Composition with vagina bacteriostasis effect, lotion containing composition and preparation method of lotion

Abstract

The invention provides a composition with vaginal bacteriostasis, the composition comprises chlorhexidine acetate, a Chinese herbal medicine preparation, lactic acid and a lactobacillus fermentation product, the Chinese herbal medicine preparation comprises cortex phellodendri, fructus cnidii, radix sophorae flavescentis and radix stemonae, and the pH value of the composition is 3.8-4.5. The invention also provides a lotion containing the composition and having a vaginal bacteriostasis effect and a preparation method of the lotion, besides the traditional bacteriostasis component chlorhexidine acetate, the traditional Chinese medicine bacteriostasis component, lactic acid and a lactobacillus fermentation product are also added, and all the components have a synergistic effect on vaginal bacteriostasis after being combined, so that the composition has a good effect on vaginal bacteriostasis. The pH value of the lotion is adjusted to 3.8-4.5 by the added lactic acid, so that the normal acidity of the vaginal cavity is not damaged, the growth of vaginal bacillus is facilitated, the lotion does not contain sugar substances such as chitosan and glucose, the growth and reproduction of pathogenic bacteria and trichomonas vaginalis are not facilitated, and the lotion has a special antibacterial function while the biological characteristics of the vaginal cavity are maintained.

Description

Technical Field

[0001] The invention belongs to the technical field of female care, and specifically relates to a composition with vaginal antibacterial effect, an external preparation including the composition, and also relates to a washing liquid with vaginal antibacterial effect and a preparation method thereof. Background Art

[0002] Vaginitis is a common gynecological disease, often manifested by vulvar itching, local erosion, increased vaginal discharge, accompanied by symptoms such as frequent urination and dysuria. It is also one of the gynecological diseases with a higher incidence rate. If not treated in time, it can easily cause cervicitis. In severe cases, it can infect the pelvic cavity, upper reproductive tract, abdominal cavity, etc. It is a common and frequently occurring gynecological disease with a high recurrence rate and is distributed in all age groups, affecting the patient's physical and mental health and quality of life.

[0003] In order to prevent the occurrence of vaginitis and relieve the symptoms of vaginitis, many women use various gynecological cleansers to clean their private parts. There are two types of female private part care products on the market. One type uses chemical fungicides such as chlorhexidine acetate. The skin of the female private parts is relatively sensitive. A large amount of chemical fungicides can easily cause skin irritation. Long-term use can also easily lead to bacterial resistance and destroy beneficial bacteria. The other type is Chinese herbal medicine products. The dosage form is mostly a flushing agent or suppository. Because it uses natural Chinese herbal medicine ingredients, it has little harm to the human body, no side effects, and is safe and reliable. However, there are problems such as poor treatment effect, long treatment time, and easy recurrence after treatment.

[0004] Chinese patent document CN103446177A discloses a lotion for treating gynecological diseases, which is composed of chitosan of a specific molecular weight and deacetylation degree, chlorhexidine, glycerol, an acidulant and purified water, wherein the acidulant is a mixture of lactic acid, acetic acid or hydrochloric acid-acetic acid, and the acidulant is added to adjust the pH to 3.8-5.8, and the prepared lotion can be used to treat candidal vaginitis, bacterial vaginitis, trichomonas vaginitis or cervicitis in women. However, although the chitosan in the lotion has antibacterial and antibacterial effects, the sugar substances in the chitosan also provide energy and nutrition for bacteria, which has a certain destructive effect on the antibacterial and antibacterial effects. Summary of the invention

[0005] In view of the defects of the prior art, the object of the present invention is to provide a composition with vaginal antibacterial effect, and an external preparation including the composition.

[0006] Another object of the present invention is to provide a lotion comprising the above-mentioned composition having vaginal antibacterial effect and a preparation method thereof.

[0007] To achieve the above purpose, the solution adopted by the present invention is as follows:

[0008] In a first aspect, the present invention provides a composition having vaginal antibacterial effect, comprising chlorhexidine acetate, a Chinese herbal preparation, lactic acid and a lactobacillus fermentation product, wherein the raw materials of the Chinese herbal preparation include Phellodendron chinense, Fructus Cnidium monnieri, Sophora flavescens and Stemona japonica, and the pH value of the composition is 3.8-4.5.

