Female bacteriostatic agent with Chinese herbal medicine extract and preparation method thereof

Abstract

The invention belongs to the technical field of antibacterial care products, and relates to a female bacteriostatic agent with Chinese herbal medicine extracts and a preparation method of the female bacteriostatic agent. The female bacteriostatic agent with the Chinese herbal medicine extract comprises the following raw materials in parts by weight: 3-8 parts of the Chinese herbal medicine extract, 0.5-4 parts of glycerol, 6-15 parts of carboxymethyl chitosan, 1-3 parts of nicotinamide, 0.1-1 part of lactic acid, 1-10 parts of a surfactant and 80-150 parts of purified water, the Chinese herbal medicine extract is prepared from the following raw materials: fructus kochiae, motherwort, witch hazel and white birch bark; the female bacteriostatic agent is simple in formula and rigorous in proportion, all the components interact with one another, and the obtained female bacteriostatic agent can have a strong inhibiting effect on pathogenic bacteria in a short time, is small in side effect and high in safety and has a wide clinical application prospect.

Description

Technical Field

[0001] The present invention relates to the technical field of antibacterial care products, and more specifically, it relates to a female bacteriostatic agent with Chinese herbal medicine extracts and a preparation method thereof. Background Art

[0002] The private health of women has long been a concern. Due to the special physiological structure of the female reproductive system, it is vulnerable to the invasion of pathogens such as bacteria and fungi, leading to various gynecological diseases. Relevant data show that globally, the incidence of gynecological diseases continues to rise, seriously affecting the quality of life and physical and mental health of women. Against this background, as a commonly used product for preventing and alleviating gynecological diseases, the market demand for female bacteriostatic agents is increasing day by day. Traditional female bacteriostatic agents mainly rely on chemical components. Although they can inhibit the growth of bacteria to a certain extent, long-term use will disrupt the vaginal microecological balance, weaken the self-defense ability of the vagina, and bring side effects such as allergies and drug resistance, damaging women's health. Taking common antibacterial agents containing antibiotics as an example, frequent use will damage the beneficial bacteria in the vagina, cause dysbacteriosis, increase the risk of fungal infection, and trigger diseases such as mycotic vaginitis. In the long term, it will also lead to bacteria developing drug resistance and reducing the subsequent treatment effect. At present, traditional Chinese medicine has accumulated rich theoretical and practical experience in the prevention and treatment of gynecological diseases. Applying Chinese herbal medicine extracts to female bacteriostatic agents can not only play a bacteriostatic role but also avoid the disadvantages of chemically synthesized components, regulate and restore the vaginal microecological balance, improve the immunity of the female reproductive system, and meet the needs of consumers for safe and effective female bacteriostatic products.

[0003] Chinese Patent CN119326861A discloses a female private part care solution and a preparation method thereof. Specifically, take rhubarb, angelica dahurica, turmeric, polygonum cuspidatum, catechu, dragon's blood, calamine powder and make up the remaining mass fraction with pure water. The above medicinal materials are immersed in ethanol at 46°C for 12 hours, then added to a flash extractor for extraction, and then filtered to obtain an extract; after adding pure water to the roughly filtered extract, it is subjected to reduced pressure distillation at 72°C until no liquid continuously flows out, and the remaining liquid is collected and adjusted to pH 3.5 with 88% lactic acid to obtain the female private part care solution; although the care solution uses a variety of traditional Chinese medicines with medicinal value, the activity of some thermosensitive components may be reduced or even inactivated during the extraction process, directly affecting the bacteriostatic effect of the care solution. Based on the above statement, the present invention provides a female bacteriostatic agent with Chinese herbal medicine extracts and a preparation method thereof. Summary of the Invention

[0004] In order to solve the problem of poor bacteriostatic effect of existing female private part care solutions, the present invention provides a female bacteriostatic agent with Chinese herbal medicine extracts and a preparation method thereof.

[0005] In a first aspect, the present invention provides a female bacteriostatic agent with a Chinese herbal medicine extract, adopting the following technical solution: A female bacteriostatic agent with a Chinese herbal medicine extract, comprising the following raw materials in parts by weight: 3 - 8 parts of Chinese herbal medicine extract, 0.5 - 4 parts of glycerol, 6 - 15 parts of carboxymethyl chitosan, 1 - 3 parts of nicotinamide, 0.1 - 1 part of lactic acid, 1 - 10 parts of surfactant, and 80 - 150 parts of purified water; The Chinese herbal medicine extract is prepared from Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla Suk.

