Gynecological probiotic maintenance gel containing natural compound prebiotics and plant extracts and preparation method of gynecological probiotic maintenance gel

Abstract

The invention relates to the technical field of gynecological external nursing products for improving ecological balance of private parts of women, in particular to gynecological probiotic nursing gel containing natural compound prebiotics and plant extracts and a preparation method of the gynecological probiotic nursing gel. The traditional Chinese medicine is used for maintaining and recovering micro-ecological balance and self-cleaning function of female private parts, warming meridians and nourishing uterus, and repairing wounds. The gel is prepared from the following raw materials in parts by weight: natural compound prebiotics, a plant extract, biotin, a humectant, a solubilizer, a gel matrix and purified water. The natural compound prebiotics are prepared by mixing codonopsis pilosula, burdock root, astragalus membranaceus, liquorice and isomaltooligosacharide, extracting and concentrating; the plant extracts comprise zedoary turmeric oil, agilawood oil, frankincense oil, Chinese mugwort oil, centella asiatica extract, raspberry extract and fructus cnidii extract; the composition is prepared by a certain preparation method.

Description

Technical Field

[0001] This invention relates to the technical field of gynecological external care products for restoring and improving the ecological balance of the female private parts, specifically to a gynecological probiotic and nourishing gel made of natural compound prebiotics and plant extracts and its preparation method. Background Technology

[0002] The vagina of a normal woman is a complex micro-ecosystem. The beneficial bacteria in the female private parts, especially the probiotics mainly composed of lactobacilli, play a vital role in women's reproductive health, mainly including the following aspects:

[0003] 1. Maintain vaginal microecological balance

[0004] Probiotics produce lactic acid through metabolism, maintaining the vaginal environment at a slightly acidic level (pH 3.8–4.5). This acidic environment inhibits the growth and reproduction of harmful bacteria. At the same time, the probiotic flora occupy the surface of the vaginal mucosa, forming a biological barrier that prevents harmful bacteria from adhering and colonizing, thereby maintaining the dynamic balance of the vaginal flora.

[0005] 2. Prevent vaginal infections

[0006] Some probiotics can secrete antibacterial substances such as bacteriocins and hydrogen peroxide, which directly inhibit the growth of pathogenic bacteria such as Candida albicans and Gardnerella vaginalis. For example, Lactobacillus reuteri and Lactobacillus rhamnosus can reduce the risk of recurrence of bacterial vaginosis and vulvovaginal candidiasis.

[0007] 3. Relieves inflammatory response

[0008] Probiotics competitively adhere to the vaginal mucosa, reducing the inflammatory response caused by pathogen invasion. Simultaneously, they may regulate the activity of local immune cells, alleviating discomfort such as itching and redness, and promoting the repair of damaged mucosa.

[0009] 4. Regulate local immunity

[0010] Probiotics can interact with vaginal epithelial cells, enhancing the mucosal barrier function. They can also stimulate the production of secretory immunoglobulin A, improving the vagina's defense against pathogens and reducing the probability of recurrent infections.

[0011] 5. Helps improve urinary tract health

[0012] The vagina and urethra are anatomically close, and an imbalance in the vaginal flora may increase the risk of urinary tract infections. Supplementing with probiotics helps maintain the overall stability of the urogenital microenvironment and reduces the colonization of pathogenic bacteria such as E. coli.

[0013] 6. Traditional Chinese medicine often says that "nine out of ten women suffer from coldness in the uterus." Women often suffer from yin deficiency and uterine coldness due to factors such as menstruation, vaginal discharge, and childbirth. Warming the meridians and nourishing the uterus can help them recover and maintain a healthy state.

[0014] Currently, the main types of gynecological care products on the market are as follows:

[0015] 1. Antibiotics: Used to treat infections caused by specific pathogens, but they can be resistant and disrupt the balance of normal flora (including lactobacilli), leading to dysbiosis of the vaginal flora.

[0016] 2. Probiotic preparations: These directly supplement exogenous lactobacilli. The activity of these preparations is easily damaged during production, storage, and transportation, and the colonization effect varies from person to person. Furthermore, exogenous probiotics introduced into the genital area may compete with and exclude endogenous probiotics, hindering the formation of a probiotic mucosal barrier and impeding the development of a normal microecological environment in the genital area.