[0009] Preferably, the Chinese herbal medicine preparation is the powder of each raw material medicine, or the water or organic solvent extract of each raw material medicine; the probiotic powder is a powder formed by embedding the probiotic bacteria with a wall material and then freeze-drying or spray-drying.

[0010] Preferably, the mass ratio of the chlorhexidine acetate, the Chinese herbal medicine preparation, lactic acid and the lactobacillus fermentation product is (1-20):1:(1-20):(0.1-10).

[0011] In a second aspect, the present invention also provides a use of the composition having vaginal antibacterial effect as described above in the preparation of a product for preventing or treating vaginal antibacterial effect.

[0012] In a third aspect, the present invention further provides an external preparation having vaginal antibacterial effect, comprising the composition having vaginal antibacterial effect as described above.

[0013] Preferably, the external preparation is administered topically into the vagina.

[0014] Preferably, the dosage form of the external preparation includes any one of lotion, suppository, effervescent tablet, ointment, gel and foam.

[0015] In a fourth aspect, the present invention further provides a vaginal antibacterial lotion comprising the following components in percentage by mass:

[0016]

[0017] In a fifth aspect, the present invention also provides a method for preparing the above-mentioned vaginal antibacterial lotion, comprising the following steps:

[0018] Step (1), dissolving menthol and borneol in 95% ethanol and hydrogenated castor oil CO40 until fully dissolved to form solution A;

[0019] Step (2), dissolving chlorhexidine acetate in glycerol, 1,3-butanediol and purified water, and heating to promote dissolution to form solution B;

[0020] Step (3), adding the B solution cooled to room temperature to the A solution and stirring evenly;

[0021] Step (4), adding the Phellodendron chinense extract, the Cnidium monnieri extract, the Sophora flavescens extract, the Stemona tuber extract and the lactobacillus fermentation product to the mixed solution obtained in step (3), and mixing them thoroughly;

[0022] Step (5), adding lactic acid to the mixed solution obtained in step (4).

[0023] Preferably, the pH value of the washing liquid is 3.8-4.5.

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

[0025] The invention provides a washing liquid comprising a composition with vaginal antibacterial effect. In addition to the traditional antibacterial component chlorhexidine acetate, a traditional Chinese medicine antibacterial component, lactic acid and a lactobacillus fermentation product are added. The components have a synergistic effect on vaginal antibacterial after being combined. The added lactic acid adjusts the pH value of the washing liquid to 3.8-4.5, which will not destroy the normal acidity of the vaginal cavity and is conducive to the growth of vaginal bacilli. In addition, the washing liquid does not contain sugar substances such as chitosan and glucose, which is not conducive to the growth and reproduction of pathogenic bacteria and vaginal trichomonas. The washing liquid has a special antibacterial function while maintaining the biological characteristics of the vaginal cavity. DETAILED DESCRIPTION

[0026] The invention provides a composition with vaginal antibacterial effect, comprising chlorhexidine acetate, Chinese herbal medicine preparation and lactic acid.

[0027] In a composition with vaginal antibacterial effect provided by the present invention, the raw materials of the Chinese herbal medicine preparation include Phellodendron chinense, Cnidium monnieri, Sophora flavescens and Stemona tuberosa, which can be powders of each raw material medicine or water or organic solvent extracts of each raw material medicine.

[0028] In a composition with vaginal antibacterial effect provided by the present invention, chlorhexidine acetate is used as a traditional antibacterial component, which is a broad-spectrum bactericidal disinfectant, also known as chlorhexidine, and is a divalent cationic surfactant. It has obvious affinity for bacteria and has antibacterial effect on both Gram-positive and Gram-negative bacteria. Among the genus Streptococcus, the sensitivity to Streptococcus mutans is stronger than that of other bacteria.

[0029] In a composition with vaginal antibacterial effect provided by the present invention, chlorhexidine acetate is mixed with a Chinese herbal preparation including Phellodendron chinense, Cnidium monnieri, Sophora flavescens and Stemona japonica, and has a synergistic bactericidal effect. The synergistic bactericidal effect may be that the addition of the Chinese herbal preparation can reduce the dosage of chlorhexidine acetate, and low-concentration chlorhexidine acetate is easily adsorbed on the cell membrane of bacteria for a long time, thereby increasing the permeability of the cell membrane and facilitating the penetration of the bactericidal components of the Chinese herbal medicine into the cells, further enhancing the bactericidal effect.

