to obtain a mixed solution containing carbomer and carboxymethyl cellulose; S3 Gel formation: slowly add the prepared chlorine dioxide chelating solution to the mixed solution containing carbomer and carboxymethyl cellulose, and add 15 parts of poloxamer at the same time, stirring continuously, so that the poloxamer and the mixed solution are fully mixed and uniformly formed to form a uniform gel system; S4 pH value adjustment: Use a calibrated precision pH meter to completely immerse the electrode in the gel, read the initial pH value, and add an appropriate amount of acid or alkali solution according to the measured pH value to adjust the pH value of the gel system to 4.5±0.5. The measured value is 4.91; S5 Finished product packaging: Transfer the prepared gel to a gel tube with a dispenser, ensuring that the package is well sealed to obtain a fast-acting and long-lasting gynecological antibacterial gel product.

[0052] The step S5 applicator of the present invention comprises a gel medicine tube 1, the bottom end of the gel medicine tube 1 is provided with a discharge port, the top end of the gel medicine tube 1 is provided with a medicine groove, and the inner wall of the medicine groove is provided with a sliding card push plate 2; it is characterized in that it also comprises a front shell 3, a rear shell 4 and two groups of semicircular fixed rings 5, the gel medicine tube 1 is arranged as multiple groups, the front shell 3 is clamped with the rear shell 4 through a clamping assembly, the inner ends of the front shell 3 and the rear shell 4 are respectively provided with multiple groups of medicine tube grooves and multiple groups of guide grooves, the multiple groups of gel medicine tubes 1 are respectively clamped with the multiple groups of medicine tube grooves, the multiple groups of medicine tube grooves are respectively connected with the multiple groups of guide grooves, the bottom ends of the front shell 3 and the rear shell 4 are respectively connected with the semicircular fixed rings 5, the two groups of semicircular fixed rings 5 ​​are connected to form a guide ring, the guide ring is connected with the mixing tube head assembly, the multiple groups of guide grooves are all connected with the guide ring, the bottom ends of the front shell 3 and the rear shell 4 are provided with an insertion assembly, the front shell 3 and the rear shell 4 are respectively provided with sliding pusher assemblies; the present invention is designed to accommodate and mix two or more different types of gel drugs at the same time, and the user can complete the administration process of multiple drugs in one operation, which greatly improves the treatment efficiency, and the optimized structure makes the whole device easy to assemble, disassemble and clean, which not only facilitates the operation of medical staff, but also improves the patient's experience of use, and the sliding pusher assembly is used to ensure that the amount of gel pushed each time is accurate and consistent, which helps to ensure the efficacy while reducing waste, and secondly, multiple groups of rubber rings on the sliding pusher assembly can be clamped with the medicine tube groove to ensure hygiene when not in use, thereby preventing the product from being contaminated with bacteria when not in use, thereby improving the medication efficiency and reducing secondary infection caused by multiple uses of the gel, thereby enhancing practicality. The mixing tube head assembly includes a fixed cover 6, a support block 8 and a double helical blade 9, the outer wall of the guide ring is respectively provided with a first thread, the bottom end of the fixed cover 6 is provided with a discharge pipe 7, the inner end of the fixed cover 6 is provided with a second thread, the fixed cover 6 is threadedly connected to the guide ring, the bottom end of the support block 8 is connected to the double helical blade 9, two groups of feed through holes are provided at the top of the support block 8, the top of the support block 8 is tightly attached to the front shell 3 and the rear shell 4, the support block 8 is clamped with the guide ring, and the double helical blade 9 is inserted into the discharge pipe; first, the support block and the fixed ring are clamped, so that the two groups of guide grooves are aligned with the two groups of feed through holes, and then the fixed cover is threadedly connected to the two groups of fixed rings, and it is ensured that the double helical blade is inserted into the discharge pipe, and then the insertion assembly is clamped for later practical use, thereby enhancing practicality.

[0053] Except for the different mass fractions of each component in Example 2-5, the remaining operations are the same as Example 1 to obtain a fast and long-acting gynecological antibacterial gel product.

[0054] Comparative Example 1 Ethylenediaminetetraacetic acid disodium salt is substituted for N,N-dicarboxymethylalanine trisodium, and the remaining operations are the same as those in Example 3 to obtain a gynecological antibacterial gel product.

