Condom containing prebiotics and used for adjusting female micro-ecological environment

Abstract

The invention relates to a condom containing prebiotics and used for adjusting the micro-ecological environment of women. The condom containing the prebiotics and used for adjusting the female micro-ecological environment comprises a condom body, wherein the outer surface of the condom body is coated with a coating containing the prebiotics and a hyaluronic acid liquid lubricant; the prebiotics are selected from one or more of fructo-oligosaccharide, galactooligosaccharide, inulin, lactulose, alpha-glucan oligosaccharide and the like; the mass percentage content of the prebiotics in the coating is 0.1%-5%; and the mass percentage of the lubricant is 5%-10%. The condom containing prebiotics and used for regulating the female micro-ecological environment has the characteristics of promoting micro-ecological balance, enhancing immunity, improving reproductive health and the like, can greatly prevent disease transmission, promote sexual health and improve life quality, and has a very wide development prospect.

Description

Technical Field

[0001] The invention relates to a condom containing prebiotics and used for regulating female microecological environment, belonging to the field of medicine and health. Background Art

[0002] In the field of women's health, the balance of vaginal microecology plays a vital role in preventing and treating a variety of gynecological diseases. The vaginal microecology system is composed of a variety of microorganisms, including beneficial bacteria such as lactobacilli, which together maintain the acid-base balance and self-cleaning function of the vagina. However, various factors in modern life, such as the abuse of antibiotics, unclean sexual life, and bad hygiene habits, may destroy the balance of vaginal microecology and lead to the occurrence of gynecological diseases such as bacterial vaginitis, candidal vaginitis, and trichomoniasis.

[0003] To address this problem, traditional treatment methods often focus on using antibiotics or antifungal drugs to kill pathogens, but this method often has problems such as large side effects and easy recurrence. Therefore, finding a safer, more effective and lasting solution has become an important topic in the medical and scientific research fields.

[0004] As a popular contraceptive tool, condoms play a key role in preventing sexually transmitted diseases and achieving contraception. However, the design of existing condoms mainly focuses on their basic functions, namely contraception and blocking sexually transmitted pathogens. Currently, most condoms on the market are made of natural rubber, and methyl silicone oil is generally used as a lubricant. Due to its non-volatile and water-insoluble properties, methyl silicone oil has poor affinity with human skin in actual use, and may give users a greasy feeling after use. Long-term use of condoms containing methyl silicone oil may cause the lubricant to enter the vaginal folds during friction, making it difficult to clean thoroughly. Long-term residue may weaken the body's natural defense mechanism, provide conditions for the growth of pathogens, and increase the risk of reproductive tract diseases in women.

[0005] Disadvantages of existing condoms include: Ignoring the impact of condoms on vaginal flora: Although condoms play an important role in contraception and prevention of sexually transmitted diseases, existing technologies often do not fully consider their impact on the balance of female vaginal flora. The normal flora in the female vagina is essential for maintaining reproductive health, and the use of condoms may disrupt this balance.

[0006] Condom pH does not match the vaginal environment: Under normal circumstances, the female vaginal environment is slightly acidic, with a pH slightly below neutral. However, the pH of existing condoms usually does not match this slightly acidic environment, which may cause the pH of vaginal secretions to increase during use, thereby disrupting the natural balance of vaginal flora and increasing the risk of female vaginitis.

[0007] Potential hazards of silicone oil lubricants: In order to improve the smoothness of use, existing condoms often add silicone oil as a lubricant. The use of silicone oil may not only disrupt the balance of vaginal flora, but also some silicone oil may remain in the vagina after each use. As the number of uses increases, these residual silicone oils may accumulate, negatively affecting the growth of normal flora in the vagina, causing the balance of flora to be disrupted, thereby increasing the risk of women suffering from vaginal inflammation.

[0008] The microecological environment of the female vagina constitutes a complex biological system, and its stability has a significant impact on female reproductive health. The disruption of the microecological balance may lead to the occurrence of a variety of gynecological diseases. However, the condoms currently on the market do not take into account the regulation of the microecological environment of the female reproductive system when designing, and fail to fully meet the needs of maintaining and promoting female reproductive health. Summary of the invention

[0009] In order to overcome the above technical problems existing in the prior art, the object of the present invention is to provide a condom containing prebiotics for regulating the female microecological environment.

[0010] The present invention provides a condom containing prebiotics for regulating female microecological environment, comprising: A condom body, wherein the outer surface of the condom body is coated with a coating containing prebiotics and a hyaluronic acid liquid lubricant; the prebiotics are selected from one or more of oligofructose, oligogalactose, inulin, lactulose, α-glucan oligosaccharide, etc.; the mass percentage of the prebiotics in the coating is 0.1% to 5%; the mass percentage of the lubricant is 5% to 10%.

[0011] The present invention aims to develop a new type of condom by introducing prebiotic ingredients, which can not only effectively prevent pregnancy and prevent sexually transmitted diseases, but also pay attention to and actively regulate the female vaginal microecological environment to reduce the health risks that may be caused by long-term use of traditional condoms, and provide women with more comprehensive and detailed reproductive health protection.

[0012] Preferably, the condom body further comprises prebiotic microcapsules and protein-based foamy colloid; the hyaluronic acid is selected from sodium hyaluronate; and the coating further comprises auxiliary materials that facilitate the attachment and stability of prebiotics, such as chitosan and gelatin.

[0013] Preferably, the method for preparing the condom body comprises: Rubber latex, antioxidants, preservatives and thickeners are mixed in a certain proportion, and then stirred and heated in a temperature-controlled container to fully blend the various ingredients to form a uniform raw material liquid; then a special glass or metal mold is used to slowly inject the raw material liquid into the mold, and the raw material liquid is evenly spread in the mold through a stretching and blowing process to form the initial shape of the condom, and then the condom is heated and cured in the mold, and finally the cured condom is peeled off the mold, and trimmed and finished to obtain the condom body.

[0014] Preferably, the preparation of the lubricant comprises: Dissolve hyaluronic acid in deionized water, add appropriate amount of auxiliary materials, and form a uniform hyaluronic acid lubricant solution through certain stirring.

[0015] Preferably, the preparation process of the condom in the ecological environment comprises at least one of the following features (1) to (3): Hyaluronic acid is selected from sodium hyaluronate, and the mass ratio of hyaluronic acid to deionized water is (0.5~1):10; The auxiliary material comprises at least one of xanthan gum, propylene glycol and glycerin, and the mass ratio of the auxiliary material to hyaluronic acid is (0.5-1):10; The stirring time is 30~60min, the temperature is 50~80℃, and the stirring speed is 400~700rpm.

[0016] Preferably, the preparation of the protein-based foamy glue comprises: With animal and plant proteins as the matrix, add appropriate amount of emulsifier and form a uniform protein-based foamy colloid through certain stirring.

[0017] Preferably, the condom of the ecological environment comprises at least one of the following features (1) to (4): The protein comprises at least one of whey protein or soy protein; The emulsifier includes at least one of isinglass, lecithin or glyceride; The mass ratio of emulsifier to protein is 1:(5~10); The stirring time is 20~40min, the temperature is 30~40℃, and the stirring speed is 400~700rpm.

[0018] Preferably, the preparation of the condom containing prebiotics for regulating the female microecological environment comprises: Prebiotic microcapsules, prebiotic coatings, lubricants, and protein-based foamy colloids are mixed in a certain proportion to prepare a mixed solution, and then the prepared condom body is put into the mixed solution after pretreatment such as cleaning and disinfection. The effective substances in the mixed solution are fully attached to the surface of the condom through an immersion method, and then the immersion-treated condoms are dried to prepare condoms containing prebiotics for regulating the female microecological environment.