[0006] Preferably, the preparation method of the Chinese herbal medicine extract comprises the following steps: S1. Wash, dry, pulverize, and sieve Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla Suk. to obtain Chinese herbal medicine dry powder; S2. Stir the hydrogen bond acceptor and hydrogen bond donor at a constant temperature of 60 - 80 °C until the system is clear and transparent, then cool to room temperature to form a deep eutectic solvent; subsequently, add rhamnose, propylene glycol, and water, and stir at a constant temperature of 60 - 80 °C until the system is clear and transparent to obtain a deep eutectic solvent microemulsion; S3. Mix the Chinese herbal medicine dry powder with the deep eutectic solvent microemulsion, stir, and perform extraction in an ultrasonic water bath at 60 - 70 °C, then cool to room temperature and filter. The filtrate is subjected to elution and purification treatment with macroporous resin, collect the eluate, and concentrate the eluate under reduced pressure to obtain the Chinese herbal medicine extract.

[0007] Preferably, the mass ratio of Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla Suk. is 20 - 40:8 - 15:5 - 10:6 - 18.

[0008] Preferably, the mass ratio of Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla Suk. is 30:15:9:10.

[0009] Preferably, the hydrogen bond donor is oleic acid; the hydrogen acceptor is N - ethylpyridinium bis(fluorosulfonyl)imide salt.

[0010] Preferably, the molar ratio of the hydrogen bond acceptor to the hydrogen bond donor is 1:1 - 4.

[0011] Preferably, the mass ratio of the deep eutectic solvent, rhamnose, propylene glycol, and water is 1 - 2:4 - 8:2 - 4:20.

[0012] Preferably, the mass ratio of the Chinese herbal medicine dry powder to the deep eutectic solvent microemulsion is 1 - 5:40.

[0013] Preferably, the specific steps of the elution and purification treatment are as follows: pump the filtrate into a macroporous adsorption resin column, first rinse with deionized water for 20 - 30 min, and then elute with ethanol for 60 - 90 min.

[0014] Preferably, the packing material of the macroporous adsorption resin column is any one of D-101, HP-20, AB-8, HPD417, ADS-17, DM130 or HP-20.

[0015] Preferably, the surfactant is any one or more of cocamidopropyl betaine, sodium lauroamphoacetate, potassium cocoyl glycinate, decyl glucoside, sodium cocoyl methyl taurate.

[0016] Second, the present invention provides a preparation method of a female bacteriostatic agent with Chinese herbal medicine extract, adopting the following technical scheme: A preparation method of a female bacteriostatic agent with Chinese herbal medicine extract, comprising the following steps: Weigh the Chinese herbal medicine extract, glycerol, carboxymethyl chitosan, nicotinamide, lactic acid, surfactant, and purified water according to the formula, and uniformly mix them to obtain a female bacteriostatic agent with Chinese herbal medicine extract.

[0017] The present invention has positive and beneficial effects: 1. The female bacteriostatic agent of the present invention includes a Chinese herbal medicine extract, which is prepared from Kochia scoparia, Leonurus japonicus, witch hazel, and white birch bark. Kochia scoparia has an inhibitory effect on Escherichia coli, Staphylococcus aureus, Candida albicans, etc., and can help reduce private part bacterial infections and relieve inflammation; Leonurus japonicus also has antibacterial activity and can inhibit the growth of various pathogenic bacteria, helping to maintain the microecological balance of the private part and prevent diseases such as vaginitis; Witch hazel has astringent effects, can coagulate the proteins of the skin and mucous membranes of the private part, reduce exudation, relieve local congestion and swelling, and at the same time relieve itching symptoms caused by allergies, inflammation, etc.; White birch bark can effectively inhibit the growth and reproduction of germs, and contains various antioxidant components, delaying the aging of the skin and mucous membranes of the private part, enhancing its resistance, and having significant curative effects on preventing inflammation caused by oxidative stress. In addition, the present invention strictly controls the mass ratio of the four Chinese herbal medicines, and combines the Chinese herbal medicine extract with glycerol, carboxymethyl chitosan, nicotinamide, and lactic acid, which can have a strong inhibitory effect on pathogenic bacteria in a relatively short time. Moreover, the female bacteriostatic agent has no irritation to the vagina, does not cause skin allergic reactions, has good skin affinity, is non-irritating, non-sensitizing, and is safe to use. It can relieve the discomfort and odor of the private part through the tests of subjects, has a good cleaning effect, gently cares for women's health, and is suitable for long-term use.