[0055] Comparative Example 2 Tetrasodium glutamate diacetate was used to replace trisodium N,N-dicarboxymethylalanine, and the remaining operations were the same as those in Example 3 to obtain a gynecological antibacterial gel product.

[0056] Comparative Example 3 Polyvinylpyrrolidone K30 was used to replace trisodium N,N-dicarboxymethylalanine, and the remaining operations were the same as those in Example 3 to obtain a gynecological antibacterial gel product.

[0057] Table 1 Summary of the mass fractions of the components of the gynecological antibacterial gel products prepared in Examples 1-5 and Comparative Examples 1-3

[0058] 1.2 Antibacterial experiment According to the standard of "Hygiene Requirements for Disposable Sanitary Products" GB15979-2024 (Appendix E) E6, an antibacterial experiment was carried out. At room temperature, the gynecological antibacterial gel products prepared in Examples 1-5 and Comparative Examples 1-3 acted on Escherichia coli, Staphylococcus aureus, and Candida albicans for 1 minute, respectively. The test was repeated 3 times, and the test results are shown in Table 2.

[0059] Table 2 Summary of experimental results of antibacterial rate of gynecological antibacterial gel products in each group against different strains (unit: %)

[0060] Result analysis: The antibacterial rates of Examples 1-5 against Candida albicans, Staphylococcus aureus, and Escherichia coli were all greater than 99.9%, showing an extremely excellent antibacterial effect. This shows that within the formula range determined by the present invention: 5-15 parts of poloxamer, 0.5-1 parts of carbomer, 0.5-1 parts of N,N-dicarboxymethyl alanine trisodium salt, 0.2-0.1 parts of carboxymethyl cellulose, and 50-250ppm of stable chlorine dioxide powder, pH value 4.5±0.5, good synergy is achieved between the ingredients, and the gynecological antibacterial gel has extremely excellent and stable antibacterial and anti-inflammatory properties.

[0061] From the specific composition point of view, poloxamer is a thermosensitive gel. It can quickly adapt to the temperature change after entering the human body at different contents ranging from 15 parts in Example 1 to 25 parts in Example 5, forming a gel and adhering to the vaginal mucosal folds for a long time, providing a stable platform for the antibacterial ingredients, and ensuring the durability of the antibacterial effect. Carbomer effectively increases the viscosity of the gel within the content range of 0.5-1 parts, making the gel not easy to lose in the vagina, ensuring that the antibacterial ingredients have enough contact time with the bacteria. Carboxymethyl cellulose varies between 0.2-1 parts, which not only helps to adjust the gelation temperature of poloxamer and reduce the amount of poloxamer used, but also optimizes the overall viscosity of the gel, so that the gel has good fluidity in the initial stage to penetrate into the vagina, and at the same time forms a suitable gel state under the action of body temperature, thereby synergistically enhancing the antibacterial effect. N,N-dicarboxymethylalanine trisodium salt is between 0.5-1 parts, which successfully stabilizes chlorine dioxide, keeps it active at room temperature, and can release chlorine dioxide in a timely manner in the vaginal environment, and together with other ingredients create an environment that is not conducive to the survival of bacteria. Stable chlorine dioxide powder shows a strong killing ability against a variety of pathogens in the concentration range of 50-250ppm. Even at a lower concentration of 50ppm in Example 1, it can achieve efficient antibacterial effect by synergistic effect with other ingredients, and as the concentration increases to 250ppm in Example 5, the inhibition intensity of pathogens is further improved. The pH value is between 4.48-4.91 and close to 4.5±0.5. This suitable pH range provides an ideal chemical environment for antibacterial ingredients, ensures the stability and activity of each ingredient, enables them to fully exert their antibacterial effect, and inhibits the growth and reproduction of bacteria.