[0019] Preferably, the preparation of the condom containing prebiotics for regulating the female microecological environment comprises at least one of the following features (1) to (3): The mass ratio of prebiotic microcapsules, prebiotic coating, lubricant, and protein-based foaming gel is: (1-2): (1-4): (1-3): (1-4); The immersion time is 20-40 minutes and the immersion temperature is 20-30°C. The drying temperature is: 40~50℃, and the drying time is 2~5h.

[0020] Further, the rubber latex includes at least one of natural rubber latex, polyisoprene latex or polyurethane latex; Further, the antioxidant includes at least one of α-tocopherol, butylated hydroxyanisole, butylated hydroxytoluene or dilauryl thiodipropionate; Further, the preservative includes at least one of sodium benzoate, potassium benzoate, sodium propionate or methyl paraben; Further, the thickener includes at least one of polyethylene glycol (PEG), hydroxypropyl methylcellulose or silicone oil; Further, the mass ratio of rubber latex, antioxidant, preservative and thickener is (85~92):1:1:(7~13); Further, the raw material mixing temperature is 20-25°C, the mixing processing temperature is 60-100°C, the stretch blow molding temperature is 120-150°C, and the drying temperature is 60-80°C; Furthermore, the raw material preheating time is 15 to 30 minutes, the mixing time is 45 to 90 minutes, the molding time is 1 to 2 hours, and the drying time is 2 to 4 hours.

[0021] Preferably, the preparation method of the prebiotic microcapsules comprises: Prebiotic powder is mixed with an appropriate amount of deionized water to form a uniform prebiotic solution, and the prebiotic solution is filtered or centrifuged to remove insoluble matter or impurities; the prebiotic solution and the wall material solution are mixed with the wall material solution through the emulsification cross-linking microcapsule preparation technology to form an oil-in-water (W / O) or water-in-oil (O / W) emulsion, and a cross-linking agent is added under stirring conditions to cause the wall material to undergo a cross-linking reaction to form prebiotic microcapsules, and the formed prebiotic microcapsules are separated by centrifugation, filtration, etc., and then the microcapsules are placed in a low-temperature drying oven for drying to remove residual moisture to obtain prebiotic microcapsules.

[0022] Further, the prebiotic powder includes at least one of isomaltooligosaccharide, galacto-oligosaccharide, fructo-oligosaccharide, inulin, lactulose, and α-glucan oligosaccharide; Furthermore, the mass ratio of prebiotic powder to deionized water is: 1:(5-10); Furthermore, the mass ratio of the prebiotic solution to the wall material solution is: 1:(1-4); Furthermore, the reaction temperature of the emulsification cross-linking reaction is: 40~65°C; the pH value is 5.5~7; the stirring speed is 900~1300 rpm; Further, the cross-linking agent includes at least one of glutaraldehyde, genipin or calcium chloride; Furthermore, the mass ratio of the cross-linking agent to the prebiotic solution is: 1:(4~8).

[0023] Furthermore, the drying temperature is 1~10°C and the drying time is 1~4h.

[0024] Preferably, the method for preparing the wall material solution comprises: The selected wall material is mixed with an appropriate amount of deionized water, and auxiliary materials such as emulsifiers and stabilizers are added to improve the performance of the wall material solution. The wall material solution is prepared by stirring or heating to fully dissolve the wall material.

[0025] Further, the wall material includes at least one of chitosan, sodium alginate, soy protein isolate, sodium carboxymethyl cellulose, gum arabic or ethyl cellulose; Furthermore, the mass ratio of the wall material to the deionized water is: 1:(5~10); Further, the emulsifier includes at least one of Tween 80, lecithin or glyceryl monostearate; Further, the stabilizer is at least one of xanthan gum, carrageenan or sodium carboxymethyl cellulose; Furthermore, the dissolution temperature is 40-70°C, the stirring rate is 500-800 rpm, and the dissolution time is 30-60 min.

[0026] Preferably, the preparation method of the prebiotic coating material comprises: Dissolve the prebiotics in a suitable solvent, add suitable auxiliary materials and stir continuously to form a uniform prebiotic coating material.

[0027] Further, the prebiotics include at least one of fructooligosaccharides, galacto-oligosaccharides, inulin, lactulose, α-glucan oligosaccharides, etc.; Further, the solvent includes at least one of deionized water or ethanol; Furthermore, the mass content of prebiotics in the prebiotic coating material is 0.1% to 5%; Furthermore, the auxiliary material is at least one of chitosan or gelatin, and its mass ratio to the prebiotic coating is 0.1-0.5%.

[0028] Preferably, the preparation method of the lubricant comprises: Dissolve hyaluronic acid in deionized water, add appropriate amount of auxiliary materials, and form a uniform hyaluronic acid lubricant solution through certain stirring.

[0029] Furthermore, hyaluronic acid is selected from sodium hyaluronate, and the mass ratio of hyaluronic acid to deionized water is (0.5~1):10; Furthermore, the auxiliary material comprises at least one of xanthan gum, propylene glycol and glycerin, and the mass ratio of the auxiliary material to hyaluronic acid is (0.5-1):10; Furthermore, the stirring time is 30-60 min, the temperature is 50-80° C., and the stirring speed is 400-700 rpm.

[0030] Preferably, the method for preparing the protein-based foamy glue comprises: With animal and plant proteins as the matrix, add appropriate amount of emulsifier and form a uniform protein-based foamy colloid through certain stirring.

[0031] Further, the protein includes at least one of whey protein or soy protein; Further, the emulsifier includes at least one of isinglass, lecithin or glyceride; Furthermore, the mass ratio of emulsifier to protein is 1:(5-10); Furthermore, the stirring time is 20-40 min, the temperature is 30-40° C., and the stirring speed is 400-700 rpm.

[0032] Preferably, the preparation method of the condom containing prebiotics for regulating the female microecological environment comprises: Prebiotic microcapsules, prebiotic coatings, lubricants, and protein-based foamy colloids are mixed in a certain proportion to prepare a mixed solution, and then the prepared condom body is put into the mixed solution after pretreatment such as cleaning and disinfection. The effective substances in the mixed solution are fully attached to the surface of the condom through an immersion method, and then the immersion-treated condoms are dried to prepare condoms containing prebiotics for regulating the female microecological environment.

[0033] Furthermore, the mass ratio of the prebiotic microcapsules, the prebiotic coating, the lubricant, and the protein-based foamy gel is: (1-2): (1-4): (1-3): (1-4); Furthermore, the immersion time is 20-40 minutes, and the immersion temperature is 20-30°C; Furthermore, the drying temperature is 40-50°C, and the drying time is 2-5h.

[0034] The condom containing prebiotics for regulating the female microecological environment prepared by the present invention has the characteristics of promoting microecological balance, enhancing immunity, improving reproductive health, etc. It can greatly prevent the spread of diseases, promote sexual health, and improve the quality of life, and has a very broad development prospect.