[0018] 2. The present invention uses oleic acid as a hydrogen bond acceptor and N-ethylpyridinium bis(fluorosulfonyl)imide salt as a hydrogen bond donor to form a deep eutectic solvent. The long carbon chain structure of oleic acid endows it with lipophilicity and enables it to dissolve various lipophilic substances. The ionic properties of N-ethylpyridinium bis(fluorosulfonyl)imide salt endow the deep eutectic solvent with polarity. A stable strong hydrogen bond is formed between oleic acid and N-ethylpyridinium bis(fluorosulfonyl)imide salt, which helps to break the hydrogen bonds and other intermolecular forces inside the Chinese herbal medicine cells, making the active ingredients of the Chinese herbal medicine more easily dissolved and improving the extraction efficiency.

[0019] 3. The present invention prepares a deep eutectic solvent microemulsion by mixing a deep eutectic solvent, rhamnose, propylene glycol and water in a specific ratio, and uses this deep eutectic solvent microemulsion to extract Chinese herbal medicine. Each component acts synergistically, which can not only extract the lipophilic components of Chinese herbal medicine, but also extract the water-soluble components of Chinese herbal medicine. The extraction efficiency is high, and at the same time the extraction conditions are mild, which can ensure the stability of the active ingredients in the Chinese herbal medicine extract, making the Chinese herbal medicine extract have a good antibacterial effect, and thus significantly improving the antibacterial performance of the female bacteriostatic agent of the present invention. Specific embodiments

[0020] Here, in order to more clearly explain the overall concept of the present invention, the overall solution of the present invention will be described in detail below by way of examples; in the following description, a large number of specific details are given to provide a more thorough understanding of the present invention; however, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details; in other examples, in order to avoid confusion with the present invention, some well-known technical features in the art are not described.

[0021] In the present invention, Kochia scoparia and Leonurus japonicus are both purchased from Shanghai Yuanye Bio-Technology Co., Ltd.; Witch Hazel is purchased from Ganzhou Huahan Biotechnology Co., Ltd.; Betula platyphylla bark is purchased from Ningxia Vanilla Biotechnology Co., Ltd.; N-ethylpyridinium bis(fluorosulfonyl)imide salt is purchased from Qingdao Aolik New Materials Technology Co., Ltd.

[0022] Unless otherwise specified, each raw material component in the following examples can be obtained through commercial channels, and the experimental instruments used are all conventional laboratory experimental instruments, and the performance testing methods are known testing methods in the art.

[0023] Examples 1-4 provide a female bacteriostatic agent with a Chinese herbal medicine extract and its preparation method.

[0024] Example 1

[0025] A female bacteriostatic agent with a Chinese herbal medicine extract, comprising the following raw materials in parts by weight: 3 parts of Chinese herbal medicine extract, 0.5 part of glycerol, 6 parts of carboxymethyl chitosan, 1 part of niacinamide, 0.1 part of lactic acid, 1 part of sodium lauroamphoacetate, and 80 parts of purified water; Among them, the preparation method of the Chinese herbal medicine extract includes the following steps: S1. After weighing Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla bark according to the mass ratio of 20:8:5:18, wash, dry, crush, and sieve them to obtain the Chinese herbal medicine dry powder. S2. Mix the hydrogen bond acceptor (oleic acid) and the hydrogen bond donor (N-ethylpyridinium bis(fluorosulfonyl)imide salt) according to the molar ratio of 1:1, stir at a constant temperature of 60 °C until the system is clear and transparent, cool to room temperature to form a deep eutectic solvent; then mix the deep eutectic solvent, rhamnose, propylene glycol, and water according to the mass ratio of 1:4:2:20, and stir at a constant temperature of 60 °C until the system is clear and transparent to obtain the deep eutectic solvent microemulsion. S3. Mix the Chinese herbal medicine dry powder and the deep eutectic solvent microemulsion according to the mass ratio of 1:40, stir, and extract in an ultrasonic water bath at 60 °C, cool to room temperature and filter, pump the filtrate into a D-101 macroporous adsorption resin column, first rinse with deionized water for 20 min, and then elute with ethanol for 60 min, collect the eluate, and concentrate the eluate under reduced pressure to obtain the Chinese herbal medicine extract.