[0030] In a composition with vaginal antibacterial effect provided by the present invention, the lactic acid and lactobacillus fermentation product are used to adjust the pH value of the composition to 3.8-4.5, which is close to the normal pH value in the human vagina, and can create a suitable acidic environment for the growth of vaginal lactobacilli. It has been confirmed that among the flora of the human vagina, 71.3% are lactobacilli, among which Lactobacillus crispatus accounts for the highest proportion, accounting for 37.0%, Lactobacillus iners accounts for 26.1%, Lactobacillus jensenii accounts for 4.23%, and Lactobacillus gasseri accounts for 4.23%. The lactobacilli in the human vagina produce lactic acid by fermenting the glycogen in the epithelial cells of the vaginal mucosa, thereby maintaining a lower pH value in the vagina, inhibiting the excessive growth of harmful bacteria, being beneficial to the self-cleaning effect of the vagina, maintaining the balance of the flora in the vagina, and protecting the vagina from the invasion of other pathogenic factors. The addition of lactobacillus fermentation product can supplement the lactobacillus in vagina, maintain its acidic environment, destroy the growth environment of bacteria such as trichomonas, restore the microecological balance of vagina, and the addition of lactic acid can promote the growth of lactobacillus in vagina, and promote the microecological balance of vagina in a coordinated manner. Confirmed by the embodiment of the present invention, lactic acid can also be compatible with chlorhexidine acetate and the Chinese herbal medicine preparation including Cortex Phellodendri, Fructus Cnidii, Radix Sophorae Flavescentis and Radix Stemonae, and the pathogenic bacteria (such as: Escherichia coli, Staphylococcus aureus, Candida albicans etc.) of human vagina are synergistically inhibited, and the adhesion to vaginal epithelial cells can also be improved, and the drug effect of the composition is further improved.

[0031] Moreover, in the composition of the present invention, no sugar substances such as chitosan and glucose are added. According to existing reports, chitosan, glucose and the like can increase energy for the growth of lactobacilli, and can further maintain the normal acidic environment of the vagina when combined with lactic acid, thereby improving the inhibitory effect on pathogenic bacteria. However, long-term use of vaginal wash containing sugar substances such as chitosan and glucose also has the effect of providing energy and growth and reproduction for the growth of pathogenic bacteria in the human vagina, and has a certain destructive effect on the long-term antibacterial and antibacterial effects. Therefore, the present invention also has a highly efficient antibacterial effect without adding sugar substances such as chitosan and glucose through the synergistic antibacterial effect of chlorhexidine acetate, Chinese herbal medicine preparations and lactic acid.

[0032] In a composition with vaginal antibacterial effect provided by the present invention, the mass ratio of chlorhexidine acetate, Chinese herbal medicine preparation, lactic acid and lactobacillus fermentation product is (1-20):1:(1-20):(0.1-10).

[0033] The present invention further provides use of the composition having vaginal antibacterial effect as described above in the preparation of a product for preventing or treating vaginal antibacterial effect.

[0034] The present invention also provides an external preparation with vaginal antibacterial effect, comprising the composition with vaginal antibacterial effect as described above, the external preparation is locally administered into the vagina, and its dosage form includes any one of lotion, suppository, effervescent tablet, ointment, gel and foam.

[0035] In the present invention, the "composition" and "product for preventing or treating vaginal antibacterial" are generally compositions comprising a composition having an active ingredient component (referred to as active ingredient) and pharmaceutically acceptable excipients.

[0036] In the present invention, the active ingredient components include chlorhexidine acetate, Chinese herbal medicine preparation, lactic acid and lactobacillus fermentation products, wherein the raw materials of the Chinese herbal medicine preparation include Phellodendron chinense, Cnidium monnieri, Sophora flavescens and Stemona tuber.

[0037] In the present invention, the "pharmaceutically acceptable excipients" include inert diluents, dispersants and / or granulating agents, surfactants and / or emulsifiers, disintegrants, binders, preservatives, buffers, lubricants and / or lubricating oils.

