Gynecological antibacterial gel for female HPV (human papilloma virus) and preparation process thereof

Abstract

The invention discloses gynecological antibacterial gel aiming at female HPV (human papillomavirus) and a preparation process thereof. The gynecological antibacterial gel is prepared from the following raw materials in parts by weight: 1 to 5 percent of compound fungal polysaccharide, 0.1 to 1 percent of herba centellae extract, 0.1 to 1 percent of coriolus versicolor extract, 0.1 to 1 percent of green tea extract, 0.1 to 0.8 percent of fucoidan polysaccharide sulfate and 0.1 to 1 percent of ginsenoside rg3. The preservative is prepared from, by weight, 0.1%-1% of ginsenoside rg2, 0.1%-1% of betulin, 0.1%-0.5% of sophora flower bud extract, 0.1%-1% of natural silkworm antibacterial peptide, 0.5%-1% of carbomer, 0.1%-0.2% of chlorhexidine gluconate, 3% of glycerinum, 0.6% of xylooligosaccharide, 0.6% of sodium hyaluronate middle molecules, 1.5% of hydrolyzed beta-glucan, 0.6% of 98% D-panthenol, 0.6% of provitamin B5, 0.3% of vitamin C, 0.3% of sodium ascorbate and the balance deionized water. The invention relates to the technical field of gynecological treatment. The composition contains various natural plant extracts and bioactive components, can effectively improve cervical health, can realize effective integration of a microemulsion system and a water phase system during preparation, forms a uniform and stable final product, protects the active components, and ensures the curative effect and product performance.

Description

Technical Field

[0001] The present invention relates to the technical field of gynecological treatment, in particular to a gynecological antibacterial gel targeting female HPV and a preparation process thereof. Background Art

[0002] Gynecological gel is used to treat various gynecological vaginitis and cervicitis, including bacterial vaginitis, trichomonas vaginitis, and mixed vaginitis. Gynecological gel has anti-inflammatory, bactericidal, and antipruritic effects. It has a significant inhibitory effect on the growth of pathogenic microorganisms such as Staphylococcus aureus, Escherichia coli, gonococci, Candida albicans, fungi, yeasts, etc., and has been widely used in modern medicine.

[0003] At present, antibacterial gel needs to be prepared through a microemulsification system and an aqueous phase system. However, the antibacterial gel preparation process in traditional technology is difficult to achieve effective integration of the microemulsification system and the aqueous phase system, resulting in the final product being not uniform and stable enough, and it is difficult to protect the active ingredients, which affects the performance and efficacy of the product to a certain extent.

[0004] To this end, the present invention provides a gynecological antibacterial gel targeting female HPV and a preparation process thereof to solve the above-mentioned problems. Summary of the invention

[0005] In view of the deficiencies in the prior art, the present invention provides a gynecological antibacterial gel for HPV in women and a preparation process thereof, which solves the above problems.

[0006] To achieve the above objectives, the present invention is implemented through the following technical scheme: a gynecological antibacterial gel for female HPV, the raw materials include by weight:

[0007] Composite fungal polysaccharide 1%-5%, Centella asiatica extract 0.1%-1%, Versicolor extract 0.1%-1%, Green tea extract 0.1%-1%, Fucoidan sulfate 0.1%-0.8%, Ginsenoside rg3 by weight 0.1%-1%, Ginsenoside rg2 by weight 0.1%-1%, Betulin 0.1%-1%, Sophora japonica extract 0.1%-0.5%, Cecropin 0.1%-1%, Carbomer 0. .5%-1%, chlorhexidine gluconate 0.1%-0.2%, glycerol 3%, xylo-oligosaccharides 0.6%, sodium hyaluronate medium molecule 0.6%, hydrolyzed β-glucan 1.5%, D-panthenol 98%, provitamin B5 weight portion is 0.6%, vitamin C sodium ascorbate 0.3%, vitamin E 0.3%, lecithin 1%-2%, lactic acid powder 0.5%-1%, triethanolamine 0.4%-0.6%, Polysorbate 80 weight portion is 0.8%, polyethylene glycol 1%-2%, medium chain triglycerides 1%-2%.

[0008] Preferably, a preservative is further included, which is composed of 0.5%-0.8% phenoxyethanol and 0.3%-0.6% potassium sorbate. The Centella asiatica extract is total glycosides of Centella asiatica, and the concentrations of the total glycosides of Centella asiatica and hydrolyzed β-glucan are both 80%.