[0035] In summary, the beneficial effects of the present invention are: 1. In this method, the condom of the present invention incorporates prebiotic coating technology in its design. The coating can gradually release prebiotic ingredients into the female vagina during use, effectively promoting the growth and reproduction of beneficial bacteria in the vagina, while inhibiting the colonization and proliferation of harmful bacteria. This mechanism helps to restore and maintain the balance of vaginal microecology, providing important support for female reproductive health; prebiotics are selected from natural plant extracts such as isomaltooligosaccharides, galacto-oligosaccharides, and fructooligosaccharides. These ingredients are safe and harmless, and can effectively promote the proliferation of beneficial bacteria in the vagina, such as lactobacillus, thereby maintaining the balance of vaginal microecology; 2. In this method, the preparation of prebiotic microcapsules adopts advanced microcapsule technology to encapsulate prebiotics in tiny capsules to achieve their stability and sustained release effect. This technology can protect prebiotics from the influence of the external environment and gradually release them during use, thereby playing its role in regulating vaginal microecology; 3. In this method, during the preparation of prebiotic microcapsules, the wall material solution can ensure the stability and sustained release effect of the microcapsules. Commonly used wall material solutions include natural polymer materials such as sodium alginate and chitosan. These materials have good biocompatibility and degradability, and can ensure the safety and effectiveness of the microcapsules in the body; 4. Scientific design of pH matching: The condom of the present invention is specially designed with a weakly acidic contact surface that matches the natural pH value of the female vagina. This design avoids interference with the normal pH value of the female vagina, helps maintain the natural stability of the vaginal environment, thereby preventing and reducing the occurrence of gynecological inflammation and improving the overall level of female reproductive health; 5. Multifunctionality of hyaluronic acid lubricant: The condom of the present invention innovatively adds hyaluronic acid to the lubricant. Hyaluronic acid not only has a good lubricating effect, reduces friction during use, and improves comfort, but can also be naturally absorbed by the human body, regulating and moisturizing the dry female vagina, further optimizing the condom usage experience, and at the same time having a positive impact on female reproductive health; 6. In this method, a special lubricant is added to the condom to improve the comfort of use and reduce friction. In this product, the lubricant not only has good lubrication properties, but also has a synergistic effect with prebiotics to promote the attachment and diffusion of prebiotics on the vaginal mucosa. In addition, the lubricant also uses a water-based formula, which is easy to clean and non-greasy, improving the user experience; 7. The condoms containing prebiotics for regulating the female microecological environment prepared by this method show unique advantages and functions in terms of material use, preparation process and performance. Through the supplementation and regulation of prebiotics, this product effectively maintains the balance of vaginal microecology and prevents and treats a variety of gynecological diseases. At the same time, the protein-based foaming colloid, prebiotic microcapsule technology, special coating and lubricant formula adopted by it also improve the safety and comfort of the product, providing users with a better user experience. Through the above-mentioned innovative design, the condoms of the present invention not only meet the basic functions of traditional condoms, but also show significant advantages in protecting women's reproductive health and maintaining the balance of vaginal microecology, providing women with a safer, healthier and more comfortable contraceptive option; 8. During the use of the condom of the present invention, the prebiotics in the coating can be released into the female vagina, promoting the growth and reproduction of beneficial bacteria, inhibiting the colonization and growth of harmful bacteria, thereby regulating the vaginal microecological balance; during the use of the condom of the present invention, the side in contact with the female is weakly acidic, maintaining the normal vaginal pH value of the female, thereby helping to prevent and reduce the occurrence of gynecological inflammation and improve the reproductive health level of the female. The hyaluronic acid added to the lubricant of the condom of the present invention not only plays a lubricating role, but can also be naturally absorbed by the human body. It also has a regulating effect on dry female vaginas. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 The present invention is a preparation flow chart of a condom containing prebiotics for regulating the female microecological environment. DETAILED DESCRIPTION

[0037] To make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0038] The present invention provides a preparation process of a condom containing prebiotics for regulating the female microecological environment, which specifically comprises the following steps: Step (1) Preparation of condom body S11: mixing polyisoprene emulsion, α-tocopherol, methyl paraben, polyethylene glycol, etc. in a certain proportion; S12 In a temperature-controlled container, various ingredients are fully blended by stirring and heating to form a uniform raw material liquid; S13 uses a special glass or metal mold to slowly inject the raw material liquid into the mold, and through the stretching and blowing process, the raw material liquid is evenly spread in the mold to form the initial shape of the condom, and then the condom is heated and cured in the mold. Finally, the cured condom is peeled off the mold, and trimmed and finished to obtain the condom body.

[0039] Preferably, the preparation of the condom body in step (1) comprises the following steps: S11: mixing polyisoprene emulsion, α-tocopherol, methyl parahydroxybenzoate and polyethylene glycol in a ratio of (85-92):1:1:(7-13), with the raw material mixing temperature at 20-25°C; S12: in a temperature-controlled container, stirring and heating to fully blend the various ingredients to form a uniform raw material liquid, with the mixing processing temperature at 60-100°C, the raw material preheating time at 15-30 minutes, and the mixing time at 45- 90min; S13 then uses a special glass or metal mold to slowly inject the raw material liquid into the mold, and through the stretching and blowing process, the raw material liquid is evenly spread in the mold to form the initial shape of the condom, and then the condom is heated and cured in the mold, and finally the cured condom is peeled off from the mold, and trimmed and finished to obtain the condom body, stretching and blowing molding temperature: 120~150℃, drying temperature: 60~80℃, molding time: 1~2h, drying time: 2~4h.

[0040] In this method, the polyisoprene used is a synthetic rubber known for its high elasticity. Using polyisoprene emulsion as a raw material in condom manufacturing can significantly improve the elasticity and tensile properties of condoms, providing users with better wrapping and adaptability; polyisoprene has good acid and alkali corrosion resistance, which means that the condom body can resist the acid and alkali components in body fluids (such as vaginal secretions, semen, etc.) to a certain extent, and maintain the stability and integrity of its structure; α-tocopherol (vitamin E) is a powerful antioxidant, which can effectively prevent material aging and extend the service life of condoms. Adding α-tocopherol to the condom body can enhance its antioxidant capacity and reduce the performance degradation caused by oxidation; methyl paraben is a commonly used preservative with a broad-spectrum antibacterial effect. Adding it to the condom body can inhibit the growth of bacteria and molds and improve the hygienic safety of the product.

[0041] Step (2) Preparation of prebiotic microcapsules S21 uses prebiotic powder and an appropriate amount of deionized water to mix to form a uniform prebiotic solution, and filters or centrifuges the prebiotic solution to remove insoluble matter or impurities; S22: mixing the selected wall material with an appropriate amount of deionized water, adding auxiliary materials such as an emulsifier and a stabilizer to improve the performance of the wall material solution, and fully dissolving the wall material by stirring or heating to prepare a wall material solution; S23 uses the emulsion cross-linking method to prepare microcapsules. The prebiotic solution and the wall material solution are mixed to form a water-in-oil (W / O) or oil-in-water (O / W) emulsion. Under stirring conditions, a cross-linking agent is added to cause the wall material to undergo a cross-linking reaction to form prebiotic microcapsules. The formed prebiotic microcapsules are separated by centrifugation, filtration, etc., and then the microcapsules are placed in a low-temperature drying oven for drying to remove residual moisture to obtain prebiotic microcapsules.