[0026] The preparation method of a female bacteriostatic agent with a Chinese herbal medicine extract includes the following steps: Weigh the Chinese herbal medicine extract, glycerol, carboxymethyl chitosan, nicotinamide, lactic acid, sodium lauroamphoacetate, and purified water according to the formula, and mix them evenly to obtain a female bacteriostatic agent with a Chinese herbal medicine extract.

[0027] Example 2

[0028] A female bacteriostatic agent with a Chinese herbal medicine extract includes the following raw materials in parts by weight: 5 parts of Chinese herbal medicine extract, 2.5 parts of glycerol, 10 parts of carboxymethyl chitosan, 2 parts of nicotinamide, 0.5 part of lactic acid, 5 parts of cocamidopropyl betaine, and 100 parts of purified water; Among them, the Chinese herbal medicine extract is prepared from Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla bark as raw materials, and its preparation method includes the following steps: S1. After weighing Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla bark according to the mass ratio of 30:12:7:14, wash, dry, crush, and sieve them to obtain the Chinese herbal medicine dry powder. S2. Mix the hydrogen bond acceptor (oleic acid) and the hydrogen bond donor (N-ethylpyridinium bis(fluorosulfonyl)imide salt) according to the molar ratio of 1:3, stir at a constant temperature of 70 °C until the system is clear and transparent, cool to room temperature to form a deep eutectic solvent; then mix the deep eutectic solvent, rhamnose, propylene glycol, and water according to the mass ratio of 1.5:6:3:20, and stir at a constant temperature of 70 °C until the system is clear and transparent to obtain the deep eutectic solvent microemulsion. S3. Mix the Chinese herbal medicine dry powder and the low eutectic solvent microemulsion in a mass ratio of 3:40, stir, extract in an ultrasonic water bath at 65°C, cool to room temperature and filter, pump the filtrate into an HP-20 macroporous adsorption resin column, first rinse with deionized water for 25 minutes, then elute with ethanol for 75 minutes, collect the eluate, and concentrate the eluate under reduced pressure to obtain the Chinese herbal medicine extract.

[0029] A method for preparing a female antibacterial agent with Chinese herbal medicine extracts, comprising the following steps: According to the formula, Chinese herbal extract, glycerin, carboxymethyl chitosan, niacinamide, lactic acid, cocamidopropyl betaine and purified water are weighed and uniformly mixed to obtain a female antibacterial agent with Chinese herbal extract.

[0030] Example 3

[0031] A female antibacterial agent with Chinese herbal extracts, comprising the following raw materials in parts by weight: 8 parts of Chinese herbal extracts, 4 parts of glycerol, 15 parts of carboxymethyl chitosan, 3 parts of niacinamide, 1 part of lactic acid, 10 parts of potassium cocoyl glycinate, and 150 parts of purified water; The Chinese herbal medicine extract is prepared from Kochia scoparia, Leonurus japonicus, Hamamelis virginiana and birch bark as raw materials, and the preparation method thereof comprises the following steps: S1. Weigh Kochia scoparia, Leonurus japonicus, Hamamelis virginiana, and birch bark in a mass ratio of 40:15:10:6, wash, dry, crush, and sieve to obtain Chinese herbal medicine dry powder; S2. A hydrogen bond acceptor (oleic acid) and a hydrogen bond donor (N-ethylpyridine bis(fluorosulfonyl)imide salt) are mixed at a molar ratio of 1:4, stirred at a constant temperature of 80° C. until the system is clear and transparent, and cooled to room temperature to form a low eutectic solvent; subsequently, the low eutectic solvent, rhamnose, propylene glycol and water are mixed at a mass ratio of 2:8:4:20, and stirred at a constant temperature of 80° C. until the system is clear and transparent to obtain a low eutectic solvent microemulsion; S3. Mix the Chinese herbal medicine dry powder and the low eutectic solvent microemulsion in a mass ratio of 1:8, stir, extract in an ultrasonic water bath at 70°C, cool to room temperature and filter, pump the filtrate into an ADS-17 macroporous adsorption resin column, first rinse with deionized water for 30 minutes, then elute with ethanol for 90 minutes, collect the eluate, and concentrate the eluate under reduced pressure to obtain the Chinese herbal medicine extract.

[0032] A method for preparing a female antibacterial agent with Chinese herbal medicine extracts, comprising the following steps: According to the formula, Chinese herbal extract, glycerin, carboxymethyl chitosan, niacinamide, lactic acid, potassium cocoyl glycinate and purified water are weighed and uniformly mixed to obtain a female antibacterial agent with Chinese herbal extract.