[0009] Preferably, the Coriolus versicolor extract is Coriolus versicolor polysaccharide, and the concentrations of the Coriolus versicolor polysaccharide and the composite fungal polysaccharide are both 50%, and the green tea extract is EGCG (epigallocatechin gallate), and the concentration of the EGCG (epigallocatechin gallate) is 98%.

[0010] Preferably, the Sophora japonica extract is quercetin, the concentrations of quercetin and cecropin are both 98%, and the chlorhexidine gluconate is 99% aqueous solution of chlorhexidine gluconate.

[0011] Preferably, the concentration of the xylo-oligosaccharide is 95%, the lecithin is 99% hydrogenated soybean lecithin, the concentration of the lactic acid powder is 99%, and the vitamin C and vitamin E are both 99% food grade.

[0012] A preparation process of a gynecological antibacterial gel for HPV in women, comprising the following steps:

[0013] The first step is to prepare the oil phase, which is used to dissolve the fat-soluble active ingredients and polyethylene glycol to form a stable oil phase;

[0014] The second step is to prepare the aqueous phase, which is used to dissolve the water-soluble components and adjust to a weak acidity;

[0015] The third step is premixing of surfactants to optimize the ratio of lecithin to Tween 80 to form a stable emulsified base;

[0016] The fourth step is emulsification formation, which is used to control the droplet size;

[0017] The fifth step is integration and adjustment, which is used to integrate with the main material to form a stable final product.

[0018] Preferably, the oil phase ingredients include lecithin, Polysorbate 80, medium chain triglycerides (MCT), polyethylene glycol (PEG-400), vitamin E (α-tocopherol), ginsenosides Rg3, RG2, quercetin and betulin, and the oil phase preparation steps are as follows:

[0019] In the first step, lecithin, PEG400 and Polysorbate 80 were fully mixed in the oil phase, and then medium-chain triglycerides (MCT) were gradually added to ensure uniform dispersion to form a stable microemulsion;

[0020] The second step is to add MCT into the auxiliary pot and control the temperature at 25-40℃ to ensure the stability of heat-sensitive ingredients;

[0021] The third step is to add vitamin E, Rg3, quercetin and betulin in sequence, stir at a speed of 300-500 rpm until completely dissolved, and the stirring time is 10-15 minutes.

[0022] Preferably, the aqueous phase ingredients include 80%-85% purified water, sodium hyaluronate, versicolor polysaccharide, EGCG (epigallocatechin gallate), vitamin C (sodium ascorbate) and lactic acid powder;

[0023] The aqueous phase preparation steps are as follows:

[0024] The first step is to add purified water to the main pot and control the temperature at 25-40℃ to ensure the stability of heat-sensitive ingredients;

[0025] Step 2: Add sodium hyaluronate and versicolor polysaccharide in sequence, stir until completely dissolved, and stir at a speed of 300-500 rpm for 10-15 minutes;

[0026] Step 3: Add EGCG (epigallocatechin gallate) and continue stirring at a low speed to ensure uniform dispersion. The stirring speed is 300-500 rpm and the stirring time is 10-15 minutes.

[0027] The fourth step is to use lactic acid powder to adjust the pH value of the water phase to 4.5-5.5 to form a weakly acidic environment.

[0028] Preferably, the emulsification forming step is as follows:

[0029] The first step is to slowly drop the water phase into the oil phase and stir at a low speed of 300-500 rpm for 10-15 minutes.

[0030] The second step is to add the premixed Tween 80 solution into the mixture and continue to stir evenly at a stirring speed of 300-500 rpm for 10-15 minutes;

[0031] The third step is to use a high shear homogenizer to emulsify for 3-5 minutes at a speed of 10000-15000 rpm to form a transparent or translucent microemulsion system;

[0032] The fourth step is to use a laser particle size analyzer to detect the droplet size to ensure that the particle size is within the range of 10-200nm. If the particle size is uneven, adjust the homogenization time or shear speed.

[0033] Preferably, the integration and adjustment steps are as follows:

[0034] The first step is to cool the microemulsification system to 25-30°C;

[0035] The second step is to slowly drop the microemulsified system into the main material, and stir at a low speed to mix evenly, the stirring speed is 300-500rpm, and the time is controlled within 10-15 minutes;

[0036] Step 3: Fine-tune the final pH value to 5.0-5.5 with lactic acid powder or triethanolamine;

[0037] The fourth step is to use a 0.22 μm filter membrane to remove impurities or undissolved components.