[0038] The present invention provides a product for preventing or treating vaginal bacteriostasis comprising the above composition, wherein the female subject for preventing or treating vaginal bacteriostasis exhibits symptoms of dysbiosis of the microbiota in the urogenital tract, such as bacterial vaginosis, candidal infection, human papillomavirus infection, urinary tract infection, sexually transmitted infection, etc. The product for preventing or treating vaginal bacteriostasis comprising the above composition provided by the present invention is formulated for vaginal application, and its dosage form is a cream, spray, douche or suppository, which can be achieved by adding at least one of an excipient, a bactericide, a moisturizer, an anti-allergic agent, a chelating agent and a fragrance to the composition to prepare a vaginal external preparation in the form of a douche, and when applied, the douche is applied to the vaginal cavity through a tool such as an applicator.

[0039] The present invention further provides a vaginal antibacterial lotion, comprising the following components in percentage by mass:

[0040]

[0041] The present invention also provides a method for preparing the above-mentioned vaginal antibacterial lotion, comprising the following steps:

[0042] Step (1), dissolving menthol and borneol in 95% ethanol and hydrogenated castor oil CO40 until fully dissolved to form solution A;

[0043] Step (2), dissolving chlorhexidine acetate in glycerol, 1,3-butanediol and purified water, and heating to promote dissolution to form solution B;

[0044] Step (3), adding the B solution cooled to room temperature to the A solution and stirring evenly;

[0045] Step (4), adding the Phellodendron chinense extract, the Cnidium monnieri extract, the Sophora flavescens extract, the Stemona tuber extract and the lactobacillus fermentation product to the mixed solution obtained in step (3), and mixing them thoroughly;

[0046] Step (5), adding lactic acid to the mixed solution obtained in step (4).

[0047] In the above-mentioned vaginal antibacterial lotion and its preparation method provided by the present invention, the water or organic solvent extract of the mixture of the powder of the Chinese herbal medicine ingredients Phellodendron amurense, Cnidium monnieri, Sophora flavescens and Stemona tuberosa is within the protection scope of the present invention.

[0048] In the composition with vaginal antibacterial effect provided by the present invention, the raw materials of various Chinese herbal medicines in the various raw material components as active ingredients have the following expected functions:

[0049] Treats:

[0050] Alias: Berberis, Berberis bark, Phellodendron chinense Schneid., bitter in taste, cold in nature; enters the kidney and bladder. Phellodendron chinense Schneid. is the dried bark of the plant Phellodendron chinense Schneid. of the Rutaceae family. It has the effects of clearing away heat and dampness, purging fire and detoxifying, and removing bone steaming. It is mainly used to treat damp-heat diarrhea, hot stranguria, damp-heat diarrhea, jaundice, damp-heat beriberi, impotence, bone steaming and fatigue fever, night sweats, spermatorrhea, sores, swelling and poison, eczema and itching. Phellodendron bark contains berberine, phellodendronine, magnolia alkaloids, jatrorrhizine, palmate leaf tetrandrine and other alkaloids, and contains phellodendron lactone, phellodendronone, phellodendron acid and 7-dehydrostigmasterol, β-sitosterol, campesterol, etc.; the bark of the phellodendron contains berberine, magnolia alkaloids, phellodendronine, palmate leaf tetrandrine and other alkaloids and lactones, sterols, etc. It has similar anti-pathogenic microbial effects as Coptis chinensis, and has inhibitory effects on various pathogenic bacteria such as Shigella dysenteriae, Salmonella typhi, Mycobacterium tuberculosis, Staphylococcus aureus, and hemolytic Streptococcus; it also has inhibitory effects on certain skin fungi, Leptospira, and hepatitis B surface antigen; the jatrorrhizine it contains has positive inotropic and antiarrhythmic effects similar to berberine; Phellodendron chinense extract has antihypertensive, anti-ulcer, sedative, muscle relaxant, blood sugar lowering and mouse antibody production promoting effects.