[0042] Preferably, the preparation of prebiotic microcapsules in step (2) comprises the following steps: S21: mixing 5-8 g of isomaltooligosaccharide and 5-8 g of galacto-oligosaccharide with 50-80 mL of deionized water to form a uniform prebiotic solution, filtering or centrifuging the prebiotic solution to remove insoluble matter or impurities; S22: mixing 10-14 g of sodium alginate with 50-80 mL of deionized water, adding auxiliary materials such as 1-4 g of Tween 80 and 1-4 g of sodium carboxymethyl cellulose, and fully dissolving them by stirring or heating to prepare a wall material solution, wherein the dissolution temperature is 40-70° C. and the stirring rate is 500-800 rpm. The dissolution time is 30~60min; S23 mixes 10~14mL of prebiotic solution and 20~28mL of wall material solution by adopting emulsion cross-linking microcapsule preparation technology, and adds 1~2g of glutaraldehyde under stirring conditions to make the wall material undergo cross-linking reaction to form prebiotic microcapsules. The formed prebiotic microcapsules are separated by centrifugation, filtration, etc., and then the microcapsules are placed in a low-temperature drying oven for drying to remove residual moisture to obtain prebiotic microcapsules. The reaction temperature of the emulsification cross-linking reaction is: 40~65℃; the pH value is 5.5~7; the stirring speed is 900~1300 rpm, the drying temperature is 1~10℃, and the drying time is 1~4h.

[0043] In this method, the prebiotic microcapsules prepared by the emulsification cross-linking microcapsule preparation technology can effectively protect prebiotic components such as oligosaccharides and oligosaccharides, and prevent them from being destroyed during the preparation and use process, thereby maintaining their biological activity and effectiveness; through microencapsulation, prebiotics can be more stably present in condoms, and gradually released into the female reproductive tract during use, increasing their concentration and residence time in the target site, thereby increasing the proliferation opportunities of probiotics and improving the utilization rate of prebiotics; sodium alginate, as a wall material raw material, has good film-forming properties and stability, and can protect prebiotic microcapsules from the influence of the external environment. At the same time, the addition of Tween 80 and sodium carboxymethyl cellulose further enhances the emulsification effect and stability of the wall material solution, making the preparation process of the microcapsules smoother and the quality of the finished product more reliable; the emulsification cross-linking microcapsule preparation technology can achieve the controlled release of prebiotics, so that they are gradually released in the female reproductive tract to continuously promote the growth and reproduction of probiotics, thereby more effectively regulating the microecological environment.

[0044] Step (3) Preparation of prebiotic coating material Dissolve the prebiotics in a suitable solvent, add suitable auxiliary materials and stir continuously to form a uniform prebiotic coating material.

[0045] Preferably, the preparation of the prebiotic coating material in step (3) comprises dissolving 4-8 g of α-glucan oligosaccharide or galacto-oligosaccharide in 70-140 mL of deionized water, adding 0.5-0.8 g of chitosan or gelatin and continuously stirring to form a uniform prebiotic coating material.

[0046] In this method, the α-glucan oligosaccharide and galacto-oligosaccharide used in the prepared condom prebiotic coating material are substances with prebiotic properties, which can promote the growth and reproduction of beneficial bacteria (such as lactic acid bacteria) in the female reproductive tract; these beneficial bacteria play a key role in maintaining the microecological balance of the reproductive tract; the auxiliary material chitosan and its derivatives have antibacterial properties and can inhibit the growth of a variety of harmful microorganisms, including bacteria, fungi, etc. This antibacterial effect helps to reduce the risk of reproductive tract infection; the prebiotic coating may also have a lubricating effect, which can improve the comfort of the condom and reduce discomfort during use.

[0047] Step (4) Preparation of lubricant Dissolve hyaluronic acid in deionized water, add appropriate amount of auxiliary materials, and form a uniform hyaluronic acid lubricant solution through certain stirring.

[0048] Preferably, the lubricant preparation step of step (4) comprises dissolving 3-8 g of sodium hyaluronate in 8-16 mL of deionized water, adding 0.05-0.1 g of xanthan gum, and forming a uniform hyaluronic acid lubricant solution by stirring for 30-60 min, at a temperature of 50-80° C., and at a stirring speed of 400-700 rpm.

[0049] In this method, sodium hyaluronate is used as the main cost of the lubricant. It is a powerful moisturizing factor that can absorb and lock a large amount of water, forming a moisturizing film, and effectively maintaining the moisture of the reproductive tract mucosa. At the same time, xanthan gum, as a thickener and stabilizer, can enhance the viscosity and stability of the lubricant and further enhance the lubrication effect. This moisturizing and lubricating effect helps reduce discomfort during sex and improves the comfort of sex.

[0050] Step (5) Preparation of protein-based foamy glue With animal and plant proteins as the matrix, add appropriate amount of emulsifier and form a uniform protein-based foamy colloid through certain stirring.

[0051] Preferably, the preparation step of the protein-based foamy colloid in step (5) comprises using 4-10 g of whey protein as a matrix, adding 1-4 g of lecithin, stirring at a temperature of 30-40° C. and a stirring speed of 400-700 rpm for 20-40 min to form a uniform protein-based foamy colloid.

[0052] In this method, the protein-based foamed gel prepared can effectively regulate the microecological environment together with the beneficial probiotics, promote the growth and reproduction of beneficial bacteria, and inhibit the activity of harmful bacteria, thereby helping to maintain the healthy state of the female reproductive tract; whey protein is a protein with high biological value and good film-forming and coating properties. It can form a stable and dense film to effectively protect the adhesion and stability of the prebiotic ingredients on the surface of the condom; lecithin, as a natural emulsifier and stabilizer, can further enhance the stability and uniformity of the coating.

[0053] Step (6) Preparation of a condom containing prebiotics for regulating the female microecological environment S61: mixing the prebiotic microcapsules, the prebiotic coating, the lubricant, and the protein-based foamy gel in a certain proportion to prepare a mixed solution; S62: The prepared condom body is put into the mixed solution after pretreatment such as cleaning and disinfection; the effective substances in the mixed solution are fully attached to the surface of the condom by the immersion method, and then the immersion-treated condom is dried to prepare a condom containing prebiotics for regulating the female microecological environment.

[0054] Preferably, the preparation step of the condom containing prebiotics for regulating the female microecological environment in step (6) comprises: S61 mixing prebiotic microcapsules, prebiotic coatings, lubricants, and protein-based foaming colloids in a ratio of (1-2): (1-4): (1-3): (1-4) to prepare a mixed solution; S62 placing the prepared condom body into the mixed solution after pretreatment such as cleaning and disinfection; making the surface of the condom fully adhere to the effective substances in the mixed solution by an immersion method, and then drying the immersion-treated condom to prepare a condom containing prebiotics for regulating the female microecological environment, wherein the immersion time is 20-40 min, the immersion temperature is 20-30° C., the drying temperature is 40-50° C., and the drying time is 2-5 h.

[0055] In this method, a prebiotic microcapsule, a prebiotic coating, a lubricant, and a protein-based foamy colloid are used to prepare a mixed solution, and a condom containing prebiotics for regulating the female microecological environment is prepared by combining the condom body with the impregnation method; the condom integrates the advantages of prebiotics regulating the microecological environment, lubricants improving lubricity, and protein-based foamy colloids improving comfort and safety, making its comprehensive performance more excellent. By optimizing the performance of condoms in terms of lubricity, comfort and safety, the condom can significantly improve the user's experience during use. This is of great significance for improving user satisfaction and loyalty. The addition of prebiotic ingredients enables the condom to have the function of regulating the female microecological environment while preventing contraception. This has a positive effect on maintaining female reproductive tract health and preventing gynecological diseases.

[0056] Preparation of a coating solution containing prebiotics: dissolving the selected prebiotics (inulin, α-glucan oligosaccharide) and an appropriate amount of chitosan in deionized water, stirring evenly, and preparing a coating solution with a prebiotic content of 2% (mass percentage).