[0038] Beneficial Effects

[0039] The present invention provides a gynecological antibacterial gel for HPV in women and its preparation process. Compared with the prior art, it has the following beneficial effects:

[0040] This gynecological antibacterial gel for HPV in women and its preparation process contain a variety of natural plant extracts and bioactive ingredients, which can effectively improve cervical health. During preparation, the microemulsification system and the aqueous phase system can be effectively integrated to form a uniform and stable final product, while protecting the active ingredients and ensuring efficacy and product performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 is a flow chart of Embodiment 2 of the present invention;

[0042] Figure 2 is a flow chart of the oil phase preparation of the present invention;

[0043] Figure 3 is a flow chart of the aqueous phase preparation of the present invention;

[0044] Figure 4 It is a flow chart of emulsification formation of the present invention

[0045] Figure 5 It is a flow chart of the integration and adjustment of the present invention. DETAILED DESCRIPTION

[0046] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0047] Embodiment 1:

[0048] A gynecological antibacterial gel for HPV in women, the raw materials comprising by weight:

[0049] Composite fungal polysaccharide 1%-5%, Centella asiatica extract 0.1%-1%, Versicolor extract 0.1%-1%, Green tea extract 0.1%-1%, Fucoidan sulfate 0.1%-0.8%, Ginsenoside rg3 by weight 0.1%-1%, Ginsenoside rg2 by weight 0.1%-1%, Betulin 0.1%-1%, Sophora japonica extract 0.1%-0.5%, Cecropin 0.1%-1%, Carbomer 0. .5%-1%, chlorhexidine gluconate 0.1%-0.2%, glycerol 3%, xylo-oligosaccharide 0.6%, sodium hyaluronate medium molecule 0.6%, hydrolyzed β-glucan 1.5%, D-panthenol 98%, provitamin B5 weight portion is 0.6%, vitamin C sodium ascorbate 0.3%, vitamin E 0.3%, lecithin 1%-2%, lactic acid powder 0.5%-1%, triethanolamine 0.4%-0.6%, Polysorbate 80 weight portion is 0.8%, polyethylene glycol 1%-2%, medium chain triglyceride 1%-2%, as shown in the following table:

[0050] raw material Weight / % Compound fungal polysaccharide 1-5 Centella Asiatica Extract 0.1-1 Coriolus versicolor extract 0.1-1 Green Tea Extract 0.1-1 Fucoidan Sulfate 0.1-0.8 Ginsenoside rg3 0.1-1 Ginsenoside rg2 0.1-1 Betulin 0.1-1 Sophora japonica extract 0.1-0.5 Cecropin 0.1-1 Carbomer 0.5-1 Chlorhexidine gluconate 0.1-0.2 glycerin 3 Xylo-oligosaccharide 0.6 Sodium Hyaluronate Medium Molecular Weight 0.6 Hydrolyzed β-Glucan 1.5 D-Panthenol 98% Provitamin B5 0.6 Vitamin C Sodium Ascorbate 0.3 Vitamin E 0.3 Lactic acid powder 0.5-1 =Ethanolamine 0.4-0.6 Polysorbate 80 0.8 Polyethylene glycol 1-2 Medium Chain Triglycerides 1-2 Lecithin 1-2

[0051] In this embodiment, a preservative is also included, the preservative is composed of 0.5%-0.8% phenoxyethanol and 0.3%-0.6% potassium sorbate, the Centella asiatica extract is Centella asiatica total glycosides, and the concentrations of the Centella asiatica total glycosides and hydrolyzed β-glucan are both 80%;

[0052] Among them, phenoxyethanol has a special antibacterial effect on Pseudomonas aeruginosa, and has an antibacterial effect on both Gram-positive and Gram-negative bacteria. Because it has considerable solubility in water, white mineral oil, isopropyl palmitate and other cosmetic components, coupled with its high efficiency, broad spectrum, low toxicity and non-allergic irritation, combined with potassium sorbate's very strong inhibitory effect on mold and spoilage bacteria, the finished product has a good broad-spectrum antibacterial effect and low irritation;

[0053] The coriolus versicolor extract is coriolus versicolor polysaccharide, and the concentration of the coriolus versicolor polysaccharide and the composite fungal polysaccharide is 50%; the green tea extract is EGCG (epigallocatechin gallate), and the concentration of the EGCG (epigallocatechin gallate) is 98%;

[0054] The sophora japonica extract is quercetin, the concentrations of quercetin and cecropin are both 98%, and the chlorhexidine gluconate is 99% aqueous solution of chlorhexidine gluconate;

[0055] The concentration of the oligoxylose is 95%, the lecithin is 99% hydrogenated soybean lecithin (EGCG (epigallocatechin gallate), RG3 and RG2, betulin, and versicolor polysaccharide are microemulsified to reduce their contact with oxygen in water), the concentration of the lactic acid powder is 99%, and the vitamin C and vitamin E are both 99% food grade;

[0056] In this embodiment, the concentration of ginsenoside rg3 is 18%, and the concentration of ginsenoside rg2 is 10%;

[0057] In this embodiment, a drug delivery device (3 g / piece) is also included.

