Gynecological antibacterial composition and preparation method thereof

Abstract

The invention discloses a gynecological antibacterial composition and a preparation method thereof. The gynecological antibacterial composition is prepared from 60 to 80 parts of purified water, 1 to 6 parts of pawpaw extract, 0.5 to 1 part of flos chrysanthemi indici volatile oil, 0.3 to 0.5 part of cnidium lactone, 0.1 to 0.3 part of xanthan gum, 0.8 to 1 part of fructus kochiae saponin, 3 to 4 parts of seabuckthorn seed oil, 1 to 2 parts of panthenol, 2 to 4 parts of bletilla striata gum, 1 to 1.5 parts of rhizoma polygonati polysaccharide, 3 to 8 parts of lactic acid bacteria metabolite and 0.05 to 0.1 part of nano-zinc oxide. According to the application, the nano-zinc oxide enhances the contact inactivation effect of pathogens, the papaya extract and the cnidium lactone damage the microbial structure in a targeted manner, and the thymol inhibits the formation of a biological membrane, so that the comprehensive nursing advantage of integrating bacteriostasis, anti-inflammation and repair is formed; the invention is suitable for daily protection and adjuvant therapy.

Description

Technical Field

[0001] The present invention belongs to the technical field of gynecological external preparations, and in particular relates to a gynecological antibacterial composition and a preparation method thereof. Background Art

[0002] Gynecological gels are primarily used to treat various gynecological vaginitis and cervicitis, offering anti-inflammatory, antiseptic, and antipruritic properties. Currently, silver ion gynecological antibacterial gels are commonly used. Related research, such as the article "Zhao Li, Liu Xiaoyuan. Preparation and Quality Control of Silver Ion Gynecological Topical Antibacterial Gel," is available. However, silver ion gynecological antibacterial gels have certain side effects, including localized allergic reactions and itching, which can vary from patient to patient. Furthermore, long-term use of this gel can lead to suboptimal treatment outcomes and even worsen the condition.

[0003] Current gynecological antibacterial products have the following problems:

[0004] 1. Chemically synthesized antibacterial agents can easily destroy the balance of vaginal microecology.

[0005] 2. Some Chinese herbal medicine preparations have slow onset of effect and poor ingredient stability;

[0006] 3. The emergence of drug-resistant strains leads to a decrease in the effectiveness of traditional antibiotics. Summary of the Invention

[0007] In view of this, the present invention aims to provide a gynecological antibacterial composition and a preparation method thereof to solve at least one technical problem in the background technology.

[0008] To achieve the above object, the technical solution of the present invention is achieved as follows:

[0009] A gynecological antibacterial composition, comprising, by weight:

[0010] 60-80 parts of purified water;

[0011] 1-6 parts of papaya extract;

[0012] 0.5-1 part of wild chrysanthemum essential oil;

[0013] Osthole 0.3-0.5 parts;

[0014] 0.1-0.3 parts of xanthan gum;

[0015] Kochia scoparia saponin 0.8-1 part;

[0016] 3-4 parts sea buckthorn seed oil;

[0017] 1-2 parts panthenol;

[0018] 2-4 parts of Bletilla striata glue;

[0019] 1 - 1.5 parts of polygonatum polysaccharide;

[0020] 3 - 8 parts of lactic acid bacteria metabolites;

[0021] 0.05 - 0.1 part of nano - zinc oxide;

[0022] 0.1 - 0.2 part of gallic acid;

[0023] 0.1 - 0.2 part of thymol;

[0024] 0.01 - 0.1 part of vitamin E.

[0025] Furthermore, the particle size of the nano - zinc oxide is 30 - 50 nm;

[0026] and / or, the enzyme activity of the papaya extract ≥ 800 U / g;

[0027] and / or, the content of unsaturated fatty acids in seabuckthorn seed oil ≥ 70%; and / or, the content of cineole detected by GC in wild chrysanthemum volatile oil ≥ 15%; and / or, the total saponin content of Kochia scoparia saponin ≥ 80%;

[0028] and / or, the polysaccharide content of polygonatum polysaccharide ≥ 90%;

[0029] and / or, the source of the lactic acid bacteria metabolites is the fermentation filtrate of Lactobacillus, and the lactic acid ≥ 3 mg / g.