[0017] 3. Chemical washes: Overuse can disrupt the normal pH balance and bacterial flora of the vagina.

[0018] 4. Regular moisturizing gel: It can only provide physical moisturization and does not help regulate and maintain the microecology of the private parts.

[0019] 5. Prebiotic preparations alone: ​​do not have the effects of warming the meridians or uterus.

[0020] Therefore, there is an urgent need in this field for a gynecological care product that can selectively promote the growth of beneficial bacteria (such as lactobacilli) in the vagina, inhibit harmful bacteria, and is safe, non-irritating, and has the effects of warming the meridians, soothing the uterus, and repairing the body.

[0021] The patent, with publication number CN 108815274A and titled "Fujie Nourishing and Antibacterial Gel and its Preparation Method and Application," discloses that each 100g of gel contains 5-15g of traditional Chinese medicine extract, 0.01-0.1g of alum, 0.5-2g of borneol, and 0.01-0.1g of chlorhexidine acetate, with the remainder being water. The traditional Chinese medicine extract is derived from Cnidium monnieri, Phellodendron chinense, Sophora flavescens, Scutellaria baicalensis, Rheum palmatum, and Melia toosendan bark. Patent publication number CN 112999289A, entitled "A Gynecological Antibacterial Gel and Its Preparation Method," discloses a gynecological antibacterial gel comprising the following components in parts by weight: 25-35 parts of plant extract; 0.15-0.2 parts of polyhexamethylene biguanide; 9-11 parts of glycerin; 9-11 parts of hasma oil; 9-11 parts of rose essential oil; 14-16 parts of triethanolamine; 18-22 parts of carbomer; 18-22 parts of Tween-80; 2.5-3.5 parts of ethylparaben; and 900-1100 parts of purified water. The raw materials of the plant extract include the following components in parts by weight: 90-110 parts of Sophora flavescens; 90-110 parts of Phellodendron chinense; 90-110 parts of Cnidium monnieri; 70-90 parts of Galla chinensis; and 2.5-3.5 parts of saffron. The above-mentioned products all belong to the antibacterial gel category. Chlorhexidine acetate and polyhexamethylene biguanide are disinfectants, and ethylparaben is a preservative. The application of these chemically synthesized bactericides and preservatives in feminine hygiene products kills not only pathogens and harmful bacteria in the vagina, but also beneficial bacteria (which are the vagina's natural barrier against various pathogens and viruses). This disrupts the vaginal flora balance, causing the vagina to lose its natural self-cleaning function and defense capabilities. Furthermore, long-term use can damage the vaginal skin and mucous membranes, and even cause technical problems such as tissue hyperplasia. In addition, the antibacterial and antipruritic effects are poor. Summary of the Invention

[0022] In view of this, the present invention provides a gynecological probiotic and nourishing gel of natural compound prebiotics and plant extracts and its preparation method, which is used to maintain and restore the microecological balance and self-cleaning function of the female private parts, warm the meridians and nourish the uterus, and repair wounds.

[0023] To solve the above problems, the technical solution adopted by the present invention is as follows: a gynecological probiotic and nourishing gel of natural compound prebiotics and plant extracts comprises the following raw materials in parts by weight: 5-36 parts of natural compound prebiotics, 1-5 parts of plant extracts, 0.00001-0.01 parts of biotin, 8-20 parts of moisturizer, 0.2-0.5 parts of solubilizer, 1-5 parts of gel matrix, and 33-85 parts of purified water.

[0024] Furthermore, the natural compound prebiotic includes the following ingredients by weight: 1.5-8 parts Codonopsis pilosula, 1.5-10 parts Arctium lappa root, 0.5-5 parts Astragalus membranaceus, 0.5-5 parts Glycyrrhiza uralensis, and 1-8 parts isomaltooligosaccharide.

[0025] Furthermore, the plant extract includes the following raw materials in parts by weight: 0.18-0.75 parts of Curcuma zedoaria oil, 0.15-0.75 parts of Aquilaria sinensis oil, 0.1-0.5 parts of Frankincense oil, 0.05-0.25 parts of Artemisia argyi oil, 0.2-1 parts of Centella asiatica extract, 0.2-1 parts of Raspberry extract, and 0.12-0.75 parts of Cnidium monnieri extract.