[0058] Embodiment 2:

[0059] See also Figure 1 This embodiment provides a preparation process of a gynecological antibacterial gel for female HPV based on the first embodiment, and the steps are as follows:

[0060] The first step is to prepare the oil phase, which is used to dissolve the fat-soluble active ingredients and polyethylene glycol to form a stable oil phase;

[0061] The second step is to prepare the aqueous phase, which is used to dissolve the water-soluble components and adjust to a weak acidity;

[0062] The third step is premixing of surfactants to optimize the ratio of lecithin to Tween 80 to form a stable emulsified base;

[0063] The fourth step is emulsification formation, which is used to control the droplet size;

[0064] The fifth step, integration and adjustment, is used to integrate with the main material to form a stable final product.

[0065] See also Figure 2 The oil phase ingredients include lecithin, Polysorbate 80, medium chain triglyceride (MCT), polyethylene glycol (PEG-400), vitamin E (α-tocopherol), ginsenoside Rg3, RG2, quercetin and betulin, and the oil phase preparation steps are as follows:

[0066] In the first step, lecithin, PEG400 and Polysorbate 80 were fully mixed in the oil phase, and then medium-chain triglycerides (MCT) were gradually added to ensure uniform dispersion to form a stable microemulsion;

[0067] The second step is to add MCT into the auxiliary pot and control the temperature at 25-40℃ to ensure the stability of heat-sensitive ingredients;

[0068] The third step is to add vitamin E, Rg3, quercetin and betulin in sequence, stir at a stirring speed of 300-500 rpm until completely dissolved, and the stirring time is 10-15 minutes;

[0069] The aqueous phase ingredients include 80%-85% purified water (main solvent), sodium hyaluronate (partially added, the remaining part is used in the other half), Versicolor polysaccharide, EGCG (epigallocatechin gallate), vitamin C (sodium ascorbate) and lactic acid powder (ensure pH value, partially applied, the remaining part is used in the other half of the compatibility);

[0070] See also Figure 3 , the aqueous phase preparation steps are as follows:

[0071] The first step is to add purified water to the main pot and control the temperature at 25-40℃ to ensure the stability of heat-sensitive ingredients;

[0072] Step 2: Add sodium hyaluronate and versicolor polysaccharide in sequence, stir until completely dissolved, and stir at a speed of 300-500 rpm for 10-15 minutes;

[0073] Step 3: Add EGCG (epigallocatechin gallate) and continue stirring at a low speed to ensure uniform dispersion. The stirring speed is 300-500 rpm and the stirring time is 10-15 minutes.

[0074] Step 4: Use lactic acid powder to adjust the pH value of the water phase to 4.5-5.5 to form a weakly acidic environment.

[0075] See also Figure 4 , the emulsification forming steps are as follows:

[0076] The first step is to slowly drop the water phase into the oil phase and stir at a low speed of 300-500 rpm for 10-15 minutes.

[0077] The second step is to add the premixed Tween 80 solution into the mixture and continue to stir evenly at a stirring speed of 300-500 rpm for 10-15 minutes;

[0078] The third step is to use a high shear homogenizer to emulsify for 3-5 minutes at a speed of 10000-15000 rpm to form a transparent or translucent microemulsion system;

[0079] Step 4: Use a laser particle size analyzer to measure the droplet size to ensure that the particle size is within the range of 10-200nm. If the particle size is uneven, adjust the homogenization time or shear speed;

[0080] See also Figure 5 , the integration and adjustment steps are as follows:

[0081] The first step is to cool the microemulsification system to 25-30°C;

[0082] The second step is to slowly drop the microemulsified system into the main material, and stir at a low speed to mix evenly, the stirring speed is 300-500rpm, and the time is controlled within 10-15 minutes;

[0083] Step 3: Fine-tune the final pH value to 5.0-5.5 with lactic acid powder or triethanolamine;

[0084] Step 4: Use a 0.22 μm filter membrane to remove impurities or undissolved components;

[0085] In summary, in this embodiment, the required equipment is as follows:

[0086] 1. High shear homogenizer (speed 10,000-15,000rpm);

[0087] 2. Heat the stirring pot (with temperature control function), the stirring speed is 300-500rpm, and the time is controlled within 10-15 minutes;

