Carbomer copper gluconate complex hydrogel and its preparation method and application

Abstract

The present invention provides a carbomer copper gluconate complex hydrogel, a preparation method, and applications thereof. The carbomer copper gluconate complex hydrogel is prepared in 100 ml or 100 g portions. The raw materials, calculated by mass percentage, include: 0.01% to 0.1% carbomer copper gluconate complex (calculated as copper ion addition); 1% to 2% propylene glycol; 0.1% to 0.2% sodium hyaluronate; 2% to 6% dimethicone; and the balance is an acidity regulator and water. The carbomer copper gluconate complex hydrogel not only effectively kills sperm and common pathogens, but also protects the vaginal mucosa while providing contraception, avoiding the irritation and side effects of chemical spermicides.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical and health care, and in particular relates to a carbomer copper gluconate complex hydrogel and a preparation method and application thereof. Background Art

[0002] Contraceptive products currently on the market primarily include condoms, birth control pills, and contraceptive gels. Despite their widespread use, these products each have their own drawbacks and limitations. Condoms not only provide contraception but also protect against sexually transmitted infections (STIs). However, some people are allergic to materials such as latex, which can cause discomfort, itching, and other allergic reactions. Furthermore, they can break or slip during use, leading to contraceptive failure. Short-acting oral contraceptives and emergency contraceptives are mostly hormonal and carry significant side effects, such as nausea, vomiting, dizziness, weight gain, and irregular vaginal bleeding. Oral contraceptives have the highest incidence of adverse reactions among all single contraceptive devices, and missed doses are the main cause of oral contraceptive failure. Long-term use of birth control pills can negatively impact a woman's endocrine system and increase the risk of cardiovascular disease. Traditional contraceptive gels typically use chemical spermicides such as nonoxynol-9. While effective contraceptives, long-term use can irritate the vaginal mucosa, disrupting the normal vaginal flora and causing vaginitis and other side effects. Furthermore, traditional contraceptive gels have poor antibacterial properties and are ineffective in preventing STIs. In order to solve the above problems, there is an urgent need for a new type of contraceptive gel that is not only effective in preventing pregnancy but also has good antibacterial properties and is non-irritating to the vaginal mucosa, thereby protecting women's reproductive health. Summary of the Invention

[0003] In order to solve the problems existing in the prior art, the present invention provides a carbomer copper gluconate complex hydrogel and its preparation method and application. The carbomer copper gluconate complex hydrogel can not only effectively kill sperm and common pathogens, but also protect the vaginal mucosa while achieving contraception, avoiding the irritation and side effects caused by chemical spermicides.

[0004] To achieve the above objectives, the present invention provides the following technical solution: a carbomer copper gluconate complex hydrogel, the raw materials of which include carbomer copper gluconate complex, propylene glycol, sodium hyaluronate, dimethicone, an acidity regulator and water.

[0005] Furthermore, the carbomer copper gluconate complex hydrogel has a specification of 100 ml or 100 g per portion, and the raw materials include, by mass percentage:

[0006] 0.01% to 0.1% carbomer copper gluconate complex, the amount of carbomer copper gluconate complex added is calculated based on the amount of copper ions added;

[0007] 1% to 2% propylene glycol;

[0008] 0.1% to 0.2% sodium hyaluronate; 2% to 6% dimethicone;

[0009] The balance is acidity regulator and water.

[0010] Furthermore, the acidity regulator is lactic acid.

[0011] Furthermore, the acidity regulator adjusts the pH value of the carbomer copper gluconate complex hydrogel to 3.8-4.5.

[0012] The present invention provides a method for preparing a carbomer copper gluconate complex hydrogel, which comprises the following specific steps:

[0013] S1: mixing equal volumes of carbomer solution and copper gluconate solution to obtain a carbomer copper gluconate complex;

[0014] S2 adds propylene glycol, sodium hyaluronate, dimethicone, an acidity regulator and water to the carbomer copper gluconate complex, adjusts the pH value to 3.8-4.5, and obtains the carbomer copper gluconate complex hydrogel.

[0015] Furthermore, the carbomer copper gluconate complex hydrogel has a specification of 100 ml or 100 g per portion, and the raw materials include, by mass percentage:

[0016] 0.01% to 0.1% carbomer copper gluconate complex, the amount of carbomer copper gluconate complex added is calculated based on the amount of copper ions added;

[0017] 1% to 2% propylene glycol;

[0018] 0.1% to 0.2% sodium hyaluronate; 2% to 6% dimethicone;

[0019] The balance is acidity regulator and water.

[0020] Furthermore, the acidity regulator is citric acid or lactic acid.

[0021] The present invention also provides an antibacterial contraceptive hydrogel, comprising the carbomer copper gluconate complex hydrogel or the carbomer copper gluconate complex hydrogel prepared by the above method.