[0026] Furthermore, the gel matrix is ​​carbomer or cellulose.

[0027] Furthermore, the moisturizer is glycerin or butylene glycol.

[0028] Furthermore, the solubilizer is a polysorbate.

[0029] A method for preparing a gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts includes the following steps:

[0030] 1) Preparation of natural compound prebiotics: Codonopsis pilosula, burdock root, Astragalus membranaceus, licorice, and isomaltooligosaccharide are mixed and then purified water is added for extraction and concentration for later use.

[0031] 2) Disperse the gel matrix in purified water, then add a humectant, and wait for complete swelling to form phase A;

[0032] 3) Dissolve Centella asiatica extract, raspberry extract and Cnidium monnieri extract in purified water, let stand and filter, add biotin to the filtrate and stir to dissolve to form phase B;

[0033] 4) Add solubilizer and purified water to Curcuma zedoaria oil, agarwood oil, frankincense oil, Artemisia argyi oil, and stir evenly to form phase C;

[0034] 5) Mix phase B and phase c evenly, then add the natural compound prebiotic from step 1) and mix evenly to form phase D;

[0035] 6) Add phase D to phase A and mix thoroughly;

[0036] 7) Adjust the pH of the mixture to 3.8–4.5;

[0037] 8) Add purified water to the total volume and homogenize;

[0038] 9) Dispensing and sterilization.

[0039] Compared with the prior art, the beneficial effects of the present invention are:

[0040] 1) Highly targeted: This invention combines natural compound prebiotics with carefully selected plant extracts that have the effects of warming the meridians and nourishing the uterus, repairing wounds, regulating qi and relieving itching. Its nourishing effect is superior to that of prebiotics alone or pure plant extracts. The natural compound prebiotics used can selectively provide "food" for the vagina's own native beneficial bacteria (such as lactobacilli), effectively promoting the proliferation, colonization and acid production of native beneficial bacteria (such as lactobacilli) in the vagina, inhibiting the growth of harmful bacteria, restoring the microecological balance, warming the meridians and nourishing the uterus, regulating qi and relieving itching, and is highly safe.

[0041] 2) Restoring the microecology: The formula of this invention can promote the proliferation of endogenous beneficial bacteria in the private parts, fundamentally helping to restore and maintain a healthy vaginal microecological balance and self-cleaning function, and improve its own defense capabilities.

[0042] 3) High safety: The invention uses pure natural compound prebiotics and plant extracts, which are mild in composition and do not contain antibiotics, hormones or chemically synthesized bactericides and preservatives. The pH value is consistent with the healthy vaginal environment, avoiding secondary damage to the normal flora. Detailed Implementation

[0043] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. It should be understood that the following embodiments are only used to explain the present invention and are not intended to limit the present invention.

[0044] This invention utilizes a concentrated aqueous extract of a mixture of Codonopsis pilosula, burdock root, Astragalus membranaceus, Glycyrrhiza uralensis, and isomaltooligosaccharide. Furthermore, Centella asiatica, raspberry extract, and biotin exhibit synergistic effects with the prebiotics, promoting the proliferation and colonization of beneficial bacteria in the female genital area, inhibiting the growth of various pathogenic bacteria, maintaining the mucosal barrier of the genital area to resist the invasion of external pathogens, and enhancing the self-cleaning and defense functions of the genital area. Plant extracts (including Curcuma zedoaria oil, Aquilaria sinensis oil, Frankincense oil, Artemisia argyi oil, Centella asiatica extract, raspberry extract, and Cnidium monnieri extract) have effects such as warming the meridians and nourishing the uterus, regulating qi and relieving itching, promoting tissue repair and wound healing.

[0045] Example 1:

[0046] A gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts comprises the following ingredients in parts by weight: 5 parts natural compound prebiotics, 1 part plant extracts, 0.00001 parts biotin, 8 parts glycerin, 0.2 parts polysorbate 60, 1 part carbomer, and 85 parts purified water.

[0047] The natural compound prebiotics consist of 1.5 parts Codonopsis pilosula, 1.5 parts Arctium lappa root, 0.5 parts Astragalus membranaceus, 0.5 parts Glycyrrhiza uralensis, and 1 part isomaltooligosaccharide.