[0088] 3. Magnetic stirrer (suitable for low-speed stirring stage), stirring speed is 300-500rpm, and the time is controlled within 10-15 minutes;

[0089] 4. Laser particle size analyzer (to detect droplet size);

[0090] 5. pH meter (to adjust and monitor pH range);

[0091] In this embodiment:

[0092] 1. The temperature needs to be controlled within the range of 30-40°C, and the temperature of the oil phase and the water phase should be kept at **≤40°C** to avoid destroying the active ingredients (such as vitamin E, EGCG (epigallocatechin gallate)). Control it at 25-40°C to ensure the stability of heat-sensitive ingredients;

[0093] 2. Ensure uniform droplet size by adjusting the homogenization time (3-5 minutes) and shear speed (10,000-15,000 rpm);

[0094] 3. The entire microemulsification process must be carried out under light-proof conditions, especially for the parts containing EGCG (epigallocatechin gallate), vitamin E and other easily oxidized ingredients. Avoid photo-oxidation-induced degradation of ingredients;

[0095] 4. After preparation, stability tests (stratification, particle size distribution, appearance, pH change) are required to verify the emulsification effect, including stratification, particle size distribution, storage time test, including stratification, particle size distribution, storage conditions and long-term observation. In addition, the following stability tests are performed: (1) thermal stability: storage at 4°C, 25°C and 40°C, and observation for 6 months, (2) light stability: exposure to ultraviolet light and strong light environment;

[0096] And according to the properties and functions of each ingredient in the formula, the ingredients that do not require microemulsification treatment are sorted separately. The following is the analysis and process plan:

[0097] 1. Analysis of ingredients that do not require microemulsification;

[0098] 1. Ingredients that do not require microemulsification

[0099] The properties of these ingredients determine that they have good solubility or stability in aqueous solutions or formulation systems and do not require special treatment:

[0100] Complex fungal polysaccharides: water-soluble, directly dissolved in the water phase.

[0101] Centella asiatica extract: water-soluble, add directly into the aqueous phase.

[0102] Xylooligosaccharides: water-soluble, directly soluble in water phase.

[0103] Fucoidan Sulfate

[0104] Carbomer

[0105] Cecropin

[0106] D-Panthenol: Water-soluble, easily soluble in water phase.

[0107] Chlorhexidine gluconate: water-soluble, can be added directly as a preservative.

[0108] β-Glucan: water-soluble, has strong immunomodulatory effects, and can be directly dissolved.

[0109] Sodium hyaluronate: medium molecular weight, cosmetic grade, water soluble. (remainder)

[0110] Lactic acid: adjusts pH, water soluble.

[0111] Triethanolamine: adjust pH, water soluble.

[0112] Glycerin: A water-soluble humectant.

[0113] Chelating agent: water-soluble, enhances formula stability.

[0114] Phenoxyethanol

[0115] Potassium Sorbate

[0116] 2. Separately organized configuration process flow;

[0117] These ingredients constitute the aqueous phase and can be integrated with the microemulsion system after being separately formulated;

[0118] 2. Separate configuration process

[0119] 1. Preparation equipment

[0120] Preparation main pot: with heating and stirring functions. The stirring speed is 300-500rpm and the time is controlled within 10-15 minutes.

[0121] pH measuring equipment: pH meter.

[0122] Temperature control equipment: Ensure that the water phase temperature does not exceed 40°C. Control it at 25-40°C to ensure the stability of heat-sensitive components.

[0123] 2. Preparation process steps

[0124] Step 1: Prepare the solvent

[0125] 1. Add purified water to the main pot and control the temperature at 25-40℃ to ensure the stability of heat-sensitive ingredients.

[0126] Step 2: Dissolve the base ingredients

[0127] 1. While stirring, add the following ingredients in sequence, making sure each ingredient is completely dissolved before adding the next one: stirring speed is 300-500rpm, and the time is controlled within 10-15 minutes.

[0128] Complex fungal polysaccharides.

[0129] Centella asiatica extract.

[0130] Xylo-oligosaccharides.

[0131] Beta-glucan.

[0132] D-Panthenol.

[0133] Chlorhexidine gluconate.

[0134] glycerin.

[0135] Sodium hyaluronate.

[0136] EDTA. Etc.

[0137] Step 3: Adjust pH

[0138] 1. Based on the initial measured pH value, adjust the pH to the target range of 5.0 to 5.5 using lactic acid (0.5%-1%) and triethanolamine (0.6%-0.8%).

[0139] Step 4: Cool down and stir at a speed of 300-500 rpm for 10-15 minutes.