[0030] A preparation method of a gynecological antibacterial composition, comprising the following steps:

[0031] S1: Mix seabuckthorn seed oil, wild chrysanthemum volatile oil, osthole, and vitamin E, and disperse them by water - bath ultrasonic to obtain an oil phase;

[0032] S2: Heat purified water to 45 - 50 °C, add bletilla striata gum to the purified water for pre - swelling, then add papaya extract, xanthan gum, and polygonatum polysaccharide, cool down to 38 °C, add panthenol and Kochia scoparia saponin, pre - disperse nano - zinc oxide into a homogeneous slurry with 4 - 6% glycerol and then add it, and homogenize to form a stable water phase;

[0033] S3: Drop the oil phase obtained in step S1 into the water phase obtained in step S2 at a speed of 0.5 - 1.5 mL / min, simultaneously perform high - speed shear emulsification at 8000 - 10000 rpm for 5 - 10 min, and then perform shear emulsification at 3000 - 5000 rpm for 10 - 20 minutes to stabilize the emulsion; obtain a primary emulsion;

[0034] S4: After the primary emulsion is cooled to 30 °C, add lactic acid bacteria metabolites, gallic acid, and thymol, let it stand and age for 1.8 - 2.2 h, adjust the pH to 4 - 5 with 0.1 M lactic acid, filter through a 0.22 - μm microporous membrane, detect the stability and then sterilize, and fill.

[0035] Further, in step S1, the temperature of the water bath ultrasonic treatment is 58 - 62 °C, and the time is 9 - 11 min;

[0036] And / or, the homogenization in step S2 is at 5000 rpm for 10 minutes.

[0037] Use of the gynecological antibacterial composition prepared from the above-mentioned gynecological antibacterial composition in the preparation of gynecological antibacterial drugs.

[0038] A gynecological lotion, the gynecological antibacterial composition prepared from the above-mentioned gynecological antibacterial composition.

[0039] Finally, adjust the pH to 4.8 - 5.2 with gallic acid, sterilize and filter through a 0.22 μm microporous membrane, and fill with nitrogen to obtain the finished product. This process effectively retains the activity of heat-sensitive components through staged temperature control and gradient addition. The dispersion degree of nano-zinc oxide reaches D90 < 200 nm, and the centrifugal stability of the product (4000 rpm, 15 min) shows no stratification.

[0040] This gynecological antibacterial composition achieves comprehensive effects of broad-spectrum antibacterial, anti-inflammatory repair, and microecological balance regulation through the synergistic action of multiple components. In terms of antibacterial, the volatile oil of wild chrysanthemum, osthole, and thymol form a composite antibacterial system, which respectively destroys the microbial cell membrane, interferes with fungal metabolism, and penetrates the pathogen protein, synergistically covering bacteria, fungi, and viruses; at the same time, gallic acid, nano-zinc oxide, and lactic acid bacteria metabolites jointly combat biofilm formation, effectively solving the problem of stubborn infections. In terms of anti-inflammatory repair, polygonatum polysaccharide, saponins of Kochia scoparia, and vitamin E synergistically inhibit inflammatory factors, reducing swelling, redness, and itching; bletilla striata gum, nano-zinc oxide, and seabuckthorn seed oil jointly promote the healing of mucosal wounds, while xanthan gum and panthenol enhance the moisturizing and lubricating functions, maintaining tissue integrity.

[0041] Microecological regulation is the unique advantage of this formula. The metabolites of lactic acid bacteria and papaya extract synergistically maintain an acidic environment, inhibiting the reproduction of pathogenic bacteria; polygonatum polysaccharide acts as a prebiotic to promote the growth of lactic acid bacteria, forming a two-way regulation of "inhibiting pathogenic bacteria - promoting probiotics" with saponins of Kochia scoparia. For different infection types, the components can synergize intelligently: for example, osthole, gallic acid, and nano-zinc oxide specifically target the hyphae and spores of Candida; the volatile oil of wild chrysanthemum, thymol, and lactic acid bacteria are combined to quickly eliminate the pathogens of bacterial vaginitis. This multi-target and hierarchical synergistic design not only avoids the drug resistance problem of traditional antibacterial agents but also achieves the antibacterial effect of treating both the symptoms and the root causes through multiple mechanisms such as nutritional competition, immune activation, and physical barriers, especially suitable for complex or recurrent gynecological inflammations.

[0042] Compared with the prior art, the gynecological antibacterial composition and its preparation method of the present invention have the following advantages:

[0043] 1. In the gynecological bacteriostatic composition, papaya extract, osthole, gallic acid, and thymol have a synergistic bacteriostatic effect and can effectively inhibit common pathogenic bacteria (such as Candida albicans, Staphylococcus aureus, etc.); at the same time, the metabolites of lactic acid bacteria and lactic acid regulate the pH to weakly acidic, promote the colonization of beneficial vaginal flora, repair the microecological balance, and reduce the risk of recurrence of infection.