[0048] The plant extracts are 0.18 parts of Curcuma zedoaria oil, 0.15 parts of Aquilaria sinensis oil, 0.1 parts of Frankincense oil, 0.05 parts of Artemisia argyi oil, 0.2 parts of Centella asiatica extract, 0.2 parts of Raspberry extract, and 0.12 parts of Cnidium monnieri extract.

[0049] A method for preparing a gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts includes the following steps:

[0050] 1) Preparation of natural compound prebiotics: Codonopsis pilosula, burdock root, Astragalus membranaceus, Glycyrrhiza uralensis, and isomaltooligosaccharide are mixed and then purified water is added for extraction and concentration for later use.

[0051] 2) Disperse carbomer in purified water, then add glycerol, and wait for complete swelling to form phase A;

[0052] 3) Dissolve Centella asiatica extract, raspberry extract and Cnidium monnieri extract in purified water, let stand and filter, add biotin to the filtrate and stir to dissolve to form phase B;

[0053] 4) Add turmeric oil, agarwood oil, frankincense oil, and Artemisia argyi oil to polysorbate 60 and purified water, mix and stir evenly to form phase C;

[0054] 5) Mix phase B and phase c evenly, then add the natural compound prebiotic from step 1) and mix evenly to form phase D;

[0055] 6) Add phase D to phase A and mix thoroughly;

[0056] 7) Adjust the pH of the mixture to 3.8;

[0057] 8) Add water to the total volume and homogenize;

[0058] 9) Dispensing and sterilization.

[0059] Example 2:

[0060] A gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts comprises the following raw materials in parts by weight: 36 parts natural compound prebiotics, 5 parts plant extracts, 0.01 parts biotin, 20 parts butylene glycol, 0.5 parts polysorbate, 5 parts cellulose, and 33 parts purified water.

[0061] The natural compound prebiotics consist of 8 parts Codonopsis pilosula, 10 parts Arctium lappa root, 5 parts Astragalus membranaceus, 5 parts Glycyrrhiza uralensis, and 8 parts isomaltooligosaccharide.

[0062] The plant extracts are 0.75 parts of Curcuma zedoaria oil, 0.75 parts of Aquilaria sinensis oil, 0.5 parts of Frankincense oil, 0.25 parts of Artemisia argyi oil, 1 part of Centella asiatica extract, 1 part of Raspberry extract, and 0.75 parts of Cnidium monnieri extract.

[0063] A method for preparing a gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts includes the following steps:

[0064] 1) Preparation of natural compound prebiotics: Codonopsis pilosula, burdock root, Astragalus membranaceus, Glycyrrhiza uralensis, and isomaltooligosaccharide are mixed and then purified water is added for extraction and concentration for later use.

[0065] 2) Disperse cellulose in purified water, then add butanediol, and wait for complete swelling to form phase A;

[0066] 3) Dissolve Centella asiatica extract, raspberry extract and Cnidium monnieri extract in purified water, let stand and filter, add biotin to the filtrate and stir to dissolve to form phase B;

[0067] 4) Add turmeric oil, agarwood oil, frankincense oil, and Artemisia argyi oil to polysorbate 20 and purified water, and mix thoroughly to form phase C:

[0068] 5) Mix phase B and phase c evenly, then add the natural compound prebiotic from step 1) and mix evenly to form phase D;

[0069] 6) Add phase D to phase A and mix thoroughly;

[0070] 7) Adjust the pH of the mixture to 3.9;

[0071] 8) Add water to the total volume and homogenize;

[0072] 9) Dispensing and sterilization.

[0073] Example 3:

[0074] A gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts comprises the following raw materials in parts by weight: 7 parts natural compound prebiotics, 2 parts plant extracts, 0.00035 parts biotin, 7 parts butylene glycol, 0.2 parts polysorbate ester, 1.5 parts carbomer, and 82 parts purified water.

[0075] The natural compound prebiotics consist of 1.6 parts Codonopsis pilosula, 2 parts Arctium lappa root, 1 part Astragalus membranaceus, 0.9 parts Glycyrrhiza uralensis, and 1.5 parts isomaltooligosaccharide.