[0033] Example 4

[0034] A female bacteriostatic agent with Chinese herbal medicine extract, comprising the following raw materials in parts by weight: 3 parts of Chinese herbal medicine extract, 0.5 part of glycerol, 6 parts of carboxymethyl chitosan, 1 part of nicotinamide, 0.1 part of lactic acid, 1 part of sodium lauroamphoacetate, and 80 parts of purified water; Among them, the Chinese herbal medicine extract is prepared from Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla as raw materials, and its preparation method comprises the following steps: S1. After weighing according to the mass ratio of Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla of 30:15:9:10, washing, drying, pulverizing, and sieving to obtain Chinese herbal medicine dry powder; S2. Mix the hydrogen bond acceptor (oleic acid) and the hydrogen bond donor (N-ethylpyridine bisfluorosulfonylimide salt) in a molar ratio of 1:1, stir at a constant temperature of 60 °C until the system is clear and transparent, cool to room temperature to form a deep eutectic solvent; then mix the deep eutectic solvent, rhamnose, propylene glycol, and water in a mass ratio of 1:4:2:20, and stir at a constant temperature of 60 °C until the system is clear and transparent to obtain a deep eutectic solvent microemulsion; S3. Mix the Chinese herbal medicine dry powder and the deep eutectic solvent microemulsion in a mass ratio of 1:40, stir, extract in an ultrasonic water bath at 60 °C, cool to room temperature and filter, pump the filtrate into a D-101 macroporous adsorption resin column, first rinse with deionized water for 20 min, then elute with ethanol for 60 min, collect the eluate, and concentrate the eluate under reduced pressure to obtain the Chinese herbal medicine extract.

[0035] A preparation method of a female bacteriostatic agent with Chinese herbal medicine extract, comprising the following steps: Weigh the Chinese herbal medicine extract, glycerol, carboxymethyl chitosan, nicotinamide, lactic acid, sodium lauroamphoacetate, and purified water according to the formula, and mix them evenly to obtain a female bacteriostatic agent with Chinese herbal medicine extract.

[0036] In order to verify the performance of the female bacteriostatic agent provided by the present invention, the applicant set up Comparative Examples 1-4, wherein:

[0037] Comparative Example 1 A female bacteriostatic agent with Chinese herbal medicine extract, comprising the following raw materials in parts by weight: 3 parts of Chinese herbal medicine extract, 0.5 part of glycerol, 6 parts of carboxymethyl chitosan, 1 part of nicotinamide, 0.1 part of lactic acid, 1 part of sodium lauroamphoacetate, and 80 parts of purified water; Among them, the Chinese herbal medicine extract is prepared from Kochia scoparia, Leonurus japonicus, and Hamamelis mollis as raw materials, and its preparation method comprises the following steps: S1. After weighing according to the mass ratio of Kochia scoparia, Leonurus japonicus, and Hamamelis mollis of 20:8:5, washing, drying, pulverizing, and sieving to obtain Chinese herbal medicine dry powder; S2. Mix the hydrogen bond acceptor (oleic acid) and the hydrogen bond donor (N-ethylpyridinium bis(fluorosulfonyl)imide salt) in a molar ratio of 1:1, stir at a constant temperature of 60 °C until the system becomes clear and transparent, cool to room temperature to form a deep eutectic solvent; then mix the deep eutectic solvent, rhamnose, propylene glycol and water in a mass ratio of 1:4:2:20, and stir at a constant temperature of 60 °C until the system becomes clear and transparent to obtain a deep eutectic solvent microemulsion; S3. Mix the dry Chinese herbal medicine powder and the deep eutectic solvent microemulsion in a mass ratio of 1:40, stir, and extract in an ultrasonic water bath at 60 °C. Cool to room temperature and filter. Pump the filtrate into a D-101 macroporous adsorption resin column, first rinse with deionized water for 20 min, then elute with ethanol for 60 min, collect the eluate, and concentrate the eluate under reduced pressure to obtain the Chinese herbal medicine extract.

[0038] A preparation method of a female bacteriostatic agent with Chinese herbal medicine extract, comprising the following steps: Weigh the Chinese herbal medicine extract, glycerol, carboxymethyl chitosan, niacinamide, lactic acid, sodium lauroamphoacetate, and purified water according to the formula, and mix them evenly to obtain a female bacteriostatic agent with Chinese herbal medicine extract.