[0022] The present invention also provides the use of the carbomer copper gluconate complex hydrogel or the carbomer copper gluconate complex hydrogel prepared by the above method in antibacterial and / or contraceptive aspects.

[0023] The present invention also provides a lubricant, characterized in that it comprises the above-mentioned carbomer copper gluconate complex hydrogel or the carbomer copper gluconate complex hydrogel prepared by the above-mentioned method.

[0024] Compared with the prior art, the present invention has at least the following beneficial effects:

[0025] The present invention provides a carbomer copper gluconate complex hydrogel, wherein the active ingredient carbomer copper gluconate complex hydrogel has a spermicidal effect, providing a new option for contraception, and is particularly suitable for people seeking non-hormonal contraceptive methods. Carbomer can slowly release copper ions, thereby improving the durability of the antibacterial effect and avoiding the initial high-concentration toxicity and late low-concentration failure problems caused by the rapid release of copper ions. Sodium hyaluronate not only gives the hydrogel an ideal texture and viscosity, but also significantly enhances the moisturizing properties of the product, thereby improving the user's comfort. The addition of propylene glycol, a moisturizer, and a pH regulator further ensures the health and moisture balance of the vaginal environment. Dimethicone, as an effective lubricant, enhances the user experience of the product and ensures the safety and comfort of long-term use.

[0026] The preparation method of the present invention is concise and clear, easy to operate, and conducive to industrial production. By precisely controlling the addition amount of each raw material, the quality and stable performance of the final product can be ensured. No harmful solvents or high temperature and high pressure conditions are required during the preparation process, and the method is environmentally friendly.

[0027] The carbomer copper gluconate complex hydrogel of the present invention, when used as an antibacterial contraceptive hydrogel, combines the dual effects of antibacterial and contraception, provides more comprehensive protection for sexual health, and is suitable for people of different age groups and physiological conditions, especially those who are sensitive to hormones or seek non-drug contraceptive methods. In the form of a hydrogel, it is easy to apply and use and will not interfere with the natural feeling of sexual life.

[0028] When the carbomer copper gluconate complex hydrogel of the present invention is used as a lubricant, the lubricating effect of dimethyl silicone oil significantly enhances the comfort and smoothness of sexual life. In addition, the lubricant has mild ingredients, is safe and reliable for long-term use, and will not disrupt the vaginal microecological balance. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 : Schematic diagram of the staining of sperm by the carbomer copper gluconate complex hydrogel of the present invention;

[0030] Figure 2 : Performance diagram of the carbomer copper gluconate complex hydrogel of the present invention in the sperm-killing effect experiment;

[0031] Figure 3 : Comparison of the killing effect on Candida albicans before and after the drop plate experiment and the statistical graph of Candida albicans survival rate. DETAILED DESCRIPTION

[0032] The present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0033] The present invention provides a carbomer copper gluconate complex hydrogel, each serving having a specification of 100 ml or 100 g, which comprises the following components in terms of mass percentage:

[0034] 0.01% to 0.1% carbomer copper gluconate complex, the amount of carbomer copper gluconate complex added is calculated based on the amount of copper ions added;

[0035] 1% to 2% propylene glycol;

[0036] 0.1% to 0.2% sodium hyaluronate;

[0037] 2% to 6% dimethyl silicone oil;

[0038] The balance is water and acidity regulator.

[0039] The preparation method of the above-mentioned carbomer copper gluconate complex hydrogel is specifically as follows:

[0040] S1. Slowly sprinkle carbomer into an appropriate amount of water, stir evenly, and let it stand overnight to completely dissolve to prepare a carbomer solution;

[0041] S2, dissolving copper gluconate in water of the same volume as S1, stirring evenly to prepare a copper gluconate solution;

[0042] S3, mixing the carbomer solution and the copper gluconate solution in a volume ratio of 1:1, stirring evenly, and reacting at room temperature for 2 hours to form a carbomer copper gluconate complex;

[0043] S4. Add propylene glycol, sodium hyaluronate and dimethicone to the carbomer copper gluconate complex solution and stir evenly;

[0044] S5. Stir slowly with a blender until uniform, ensuring all ingredients are fully mixed;

[0045] S6. Continue the reaction at room temperature for 1 hour, and add water to 100 ml or 100 g to obtain a carbomer copper gluconate complex hydrogel.

[0046] S7. Use a weak acidic solution (such as diluted lactic acid solution) to adjust the pH value of the mixture to 3.8-4.5 to ensure the stability and safety of the product.

[0047] The carbomer copper gluconate complex hydrogel prepared by the present invention has the following advantages:

[0048] 1. Stability and durability

[0049] Carbomer is a high-molecular-weight synthetic polymer with excellent viscosity-regulating and thickening properties, forming a stable colloidal structure. When combined with copper gluconate, carbomer provides a more stable matrix, extending the release time of copper ions. Sustained-release effect: Carbomer slowly releases copper ions, enhancing the durability of the antibacterial effect and avoiding the initial toxicity of high concentrations and the subsequent ineffectiveness of low concentrations caused by rapid copper ion release.