[0057] Treatment of condoms: After pretreatment such as cleaning and disinfection, the condom body is immersed in the above-mentioned coating solution by dipping method and left for a certain period of time so that the inner surface of the condom is fully adhered to the coating solution.

[0058] Drying: Dry the treated condoms to remove excess moisture and allow the coating to stably adhere to the inner surface of the condom.

[0059] Application Example 1: Inulin and α-glucan oligosaccharide were used as prebiotics to prepare condoms according to the above method. 100 volunteers were selected for trial use. After a period of use, the changes in vaginal flora were detected, and it was found that the number of beneficial bacteria increased significantly, the number of harmful bacteria decreased, and the users did not experience adverse reactions. At the same time, after having sex, the vagina of women with dry vagina became more moisturized and their sex life became more enjoyable.

[0060] Application Example 2: Galacto-oligosaccharide was selected as a prebiotic, and the above experimental process was repeated to obtain similar results, which further verified the effectiveness and safety of the present invention.

[0061] Example 1 The present invention provides a preparation process of a condom containing prebiotics for regulating the female microecological environment, which specifically comprises the following steps: Step (1) Preparation of condom body S11: polyisoprene emulsion, α-tocopherol, methyl paraben and polyethylene glycol are mixed in a ratio of 85:1:1:7, and the raw material mixing temperature is 20°C; S12 is in a temperature-controlled container, through stirring and heating, the various ingredients are fully integrated to form a uniform raw material liquid, the mixing processing temperature is: 60°C, the raw material preheating time is: 15min, and the mixing time is: 45min; S13 then uses a special glass or metal mold to slowly inject the raw material liquid into the mold, and through the stretching and blowing process, the raw material liquid is evenly spread in the mold to form the initial shape of the condom, and then the condom is heated and cured in the mold, and finally the cured condom is peeled off from the mold, and trimmed and finished to obtain the condom body, the stretching and blowing molding temperature is: 120° C., the drying temperature is: 60° C., the molding time is: 1 hour, and the drying time is: 2 hours; Step (2) Preparation of prebiotic microcapsules S21: 5 g of isomaltooligosaccharide and 5 g of galacto-oligosaccharide were mixed with 50 mL of deionized water to form a uniform prebiotic solution, and the prebiotic solution was filtered or centrifuged to remove insoluble matter or impurities; S22: 10 g of sodium alginate was mixed with 50 mL of deionized water, and auxiliary materials such as 1 g of Tween 80 and 1 g of sodium carboxymethyl cellulose were added, and the wall material solution was prepared by stirring or heating to fully dissolve the mixture. The dissolution temperature was 40 ° C, the stirring rate was 500 rpm, and the dissolution time was 30 min. S23 10mL of prebiotic solution and 20mL of wall material solution were mixed by emulsification cross-linking microcapsule preparation technology, and 1g of glutaraldehyde was added under stirring conditions to make the wall material undergo cross-linking reaction to form prebiotic microcapsules. The formed prebiotic microcapsules were separated by centrifugation, filtration, etc., and then the microcapsules were placed in a low-temperature drying oven for drying to remove residual moisture to obtain prebiotic microcapsules. The reaction temperature of the emulsification cross-linking reaction was 40°C; the pH value was 5.5; the stirring speed was 900 rpm, the drying temperature was 1°C, and the drying time was 1h; Step (3) Preparation of prebiotic coating material Dissolve 5 g of α-glucan oligosaccharide in 100 mL of deionized water, add 0.5 g of chitosan and stir continuously to form a uniform prebiotic coating material; Step (4) Preparation of lubricant Dissolve 5 g of sodium hyaluronate in 10 mL of deionized water, add 0.05 g of xanthan gum, and stir to form a uniform hyaluronic acid lubricant solution. The stirring time is 30 min, the temperature is 50 ° C, and the stirring speed is 400 rpm; Step (5) Preparation of protein-based foamy glue Using 4 g of whey protein as the matrix, adding 1 g of lecithin, stirring at 30°C and 400 rpm for 20 min to form a uniform protein-based foamy gel; Step (6) Preparation of a condom containing prebiotics for regulating the female microecological environment S61: 1 g of prebiotic microcapsules, 3 g of prebiotic coating, 2 g of lubricant, and 1 g of protein-based foamy gel to prepare a mixed solution; S62: The prepared condom body is put into the mixed solution after being pre-treated by cleaning and disinfection; the effective substances in the mixed solution are fully adhered to the surface of the condom by the immersion method, and then the immersion-treated condom is dried to prepare a condom containing prebiotics for regulating the female microecological environment, the immersion time is 20 minutes, the immersion temperature is 20°C, the drying temperature is 40°C, and the drying time is 2 hours.

[0062] Example 2 Step (1) Preparation of condom body S11: polyisoprene emulsion, α-tocopherol, methyl paraben and polyethylene glycol are mixed in a ratio of 89:1:1:9, and the raw material mixing temperature is 24°C; S12 is in a temperature-controlled container, through stirring and heating, the various ingredients are fully integrated to form a uniform raw material liquid, the mixing processing temperature is: 80℃, the raw material preheating time is: 25min, and the mixing time is: 75min; S13 then uses a special glass or metal mold to slowly inject the raw material liquid into the mold, and through the stretching and blowing process, the raw material liquid is evenly spread in the mold to form the initial shape of the condom, and then the condom is heated and cured in the mold, and finally the cured condom is peeled off from the mold, and trimmed and finished to obtain the condom body, the stretching and blowing molding temperature is: 140° C., the drying temperature is: 70° C., the molding time is: 1.6 hours, and the drying time is: 3 hours; Step (2) Preparation of prebiotic microcapsules S21: 7 g of isomaltooligosaccharide and 7 g of galacto-oligosaccharide were mixed with 70 mL of deionized water to form a uniform prebiotic solution, and the prebiotic solution was filtered or centrifuged to remove insoluble matter or impurities; S22: 13 g of sodium alginate is mixed with 70 mL of deionized water, and auxiliary materials such as 3 g of Tween 80 and 3 g of sodium carboxymethyl cellulose are added, and the wall material solution is prepared by stirring or heating to fully dissolve the mixture, and the dissolution temperature is 60 ° C, the stirring rate is 700 rpm, and the dissolution time is 50 min; S23 13mL of prebiotic solution and 26mL of wall material solution were mixed by emulsification cross-linking microcapsule preparation technology, and 1.6g of glutaraldehyde was added under stirring conditions to make the wall material undergo cross-linking reaction to form prebiotic microcapsules. The formed prebiotic microcapsules were separated by centrifugation, filtration, etc., and then the microcapsules were placed in a low-temperature drying oven for drying to remove residual moisture to obtain prebiotic microcapsules. The reaction temperature of the emulsification cross-linking reaction was 55°C; the pH value was 6.5; the stirring speed was 1200 rpm, the drying temperature was 6°C, and the drying time was 3h; Step (3) Preparation of prebiotic coating material 3 g of α-glucan oligosaccharide and 3 g of inulin were dissolved in 130 mL of deionized water, and 0.7 g of chitosan was added and stirred continuously to form a uniform prebiotic coating material; Step (4) Preparation of lubricant Dissolve 5 g of sodium hyaluronate in 12 mL of deionized water, add 0.08 g of xanthan gum, and stir to form a uniform hyaluronic acid lubricant solution. The stirring time is 50 min, the temperature is 70°C, and the stirring speed is 600 rpm. Step (5) Preparation of protein-based foamy glue Using 8g of whey protein as the matrix, adding 3g of lecithin, stirring at a temperature of 36°C and a stirring speed of 600rpm for 35min, a uniform protein-based foamy gel was formed; Step (6) Preparation of a condom containing prebiotics for regulating the female microecological environment S61: 2 g of prebiotic microcapsules, 3 g of prebiotic coating, 2 g of lubricant, and 2 g of protein-based foamy gel to prepare a mixed solution; S62: The prepared condom body is put into the mixed solution after pretreatment such as cleaning and disinfection; the effective substances in the mixed solution are fully attached to the surface of the condom by the immersion method, and then the immersion-treated condom is dried to prepare a condom containing prebiotics for regulating the female microecological environment, the immersion time is 35 minutes, the immersion temperature is 26°C, the drying temperature is 46°C, and the drying time is 4 hours.