[0039] Comparative Example 2 A female bacteriostatic agent with Chinese herbal medicine extract, comprising the following raw materials in parts by weight: 3 parts of Chinese herbal medicine extract, 0.5 part of glycerol, 6 parts of carboxymethyl chitosan, 1 part of niacinamide, 0.1 part of lactic acid, 1 part of sodium lauroamphoacetate, and 80 parts of purified water; Among them, the Chinese herbal medicine extract is prepared from motherwort, witch hazel, and white birch bark as raw materials, and its preparation method comprises the following steps: S1. Weigh motherwort, witch hazel, and white birch bark in a mass ratio of 8:5:18, wash, dry, crush, and sieve to obtain dry Chinese herbal medicine powder; S2. Mix the hydrogen bond acceptor (oleic acid) and the hydrogen bond donor (N-ethylpyridinium bis(fluorosulfonyl)imide salt) in a molar ratio of 1:1, stir at a constant temperature of 60 °C until the system becomes clear and transparent, cool to room temperature to form a deep eutectic solvent; then mix the deep eutectic solvent, rhamnose, propylene glycol and water in a mass ratio of 1:4:2:20, and stir at a constant temperature of 60 °C until the system becomes clear and transparent to obtain a deep eutectic solvent microemulsion; S3. Mix the dry Chinese herbal medicine powder and the deep eutectic solvent microemulsion in a mass ratio of 1:40, stir, and extract in an ultrasonic water bath at 60 °C. Cool to room temperature and filter. Pump the filtrate into a D-101 macroporous adsorption resin column, first rinse with deionized water for 20 min, then elute with ethanol for 60 min, collect the eluate, and concentrate the eluate under reduced pressure to obtain the Chinese herbal medicine extract.

[0040] A preparation method of a female bacteriostatic agent with Chinese herbal medicine extract, comprising the following steps: Weigh the Chinese herbal medicine extract, glycerol, carboxymethyl chitosan, nicotinamide, lactic acid, sodium lauroamphoacetate, and purified water according to the formula, and uniformly mix them to obtain a female bacteriostatic agent with Chinese herbal medicine extract.

[0041] Control Example 3 A female bacteriostatic agent with Chinese herbal medicine extract, comprising the following raw materials in parts by weight: 3 parts of Chinese herbal medicine extract, 0.5 part of glycerol, 6 parts of carboxymethyl chitosan, 1 part of nicotinamide, 0.1 part of lactic acid, 1 part of sodium lauroamphoacetate, and 80 parts of purified water; Among them, the Chinese herbal medicine extract is prepared from Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla as raw materials, and its preparation method comprises the following steps: S1. After weighing Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla according to the mass ratio of 20:8:5:18, wash, dry, crush, and sieve them to obtain Chinese herbal medicine dry powder; S2. Mix the hydrogen bond acceptor (oleic acid) and the hydrogen bond donor (choline) in a molar ratio of 1:1, stir at a constant temperature of 60 °C until the system is clear and transparent, cool to room temperature to form a deep eutectic solvent; then mix the deep eutectic solvent, rhamnose, propylene glycol, and water in a mass ratio of 1:4:2:20, and stir at a constant temperature of 60 °C until the system is clear and transparent to obtain a deep eutectic solvent microemulsion; S3. Mix the Chinese herbal medicine dry powder and the deep eutectic solvent microemulsion in a mass ratio of 1:40, stir, extract in an ultrasonic water bath at 60 °C, cool to room temperature and filter, pump the filtrate into a D-101 macroporous adsorption resin column, first rinse with deionized water for 20 min, then elute with ethanol for 60 min, collect the eluate, and concentrate the eluate under reduced pressure to obtain the Chinese herbal medicine extract.

[0042] A preparation method of a female bacteriostatic agent with Chinese herbal medicine extract, comprising the following steps: Weigh the Chinese herbal medicine extract, glycerol, carboxymethyl chitosan, nicotinamide, lactic acid, sodium lauroamphoacetate, and purified water according to the formula, and uniformly mix them to obtain a female bacteriostatic agent with Chinese herbal medicine extract.