[0051] Cnidium monnieri:

[0052] Alias: snake rice, snake pearl, snake millet, snake bed kernel, etc., pungent, bitter, warm in nature; enter the spleen and kidney meridians. Cnidium monnieri is the fruit of Cnidium monnieri (L.) Cuss., a plant of the genus Cnidium in the family Apiaceae. It has the effects of warming the kidney and strengthening yang, drying dampness and killing insects, and dispelling wind and relieving itching. It is mainly used to treat genital itching, eczema, scabies; cold and damp leucorrhea, dampness and low back pain; impotence due to kidney deficiency, infertility due to uterine cold, etc. The fruit of Cnidium monnieri contains 1.3% volatile oil, and 27 components have been separated from the oil. It also contains coumarins and other ingredients, such as cnidium monnieri and pepper toxin. Cnidium monnieri has an inhibitory effect on drug-resistant Staphylococcus aureus, Pseudomonas aeruginosa, dermatophytes, and Trichomonas.

[0053] Sophora flavescens:

[0054] Alias: ground sophora, mountain sophora, wild sophora; bitter in taste, cold in nature; in the heart, liver, and stomach. It is the dried root of Sophora flavescens Ait. of the genus Sophora in the Leguminosae family. It has the effects of clearing away heat and dampness, killing insects, and diuresis. It is mainly used to treat damp-heat diarrhea, blood in the stool, jaundice, damp-heat diarrhea, vaginal swelling and itching, eczema and wet sores, itchy skin, scabies, and damp-heat urination. This product contains alkaloids such as matrine, oxymatrine, isomatrine, sophoracarpine, isosophoracarpine, sophoramine, oxysophoracarpine, and flavonoid compounds such as berberine C, berberine G, isomatrine, matrine, and neomatrine. This product has a significant inhibitory effect on the heart, slowing down the heart rate, weakening the myocardial contractility, and reducing cardiac output; Sophora flavescens, matrine, and Sophora flavescens flavonoids all have antiarrhythmic effects; Sophora flavescens injection can counteract arrhythmias caused by aconitine, with a fast and lasting effect, and has a hypotensive effect; its decoction has an inhibitory effect on tuberculosis, Shigella dysenteriae, Staphylococcus aureus, and Escherichia coli, and also has an inhibitory effect on a variety of skin fungi. It also has diuretic, anti-inflammatory, anti-allergic, sedative, antiasthmatic, expectorant, white blood cell increase, and anti-tumor effects.

[0055] Hundreds:

[0056] Other names: Stemona root, white bud; sweet, bitter, slightly warm; enters the lung meridian. It is the dried root of Stemona ja ponica (BL.) Miq., Stemona sessile folia (Miq) Franch. et Sav., or Stemona tuberosa Lour. of the Stemonaceae family. It has the effects of moistening the lungs and relieving coughs, killing insects and lice. It is mainly used to treat new and long-term coughs, whooping coughs, coughs caused by tuberculosis, pinworms, vaginal trichomonas, head lice and scabies. Stemona contains a variety of alkaloids, such as stemonine, stemonidine, prostemonine, substemonine, erect stemonine, parastemonine, trepanning stemonine, etc., as well as sugars, lipids, proteins, succinic acid, etc. The decoction and wine extract of Stemona have different degrees of inhibitory effect on pneumococcus, beta-hemolytic streptococcus, meningococcus, Staphylococcus aureus, Staphylococcus albus, Shigella dysenteriae, Typhoid Bacteria, Paratyphoid Bacteria, Escherichia coli, Proteus, Diphtheria Bacteria, Plague Bacteria, Subtilis Bacteria, Vibrio cholerae, and Tuberculosis Bacteria; it has a certain inhibitory effect on some viruses and pathogenic skin fungi. The water or alcohol extract of Stemona has the effect of expelling and killing head lice, clothing lice, pubic lice, bed bugs, fly maggots, pinworms, etc. Stemona has the power to kill insects and lice. It is mostly used to treat pinworms. Make a concentrated decoction of this product and keep it for enema before going to bed. For the treatment of vaginal trichomoniasis, it can be used alone, or with a decoction of Cnidium monnieri, Sophora flavescens, etc. for sitz baths and external washing. For the treatment of head lice, body lice and scabies, it can be made into a 20% ethanol solution or a 50% water decoction for external application.