[0062] The antibacterial rates of Comparative Examples 1-3 are all less than 50%, which is in sharp contrast to the examples. Comparative Example 1 uses disodium ethylenediaminetetraacetic acid to replace trisodium N, N-dicarboxymethyl alanine, Comparative Example 2 uses tetrasodium glutamate diacetate, and Comparative Example 3 uses polyvinylpyrrolidone K30. Although these alternative chelating agents can chelate chlorine dioxide, in actual use, they cannot release chlorine dioxide as effectively as trisodium N, N-dicarboxymethyl alanine, resulting in the bactericidal effect of chlorine dioxide not being fully exerted, thereby seriously weakening the overall antibacterial performance of the product. This fully demonstrates the unique importance of trisodium N, N-dicarboxymethyl alanine in the formula of the present invention. It can not only stabilize chlorine dioxide and prevent it from decomposing during storage and preparation, but also accurately release chlorine dioxide under specific conditions in the vagina, so that chlorine dioxide can quickly contact with pathogens and exert its powerful bactericidal ability, achieving a rapid antibacterial effect. This result shows that in the gel formula of the present invention, N,N-dicarboxymethylalanine trisodium salt is one of the key factors to ensure the antibacterial effect, and its performance advantages are difficult to replace by other similar chelating agents.

[0063] By analyzing the changes in the content of each component in the embodiment, it can be found that there is a certain correlation between the change in the content of the component and the antibacterial effect. From Example 1 to Example 5, it is shown that the increase in the content of poloxamer helps to enhance the adhesion and stability of the gel in the vagina. As its content increases, the gel forms a denser structure after gelation at body temperature, better locks the antibacterial ingredients and prolongs the action time. The increase in the content of carboxymethyl cellulose in Example 3-5 further optimizes the rheological properties of the gel, so that it has better fluidity in the initial stage to penetrate into the vaginal folds, and can more accurately adjust the degree of gelation under the action of body temperature, thereby assisting the antibacterial ingredients to play a role. The rising trend of the chlorine dioxide content in Example 1-5 is a factor that leads to the enhancement of the antibacterial effect. At a lower content of 50ppm, the antibacterial rate is already extremely high, indicating that in this formulation system, the synergistic effect of chlorine dioxide and other ingredients enables it to exert excellent antibacterial effects at relatively low concentrations. Carbomer and N,N-dicarboxymethylalanine trisodium salt stably play the role of viscosity increasing and stabilizing chlorine dioxide within the respective content range of 0.5-1 part, and cooperate with other ingredients to maintain the performance and antibacterial effect of the gel.

[0064] 1.3 Vaginal mucosal irritation test According to the "Procedures and Methods for Toxicological Evaluation of Safety of Disinfectants" (GB / T3896-2020), the ambient temperature was 21-24°C and the relative humidity was 49-52%, and the gynecological antibacterial gel product prepared in Examples 1-5 was experimented as is.

[0065] Six female New Zealand rabbits weighing 2.0kg-2.8kg were randomly divided into an experimental group and a control group, with 3 rabbits in each group. 2mL of the original sample was slowly injected into the vagina through the catheter, and the animals in the control group were treated with normal saline in the same way, which was repeated every 24 hours for 5 consecutive days. The animals were killed, the vagina was removed, and the congestion, edema and other manifestations were observed with the naked eye, and then fixed in 10% formalin solution for 24 hours. The tissue sections of the two ends and three central parts of the vagina were taken for preparation, and pathological examination was performed after HE staining. The stimulation response scores of the three parts of the three animals in the experimental group were added together and then divided by the total number of observations (number of animals × 3). The scoring method of the control group was the same. After the stimulation index was obtained by subtracting the average score of the experimental group from the average score of the control group, the stimulation intensity was graded. The test results are shown in Table 3.

[0066] Table 3 Summary of experimental results on the irritation of the gynecological antibacterial gel products of each group in Examples 1-5 to the vaginal mucosa