[0043] Control Example 4 A female bacteriostatic agent with Chinese herbal medicine extract, comprising the following raw materials in parts by weight: 3 parts of Chinese herbal medicine extract, 0.5 part of glycerol, 6 parts of carboxymethyl chitosan, 1 part of nicotinamide, 0.1 part of lactic acid, 1 part of sodium lauroamphoacetate, and 80 parts of purified water; Among them, the Chinese herbal medicine extract is prepared from Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla as raw materials, and its preparation method comprises the following steps: S1. Weigh Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla Suk. according to the mass ratio of 20:8:5:18, wash them, dry them, crush them, sieve them, and obtain the dry Chinese herbal medicine powder. S2. Mix the hydrogen bond acceptor (oleic acid) and the hydrogen bond donor (N-ethylpyridinium bis (fluorosulfonyl) imide salt) according to the molar ratio of 1:1, stir them at a constant temperature of 60 °C until the system is clear and transparent, and cool them to room temperature to form a deep eutectic solvent. S3. Mix the dry Chinese herbal medicine powder and the deep eutectic solvent according to the mass ratio of 1:40, stir them, extract them in an ultrasonic water bath at 60 °C, cool them to room temperature and filter them, pump the filtrate into a D-101 macroporous adsorption resin column, first rinse it with deionized water for 20 min, and then elute it with ethanol for 60 min, collect the eluate, and concentrate the eluate under reduced pressure to obtain the Chinese herbal medicine extract.

[0044] A preparation method of a female bacteriostatic agent containing a Chinese herbal medicine extract, comprising the following steps: Weigh the Chinese herbal medicine extract, glycerol, carboxymethyl chitosan, niacinamide, lactic acid, sodium lauroamphoacetate, and purified water according to the formula, and mix them evenly to obtain a female bacteriostatic agent containing a Chinese herbal medicine extract.

[0045] Test the main properties of the female bacteriostatic agents obtained in Examples 1-4 and Comparative Examples 1-4 respectively, and obtain the following result parameters: 1. In vitro antibacterial performance test The test strains are selected as Staphylococcus aureus (ATCC6538), Escherichia coli (ATCC25922), and Candida albicans (ATCC10231). The above strains are of the 3rd to 5th generations, and a bacterial suspension is prepared with 0.03 mol / L PBS; operate according to Appendix C of the national standard GB15979-2002 "Hygienic Standard for Disposable Sanitary Products", take the female bacteriostatic agents obtained in Examples 1-4 and Comparative Examples 1-4 as samples, with the action time of 2 min, 5 min, 10 min, and 20 min, and repeat the test 3 times, and the test temperature is 22 °C. Among them, Staphylococcus aureus (ATCC6538) and Escherichia coli (ATCC25922) are provided by Beina Chuanglian, and Candida albicans (ATCC10231) is provided by the China Center for Industrial Culture Collection; the results are shown in Table 1.

[0046] Table 1:

[0047] As can be seen from the results in Table 1, the female bacteriostatic agents obtained in Examples 1-4 of the present invention have obvious advantages over Comparative Examples 1-4, have strong bacteriostatic effects on Staphylococcus aureus, Escherichia coli and Candida albicans, with a bacteriostatic rate > 99.99%, can achieve a rapid bacteriostatic effect, and can maintain the balance of the female private part flora.

[0048] 2. Irritation test Using the female bacteriostatic agents obtained in Examples 1-4 and Comparative Examples 1-4 as samples, their skin irritation tests were evaluated. Randomly select 40 healthy adult rabbits, divide them into 8 groups, with 5 rabbits in each group, and select 4 shaved areas of 9 cm on the back of each rabbit 2 , and apply the female bacteriostatic agents obtained in Examples 1-4 and Comparative Examples 1-4 to the shaved areas of 5 rabbits respectively, apply once every 8 hours, and observe the conditions of the applied areas at 24h, 48h and 72h.

[0049] After testing, none of the 40 tested rabbits showed local irritation reactions such as skin erythema and edema, indicating that the female bacteriostatic agent obtained by the present invention is safe and non-irritating, without any adverse reactions.

[0050] 3. Clinical effect test Using the female bacteriostatic agents obtained in Examples 1-4 and Comparative Examples 1-4 as samples, randomly select 40 subjects aged 20-60 with vulvar itching, pain and odor for clinical testing of the samples. The 40 subjects are randomly divided into 8 groups, with 5 people in each group. Spray about 2-5 mL of the vaginal bacteriostatic care solution on the internal and external genitals, spray once every night after cleaning the vulva, and spray continuously for 20 days. Record the effect scores of the subjects on the samples in terms of itching and pain relief, clearing heat and drying dampness, and odor removal, and take the average of the scores in the group; among them, 9-10 points means very good effect, 7-8 points means better effect, 5-6 points means average effect, 3-4 points means poor effect, and 1-2 points means very poor effect; the results are shown in Table 2.