[0057] The present invention is further described below in conjunction with examples, the purpose of which is to better understand the content of the present invention and reflect the essential characteristics of the present invention, so the examples cited should not be regarded as limiting the scope of protection of the present invention. It is also particularly pointed out here that the specific experimental methods and equipment involved in the examples are conventional methods or implemented under the conditions recommended by the manufacturer's instructions unless otherwise specified, and the reagents involved are commercially available unless otherwise specified.

[0058] Embodiment 1:

[0059] This embodiment provides a vaginal antibacterial lotion, comprising the following components in percentage by mass:

[0060]

[0061]

[0062] The preparation method of the above-mentioned lotion with vaginal antibacterial effect comprises the following steps:

[0063] 1. Dissolve menthol and borneol in 95% ethanol and hydrogenated castor oil CO40 until fully dissolved to form solution A;

[0064] 2. Dissolve chlorhexidine acetate in glycerol, 1,3-butanediol and purified water, and heat to promote dissolution to form solution B;

[0065] 3. Add solution B that has cooled to room temperature into solution A and stir evenly;

[0066] 4. Add the Phellodendron chinense extract, the Cnidium monnieri extract, the Sophora flavescens extract and the Stemona japonica extract to the mixed solution obtained in step (3), and mix thoroughly;

[0067] 5. Add lactic acid to the mixed solution obtained in step (4).

[0068] Embodiment 2:

[0069] This embodiment provides a vaginal antibacterial lotion, comprising the following components in percentage by mass:

[0070]

[0071] The preparation method of the above-mentioned vaginal antibacterial lotion is as described in Example 1.

[0072] Embodiment 3:

[0073] This embodiment provides a vaginal antibacterial lotion, comprising the following components in percentage by mass:

[0074]

[0075] The preparation method of the above-mentioned vaginal antibacterial lotion is as described in Example 1.

[0076] Comparative Example 1:

[0077] Based on the formula of the lotion in Example 1, the extract of Phellodendron amurense, the extract of Cnidium monnieri, the extract of Sophora flavescens and the extract of Stemona japonica were not added, and the rest was the same as in Example 1.

[0078] Comparative Example 2:

[0079] Based on the formula of the washing liquid in Example 1, lactic acid and lactobacillus fermentation product are not added, and the rest is the same as in Example 1.

[0080] Comparative Example 3:

[0081] Based on the formulation of the lotion in Example 1, lactic acid is not added, and the rest is the same as in Example 1.

[0082] Comparative Example 4:

[0083] Based on the formula of the washing liquid in Example 1, no lactobacillus fermentation product is added, and the rest is the same as in Example 1.

[0084] Efficacy test:

[0085] 1. pH value determination:

[0086] Basis: Ministry of Health "Technical Specifications for Disinfection" (2002 edition) 2.2.1.4 Determination of pH value.

[0087] Testing instrument: FE28 pH meter.

[0088] Standard buffer for calibration: potassium hydrogen phthalate pH (25°C) = 4.00; mixed phosphate pH (25°C) = 6.86; sodium tetraborate pH (25°C) = 9.18.

[0089] Test conditions: 25°C, relative humidity 50%. The test was repeated twice.

[0090] Operation steps: Turn on the PXS-270 ion meter and stabilize it for 20 minutes. After cleaning the electrode with deionized water, calibrate it with a standard solution pH = 4.00, then clean the electrode with deionized water, and then calibrate it with a standard solution pH = 9.18. After the calibration is confirmed, clean the electrode with deionized water and test the standard solution pH = 6.86. The calibration is completed when the pH value reading is within ± 0.02. Determine the sample pH value (25 ° C), repeat 2 times for each batch of samples, and take the average.

[0091] The average values ​​of pH (25°C) of the solutions with the highest concentration of the sample stock solutions are shown in Table 1.

[0092] Table 1 pH measurement results of antibacterial lotion samples of the present invention

[0093]

[0094] 2. Lead, arsenic and mercury content:

[0095] Basis: "Technical Specifications for Safety of Cosmetics" (2015 edition), Chapter 4, 1.6, 1.2.

[0096] Instrument: PLASMAQUANTMS inductively coupled plasma mass spectrometer, Jena, Germany.