[0067] Result analysis: The test results of Examples 1-5 are all non-irritating, which provides strong support for the gynecological antibacterial gel from the perspective of safety. The N, N-dicarboxymethyl alanine trisodium used as a green chelating agent has good toxicological safety, which is one of the important factors for the non-irritation of the gel. During the contact between the gel and the vaginal mucosa, N, N-dicarboxymethyl alanine trisodium will not cause adverse reactions such as congestion and edema of the vaginal mucosa, indicating that it has good biocompatibility with the vaginal mucosa. At the same time, this also means that in the entire formula system, N, N-dicarboxymethyl alanine trisodium has good compatibility with other ingredients such as poloxamer, carbomer, carboxymethyl cellulose, and stable chlorine dioxide powder. When these ingredients work together, they will not produce substances that are irritating to the vaginal mucosa due to chemical reactions or physical effects between each other, nor will they change the normal physiological environment of the vaginal mucosa, thereby ensuring the safety of the product. The non-toxic and non-irritating properties of poloxamer are reflected when it is combined with trisodium N, N-dicarboxymethyl alanine and other ingredients. Although carbomer is used as a viscosity enhancer, it will not cause adverse stimulation to the vaginal mucosa due to increasing the viscosity of the gel in the formula. Carboxymethyl cellulose and stable chlorine dioxide powder also maintain friendliness to the vaginal mucosa when synergizing with other ingredients, jointly ensuring that the gel will not cause additional discomfort or harm to the user while exerting an antibacterial effect. In the field of female private care, the safety of the product is crucial. Since the gel of the present invention is non-irritating, this allows the gynecological antibacterial gel product to be safely used in daily care and the prevention and treatment of gynecological diseases. Users can use the product with confidence without worrying about vaginal discomfort or damage caused by the use of the gel. This not only improves the practicality and user acceptance of the product, but also lays a solid foundation for the promotion and application of the product in the market.

Claims

1. A fast and long-acting gynecological antibacterial gel, characterized in that: Specifically include: 5-15 parts of poloxamer, 0.5-1 parts of carbomer, 0.5-1 parts of N, N-dicarboxymethyl alanine trisodium salt, 0.2-0.1 parts of carboxymethyl cellulose and 50-250ppm of stable chlorine dioxide powder.

2. A method for preparing a fast and long-acting gynecological antibacterial gel, characterized in that: The specific steps include: S1 Preparation of chlorine dioxide chelate solution: Measure an appropriate amount of water, add 0.5-1 part of N, N-dicarboxymethyl alanine trisodium salt into the water, stir thoroughly to dissolve it completely, and obtain N, N-dicarboxymethyl alanine trisodium salt solution, slowly add 50-250ppm of stable chlorine dioxide powder into the solution, and continue stirring until the color of chlorine dioxide completely disappears and the solution becomes colorless, thereby forming a stable chlorine dioxide chelate solution; Preparation of S2 gel matrix: Take an appropriate amount of water, add 0.2-0.1 parts of carboxymethyl cellulose into the water, stir evenly to ensure that the carboxymethyl cellulose is completely dispersed and dissolved to form a carboxymethyl cellulose solution, add 0.5-1 parts of carbomer, continue stirring until the carbomer is completely dissolved, and obtain a mixed solution containing carbomer and carboxymethyl cellulose; S3 Gel formation: slowly add the prepared chlorine dioxide chelating solution to the mixed solution containing carbomer and carboxymethyl cellulose, and add 5-15 parts of poloxamer while stirring continuously to fully mix the poloxamer and the mixed solution to form a uniform gel system; S4 pH value adjustment: Use a calibrated precision pH meter to completely immerse the electrode in the gel, read the initial pH value, and add an appropriate amount of acid or alkali solution according to the measured pH value to adjust the pH value of the gel system to 4.5±0.5; S5 Finished product packaging: Transfer the prepared gel to a gel tube with a dispenser, ensuring that the package is well sealed to obtain a fast-acting and long-lasting gynecological antibacterial gel product.

3. The method for preparing a fast and long-acting gynecological antibacterial gel according to claim 2, characterized in that: The step S1 of preparing the chlorine dioxide chelating solution specifically includes the following operations: measuring an appropriate amount of purified water, slowly adding 0.5-1 part of N,N-dicarboxymethyl alanine trisodium salt into the water, turning on the stirring device, setting the stirring speed to 300-500 rpm, and stirring for 5-10 minutes, until the N,N-dicarboxymethyl alanine trisodium salt is completely dissolved to obtain a clear and transparent N,N-dicarboxymethyl alanine trisodium salt solution; taking 50-250ppm of stable chlorine dioxide powder, and slowly adding the chlorine dioxide powder to the N,N-dicarboxymethyl alanine trisodium salt solution while maintaining continuous stirring at a stirring speed of 200-300 rpm; continuing stirring for 10-20 minutes, observing the color change of the solution, until the yellow-green color of the chlorine dioxide completely disappears, the solution becomes colorless and transparent, and a stable chlorine dioxide chelating solution is formed.