[0044] 2. The volatile oil of wild chrysanthemum, saponins of Kochia scoparia, and polysaccharides of Polygonatum sibiricum in this application can relieve inflammatory reactions such as itching and swelling; seabuckthorn seed oil, panthenol, and vitamin E form a lipid protective film to promote mucosal repair; nano-zinc oxide and bletilla striata gum enhance the physical barrier function, reduce external stimulation, and improve local defense ability.

[0045] 3. In this application, natural plant components (such as bletilla striata gum and xanthan gum) are used as carriers to avoid the stimulation of chemical preservatives; through ultrasonic emulsification and gradient homogenization processes, the components are ensured to be evenly dispersed, and xanthan gum and seabuckthorn seed oil synergistically improve the stability of the system and extend the action time of active ingredients.

[0046] 4. The nano-zinc oxide in this application enhances the effect of contact inactivation of pathogens, papaya extract and osthole target and destroy the microbial structure, and thymol inhibits the formation of biofilms, forming a comprehensive nursing advantage of "bacteriostasis - anti-inflammatory - repair", which is suitable for daily protection and adjuvant treatment. Detailed implementation mode

[0047] It should be noted that, without conflict, the embodiments and features in the embodiments of the present invention can be combined with each other.

[0048] The present invention will be described in detail below with reference to the embodiments.

[0049] Staphylococcus aureus, Escherichia coli, and Candida albicans were all purchased from the China General Microbiological Culture Collection Center.

[0050] Example 1

[0051] Accurately weigh 35 g of seabuckthorn seed oil, 7 g of wild chrysanthemum volatile oil, 4 g of osthol, and 0.1 g of vitamin E, place them in a 60°C constant temperature water bath, and ultrasonically treat (300 W, 40 kHz) for 10 minutes. Pass through a 100-mesh stainless steel sieve and keep warm at 50°C for standby; take 700 g of purified water, heat it to 50°C, add 30 g of bletilla striata gum, stir and swell at 800 rpm for 30 minutes, successively add 30 g of papaya extract, 2 g of xanthan gum, and 12 g of polygonatum polysaccharide. After cooling to 38°C, add 15 g of panthenol and 9 g of saponins of Kochia scoparia. Pre-disperse 0.8 g of nano-zinc oxide and 16 g of 5% glycerol (5000 rpm / 5 minutes) and then add them, homogenize at 5000 rpm for 10 minutes to form a homogeneous aqueous phase (viscosity about 1000 cP). The oil phase is dropped into the aqueous phase at a speed of 1 mL / min, and simultaneously, high-speed shearing is carried out at 10000 rpm for 5 minutes (temperature controlled at 50 ± 1°C), and then continue to shear at 5000 rpm for 15 minutes (under nitrogen protection). Detect the primary emulsion: D90 ≤ 300 nm, 4000 rpm / 30 min, cool to 30°C, add 50 g of lactic acid bacteria metabolites, 1.5 g of gallic acid, and 1.5 g of thymol (pre-dissolved in 1% Tween 80), stand and age for 2 hours (slow stirring at 200 rpm), adjust the pH to 4.8 with 0.1 M lactic acid, filter through a 0.22 μm filter membrane to sterilize, and fill with nitrogen into amber sterile bottles.

[0052] The diameter of the inhibitory zone of Candida albicans is measured by the agar diffusion method (Kirby - Bauer method): Pour the sterilized Mueller - Hinton agar medium (containing 2% glucose and 0.5 μg / mL methylene blue) into a petri dish, and evenly coat the Candida albicans suspension (0.5 McFarland turbidity, about 1×10 8 CFU / mL). After the surface is dry, use a sterile punch to prepare a 6 - mm - diameter hole in the agar, add 100 μL of the sample to be tested (the inhibitory composition prepared in the example), and after culturing at 35°C for 24 hours, use a vernier caliper to measure the maximum vertical distance between the clear inhibitory edges of the inhibitory zone edge (including the hole diameter), and take the average value of three repeated experiments.