[0140] 1. Cool down to room temperature (about 25-30°C), continue stirring until the liquid is completely uniform, the stirring speed is 300-500rpm, and the time is controlled within 10-15 minutes.

[0141] 3. Integration of water phase process and microemulsification

[0142] 1. Integration of microemulsification system:

[0143] The aqueous phase is gradually added to the microemulsified system under stirring conditions, and slowly mixed until uniform. The stirring speed is 300-500 rpm, and the time is controlled within 10-15 minutes.

[0144] A low-speed stirrer or a spiral stirrer can be used to avoid destroying the stability of the microemulsion droplets. The stirring speed is 300-500 rpm and the time is controlled within 10-15 minutes.

[0145] 2. Post-integration quality control:

[0146] Test the pH of the final product (should be 5.0-5.5) and make minor adjustments if necessary.

[0147] Check for homogeneity, clarity and possible delamination.

[0148] Control the temperature below 30-40℃ to protect heat-sensitive components. Control the temperature at 25-40℃ to ensure the stability of heat-sensitive components.

[0149] Among them, the configuration of the final recipe is divided into the following two modules:

[0150] 1. Microemulsification system configuration:

[0151] It includes active ingredients that need to be microemulsified, such as the fusion of oil phase (water-insoluble ingredients) and water phase (EGCG (epigallocatechin gallate), fucoidan sulfate, etc.) to form a stable microemulsified particle size (10-200nm).

[0152] 2. Non-microemulsified ingredient configuration:

[0153] It includes water-soluble ingredients (such as sodium hyaluronate, Centella asiatica extract, D-panthenol, fungal polysaccharides, etc.) dissolved separately as the water phase base.

[0154] Finally, the two parts are combined under low shear conditions to form a complete formula;

[0155] In detail, after the microemulsified system and the non-microemulsified aqueous phase system are prepared separately, they need to be integrated through a reasonable mixing process to form a stable and uniform final product;

[0156] 1. The process objectives are as follows:

[0157] 1. Uniformity:

[0158] Ensure that the microemulsion system and water phase ingredients are fully mixed to avoid stratification or particle aggregation.

[0159] 2. Stability:

[0160] Protect the microemulsion droplet structure to prevent the destruction of its particle size distribution or stability during the mixing process.

[0161] 3. Suitable pH and texture:

[0162] Adjust the pH and texture of the final system to meet the target use requirements.

[0163] 2. The equipment required for mixing is as follows

[0164] 1. Low-speed agitator: The stirring speed is 300-500rpm, and the time is controlled within 10-15 minutes, such as magnetic agitator and propeller agitator, which are used to prevent severe shearing from destroying the droplet structure. The stirring speed is 300-500rpm, and the time is controlled within 10-15 minutes;

[0165] 2. pH meter:

[0166] Used to monitor pH during mixing to ensure it is within the target range (5.0-5.5).

[0167] 3. Temperature control equipment:

[0168] Maintain the mixing temperature at 25-40°C to avoid inactivation of heat-sensitive ingredients and ensure the stability of heat-sensitive ingredients.

[0169] 3. Process steps

[0170] 1. Raw material preparation

[0171] 1. Microemulsification system:

[0172] Ensure that the microemulsion system has been cooled to 25-30°C and the particle size distribution is uniform (10-200nm).

[0173] 2. Non-microemulsified aqueous phase system:

[0174] Ensure that the aqueous phase system has been prepared, the temperature is controlled at 25-40℃, there are no undissolved particles, and it is controlled at 25-40℃ to ensure the stability of heat-sensitive components.

[0175] 2. Preliminary mixing

[0176] 1. Joining order:

[0177] First add the water phase system into the main pot and keep stirring (300-500rpm). The stirring speed is 300-500rpm and the time is controlled within 10-15 minutes.

[0178] Slowly add the microemulsified system, stirring while adding to ensure that each part is completely mixed. The stirring speed is 300-500rpm and the time is controlled within 10-15 minutes.

[0179] 2. Stirring conditions: stirring speed is 300-500rpm, time is controlled within 10-15 minutes

[0180] The initial mixing stage uses low-speed stirring (300-500 rpm) to avoid destroying the microemulsion droplets. The stirring speed is 300-500 rpm and the time is controlled within 10-15 minutes.

[0181] 3. Homogenization

[0182] 1. Stirring enhancement: The stirring speed is 300-500rpm and the time is controlled within 10-15 minutes.

[0183] After low-speed mixing is completed, increase the stirring speed to 600-800rpm and stir for 5-10 minutes to ensure that the whole material is uniform.