[0063] Example 3 Step (1) Preparation of condom body S11: polyisoprene emulsion, α-tocopherol, methyl paraben and polyethylene glycol are mixed in a ratio of 89:1:1:9, and the raw material mixing temperature is 24°C; S12 is in a temperature-controlled container, through stirring and heating, the various ingredients are fully integrated to form a uniform raw material liquid, the mixing processing temperature is: 80℃, the raw material preheating time is: 25min, and the mixing time is: 75min; S13 then uses a special glass or metal mold to slowly inject the raw material liquid into the mold, and through the stretching and blowing process, the raw material liquid is evenly spread in the mold to form the initial shape of the condom, and then the condom is heated and cured in the mold, and finally the cured condom is peeled off from the mold, and trimmed and finished to obtain the condom body, the stretching and blowing molding temperature is: 140° C., the drying temperature is: 70° C., the molding time is: 1.6 hours, and the drying time is: 3 hours; Step (2) Preparation of prebiotic microcapsules S21: 7 g of isomaltooligosaccharide and 7 g of galacto-oligosaccharide were mixed with 70 mL of deionized water to form a uniform prebiotic solution, and the prebiotic solution was filtered or centrifuged to remove insoluble matter or impurities; S22: 13 g of sodium alginate is mixed with 70 mL of deionized water, and auxiliary materials such as 3 g of Tween 80 and 3 g of sodium carboxymethyl cellulose are added, and the wall material solution is prepared by stirring or heating to fully dissolve the mixture, and the dissolution temperature is 60 ° C, the stirring rate is 700 rpm, and the dissolution time is 50 min; S23 13mL of prebiotic solution and 26mL of wall material solution were mixed by emulsification cross-linking microcapsule preparation technology, and 1.6g of glutaraldehyde was added under stirring conditions to make the wall material undergo cross-linking reaction to form prebiotic microcapsules. The formed prebiotic microcapsules were separated by centrifugation, filtration, etc., and then the microcapsules were placed in a low-temperature drying oven for drying to remove residual moisture to obtain prebiotic microcapsules. The reaction temperature of the emulsification cross-linking reaction was 55°C; the pH value was 6.5; the stirring speed was 1200 rpm, the drying temperature was 6°C, and the drying time was 3h; Step (3) Preparation of prebiotic coating material Dissolve 6 g of galacto-oligosaccharide in 130 mL of deionized water, add 0.7 g of gelatin and stir continuously to form a uniform prebiotic coating material; Step (4) Preparation of lubricant Dissolve 6 g of sodium hyaluronate in 16 mL of deionized water, add 0.08 g of xanthan gum, and form a uniform hyaluronic acid lubricant solution by stirring for 50 min at a temperature of 70°C and a stirring speed of 600 rpm; Step (5) Preparation of protein-based foamy glue Using 8g of whey protein as the matrix, adding 3g of lecithin, stirring at a temperature of 36°C and a stirring speed of 600rpm for 35min, a uniform protein-based foamy gel was formed; Step (6) Preparation of a condom containing prebiotics for regulating the female microecological environment S61: 2 g of prebiotic microcapsules, 3 g of prebiotic coating, 2 g of lubricant, and 2 g of protein-based foamy gel to prepare a mixed solution; S62: The prepared condom body is put into the mixed solution after pretreatment such as cleaning and disinfection; the effective substances in the mixed solution are fully attached to the surface of the condom by the immersion method, and then the immersion-treated condom is dried to prepare a condom containing prebiotics for regulating the female microecological environment, the immersion time is 35 minutes, the immersion temperature is 26°C, the drying temperature is 46°C, and the drying time is 4 hours.

[0064] Example 4 Step (1) Preparation of condom body S11: polyisoprene emulsion, α-tocopherol, methyl parahydroxybenzoate and polyethylene glycol are mixed in a ratio of 92:1:1:13, and the raw material mixing temperature is 25°C; S12 In a temperature-controlled container, various ingredients are fully integrated by stirring and heating to form a uniform raw material liquid. The mixing processing temperature is 100°C, the raw material preheating time is 30 minutes, and the mixing time is 90 minutes. S13 then uses a special glass or metal mold to slowly inject the raw material liquid into the mold, and through the stretching and blowing process, the raw material liquid is evenly spread in the mold to form the initial shape of the condom, and then the condom is heated and cured in the mold, and finally the cured condom is peeled off from the mold, and trimmed and finished to obtain the condom body, the stretching and blowing molding temperature is: 150° C., the drying temperature is: 80° C., the molding time is 2 hours, and the drying time is: 4 hours; Step (2) Preparation of prebiotic microcapsules S21: 8 g of isomaltooligosaccharide and 8 g of galacto-oligosaccharide were mixed with 80 mL of deionized water to form a uniform prebiotic solution, and the prebiotic solution was filtered or centrifuged to remove insoluble matter or impurities; S22: 14 g of sodium alginate is mixed with 80 mL of deionized water, and auxiliary materials such as 4 g of Tween 80 and 4 g of sodium carboxymethyl cellulose are added, and the wall material solution is prepared by stirring or heating to fully dissolve the mixture, and the dissolution temperature is 70° C., the stirring rate is 800 rpm, and the dissolution time is 60 min. S23 14 mL of prebiotic solution and 28 mL of wall material solution were mixed by emulsification cross-linking microcapsule preparation technology, and 2 g of glutaraldehyde was added under stirring conditions to make the wall material undergo cross-linking reaction to form prebiotic microcapsules. The formed prebiotic microcapsules were separated by centrifugation, filtration, etc., and then the microcapsules were placed in a low-temperature drying oven for drying to remove residual moisture to obtain prebiotic microcapsules. The reaction temperature of the emulsification cross-linking reaction was 65°C; the pH value was 7; the stirring speed was 1300 rpm, the drying temperature was 10°C, and the drying time was 4h; Step (3) Preparation of prebiotic coating material 3 g of galacto-oligosaccharide and 3 g of α-glucan oligosaccharide were dissolved in 80 mL of deionized water, and 0.4 g of chitosan and 0.4 g of gelatin were added and stirred continuously to form a uniform prebiotic coating material; Step (4) Preparation of lubricant Dissolve 5 g of sodium hyaluronate in 16 mL of deionized water, add 0.1 g of xanthan gum, and form a uniform hyaluronic acid lubricant solution by stirring for 60 min at a temperature of 80 ° C and a stirring speed of 700 rpm; Step (5) Preparation of protein-based foamy glue Using 10g of whey protein as the matrix, adding 4g of lecithin, stirring at a temperature of 40°C and a stirring speed of 700rpm for 40min, a uniform protein-based foamy gel was formed; Step (6) Preparation of a condom containing prebiotics for regulating the female microecological environment S61: 2 g of prebiotic microcapsules, 3 g of prebiotic coating, 3 g of lubricant, and 2 g of protein-based foamy gel to prepare a mixed solution; S62: The prepared condom body is put into the mixed solution after pretreatment such as cleaning and disinfection; the effective substances in the mixed solution are fully attached to the surface of the condom by the immersion method, and then the immersion-treated condom is dried to prepare a condom containing prebiotics for regulating the female microecological environment, the immersion time is 40 minutes, the immersion temperature is 30°C, the drying temperature is 50°C, and the drying time is 5 hours.