[0050] 2. Biocompatibility and low toxicity

[0051] Carbomer has excellent biocompatibility and is widely used in pharmaceutical formulations and body lubricants. It is non-irritating and non-allergic to skin and mucous membranes. Reduced toxicity: Carbomer's high molecular weight structure reduces direct contact with free copper ions, lowering their potential toxicity and improving product safety.

[0052] 3. Enhanced antibacterial properties

[0053] Synergistic effect: The complex of carbomer and copper ions has stronger antibacterial properties than copper gluconate alone. The polymer network structure of carbomer can adsorb and fix more copper ions, increasing the local copper ion concentration and antibacterial effect.

[0054] Broad-spectrum antibacterial: Carbomer-copper complex is not only effective against Candida albicans, but also has a broad-spectrum antibacterial effect against many other bacteria and fungi.

[0055] 4. Improve user experience

[0056] Viscosity adjustment: Carbomer can provide appropriate viscosity to ensure good coating and durability of the complex hydrogel in the reproductive system without being too thin or viscous.

[0057] Moisturizing effect: The addition of propylene glycol and sodium hyaluronate further enhances the moisturizing effect of the complex hydrogel, ensuring comfort and lubrication during use;

[0058] Lubricating effect: Dimethyl silicone oil can provide long-term lubrication during use.

[0059] In summary, carbomer copper gluconate complex hydrogel is superior to simple copper gluconate hydrogel in terms of stability, antibacterial properties, biocompatibility and usage experience, and can be used as a more ideal antibacterial contraceptive hydrogel.

[0060] The above-mentioned carbomer copper gluconate complex hydrogel is used as an antibacterial contraceptive hydrogel product, wherein the antibacterial effect specifically inhibits bacterial infection caused by Candida albicans, and the killing rate of Candida albicans reaches 93.3%; and the carbomer copper gluconate complex hydrogel can significantly reduce sperm survival rate, thus having a contraceptive function.

[0061] The specific usage of the antibacterial and spermicidal contraceptive hydrogel product is as follows:

[0062] Each tube of this product is 5g and is in gel form.

[0063] S1. Tear open the aluminum foil bag, take out the applicator, and place the antibacterial and spermicidal contraceptive hydrogel in the applicator.

[0064] S2. Remove the sheath at the front of the applicator and remove the end cap.

[0065] S3. Insert the sheath into the socket at the end of the applicator as a push rod.

[0066] S4. The recipient lies on his back with his buttocks raised 20 to 30 cm and his legs bent and spread apart.

[0067] S5. Slowly insert the applicator deep into the vagina, push in the push rod, and completely inject the antibacterial and spermicidal contraceptive hydrogel into the vagina.

[0068] S6. Remove the applicator and maintain this position for 5 minutes.

[0069] In summary, the carbomer copper gluconate complex hydrogel of the present invention has a strong bactericidal and spermicidal mechanism, can quickly reduce the risk of genital infection, effectively reduce the chance of pregnancy, and has long-lasting lubricating properties, ensuring comfort and safety during use, and preventing the further spread of bacteria and other microorganisms in the body.

[0070] Example 1

[0071] A preparation process of a carbomer copper gluconate complex hydrogel comprises the following steps:

[0072] S1. Prepare ingredients:

[0073] Weigh 2 grams of carbomer;

[0074] Weigh 0.03 g of copper gluconate (i.e., 0.03% carbomer copper gluconate complex);

[0075] Weigh 1.5 ml of propylene glycol, 0.15 g of sodium hyaluronate, 4 ml of dimethicone, and an appropriate amount of lactic acid;

[0076] Prepare an appropriate amount of purified water.

[0077] S2. Prepare carbomer solution:

[0078] Slowly sprinkle the carbomer into 20 ml of purified water, stirring well to prevent clumping. Let it sit overnight to completely dissolve.

[0079] S3. Preparation of copper gluconate solution:

[0080] Dissolve copper gluconate in 20 ml of purified water and stir evenly to obtain a copper gluconate solution.

[0081] S4. Chemical cross-linking reaction:

[0082] The carbomer solution and the copper gluconate solution were mixed at a volume ratio of 1:1, stirred evenly, and reacted at room temperature for 2 hours to form a carbomer copper gluconate complex.

[0083] S5. Preparation of Carbomer Copper Gluconate Complex Hydrogel:

[0084] Add 1.5 ml of propylene glycol, 0.15 g of sodium hyaluronate, and 4 ml of dimethicone to the carbomer copper gluconate complex solution and stir until uniform. Stir slowly with a blender until all ingredients are thoroughly mixed. Continue the reaction at room temperature for 1 hour to obtain the carbomer copper gluconate hydrogel.

[0085] S6. Homogenization and hydration:

[0086] Continue stirring the mixture to ensure uniformity; add purified water to 100 ml and stir evenly.