[0184] 2. Temperature control requirements:

[0185] The temperature is always controlled at 25-40℃ to avoid degradation of heat-sensitive ingredients (such as EGCG (epigallocatechin gallate), Rg3 and RG2). Controlled at 25-40℃ to ensure the stability of heat-sensitive ingredients.

[0186] 4. pH adjustment

[0187] 1. Monitor pH:

[0188] The pH of the mixed system was measured in real time using a pH meter, with a target range of 5.0-5.5.

[0189] 2. Adjustment method:

[0190] If the pH is low, slowly add triethanolamine to adjust.

[0191] If the pH is too high, adjust it drop by drop with lactic acid to avoid excessive acidity causing degradation of ingredients.

[0192] 5. Texture adjustment

[0193] 1. Observe the texture:

[0194] Check whether the system shows stratification, particles or uneven emulsion droplets after mixing.

[0195] 2. Texture optimization:

[0196] If you need to increase the texture viscosity or improve the feel, you can adjust the concentration of sodium hyaluronate or carbomer appropriately to ensure that the final system is smooth.

[0197] 6. End point confirmation

[0198] 1. Quality inspection:

[0199] Particle size distribution: Ensure that the emulsion droplets are uniform and the particle size is between 10-200nm.

[0200] Appearance: The system should be uniform, transparent or translucent, without stratification or flocculation.

[0201] pH value: within the target range.

[0202] 2. Cooling and storage:

[0203] The final mixed system is cooled to room temperature and packaged into light-proof packaging containers to prevent the influence of light and oxygen and to avoid degradation of ingredients caused by photooxidation.

[0204] 4. Key points of the process

[0205] 1. Avoid severe shearing:

[0206] Avoid using high shear equipment during mixing to protect the microemulsion droplet structure.

[0207] 2. Mixing order:

[0208] The microemulsion system is always slowly added to the water phase to avoid the water phase directly impacting the microemulsion droplets.

[0209] 3.Precise pH adjustment:

[0210] Adjust drop by drop to avoid adding too much acid or alkali at one time, which will affect the stability of the system.

[0211] 4. Keep away from light during the whole process: avoid photo-oxidation and degradation of ingredients

[0212] For oxidation-sensitive ingredients such as EGCG (epigallocatechin gallate) and vitamin E, keep them away from light throughout the process to avoid degradation of ingredients caused by photooxidation;

[0213] After the product is produced, the mixed liquid is poured into a 3g syringe, the syringe is placed in an aluminum foil bag, and 1g of desiccant is added to the aluminum foil bag. After sealing, it is stored away from light. Appropriate packaging and storage conditions can extend the shelf life of the product, maintain the stability and efficacy of the ingredients, and avoid degradation of the ingredients caused by photooxidation.

[0214] Meanwhile, the contents not described in detail in this specification belong to the prior art known to those skilled in the art.

[0215] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0216] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A gynecological antibacterial gel for HPV in women, characterized by: The raw materials include by weight: Composite fungal polysaccharide 1%-5%, Centella asiatica extract 0.1%-1%, Versicolor extract 0.1%-1%, Green tea extract 0.1%-1%, Fucoidan sulfate 0.1%-0.8%, Ginsenoside rg3 by weight 0.1%-1%, Ginsenoside rg2 by weight 0.1%-1%, Betulin 0.1%-1%, Sophora japonica extract 0.1%-0.5%, Cecropin 0.1%-1%, Carbomer 0. .5%-1%, chlorhexidine gluconate 0.1%-0.2%, glycerol 3%, xylo-oligosaccharides 0.6%, sodium hyaluronate medium molecule 0.6%, hydrolyzed β-glucan 1.5%, D-panthenol 98%, provitamin B5 weight portion is 0.6%, vitamin C sodium ascorbate 0.3%, vitamin E 0.3%, lecithin 1%-2%, lactic acid powder 0.5%-1%, triethanolamine 0.4%-0.6%, Polysorbate 80 weight portion is 0.8%, polyethylene glycol 1%-2%, medium chain triglycerides 1%-2%.

2. The gynecological antibacterial gel for HPV in women according to claim 1, characterized in that: The invention also comprises a preservative, which is composed of 0.5%-0.8% phenoxyethanol and 0.3%-0.6% potassium sorbate. The Centella asiatica extract is total glycosides of Centella asiatica, and the concentrations of the total glycosides of Centella asiatica and the hydrolyzed beta-glucan are both 80%.