[0065] Comparative Example 1 Step (1) Preparation of condom body S11: polyisoprene emulsion, methyl paraben and polyethylene glycol are mixed in a ratio of 85:1:7, and the raw material mixing temperature is 20°C; S12 is in a temperature-controlled container, through stirring and heating, the various ingredients are fully integrated to form a uniform raw material liquid, the mixing processing temperature is: 60°C, the raw material preheating time is: 15min, and the mixing time is: 45min; S13 then uses a special glass or metal mold to slowly inject the raw material liquid into the mold, and through the stretching and blowing process, the raw material liquid is evenly spread in the mold to form the initial shape of the condom, and then the condom is heated and cured in the mold, and finally the cured condom is peeled off from the mold, and trimmed and finished to obtain the condom body, the stretching and blowing molding temperature is: 120° C., the drying temperature is: 60° C., the molding time is: 1 hour, and the drying time is: 2 hours; Step (2) Preparation of prebiotic microcapsules S21: 5 g of isomaltooligosaccharide and 5 g of galacto-oligosaccharide were mixed with 50 mL of deionized water to form a uniform prebiotic solution, and the prebiotic solution was filtered or centrifuged to remove insoluble matter or impurities; S22: 10 g of sodium alginate is mixed with 50 mL of deionized water, and the mixture is fully dissolved by stirring or heating to prepare a wall material solution, wherein the dissolution temperature is 40° C., the stirring rate is 500 rpm, and the dissolution time is 30 min; S23 10mL of prebiotic solution and 20mL of wall material solution were mixed by emulsification cross-linking microcapsule preparation technology, and 1g of glutaraldehyde was added under stirring conditions to make the wall material undergo cross-linking reaction to form prebiotic microcapsules. The formed prebiotic microcapsules were separated by centrifugation, filtration, etc., and then the microcapsules were placed in a low-temperature drying oven for drying to remove residual moisture to obtain prebiotic microcapsules. The reaction temperature of the emulsification cross-linking reaction was 40°C; the pH value was 5.5; the stirring speed was 900 rpm, the drying temperature was 1°C, and the drying time was 1h; Step (3) Preparation of protein-based foamy glue Using 4 g of whey protein as the matrix, adding 1 g of lecithin, stirring at 30°C and 400 rpm for 20 min to form a uniform protein-based foamy gel; Step (4) Preparation of a condom containing prebiotics for regulating the female microecological environment S61: 1 g of prebiotic microcapsules and 6 g of protein-based foamy gel are mixed to prepare a mixed solution; S62: The prepared condom body is put into the mixed solution after being pre-treated by cleaning and disinfection; the effective substances in the mixed solution are fully adhered to the surface of the condom by the immersion method, and then the immersion-treated condom is dried to prepare a condom containing prebiotics for regulating the female microecological environment, the immersion time is 20 minutes, the immersion temperature is 20°C, the drying temperature is 40°C, and the drying time is 2 hours.

[0066] Comparative Example 2 Step (1) Preparation of condom body S11: polyisoprene emulsion, methyl paraben and polyethylene glycol are mixed in a ratio of 92:1:13, and the raw material mixing temperature is 25°C; S12 In a temperature-controlled container, various ingredients are fully integrated by stirring and heating to form a uniform raw material liquid. The mixing processing temperature is 100°C, the raw material preheating time is 30 minutes, and the mixing time is 90 minutes. S13 then uses a special glass or metal mold to slowly inject the raw material liquid into the mold, and through the stretching and blowing process, the raw material liquid is evenly spread in the mold to form the initial shape of the condom, and then the condom is heated and cured in the mold, and finally the cured condom is peeled off from the mold, and trimmed and finished to obtain the condom body, the stretching and blowing molding temperature is: 150° C., the drying temperature is: 80° C., the molding time is 2 hours, and the drying time is: 4 hours; Step (2) Preparation of prebiotic microcapsules S21: 8 g of isomaltooligosaccharide and 8 g of galacto-oligosaccharide were mixed with 80 mL of deionized water to form a uniform prebiotic solution, and the prebiotic solution was filtered or centrifuged to remove insoluble matter or impurities; S22: 14 g of sodium alginate is mixed with 80 mL of deionized water, and the mixture is fully dissolved by stirring or heating to prepare a wall material solution, wherein the dissolution temperature is 70° C., the stirring rate is 800 rpm, and the dissolution time is 60 min; S23 14 mL of prebiotic solution and 28 mL of wall material solution were mixed by emulsification cross-linking microcapsule preparation technology, and 2 g of glutaraldehyde was added under stirring conditions to make the wall material undergo cross-linking reaction to form prebiotic microcapsules. The formed prebiotic microcapsules were separated by centrifugation, filtration, etc., and then the microcapsules were placed in a low-temperature drying oven for drying to remove residual moisture to obtain prebiotic microcapsules. The reaction temperature of the emulsification cross-linking reaction was 65°C; the pH value was 7; the stirring speed was 1300 rpm, the drying temperature was 10°C, and the drying time was 4h; Step (3) Preparation of protein-based foamy glue Using 10g of whey protein as the matrix, adding 4g of lecithin, stirring at a temperature of 40°C and a stirring speed of 700rpm for 40min, a uniform protein-based foamy gel was formed; Step (4) Preparation of a condom containing prebiotics for regulating the female microecological environment S61 2 g of prebiotic microcapsules and 7 g of protein-based foamy gel are mixed to prepare a mixed solution; S62: The prepared condom body is put into the mixed solution after pretreatment such as cleaning and disinfection; the effective substances in the mixed solution are fully attached to the surface of the condom by the immersion method, and then the immersion-treated condom is dried to prepare a condom containing prebiotics for regulating the female microecological environment, the immersion time is 40 minutes, the immersion temperature is 30°C, the drying temperature is 50°C, and the drying time is 5 hours.

[0067] The condoms containing prebiotics for regulating the female microecological environment obtained in Examples 1-4 and the products of Comparative Examples 1-2 were tested, and the specific testing methods are as follows: Vaginal flora changes test 100 volunteers were selected for trial use. After using the condoms prepared in the embodiment and the comparative example for a period of time, the changes in vaginal flora were detected.

[0068] Prebiotic release performance test The prepared prebiotic-containing condom is placed in a solution simulating a vaginal environment, samples are taken at regular intervals (such as at certain time intervals), and the release rate and cumulative release amount of the prebiotics are recorded and calculated using high performance liquid chromatography.