[0076] The plant extracts are 0.25 parts of Curcuma zedoaria oil, 0.23 parts of Aquilaria sinensis oil, 0.3 parts of Frankincense oil, 0.1 parts of Artemisia argyi oil, 0.8 parts of Centella asiatica extract, 0.6 parts of Raspberry extract, and 0.24 parts of Cnidium monnieri extract.

[0077] A method for preparing a gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts includes the following steps:

[0078] 1) Preparation of natural compound prebiotics: Codonopsis pilosula, burdock root, Astragalus membranaceus, Glycyrrhiza uralensis, and isomaltooligosaccharide are mixed and then purified water is added for extraction and concentration for later use.

[0079] 2) Disperse carbomer in purified water, then add butanediol, and wait for complete swelling to form phase A;

[0080] 3) Dissolve Centella asiatica extract, raspberry extract and Cnidium monnieri extract in purified water, let stand and filter, add biotin to the filtrate and stir to dissolve to form phase B;

[0081] 4) Add turmeric oil, agarwood oil, frankincense oil, and Artemisia argyi oil to polysorbate 20 and purified water, and mix thoroughly to form phase C:

[0082] 5) Mix phase B and phase c evenly, then add the natural compound prebiotic from step 1) and mix evenly to form phase D;

[0083] 6) Add phase D to phase A and mix thoroughly;

[0084] 7) Adjust the pH of the mixture to 4;

[0085] 8) Add water to the total volume and homogenize;

[0086] 9) Dispensing and sterilization.

[0087] Example 4:

[0088] A gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts comprises the following ingredients in parts by weight: 14 parts natural compound prebiotics, 4 parts plant extracts, 0.0086 parts biotin, 10 parts glycerin, 0.4 parts polysorbate 80, 2 parts carbomer, and 70 parts purified water.

[0089] The natural compound prebiotics consist of 3.2 parts Codonopsis pilosula, 3.9 parts Arctium lappa root, 2 parts Astragalus membranaceus, 1.9 parts Glycyrrhiza uralensis, and 3 parts isomaltooligosaccharide.

[0090] The plant extracts are 0.65 parts of Curcuma zedoaria oil, 0.45 parts of Aquilaria sinensis oil, 0.35 parts of Frankincense oil, 0.15 parts of Artemisia argyi oil, 0.9 parts of Centella asiatica extract, 0.7 parts of Raspberry extract, and 0.55 parts of Cnidium monnieri extract.

[0091] A method for preparing a gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts includes the following steps:

[0092] 1) Preparation of natural compound prebiotics: Codonopsis pilosula, burdock root, Astragalus membranaceus, Glycyrrhiza uralensis, and isomaltooligosaccharide are mixed and then purified water is added for extraction and concentration for later use.

[0093] 2) Disperse carbomer in purified water, then add glycerol, and wait for complete swelling to form phase A;

[0094] 3) Dissolve Centella asiatica extract, raspberry extract and Cnidium monnieri extract in purified water, let stand and filter, add biotin to the filtrate and stir to dissolve to form phase B;

[0095] 4) Add turmeric oil, agarwood oil, frankincense oil, and Artemisia argyi oil to polysorbate 80 and purified water, mix and stir evenly to form phase C;

[0096] 5) Mix phase B and phase c evenly, then add the natural compound prebiotic from step 1) and mix evenly to form phase D;

[0097] 6) Add phase D to phase A and mix thoroughly;

[0098] 7) Adjust the pH of the mixture to 3.8;

[0099] 8) Add water to the total volume and homogenize;

[0100] 9) Dispensing and sterilization.

[0101] Example 5:

[0102] A gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts comprises the following raw materials in parts by weight: 28 parts natural compound prebiotics, 4 parts plant extracts, 0.00058 parts biotin, 12 parts butylene glycol, 0.4 parts polysorbate, 4 parts cellulose, and 52 parts purified water.

[0103] The natural compound prebiotics consist of 6.5 parts Codonopsis pilosula, 7.9 parts Arctium lappa root, 3.8 parts Astragalus membranaceus, 3.8 parts Glycyrrhiza uralensis, and 6 parts isomaltooligosaccharide.

[0104] The plant extracts are 0.6 parts of Curcuma zedoaria oil, 0.6 parts of Aquilaria sinensis oil, 0.3 parts of Frankincense oil, 0.2 parts of Artemisia argyi oil, 0.5 parts of Centella asiatica extract, 0.5 parts of Raspberry extract, and 0.5 parts of Cnidium monnieri extract.