[0051] Table 2:

[0052] As can be seen from the results in Table 2, the female bacteriostatic agents obtained in Examples 1-4 of the present invention have excellent effects in relieving itching, clearing heat and drying dampness, and removing odor compared with Comparative Examples 1-4, can effectively relieve the discomfort of the subjects' private parts, care for women's health, and are suitable for long-term use.

[0053] This specific embodiment is only an explanation of the present invention, and it is not a limitation of the present invention. Those skilled in the art can make modifications without creative contributions to this embodiment according to needs after reading this specification, but as long as they are within the scope of the claims of the present invention, they are protected by the patent law.

Claims

1. A female bacteriostatic agent with Chinese herbal medicine extract, characterized in that, It comprises the following raw materials in parts by weight: 3 - 8 parts of Chinese herbal medicine extract, 0.5 - 4 parts of glycerol, 6 - 15 parts of carboxymethyl chitosan, 1 - 3 parts of niacinamide, 0.1 - 1 part of lactic acid, 1 - 10 parts of surfactant, and 80 - 150 parts of purified water; The Chinese herbal medicine extract is prepared from Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla Suk.

2. The female bacteriostatic agent with Chinese herbal medicine extract according to claim 1, characterized in that The preparation method of the Chinese herbal medicine extract comprises the following steps: S1. Wash, dry, crush, and sieve Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla Suk. to obtain dry Chinese herbal medicine powder; S2. Stir the hydrogen bond acceptor and hydrogen bond donor at a constant temperature of 60 - 80 °C until the system is clear and transparent, cool to room temperature to form a deep eutectic solvent; then add rhamnose, propylene glycol, and water, and stir at a constant temperature of 60 - 80 °C until the system is clear and transparent to obtain a deep eutectic solvent microemulsion; S3. Mix the dry Chinese herbal medicine powder with the deep eutectic solvent microemulsion, stir, and perform extraction in an ultrasonic water bath at 60 - 70 °C, cool to room temperature and filter, elute and purify the filtrate with macroporous resin, collect the eluate, and concentrate the eluate under reduced pressure to obtain the Chinese herbal medicine extract.

3. The female bacteriostatic agent with Chinese herbal medicine extract according to claim 2, characterized in that, The mass ratio of Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla Suk. is 20 - 40:8 - 15:5 - 10:6 - 18.

4. The female bacteriostatic agent with Chinese herbal medicine extract according to claim 3, characterized in that, The mass ratio of Kochia scoparia, Leonurus japonicus, Hamamelis mollis, and Betula platyphylla Suk. is 30:15:9:

10.

5. The female bacteriostatic agent with Chinese herbal medicine extract according to claim 2, characterized in that, The hydrogen bond donor is oleic acid; the hydrogen acceptor is N - ethylpyridinium bis(fluorosulfonyl)imide.

6. The female bacteriostatic agent with Chinese herbal medicine extract according to claim 2, characterized in that, The molar ratio of the hydrogen bond acceptor to the hydrogen bond donor is 1:1 - 4.

7. The female bacteriostatic agent with Chinese herbal medicine extract according to claim 2, characterized in that, The mass ratio of the deep eutectic solvent, rhamnose, propylene glycol, and water is 1 - 2:4 - 8:2 - 4:

20.

8. The female bacteriostatic agent with Chinese herbal medicine extract according to claim 2, characterized in that, The mass ratio of the dry Chinese herbal medicine powder to the deep eutectic solvent microemulsion is 1 - 5:

40.

9. The female bacteriostatic agent with Chinese herbal medicine extract according to claim 2, wherein, The specific steps of the elution and purification treatment are as follows: pump the filtrate into a macroporous adsorption resin column, first rinse with deionized water for 20 - 30 min, and then elute with ethanol for 60 - 90 min.

10. A method for preparing a female bacteriostatic agent with Chinese herbal medicine extract according to any one of claims 1-9, characterized in that, It comprises the following steps: Weigh the Chinese herbal medicine extract, glycerol, carboxymethyl chitosan, niacinamide, lactic acid, surfactant, and purified water according to the formula, and mix them evenly to obtain a female bacteriostatic agent containing Chinese herbal medicine extract.

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