[0087] S7. Adjust pH value:

[0088] The pH value of the mixture is adjusted to 3.8 to 4.5 using a weak acidic solution (such as a diluted lactic acid solution) to ensure product stability and safety. The resulting carbomer copper gluconate complex hydrogel is packaged into single-dose packages and sealed for storage.

[0089] Example 2

[0090] S1. Prepare ingredients:

[0091] Weigh 2 grams of carbomer;

[0092] Weigh 0.04 g of copper gluconate (i.e., 0.04% carbomer copper gluconate complex);

[0093] Weigh 1 ml of propylene glycol, 0.1 g of sodium hyaluronate, 2 ml of dimethicone, and an appropriate amount of lactic acid;

[0094] Prepare an appropriate amount of purified water.

[0095] S2. Prepare carbomer solution:

[0096] Slowly sprinkle the carbomer into 20 ml of purified water, stirring well to prevent clumping. Let it sit overnight to completely dissolve.

[0097] S3. Preparation of copper gluconate solution:

[0098] Dissolve copper gluconate in 20 ml of purified water and stir evenly to obtain a copper gluconate solution.

[0099] S4. Chemical cross-linking reaction:

[0100] The carbomer solution and the copper gluconate solution were mixed at a volume ratio of 1:1, stirred evenly, and reacted at room temperature for 2 hours to form a carbomer copper gluconate complex.

[0101] S5. Preparation of Carbomer Copper Gluconate Complex Hydrogel:

[0102] Add 1 ml of propylene glycol, 0.1 g of sodium hyaluronate, and 2 ml of dimethicone to the carbomer copper gluconate complex solution and stir until uniform. Stir slowly with a blender until all ingredients are thoroughly mixed. Continue the reaction at room temperature for 1 hour to obtain a carbomer copper gluconate complex hydrogel.

[0103] S6. Homogenization and hydration:

[0104] Continue stirring the mixture to ensure uniformity; add purified water to 100 ml and stir evenly.

[0105] S7. Adjust pH value:

[0106] The pH value of the mixture is adjusted to 3.8 to 4.5 using a weak acidic solution (such as a diluted lactic acid solution) to ensure product stability and safety. The resulting carbomer copper gluconate complex hydrogel is packaged into single-dose packages and sealed for storage.

[0107] Example 3

[0108] S1. Prepare ingredients:

[0109] Weigh 2 grams of carbomer;

[0110] Weigh 0.02 g of copper gluconate (i.e., 0.02% carbomer copper gluconate complex);

[0111] Weigh 2 ml of propylene glycol, 0.2 g of sodium hyaluronate, 6 ml of dimethicone, and an appropriate amount of lactic acid;

[0112] Prepare an appropriate amount of purified water.

[0113] S2. Prepare carbomer solution:

[0114] Slowly sprinkle the carbomer into 20 ml of purified water, stirring well to prevent clumping. Let it sit overnight to completely dissolve.

[0115] S3. Preparation of copper gluconate solution:

[0116] Dissolve copper gluconate in 20 ml of purified water and stir evenly to obtain a copper gluconate solution.

[0117] S4. Chemical cross-linking reaction:

[0118] The carbomer solution and the copper gluconate solution were mixed at a volume ratio of 1:1, stirred evenly, and reacted at room temperature for 2 hours to form a carbomer copper gluconate complex.

[0119] S5. Preparation of Carbomer Copper Gluconate Complex Hydrogel:

[0120] Add 2 ml of propylene glycol, 0.2 g of sodium hyaluronate, and 6 ml of dimethicone to the carbomer copper gluconate complex solution and stir until uniform. Slowly stir with a blender until all ingredients are thoroughly mixed. Continue the reaction at room temperature for 1 hour to obtain a carbomer copper gluconate complex hydrogel.

[0121] S6. Homogenization and hydration:

[0122] Continue stirring the mixture to ensure uniformity; add purified water to 100 ml and stir evenly.

[0123] S7. Adjust pH value:

[0124] The pH value of the mixture is adjusted to 3.8 to 4.5 using a weak acidic solution (such as a diluted lactic acid solution) to ensure product stability and safety. The resulting carbomer copper gluconate complex hydrogel is packaged into single-dose packages and sealed for storage.

[0125] Test 1

[0126] Verification of the spermicidal function of carbomer copper gluconate complex hydrogel

[0127] Experimental Materials and Methods

[0128] To verify the spermicidal function of this product, the following experiment was conducted to evaluate the product's spermicidal effect by measuring sperm survival rate. In this experiment, sperm were exposed to a laboratory environment and inactivated for a certain period of time. The following preparations were required before the experiment:

[0129] 1. Semen collection and liquefaction:

[0130] The semen sample is collected after the subject has abstained from sex for at least 2 days and up to 7 days. After collection, the semen is placed in an incubator at 37°C until it completely liquefies, which usually takes 30 minutes to 1 hour.