[0105] The preparation method of a gynecological probiotic and health care gel containing natural compound prebiotics and plant extracts is the same as that in Example 2.

[0106] Example 6:

[0107] A gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts comprises the following ingredients in parts by weight: 9 parts natural compound prebiotics, 5 parts plant extracts, 0.01 parts biotin, 9 parts glycerin, 0.45 parts polysorbate ester, 4 parts cellulose, and 73 parts purified water.

[0108] The natural compound prebiotics consist of 2.1 parts Codonopsis pilosula, 2.5 parts Arctium lappa root, 1.2 parts Astragalus membranaceus, 1.2 parts Glycyrrhiza uralensis, and 2 parts isomaltooligosaccharide.

[0109] The plant extracts are 0.7 parts of Curcuma zedoaria oil, 0.7 parts of Aquilaria sinensis oil, 0.3 parts of Frankincense oil, 0.2 parts of Artemisia argyi oil, 0.9 parts of Centella asiatica extract, 0.9 parts of Raspberry extract, and 0.7 parts of Cnidium monnieri extract.

[0110] A method for preparing a gynecological probiotic and nourishing gel containing natural compound prebiotics and plant extracts includes the following steps:

[0111] 1) Preparation of natural compound prebiotics: Codonopsis pilosula, burdock root, Astragalus membranaceus, Glycyrrhiza uralensis, and isomaltooligosaccharide are mixed and then purified water is added for extraction and concentration for later use.

[0112] 2) Disperse cellulose in purified water, then add glycerol, and wait for complete swelling to form phase A;

[0113] 3) Dissolve Centella asiatica extract, raspberry extract and Cnidium monnieri extract in purified water, let stand and filter, add biotin to the filtrate and stir to dissolve to form phase B;

[0114] 4) Add turmeric oil, agarwood oil, frankincense oil, and Artemisia argyi oil to polysorbate 60 and purified water, and mix thoroughly to form phase C:

[0115] 5) Mix phase B and phase c evenly, then add the natural compound prebiotic from step 1) and mix evenly to form phase D;

[0116] 6) Add phase D to phase A and mix thoroughly;

[0117] 7) Adjust the pH of the mixture to 4.2;

[0118] 8) Add water to the total volume and homogenize;

[0119] 9) Dispensing and sterilization.

[0120] The sensory and physicochemical properties of the gel of this invention are shown in Table 1.

[0121] Table 1

[0122]

[0123] The microbiological indicators of the gel of this invention are shown in Table 2.

[0124] Table 2

[0125]

[0126] Functional tests (lactic acid bacteria enrichment tests) were conducted using Example 3 of this study.

[0127] I. Equipment 2

[0128] 1. Sample 3: Gel.

[0129] 2. Test strain: Lactobacillus rhamnosus ATCC7469, cultured for 3 generations, provided by China Culture Collection Center.

[0130] 3. MRS culture medium was provided by Beijing Luqiao Technology Co., Ltd.

[0131] 4. 0.85% physiological saline, 0.03 mol / L phosphate buffered solution (PBS),

[0132] 5. Sterile graduated pipettes, sterile petri dishes, sterile test tubes, constant temperature incubators, etc.

[0133] II. Methods

[0134] 1. Sample Preparation: Test Sample: Aseptically place 25g of the test sample into a sterile glass bottle containing 225ml of diluent (NaCl-tryptone) (with an appropriate number of glass beads pre-placed in the bottle) or a sterile homogenizing bag, mix thoroughly to prepare a 1:10 homogeneous dilution, and use it as the sample group. Blank Sample: Aseptically place 25g of the test sample into a sterile glass bottle containing 225ml of diluent (NaCl-tryptone) (with an appropriate number of glass beads pre-placed in the bottle) or a sterile homogenizing bag, mix thoroughly to prepare a 1:10 homogeneous dilution, and use it as the blank sample group. Positive Control: Take 250ml of diluent (NaCl-tryptone) as the positive control, and conduct the test according to GB 4789.35~2023 "National Food Safety Standard for Microbiological Examination of Food - Examination of Lactic Acid Bacteria" and Q / HRB013~2025.