4. The method for preparing the fast and long-acting gynecological antibacterial gel according to claim 2, characterized in that: The preparation of the gel matrix in step S2 specifically includes the following operations: taking an appropriate amount of purified water in a clean container, slowly sprinkling 0.2-0.1 parts of carboxymethyl cellulose into the water, first stirring at a low speed of 100-200 rpm to evenly disperse the carboxymethyl cellulose powder in the water; gradually increasing the stirring speed to 300-400 rpm, and continuing stirring for 10-15 minutes to ensure that the carboxymethyl cellulose is completely dissolved to obtain a uniform carboxymethyl cellulose solution with a certain viscosity; adding 0.5-1 parts of carbomer to the carboxymethyl cellulose solution, adjusting the stirring speed to 200-300 rpm, and stirring for 15-25 minutes until the carbomer is completely dissolved to form a uniform mixed solution containing carbomer and carboxymethyl cellulose; during the stirring process, the temperature of the heated solution is controlled at 40-50°C.

5. The method for preparing the rapid and long-acting gynecological antibacterial gel according to claim 2, characterized in that: The gel forming step S3 specifically includes the following operations: slowly adding the prepared chlorine dioxide chelating solution to the mixed solution containing carbomer and carboxymethyl cellulose, and at the same time slowly pouring 5-15 parts of poloxamer into the mixed system, and continuously stirring during the addition process, and the stirring speed is maintained at 200-300 rpm; after the poloxamer is added, stirring is continued for 20-30 minutes to uniformly disperse the poloxamer and other ingredients to form a uniform gel system.

6. The method for preparing the fast and long-acting gynecological antibacterial gel according to claim 2, characterized in that: The finished product packaging in step S5 specifically includes the following operations: using aseptic operation technology, transferring the prepared gel through a sterile funnel or a syringe and other tools into a pre-sterilized gel tube with a dispenser, and sealing the gel tube by heat sealing or screw-on sealing to obtain a fast and long-acting gynecological antibacterial gel product.

7. The fast and long-acting gynecological antibacterial gel according to claim 1, characterized in that: The method for using the gynecological antibacterial gel specifically includes the following operations: insert the front slender part of the applicator into the vagina along the posterior wall of the vagina to a depth of 7-10 cm, slowly push the push rod of the applicator to evenly push the gel into the vagina so that the gel can fully contact the vaginal mucosa, and after the gel is pushed, maintain a supine or semi-recumbent position and rest for 2-3 minutes.

8. The method for preparing the rapid and long-acting gynecological antibacterial gel according to claim 2, characterized in that: The step S5 drug delivery device comprises a gel drug tube (1), the bottom end of the gel drug tube (1) is provided with a discharge port, the top end of the gel drug tube (1) is provided with a drug groove, and the inner wall of the drug groove is provided with a sliding clamping push plate (2); it also comprises a front shell (3), a rear shell (4) and two groups of semicircular fixed rings (5), the gel drug tube (1) is arranged in multiple groups, the front shell (3) is clamped with the rear shell (4) through a clamping assembly, the inner ends of the front shell (3) and the rear shell (4) are respectively provided with multiple groups of drug tube grooves and multiple groups of guide grooves, the multiple groups of gel drug tubes (1) are respectively clamped with the multiple groups of drug tube grooves, the multiple groups of drug tube grooves are respectively connected with the multiple groups of guide grooves, the bottom ends of the front shell (3) and the rear shell (4) are respectively connected with the semicircular fixed rings (5), the two groups of semicircular fixed rings (5) are butt-jointed to form a guide ring, and the guide ring is connected to the mixing tube head assembly The plurality of guide grooves are connected to the guide ring, the bottom ends of the front shell (3) and the rear shell (4) are provided with insertion components, and the front shell (3) and the rear shell (4) are respectively provided with sliding pusher components; the mixing tube head component comprises a fixed cover (6), a support block (8) and a double helical blade (9), the outer wall of the guide ring is respectively provided with a first thread, the bottom end of the fixed cover (6) is provided with a discharge pipe (7), the inner end of the fixed cover (6) is provided with a second thread, the fixed cover (6) is threadedly connected to the guide ring, the bottom end of the support block (8) is connected to the double helical blade (9), the top end of the support block (8) is provided with two groups of feed through holes, the top end of the support block (8) is tightly attached to the front shell (3) and the rear shell (4), the support block (8) is clamped with the guide ring, and the double helical blade (9) is inserted into the discharge pipe.

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