[0131] 2. Semen sampling and dilution:

[0132] The liquefied semen sample is sampled with a clean pipette and appropriately diluted to ensure that sperm can be clearly observed under a microscope. The diluted semen sample is placed in a sterile centrifuge tube.

[0133] 3. Wet mount preparation:

[0134] Take out an appropriate amount (e.g., 10 μl) of the thoroughly mixed semen sample, place it on a clean glass slide, and cover it with a coverslip to form a pool about 20 μm deep.

[0135] After the experiment officially began, the sperm was exposed to a laboratory environment for an inactivation time test. The laboratory temperature was maintained at 22°C to 25°C, and the humidity was controlled at 40% to 60% to simulate common room temperature conditions. During the experiment, the sperm was stored in sterile centrifuge tubes, and aseptic operations ensured the reliability and repeatability of the experimental environment. All operations were performed in an environment with air circulation but no direct wind source to avoid airflow interfering with the experimental results. The experimental data was observed and recorded under a microscope, with time units accurate to seconds to ensure the accuracy and scientific nature of the data.

[0136] Formal testing of spermicidal methods:

[0137] Reagent preparation

[0138] 1. NaCl solution, 0.9% (w / v):

[0139] Dissolve 0.9 g of NaCl in 100 ml of pure water.

[0140] 2. Eosin Y solution, 0.5% (w / v):

[0141] 0.5 g of Eosin Y (CI45380) was dissolved in 100 ml of 0.9% NaCl solution.

[0142] Sample preparation

[0143] S1. Sample preparation:

[0144] Fresh semen samples were taken and divided into a control group and an experimental group. Each group of samples was tested three times to ensure the reliability and repeatability of the data.

[0145] S2. Processing process:

[0146] The control group samples did not add carbomer copper gluconate complex hydrogel to maintain the original state of semen.

[0147] A certain amount of the carbomer copper gluconate complex hydrogel of the present invention was added to the samples of the experimental group and mixed evenly to ensure the homogeneity of the samples.

[0148] S3, static treatment:

[0149] The treated sample is left to stand for 3 to 5 minutes to ensure that the carbomer copper gluconate complex hydrogel is in full contact with the semen and takes effect.

[0150] S4. Staining detection:

[0151] Dyeing principle:

[0152] Eosin dye is an acidic dye that can bind to proteins on the sperm cell membrane. Live sperm have intact cell membranes that can repel the dye and are not stained; dead sperm have damaged cell membranes that allow the dye to enter the cell and bind to the intracellular components, resulting in a red color. Therefore, after staining, stained sperm (dead sperm) and unstained sperm (live sperm) can be observed under a microscope. Figure 1 .

[0153] Staining steps:

[0154] The treated sample was mixed with 1% eosin staining solution at a volume ratio of 1:1 and mixed thoroughly.

[0155] Take the mixed sample to prepare a smear, spread it evenly on a glass slide, and wait for it to dry naturally.

[0156] The prepared smear was observed under a microscope, the number of stained sperm (red, dead sperm) and unstained sperm (colorless, live sperm) was recorded, and the sperm survival rate was calculated.

[0157] result:

[0158] The experimental results show that the carbomer copper gluconate complex hydrogel of the present invention has a significant inhibitory effect on sperm motility. The specific data are as follows:

[0159] Experimental group: After adding this product and letting it stand for 3 to 5 minutes, the sperm survival rate decreased significantly, with an average survival rate of 0%. Under a microscope, the heads of the stained sperm (dead sperm) appeared red and dark pink.

[0160] Control group: In the sample without this product, sperm maintained a high survival rate, with an average survival rate of 85%.Under a microscope, the heads of unstained sperm (live sperm) appear white and light pink.

[0161] The above experimental data indicate that the carbomer copper gluconate complex hydrogel of the present invention not only has an excellent spermicidal effect, but also adopts the eosin staining method for verification, which is simple, rapid and accurate in operation, providing a strong experimental basis for the contraceptive function of the product.

[0162] To further evaluate the spermicidal effect of the carbomer copper gluconate complex of the present invention, spermicidal time tests were conducted at different concentrations of the carbomer copper gluconate complex. Specific experimental data are shown in Table 1:

[0163] Table 1

[0164]

[0165]

[0166] Experimental data showed that increasing the amount of carbomer copper gluconate complex added significantly reduced the time required for complete sperm inactivation. For example, in the control group, total sperm inactivation took 784 seconds, while in Experimental Group 9, where 0.09% carbomer copper gluconate complex was added, this time was shortened to 141 seconds. This trend suggests that the sperm-killing effect of carbomer copper gluconate complex increases with concentration, and that higher concentrations are able to kill all sperm more rapidly.