[0135] 2. Wash the 24-hour slant culture of the test bacteria with PBS to prepare a bacterial suspension (concentration of 100 CFU / mL to 1000 CFU / mL). Take 1 mL of the above bacterial suspension and add it to the sample group, control group and blank sample group respectively. Mix well, start timing, and let it act for 20 minutes. Then count the viable bacteria.

[0136] III. Results

[0137] In Example 3 of this invention, after 20 minutes of application, the product achieved a 42.86% increase in lactic acid bacteria, as shown in Table 3, demonstrating its synergistic effect.

[0138] Table 3. Enrichment rate of lactic acid bacteria by the product in Example 3 of this invention.

[0139]

[0140] Note: No bacterial growth was observed in the negative control group.

[0141] Functional tests (lactic acid bacteria enrichment test) and stability tests were conducted using Example 3.

[0142] I. Equipment

[0143] 1. Sample 3: Gel.

[0144] 2. Test strain: Lactobacillus rhamnosus ATCC7469, cultured for 3 generations, provided by China Culture Collection Center.

[0145] 3. MRS culture medium was provided by Beijing Luqiao Technology Co., Ltd.

[0146] 4. 0.85% physiological saline, 0.03 mol / L phosphate buffer solution (PBS).

[0147] 5. Sterile graduated pipettes, sterile petri dishes, sterile test tubes, constant temperature incubators, etc.

[0148] II. Methods

[0149] 1. Sample Preparation: The samples were subjected to enrichment stability test conditions (temperature 37℃, storage for 90 days). Test Samples: Under aseptic conditions, 25g of the sample was placed in a sterile glass bottle containing 225ml of diluent (NaCl-tryptone) (with an appropriate number of glass beads pre-placed in the bottle) or a sterile homogenizing bag, and thoroughly mixed to prepare a 1:10 homogeneous dilution. Blank Samples: Under aseptic conditions, 25g of the sample was placed in a sterile glass bottle containing 225ml of diluent (NaCl-tryptone) (with an appropriate number of glass beads pre-placed in the bottle) or a sterile homogenizing bag, and thoroughly mixed to prepare a 1:10 homogeneous dilution. Positive Control: 250ml of diluent (NaCl-tryptone) was used as a positive control, according to GB 4789.35~2023 "National Food Safety Standard - Microbiological Examination of Food - Examination of Lactic Acid Bacteria" and Q / HRB 013~2025.

[0150] 2. Wash the 24-hour slant culture of the test bacteria with PBS to prepare a bacterial suspension (concentration of 100 CFU / mL to 1000 CFU / mL). Take 1 mL of the above bacterial suspension and add it to the sample group, control group and blank sample group respectively. Mix well, start timing, and let it act for 20 minutes before counting the viable bacteria.

[0151] In Example 3 of this invention, under the stability test conditions (after 90 days of storage), the product was applied for 20 minutes, and the enrichment rate of lactic acid bacteria reached 66.67%, as shown in Table 4, proving that it has a bacterial enrichment effect.

[0152] Table 4. Enrichment rate of lactic acid bacteria by the product in Example 3 of this invention.

[0153]

[0154] Note: No bacterial growth was observed in the negative control group.

[0155] The diagram shows the irritation test of the gel on the vaginal mucosa of rabbits in Example 3 of this invention.

[0156] I. Materials and Methods

[0157] 1. Test substance: The gel in Example 3 of the present invention.

[0158] 2. Experimental animals: Six New Zealand rabbits were provided by Shaanxi Junxing Biotechnology Co., Ltd., with half males and half females, weighing 2.0 - 2.5 kg, first-class animals, production license number: SCXK(Shaan)2022 - 01, and the feed source is the same as above.

[0159] 3. Animal room environment: Temperature: 22 - 25°C, relative humidity: 45% - 55%, use license number: SYXK(Shaan)2023 - 005.

[0160] II. Vaginal Mucosa Irritation Test

[0161] 1. Test basis: The experiment was conducted according to the method in item 2.3.5 of the "Disinfection Technical Specification" (2002 edition) of the Ministry of Health.

[0162] 2. Dosage of test substance: 2 g / rabbit.