[0097] Reagent names: nitric acid (GR), 30% hydrogen peroxide (super pure), mass spectrometry tuning solution (containing Be, Mg, Co, In, Ba, Pb, Th, Ce, Tl, with a concentration of 10 μg / mL), internal standard solution (containing Li, Tb, Y, Sc, Bi, Ge, In, Rh, Re, with a concentration of 10 mg / L).

[0098] Standard solutions: lead standard stock solution (1000 mg / L), arsenic standard stock solution (100 mg / L), mercury standard stock solution (1000 mg / L).

[0099] Test conditions: 21.7°C, relative humidity 50%. The test was repeated twice.

[0100] The results of lead, arsenic and mercury content of the samples are shown in Table 2.

[0101] Table 2 Results of determination of lead, arsenic and mercury contents in the antibacterial lotion samples of Example 1 of the present invention

[0102]

[0103] Note: ① Refer to Table 2 in Chapter 1 of the Technical Specifications for Safety of Cosmetics (2015 edition).

[0104] 3. Sterilization performance test:

[0105] Basis: "Hygiene Standard for Disposable Sanitary Products" GB15979-2002 (Appendix C) C3.

[0106] Test bacteria: Escherichia coli (8099) fourth generation (provided by Guangdong Microbiological Culture Collection Center), Staphylococcus aureus (ATCC6538) fourth generation (provided by Guangdong Huankai Microbiological Technology Co., Ltd.), Candida albicans (ATCC10231) fourth generation (provided by Guangdong Huankai Microbiological Technology Co., Ltd.).

[0107] Testing conditions: ambient temperature is 18℃~26℃, relative humidity is 45%~65% PH.

[0108] Instruments and equipment: SPX-490 biochemical incubator.

[0109] Preparation of bacterial suspension: Take a 24-hour fresh slant culture of the bacteria, wash it with 5 ml of sterile PBS, and dilute it to a bacterial content of 10 4 -10 5 cfu / ml bacterial suspension for later use.

[0110] Antibacterial experiment: According to the microbroth dilution method, the test solution is sterilized by filtering with a microporous filter membrane, and diluted with the sterile liquid culture medium of the test strain according to the 2-fold dilution method to a dilution solution of 80-0.01 mg / mL. Take a microdilution plate (96 wells), add 50 μL of different concentrations of diluted sample solution and 50 μL of bacterial suspension to each well, and use 100 μL of culture medium containing bacteria without sample solution as a control, and make 3 parallels for each group. Escherichia coli and Staphylococcus aureus are cultured at 37°C for 18-24h, and Candida albicans is cultured at 25°C for 48h. Result determination: Observe the growth of bacteria in each concentration well of the 96-well plate. When there is bacterial growth (turbidity) in the control well, the growth of bacteria is completely inhibited compared with the control well. The lowest concentration corresponding to the clear culture medium is the minimum inhibitory concentration (MIC) of the composition.

[0111] The test results are shown in Table 3.

[0112] Table 3 Bactericidal performance test results of antibacterial lotion samples of the present invention

[0113]

[0114] 4. Microbiological testing:

[0115] Basis: Appendix B of "Hygiene Standard for Disposable Sanitary Products" GB 15979-2002.

[0116] Test conditions: ambient temperature is 18℃~26℃, relative humidity is 45%~65%RH.

[0117] Table 4 Microbiological index test results of the antibacterial lotion samples of Example 1 of the present invention

[0118] Detection indicators Technical requirements Test results Total bacterial colony count (CFU / mL) ≤200 <20 Total fungal colony count (CFU / mL) ≤100 <20 Coliform bacteria Not to be detected Not detected Staphylococcus aureus Not to be detected Not detected Pseudomonas aeruginosa Not to be detected Not detected Hemolytic Streptococcus Not to be detected Not detected Fungal characterization Not to be detected Not detected

[0119] 5. Vaginal mucosal irritation test:

[0120] Basis: "Procedures and methods for toxicological evaluation of safety of disinfectants" (GB / T 38496-2020).

[0121] Environment: Temperature is 18℃~26℃, relative humidity is 40%~70%.