3. The gynecological antibacterial gel for HPV in women according to claim 1, characterized in that: The coriolus versicolor extract is coriolus versicolor polysaccharide, and the concentrations of the coriolus versicolor polysaccharide and the composite fungus polysaccharide are both 50%. The green tea extract is EGCG (epigallocatechin gallate), and the concentration of the EGCG (epigallocatechin gallate) is 98%.

4. The gynecological antibacterial gel for HPV in women according to claim 1, characterized in that: The sophora japonica extract is quercetin, the concentrations of quercetin and cecropin are both 98%, and the chlorhexidine gluconate is 99% aqueous solution of chlorhexidine gluconate.

5. The gynecological antibacterial gel for HPV in women according to claim 1, characterized in that: The concentration of the xylooligosaccharide is 95%, the lecithin is 99% hydrogenated soybean lecithin, the concentration of the lactic acid powder is 99%, and the vitamin C and vitamin E are both 99% food grade.

6. A preparation process of a gynecological antibacterial gel for HPV in women, characterized by: Here are the steps: The first step is to prepare the oil phase, which is used to dissolve the fat-soluble active ingredients and polyethylene glycol to form a stable oil phase; The second step is to prepare the aqueous phase, which is used to dissolve the water-soluble components and adjust to a weak acidity; The third step is premixing of surfactants to optimize the ratio of lecithin to Tween 80 to form a stable emulsified base; The fourth step is emulsification formation, which is used to control the droplet size; The fifth step, integration and adjustment, is used to integrate with the main material to form a stable final product.

7. The preparation process of a gynecological antibacterial gel for HPV in women according to claim 6, characterized in that: The oil phase ingredients include lecithin, Polysorbate 80, medium chain triglyceride (MCT), polyethylene glycol (PEG-400), vitamin E (α-tocopherol), ginsenoside Rg3, RG2, quercetin and betulin, and the oil phase preparation steps are as follows: In the first step, lecithin, PEG400 and Polysorbate 80 were fully mixed in the oil phase, and then medium-chain triglycerides (MCT) were gradually added to ensure uniform dispersion to form a stable microemulsion; The second step is to add MCT into the auxiliary pot and control the temperature at 25-40℃ to ensure the stability of heat-sensitive ingredients; The third step is to add vitamin E, Rg3, quercetin and betulin in sequence, stir at a speed of 300-500 rpm until completely dissolved, and the stirring time is 10-15 minutes.

8. The preparation process of a gynecological antibacterial gel for HPV in women according to claim 6, characterized in that: The aqueous phase ingredients include 80%-85% purified water, sodium hyaluronate, Coriolus versicolor polysaccharide, EGCG (epigallocatechin gallate), vitamin C (sodium ascorbate) and lactic acid powder; The aqueous phase preparation steps are as follows: The first step is to add purified water to the main pot and control the temperature at 25-40℃ to ensure the stability of heat-sensitive ingredients; Step 2: Add sodium hyaluronate and versicolor polysaccharide in sequence, stir until completely dissolved, and stir at a speed of 300-500 rpm for 10-15 minutes; Step 3: Add EGCG (epigallocatechin gallate) and continue stirring at a low speed to ensure uniform dispersion. The stirring speed is 300-500 rpm and the stirring time is 10-15 minutes. The fourth step is to use lactic acid powder to adjust the pH value of the water phase to 4.5-5.5 to form a weakly acidic environment.

9. The preparation process of a gynecological antibacterial gel for HPV in women according to claim 6, characterized in that: The emulsification forming steps are as follows: The first step is to slowly drop the water phase into the oil phase and stir at a low speed of 300-500 rpm for 10-15 minutes. The second step is to add the premixed Tween 80 solution into the mixture and continue to stir evenly at a stirring speed of 300-500 rpm for 10-15 minutes; The third step is to use a high shear homogenizer to emulsify for 3-5 minutes at a speed of 10000-15000 rpm to form a transparent or translucent microemulsion system; The fourth step is to use a laser particle size analyzer to detect the droplet size to ensure that the particle size is within the range of 10-200nm. If the particle size is uneven, adjust the homogenization time or shear speed.

10. The preparation process of a gynecological antibacterial gel for HPV in women according to claim 6, characterized in that: The integration and adjustment steps are as follows: The first step is to cool the microemulsification system to 25-30°C; The second step is to slowly drop the microemulsified system into the main material, and stir at a low speed to mix evenly, the stirring speed is 300-500rpm, and the time is controlled within 10-15 minutes; Step 3: Fine-tune the final pH value to 5.0-5.5 with lactic acid powder or triethanolamine; The fourth step is to use a 0.22 μm filter membrane to remove impurities or undissolved components.

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