[0163] 3. Test method: Six non-estrus New Zealand rabbits were randomly divided into two groups, namely the test substance group and the control group, with 3 rabbits in each group. During the test, the animals were fixed in a supine position. In the test substance group, 2 g of the test substance was injected into the vagina per rabbit, and in the control group, the same volume of normal saline was given. The animals were fixed in a supine position for 4 hours to allow the test substance to fully contact the vaginal mucosa. After the test, the animals were returned to the cage for feeding. After 24 hours, the animals were sacrificed and the vaginal tissues were taken out. The phenomena such as vascular congestion and edema were carefully observed macroscopically. If there were changes, histological examinations were performed.

[0164] III. Results: After observation, the vaginal mucosa of the rabbits in the test substance group was normal in morphology, without congestion or swelling (the results are shown in Table 5).

[0165] Table 5

[0166]

[0167] IV. Conclusion: According to the grading standard of vaginal mucosa irritation reaction in the "Disinfection Technical Specification" (2002 edition) of the Ministry of Health, the gel in Example 3 of this embodiment has no irritation to the vaginal mucosa of rabbits, meeting the relevant requirements of the "Disinfection Technical Specification" (2002 edition).

[0168] The above are only the preferred embodiments of the present invention, and do not impose any form of limitation on the present invention. Any simple modification, equivalent change, and modification made to the above embodiments based on the technical essence of the present invention still fall within the protection scope of the technical solution of the present invention.

Claims

1. A natural composite prebiotic and phytoextracts gynecological prebiotic care gel, characterized in that, The gel comprises the following raw materials by weight: natural composite prebiotics 5-36 parts, plant extract 1-5 parts, biotin 0.00001-0.01 parts, humectant 8-20 parts, solubilizer 0.2-0.5 parts, gel base 1-5 parts, and purified water 33-85 parts.

2. A natural composite prebiotic and plant extract based gynecological prebiotic care gel as claimed in claim 1, wherein, The natural composite prebiotics comprises the following raw materials by weight: radix codonopsis 1.5-8 parts, burdock root 1.5-10 parts, radix astragali 0.5-5 parts, radix glycyrrhizae 0.5-5 parts, and isomaltooligosaccharide 1-8 parts.

3. A natural composite prebiotic and plant extract based gynecological prebiotic care gel as claimed in claim 1, wherein, The plant extract comprises the following raw materials by weight: zedoary oil 0.18-0.75 parts, linaloe oil 0.15-0.75 parts, frankincense oil 0.1-0.5 parts, badiotti oil 0.05-0.25 parts, centella asiatica extract 0.2-1 parts, raspberry extract 0.2-1 parts, and cnidium fruit extract 0.12-0.75 parts.

4. The natural composite prebiotic and plant extract based gynecological prebiotic care gel as claimed in claim 1, wherein, The gel base is carbomer or cellulose.

5. A natural composite prebiotic and plant extract based gynecological prebiotic care gel as claimed in claim 4, wherein, The humectant is glycerol or butylene glycol.

6. A natural composite prebiotic and plant extract gynecological prebiocare gel according to claim 5, characterized in that, The solubilizer is polysorbate.

7. A process for the preparation of a natural composite prebiotic and plant extract based gynecological prebiotic care gel as claimed in claim 1, wherein, The method comprises the following steps: 1) Preparation of natural composite prebiotics: radix codonopsis, burdock root, radix astragali, radix glycyrrhizae, and isomaltooligosaccharide are mixed, and then purified water is added for extraction and concentration; 2) The gel base is dispersed in purified water, and then a humectant is added, and the mixture is swelled to form phase A; 3) Centella asiatica extract, raspberry extract, and cnidium fruit extract are dissolved in purified water, and then the mixture is filtered and left to stand, and then biotin is added to the filtrate and stirred to form phase B; 4) Zedoary oil, linaloe oil, frankincense oil, and badiotti oil are added to a solubilizer and purified water, and then the mixture is stirred to form phase C; 5) Phase B and phase C are mixed, and then the natural composite prebiotics of step 1) is added and mixed to form phase D; 6) Phase D is added to phase A and mixed; 7) The pH value of the mixture is adjusted to 3.8-4.5; 8) Purified water is added to the full amount, and then the mixture is homogenized; 9) The mixture is packaged, sterilized, and then stored.

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