[0167] Furthermore, no sperm motility recovery was observed in any of the experimental groups within 60 minutes after treatment. This result indicates that the carbomer copper gluconate complex of the present invention not only rapidly kills sperm, but also effectively maintains its spermicidal effect within 60 minutes, preventing sperm from regaining motility.

[0168] In tests conducted at concentrations above 0.09% carbomer copper gluconate complex, we believe that levels exceeding 0.09% may not be suitable for practical applications due to potential increased toxicity and increased material costs. Therefore, while concentrations above 0.09% may further shorten sperm inactivation time, 0.09% is considered the optimal carbomer copper gluconate complex dosage for safety and cost considerations.

[0169] Subsequently, in order to intuitively demonstrate the spermicidal effect of the product, we used 0.09% carbomer copper gluconate complex solution to conduct experimental records of sperm survival under different treatment times, and observed and recorded the survival status of sperm under a microscope.

[0170] like Figure 2 The timeline shows the status of untreated sperm and sperm after treatment for 60, 120, and 180 seconds. The white circles in the figure indicate sperm that were still alive at the time of observation.

[0171] Untreated: In the untreated sample, a large number of sperm are still alive. Many sperm marked by white circles can be seen in the image, indicating that these sperm are still active under microscopic observation and have a high survival rate.

[0172] 60-second treatment: After 60 seconds of treatment, the number of viable sperm decreases. The number of sperm marked by white circles in the image is significantly reduced, indicating that some sperm have been killed after this short treatment period.

[0173] After a further 120 seconds of treatment, the sperm survival rate dropped significantly. The number of white circles in the image decreased again, indicating that more sperm were killed and the number of surviving sperm decreased significantly.

[0174] 180-second treatment: After 180 seconds of treatment with the carbomer-copper gluconate complex hydrogel, nearly all sperm were killed. Only a very small number of sperm are indicated by white circles in the image, demonstrating the strong sperm-killing effect of the carbomer-copper gluconate complex hydrogel even after this extended treatment period.

[0175] These microscopic images and white circles clearly demonstrate the sperm-killing effects of the composite hydrogel at different treatment times. These experimental results demonstrate that the composite hydrogel product of the present invention can effectively kill sperm, providing a safe and effective contraceptive method.

[0176] In summary, the experimental results verified the significant spermicidal effect and its persistence of this product at different concentrations of carbomer copper gluconate complex, and determined that 0.09% carbomer copper gluconate complex addition was the most appropriate amount, which could ensure the spermicidal effect while taking into account safety and economy.

[0177] Test 2

[0178] Verification of the killing function of carbomer copper gluconate complex hydrogel against Candida albicans

[0179] Experimental Materials and Methods

[0180] In order to verify the killing function of this product against Candida albicans, we conducted a drop plate experiment.

[0181] Materials and reagents

[0182] Candida albicans ATCC 10231, test product, sterile saline

[0183] Agar medium, sterile pipette and inoculating loop, pipette

[0184] Experimental procedures

[0185] Culture of Candida albicans:

[0186] 1. Use a sterile inoculating loop to inoculate the standard strain of Candida albicans onto the agar medium and culture it in a 37°C constant temperature incubator for 24 hours to obtain fresh colonies.

[0187] 2. Suspend the colony in sterile saline and adjust the concentration of the suspension to approximately 1×10^6 CFU / mL.

[0188] Drop plate experiment:

[0189] S1. Take 1 ml of bacterial suspension from each of the control group and the experimental group.

[0190] S2. Add 1 ml of sterile saline to the bacterial suspension of the control group and 1 ml of the test product to the bacterial suspension of the experimental group and mix well.

[0191] S3. Incubate at room temperature for 10 minutes.

[0192] S4. Take 100 μL of the bacterial suspension after the above treatment, drop it onto the agar medium, and spread it evenly using a sterile glass scraper.

[0193] S5. Culture in a 37°C constant temperature incubator for 24 hours.

[0194] S6. Observe and record the number of colonies on each culture medium.

[0195] Experimental results

[0196] Figure 3 This plate experiment shows the growth of Candida albicans under different concentrations of this product. Each culture dish corresponds to a different concentration of this product, showing the survival rate of Candida albicans under different concentrations of this product.

[0197] S1, control group: untreated Candida albicans, showing normal growth of colonies.

[0198] S2. Treatment group A: The colony growth of Candida albicans treated with this product at a low concentration (0.01% carbomer copper gluconate complex) was slightly reduced.

[0199] S3. Treatment group B: The colony count of Candida albicans treated with this product at a medium concentration (0.05% carbomer copper gluconate complex) was significantly reduced.

[0200] S4. Treatment group C: The Candida albicans colonies were almost completely eliminated after treatment with this product at a high concentration (0.1% carbomer copper gluconate complex).

[0201] 4. Data Analysis

[0202] The results of the drop plate test showed that after the test product was added to the experimental group, the colony count of Candida albicans was significantly reduced, and the killing rate reached 93.3% compared with the control group.