[0122] Animals and feeding: 24 New Zealand rabbits, female virgin rabbits, weighing 2.18kg to 2.31kg, experimental animals were purchased from Huadong Xinhua Experimental Animal Farm, Huadu District, Guangzhou, with experimental animal production license number: SCXK (Guangdong) 2019-0023, animal qualification certificate number: No. 44007600010181, and randomly divided into a control group and embodiments 1-3 and comparative examples 1-4, with 3 rabbits in each group. Feed was purchased from Beijing Huafukang Biotechnology Co., Ltd., with certificate number: 1103222200092765, and experimental animal use license number: SYXK (Guangdong) 2022-0198.

[0123] Detection method: The animals in the test group were fixed on their backs, with the vagina and vaginal opening exposed. The catheter was moistened with the test solution and gently inserted into the vagina (4cm-5cm), and 2ml of the test solution was slowly injected with a syringe, and the catheter was withdrawn to complete the poisoning. The poisoning was repeated every 24 hours for 5 consecutive days. The animals in the control group were treated in the same way with normal saline. 24 hours after the last poisoning, the animals were killed by gas embolism, and the complete vagina was removed by laparotomy. It was cut longitudinally and observed with the naked eye to see if there were any signs of congestion, edema, etc., for reference when taking pathological samples. The vagina was then placed in a 10% formalin solution and fixed for more than 24 hours. Tissues from the two ends and three central parts of the vagina were selected for preparation. After HE staining, histopathological examination was performed.

[0124] Histopathological examination results: The score was scored according to the vaginal mucosal irritation reaction scoring standard. The irritation reaction scores of the three parts of the three animals in the test group (control group) were added together and then divided by the total number of observations (number of animals x 3) to obtain the average score of the vaginal mucosal irritation reaction in the test group (control group). The irritation index was obtained by subtracting the average score of the control group from the average score of the test group, and the irritation intensity was graded according to the vaginal mucosal irritation intensity grading table. The results are shown in Table 5.

[0125] Table 5 New Zealand rabbit vaginal mucosal irritation test results of the antibacterial lotion samples of the present invention

[0126]

[0127] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A composition having vaginal antibacterial effect, characterized in that: The invention comprises chlorhexidine acetate, Chinese herbal medicine preparation, lactic acid and lactobacillus fermentation product, wherein the raw materials of the Chinese herbal medicine preparation comprise phellodendron, cnidium monnieri, sophora flavescens and radix stemonae, and the pH value of the composition is 3.8-4.

5.

2. The composition having vaginal antibacterial effect according to claim 1, characterized in that: The Chinese herbal medicine preparation is the powder of each raw material medicine, or the water or organic solvent extract of each raw material medicine.

3. The composition having vaginal antibacterial effect according to claim 1, characterized in that: The mass ratio of the chlorhexidine acetate, the Chinese herbal medicine preparation, lactic acid and the lactobacillus fermentation product is (1-20):1:(1-20):(0.1-10).

4. Use of the composition having vaginal antibacterial effect as claimed in any one of claims 1 to 3 in the preparation of a product for preventing or treating vaginal antibacterial.

5. An external preparation having vaginal antibacterial effect, characterized in that: The invention comprises a composition having vaginal antibacterial effect as described in any one of claims 1 to 3.

6. The external preparation having vaginal antibacterial effect according to claim 5, characterized in that: The external preparation is administered locally in the vagina.

7. The external preparation having vaginal antibacterial effect according to claim 6, characterized in that: The dosage form of the external preparation includes any one of lotion, suppository, effervescent tablet, ointment, gel and foam.

8. A vaginal antibacterial lotion, characterized in that: The components include the following mass percentages:

9. A method for preparing a lotion having vaginal antibacterial effect as claimed in claim 8, characterized in that: The steps include: Step (1), dissolving menthol and borneol in 95% ethanol and hydrogenated castor oil CO40 until fully dissolved to form solution A; Step (2), dissolving chlorhexidine acetate in glycerol, 1,3-butanediol and purified water, and heating to promote dissolution to form solution B; Step (3), adding the B solution cooled to room temperature to the A solution and stirring evenly; Step (4), adding the Phellodendron amurense extract, the Cnidium monnieri extract, the Sophora flavescens extract, the Stemona tuber extract and the lactobacillus fermentation product to the mixed solution obtained in step (3), and mixing them thoroughly; Step (5), adding lactic acid to the mixed solution obtained in step (4).

10. The preparation method according to claim 9, characterized in that: The pH value of the washing liquid is 3.8-4.5.

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