[0053] The diameter of the inhibitory zone of Escherichia coli is measured by the agar diffusion method (Kirby - Bauer method): Evenly coat the Escherichia coli suspension (the concentration is adjusted to 1×10 8 CFU / mL) on a sterile Mueller - Hinton agar plate, place a sterile Oxford cup or apply a filter paper containing the drug (containing the inhibitory composition to be tested), and after culturing at 37°C for 16 - 18 hours, use a vernier caliper to measure the vertical diameter from the edge to the edge of the inhibitory zone (accurate to 0.1 mm), and repeat 3 times to take the average value. The edge of the inhibitory zone is based on the clearly visible sterile growth area visible to the naked eye. If there is a blurred edge, measure the outermost extension of the inhibitory part.

[0054] The measurement of the diameter of the inhibition zone of Staphylococcus aureus was strictly carried out in accordance with the Bacteriostatic Efficacy Test Specification (General Rule 1101) of the Chinese Pharmacopoeia 2020 Edition: Using the agar diffusion method (Kirby - Bauer method), Mueller - Hinton agar plates after sterilization were evenly coated with a suspension of Staphylococcus aureus (ATCC 6538) (1×10 6 CFU / mL). After the surface was dried, a sterile Oxford cup was placed in the center of the plate, and 0.1 mL of the sample to be tested was injected. After culturing at 37 °C for 24 hours, a vernier caliper (accuracy 0.1 mm) was used to vertically measure the diameter from the edge to the edge of the inhibition zone, and the average value of three repeated experiments was taken (allowing an error of ±0.5 mm).

[0055] The diameter of the inhibition zone of Candida albicans was 18.5 ± 0.5 mm;

[0056] The diameters of the inhibition zones of Escherichia coli were 14.5 mm;

[0057] The diameter of the inhibition zone of Staphylococcus aureus was 15.8 mm.

[0058] Example 2

[0059] Accurately weigh 40 g of seabuckthorn seed oil, 5 g of wild chrysanthemum volatile oil, 5 g of osthole, and 0.2 g of vitamin E, place them in a 60 °C constant temperature water bath and ultrasonically treat (300 W, 40 kHz) for 10 minutes, pass through a 100 - mesh stainless steel sieve, and keep warm at 50 °C for standby; Take 650 g of purified water, heat it to 50 °C, add 25 g of bletilla striata gum, stir and swell at 800 rpm for 30 minutes, successively add 50 g of papaya extract, 3 g of xanthan gum, and 15 g of polygonatum polysaccharide. After cooling to 38 °C, add 20 g of panthenol and 8 g of saponins of Kochia scoparia. Pre - disperse 0.5 g of nano - zinc oxide and 14 g of 5% glycerol (5000 rpm / 5 minutes) and then add them. Homogenize at 5000 rpm for 10 minutes to form a homogeneous aqueous phase. The oil phase was dropped into the aqueous phase at a speed of 1 mL / min, and simultaneously sheared at 10000 rpm for 5 minutes (temperature controlled at 50 ± 1 °C), then continued to shear at 5000 rpm for 15 minutes (under nitrogen protection). Detect the primary emulsion: D90 ≤ 350 nm, 4000 rpm / 30 min, cool to 30 °C, add 60 g of lactic acid bacteria metabolites, 2 g of gallic acid, and 1 g of thymol (pre - dissolved in 1% Tween 80), stand and age for 2 hours (slow stirring at 200 rpm), adjust the pH to 4.8 with 0.1 M lactic acid, filter through a 0.22 μm filter membrane to remove bacteria, and fill with nitrogen into amber sterile bottles.

[0060] The diameter of the inhibition zone of Candida albicans was 19.2 ± 0.5 mm (cultured for 24 hours, agar diffusion method);

[0061] The inhibition zone diameter of Escherichia coli is 15.2 ± 0.4;

[0062] The inhibition zone diameter of Staphylococcus aureus is 16.5 ± 0.5;

[0063] Example 3

[0064] Mix seabuckthorn seed oil (40 g), volatile oil of wild chrysanthemum (5 g), osthol (5 g), and vitamin E (0.2 g), ultrasonicate in a water bath at 60 °C (300 W, 10 minutes), and filter for standby; heat purified water (750 g) to 50 °C, add bletilla striata gum (25 g) and allow it to swell for 30 minutes, then add papaya extract (20 g), xanthan gum (1.5 g), and polygonatum polysaccharide (15 g). After cooling to 38 °C, add panthenol (20 g), saponins of Kochia scoparia (8 g), and nano-zinc oxide pre-dispersed in glycerol (0.5 g + 10 g of 5% glycerol), and homogenize (4000 rpm / 8 minutes); emulsify: drop the oil phase into the water phase at 1 mL / min, shear at 10000 rpm for 5 minutes, and then shear at 5000 rpm for 15 minutes; post-treatment: cool to 30 °C, add lactic acid bacteria metabolites (60 g), gallic acid (2 g), and thymol (1 g, pre-dissolved in 1% Tween 80), let it stand and age for 1.8 hours, adjust the pH to 4.9 with 0.1 M lactic acid, filter through a 0.22 μm filter membrane, and fill with nitrogen for bottling.