[0203] in conclusion:

[0204] Experimental data showed that this product has a significant killing effect on Candida albicans, with a killing rate of up to 93.3% within 30 minutes, confirming its excellent antibacterial properties.

[0205] In addition, the antibacterial effect of this product in a short period of time was further verified by experimental data. Table 2 shows the antibacterial effect of the embodiment at 1 minute, 5 minutes and 10 minutes:

[0206] Table 2

[0207]

[0208] The experimental results above show that the antibacterial product of the example exhibited significant antibacterial efficacy (over 90%) within 1 minute, and this efficacy further increased over time. At 5 and 10 minutes, the antibacterial efficacy reached almost 100%. In contrast, commercially available antibacterial products showed no antibacterial efficacy (0%) at any time point tested.

[0209] This experimental result shows that the antibacterial product of the embodiment can significantly improve the antibacterial effect in a short period of time (only 1 minute) and maintain this efficient antibacterial performance for a longer period of time. This not only highlights the significant advantages of the embodiment in antibacterial applications, but also demonstrates its potential in practical use. The experimental data further confirmed that this product has a significant killing effect on Candida albicans, with a killing rate of up to 93.3% within 30 minutes, demonstrating its excellent antibacterial performance. This finding shows that this product performs well in rapid sterilization and provides a strong scientific basis for its promotion in related applications.

[0210] Test 3

[0211] Verification of the lubricating function of carbomer copper gluconate complex hydrogel

[0212] To verify the lubricating effect of this product, we conducted several experiments, including skin hydration measurements, durability testing, and biocompatibility testing.

[0213] Materials and Equipment

[0214] Test carbomer copper gluconate complex hydrogel, skin moisture meter, filter paper, graduated glass plate, sterile saline, agar medium,

[0215] Sterile pipette and inoculating loop

[0216] Experimental procedures

[0217] S1. Skin hydration measurement

[0218] Sample preparation:

[0219] Carbomer copper gluconate complex hydrogel was applied to the inner forearm of the volunteers.

[0220] Measurement process:

[0221] Use a skin moisture meter to measure skin moisture values ​​before use, 30 minutes after use, and 2 hours after use.

[0222] The changes in skin moisture values ​​were recorded to evaluate the moisturizing effect of carbomer copper gluconate complex hydrogel.

[0223] Experimental results:

[0224] Thirty minutes after applying the carbomer copper gluconate complex hydrogel, the skin moisture value increased from an initial 25 units to 35 units, a 40% increase.

[0225] Two hours after applying the carbomer copper gluconate complex hydrogel, skin moisture values ​​further increased to 42 units, for a total increase of 68%.

[0226] S2. Persistence test

[0227] Sample preparation:

[0228] Apply a certain amount of carbomer copper gluconate complex hydrogel on the surface of the graduated glass plate.

[0229] Measurement process:

[0230] After 0 minutes, 30 minutes, 1 hour, and 2 hours, the lubricating oil residue was adsorbed using filter paper, and its weight was measured.

[0231] The residual amount of carbomer-copper gluconate complex hydrogel at different time points was recorded to evaluate its durability.

[0232] Experimental results:

[0233] The residual amounts of the carbomer copper gluconate complex hydrogel after 0 min, 30 min, 1 h and 2 h were 100%, 85%, 70% and 55%, respectively.

[0234] S3. Biocompatibility testing

[0235] Sample preparation:

[0236] Carbomer copper gluconate complex hydrogel was applied to the inner forearm of the volunteers.

[0237] Measurement process:

[0238] Observe for skin irritation or allergic reaction within 72 hours.

[0239] Experimental results

[0240] Volunteers did not experience any skin irritation or allergic reaction after using the carbomer copper gluconate complex hydrogel within 72 hours, proving its good biocompatibility.

[0241] S3. Sensory evaluation of product lubrication function

[0242] When conducting a sensory evaluation of the lubrication function of the product, we invited seven assessors to conduct a detailed evaluation of multiple lubrication-related items. The specific evaluation criteria are as follows:

[0243] 1. Lubricity

[0244] Definition: Evaluate the lubrication effect of the product during use.

[0245] Evaluation criteria:

[0246] Very satisfied: The product can continuously provide good lubrication during use without any dryness.

[0247] Satisfactory: The product provides good lubrication most of the time, but may feel slightly dry after extended use.

[0248] General: The product may occasionally feel dry during use, requiring frequent reapplication.

[0249] Dissatisfied: The product often causes a dry feeling during use and fails to provide continuous lubrication.

[0250] 2. Persistence

[0251] Definition: Evaluates the duration of a product's lubricating effect.

[0252] Evaluation criteria:

[0253] Very satisfied: the lubricating effect lasts a long time and does not require frequent reapplication.

[0254] Satisfactory: Lubrication lasts for a while, but reapplication is necessary after extended use.

[0255] Average: Lubricating effect is short-lived and requires more frequent reapplication.