[0069] Table 1 Vaginal flora change test results

[0070] As can be seen from Table 1, the number of beneficial bacteria in the condoms containing prebiotics for regulating the female microecological environment prepared in the examples and comparative examples increased significantly, while the number of harmful bacteria decreased. The number of beneficial bacteria in the examples increased more than that in the comparative examples, while the number of harmful bacteria decreased more. This is because the prebiotic coating was creatively added during the preparation of the examples, and the use of one or more of oligogalactose, α-glucan oligosaccharide and inulin as coating prebiotics in the coating had similar results. α-glucan oligosaccharide, oligogalactose and inulin are all substances with prebiotic properties, which can promote the growth and reproduction of beneficial bacteria (such as lactic acid bacteria) in the female reproductive tract, and the auxiliary materials chitosan and its derivatives added during the preparation process have antibacterial properties, which can inhibit the growth of a variety of harmful microorganisms, including bacteria, fungi, etc. This antibacterial effect helps to reduce the risk of reproductive tract infection.

[0071] Table 2 Prebiotic release performance test results

[0072] As can be seen from Table 2, the prebiotic release performance of the condom containing prebiotics for regulating the female microecological environment prepared in the embodiment is better than the corresponding prebiotic release performance of the product prepared in the comparative example. In the preparation process of the wall material solution in the embodiment when preparing the prebiotic microcapsules, Tween 80 and sodium carboxymethyl cellulose are added to enhance the emulsification effect and stability of the wall material solution, thereby maintaining the activity and effectiveness of the prebiotics, and greatly ensuring the prebiotic release performance. In addition, a prebiotic coating material is added during the preparation process of the embodiment, which can also increase the release amount of a certain prebiotic and improve the prebiotic release performance of the product.

[0073] 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 can make non-creative modifications to the present embodiment as needed, but they are protected by patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A condom containing prebiotics for regulating the female microecological environment, characterized in that include: A condom body, the outer surface of which is coated with a coating containing prebiotics and a hyaluronic acid liquid lubricant; The prebiotics are selected from one or more of oligofructose, oligogalactose, inulin, lactulose, α-glucan oligosaccharide, etc.; the mass percentage of the prebiotics in the coating is 0.1% to 5%; the mass percentage of the lubricant is 5% to 10%.

2. A condom containing prebiotics for regulating female microecological environment according to claim 1, characterized in that: The condom body also includes prebiotic microcapsules and protein-based foamy colloid; the hyaluronic acid is selected from sodium hyaluronate; the coating also contains auxiliary materials that help the attachment and stability of prebiotics, such as chitosan and gelatin.

3. A condom containing prebiotics for regulating female microecological environment according to claim 1, characterized in that: The preparation method of the condom body comprises: Rubber latex, antioxidants, preservatives and thickeners are mixed in a certain proportion, and then stirred and heated in a temperature-controlled container to fully blend the various ingredients to form a uniform raw material liquid; then a special glass or metal mold is used to slowly inject the raw material liquid into the mold, and the raw material liquid is evenly spread in the mold through a stretching and blowing process to form the initial shape of the condom, and then the condom is heated and cured in the mold, and finally the cured condom is peeled off the mold, and trimmed and finished to obtain the condom body.

4. A condom containing prebiotics for regulating female microecological environment according to claim 2, characterized in that: Contains at least one of the following characteristics (1) to (7): (1) The rubber emulsion includes at least one of natural rubber emulsion, polyisoprene emulsion or polyurethane emulsion; (2) the antioxidant includes at least one of α-tocopherol, butylated hydroxyanisole, butylated hydroxytoluene or dilauryl thiodipropionate; (3) The preservative includes at least one of sodium benzoate, potassium benzoate, sodium propionate or methyl paraben; (4) a thickener including at least one of polyethylene glycol (PEG), hydroxypropyl methylcellulose or silicone oil; (5) The mass ratio of rubber latex, antioxidant, preservative and thickener is (85~92):1:1:(7~13); (6) Raw material mixing temperature: 20~25℃, mixing processing temperature: 60~100℃, stretch blow molding temperature: 120~150℃, drying temperature: 60~80℃; (7) Raw material preheating time: 15~30min, mixing time: 45~90min, molding time: 1~2h, drying time: 2~4h.

5. A condom containing prebiotics for regulating female microecological environment according to claim 1, characterized in that: The preparation of the prebiotic microcapsules comprises: Prebiotic powder is mixed with an appropriate amount of deionized water to form a uniform prebiotic solution, and the prebiotic solution is filtered or centrifuged to remove insoluble matter or impurities; the prebiotic solution and the wall material solution are mixed with the wall material solution through the emulsification cross-linking microcapsule preparation technology to form an oil-in-water (W / O) or water-in-oil (O / W) emulsion, and a cross-linking agent is added under stirring conditions to cause the wall material to undergo a cross-linking reaction to form prebiotic microcapsules, and the formed prebiotic microcapsules are separated by centrifugation, filtration, etc., and then the microcapsules are placed in a low-temperature drying oven for drying to remove residual moisture to obtain prebiotic microcapsules.

6. A condom containing prebiotics for regulating female microecological environment according to claim 4, characterized in that: Contains at least one of the following characteristics (1) to (6): (1) The prebiotic powder includes at least one of isomaltooligosaccharide, galacto-oligosaccharide, fructo-oligosaccharide, inulin, lactulose and α-glucan oligosaccharide; (2) The mass ratio of prebiotic powder to deionized water is: 1:(5-10); (3) The mass ratio of prebiotic solution to wall material solution is: 1:(1-4); (4) The reaction temperature of the emulsification cross-linking reaction is: 40~65℃; the pH value is 5.5~7; the stirring speed is 900~1300 rpm; (5) the cross-linking agent comprises at least one of glutaraldehyde, genipin or calcium chloride; (6) The mass ratio of the cross-linking agent to the prebiotic solution is: 1:(4-8); (7) Drying temperature: 1~10℃, drying time: 1~4h.

7. A condom containing prebiotics for regulating female microecological environment according to claim 4, characterized in that: The preparation of the wall material solution comprises: The selected wall material is mixed with an appropriate amount of deionized water, and auxiliary materials such as emulsifiers and stabilizers are added to improve the performance of the wall material solution. The wall material solution is prepared by stirring or heating to fully dissolve the wall material.

8. A condom containing prebiotics for regulating female microecological environment according to claim 6, characterized in that: Contains at least one of the following characteristics (1) to (5): (1) The wall material comprises at least one of chitosan, sodium alginate, soy protein isolate, sodium carboxymethyl cellulose, gum arabic or ethyl cellulose; (2) The mass ratio of wall material to deionized water is: 1:(5~10); (3) the emulsifier comprises at least one of Tween 80, lecithin or glyceryl monostearate; (4) The stabilizer is at least one of xanthan gum, carrageenan or sodium carboxymethyl cellulose; (5) The dissolution temperature is 40-70°C, the stirring rate is 500-800 rpm, and the dissolution time is 30-60 min.

9. A condom containing prebiotics for regulating female microecological environment according to claim 1, characterized in that: The preparation of the prebiotic coating material comprises: Dissolve the prebiotics in a suitable solvent, add suitable auxiliary materials and stir continuously to form a uniform prebiotic coating material.

10. A condom containing prebiotics for regulating female microecological environment according to claim 8, characterized in that: Contains at least one of the following characteristics (1) to (4): (1) Prebiotics include at least one of fructooligosaccharides, galacto-oligosaccharides, inulin, lactulose, α-glucan oligosaccharides, etc.; (2) The solvent includes at least one of deionized water and ethanol; (3) The mass content of prebiotics in the prebiotic coating material is 0.1% to 5%; (4) The auxiliary material is at least one of chitosan and gelatin, and its mass ratio to the prebiotic coating is 0.1-0.5%.

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