[0256] Dissatisfied: Lubrication effect lasts very short and requires frequent reapplication.

[0257] 3. Smoothness

[0258] Definition: Assessing how smooth a product is during use.

[0259] Evaluation criteria:

[0260] Very satisfied: The product applies very smoothly without any sticky or friction feeling.

[0261] Satisfactory: The product is smooth to use, but may feel slightly sticky occasionally.

[0262] Average: The product is generally smooth when used, with a noticeable stickiness or friction feeling.

[0263] Dissatisfied: The product is very sticky and has a noticeable friction feeling when used.

[0264] 4. Touch

[0265] Definition: Assess how a product feels when it comes into contact with the skin.

[0266] Evaluation criteria:

[0267] Very satisfied: The product is very soft and comfortable when in contact with the skin, without any irritation.

[0268] Satisfactory: The product is soft and comfortable when in contact with the skin, but may occasionally cause slight irritation.

[0269] General: The product is generally soft when in contact with the skin, with a certain degree of irritation.

[0270] Dissatisfied: The product is very rough when in contact with the skin and causes noticeable irritation.

[0271] 5. Ease of use

[0272] Definition: Evaluate the ease of use of a product, including packaging design, usage methods, etc.

[0273] Evaluation criteria:

[0274] Very satisfied: The product packaging is well designed, easy to use, carry and store.

[0275] Satisfied: The product packaging design is reasonable and easy to use, but it is somewhat inconvenient to carry and store.

[0276] General: The product packaging design is general, which makes it inconvenient to use, carry and store.

[0277] Dissatisfied: The product packaging design is unreasonable, very inconvenient to use, and difficult to carry and store.

[0278] All assessors gave the product a "very satisfactory" rating for lubricity, indicating that the product performed well in this regard. However, the assessors had slightly different opinions on durability, smoothness, tactile feel, and ease of use. See Table 3 for the specific results.

[0279] Table 3

[0280]

[0281]

[0282] The above evaluation results show that all reviewers gave the product a "very satisfactory" rating for lubricity, demonstrating its significant lubrication advantages. Furthermore, while there were slight variations in ratings for durability, smoothness, tactility, and ease of use, the overall rating leaned towards "satisfactory," with only a few reviewers rating individual items as "average." This suggests that the product performs well overall and meets the needs of most users, though some details still require improvement.

[0283] This sensory evaluation verified the product's outstanding lubricity and provided a basis for further optimizing other properties, laying a solid foundation for product marketing and improving user satisfaction.

[0284] Through multiple experiments and sensory evaluations, we have fully verified the lubricating properties of this product. The results demonstrate that this product excels in terms of skin hydration, long-lasting properties, and biocompatibility, offering significant moisturizing effects and good long-lasting properties without causing skin irritation or allergic reactions. Sensory evaluations revealed that all assessors rated lubricity "very satisfactory," further confirming its excellent lubricating properties. Overall ratings leaned towards "satisfactory," indicating that this product performs well in actual use and meets the needs of most users. This lays a solid foundation for product marketing and increased user satisfaction.

Claims

1. An antibacterial contraceptive hydrogel, characterized in that: Ingredients include carbomer copper gluconate complex, propylene glycol, sodium hyaluronate, dimethicone, acidity regulator, and water; The hydrogel containing carbomer copper gluconate complex has a specification of 100 ml or 100 g per portion, and the raw materials include, by mass percentage: 0.09% carbomer copper gluconate complex, where the amount of carbomer copper gluconate complex added is calculated based on the amount of copper ions added, and equal volumes of carbomer solution and copper gluconate solution are mixed to obtain carbomer copper gluconate complex; 1%~2% propylene glycol; 0.1%~0.2% sodium hyaluronate; 2%~6% dimethicone; The balance is acidity regulator and water; The acidity regulator adjusts the pH value of the carbomer copper gluconate complex hydrogel to 3.8-4.

5.

2. The antibacterial contraceptive hydrogel according to claim 1, characterized in that: The acidity regulator is citric acid or lactic acid.

3. The method for preparing an antibacterial contraceptive hydrogel according to claim 1, characterized in that: The specific steps are as follows: S1: mixing equal volumes of carbomer solution and copper gluconate solution to obtain a carbomer copper gluconate complex; S2 adds propylene glycol, sodium hyaluronate, dimethicone, an acidity regulator, and water to the carbomer copper gluconate complex, and adjusts the pH value to 3.8-4.5 to obtain the carbomer copper gluconate complex hydrogel.

4. The method for preparing an antibacterial contraceptive hydrogel according to claim 3, characterized in that: The acidity regulator is citric acid or lactic acid.

5. A lubricant, characterized in that: The invention relates to an antibacterial contraceptive hydrogel according to any one of claims 1 to 2 or an antibacterial contraceptive hydrogel prepared by the method according to any one of claims 3 to 4.

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