[0065] The inhibition zone diameter of Candida albicans is 19.8 ± 0.5 mm (cultured for 24 hours, agar diffusion method);

[0066] The inhibition zone diameter of Escherichia coli is 13.2 ± 0.4 mm;

[0067] The inhibition zone diameter of Staphylococcus aureus is 14 mm.

[0068] For the gynecological lotion prepared in Examples 1 - 3, a test group (Examples 1 - 3), a negative control group, and a blank control group were set up. Each group had 5 adult female New Zealand rabbits (body weight 2.5 - 3.0 kg). For the test group, take 0.5 mL of the gynecological lotion prepared in Examples 1 - 3 respectively, inject the test composition (0.5 mL) deep into the vagina once a day for 5 consecutive days. The blank control group was not given any treatment. 24 hours after the last administration: euthanize the animals, take out the complete vaginal tissue, and conduct pathological examination: fix the vaginal tissue in 10% formalin, and perform HE staining after paraffin sectioning.

[0069] No abnormal reactions such as congestion and edema were found in the vaginal tissues of female New Zealand rabbits, nor were any other symptoms observed. The vaginal irritation score of the rabbits in Example 1 was 0.8, and those in Example 2 and Example 3 were both 0.6, indicating that the gynecological lotion of the present invention has low irritation to the vaginal mucosa and is safe in nature.

[0070] Application Example 1:

[0071] A 35-year-old female with a history of recurrent mycotic vaginitis for 2 years. Usage effect: On the 3rd day: Itching decreased by 80%, and the secretion turned into normal milky white. On the 14th day: Colposcopy showed complete repair of the mucosa, and the culture became negative.

[0072] Application Example 2:

[0073] A 42-year-old female with vaginal relaxation and chronic inflammation after childbirth. Usage effect: On the 7th day: The pain during sexual intercourse disappeared, and she reported a significant improvement in tightness. On the 14th day: The pH value dropped from 6.1 to 4.7, and the flora detection returned to normal. The subject feedback showed a significant improvement in vaginal elasticity and relief of dryness: The subject also stated that the mucosal moisture increased. After 7 days of use, the vaginal pH value dropped from 5.5 to 4.6, and the proportion of beneficial bacteria (Lactobacillus) increased from 15% to 68% (16S rRNA sequencing).

[0074] For daily care, use 2 - 3 times a week to prevent recurrence (with a significant microecological regulation effect). For special populations, it is applicable to those with recurrent vaginitis and those who need private part repair after childbirth. It is recommended to use 1 - 2 times a day for more than 7 consecutive days. For postpartum / menopausal women, it is used to improve mucosal dryness and decreased elasticity.

[0075] Comparative Example 1

[0076] The difference from Example 1 is that 30 g of papaya extract is not added, and 730 g of purified water is added.

[0077] According to the antibacterial effect test method (suspension quantitative method) of antibacterial daily chemical products in QB / T 2738 - 2012 "Evaluation Method for Antibacterial and Bacteriostatic Effects of Daily Chemical Products", the antibacterial rates of the gynecological lotion prepared in Examples 3 - 5 and Comparative Examples 1 - 4 against Escherichia coli (ATCC 49226), Staphylococcus aureus (ATCC 29213), and Candida albicans (ATCC 10231) were tested. The experiment was repeated 3 times, and the average value was taken.

[0078] The diameter of the inhibition zone of Candida albicans was 16.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method);

[0079] The diameter of the inhibition zone of Escherichia coli was 13.2 mm;

[0080] The diameter of the inhibition zone of Staphylococcus aureus was 14.3 mm.

[0081] Comparative Example 2

[0082] The difference from Example 1 is that 7 g of wild chrysanthemum volatile oil is not added, and 707 g of purified water is added.

[0083] The inhibition zone diameter of Candida albicans was 16.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the inhibition zone diameter of Escherichia coli was 13.1 mm;

[0084] The inhibition zone diameter of Staphylococcus aureus was 14.3 mm.

[0085] Comparative Example 3

[0086] The difference from Example 1 was that 4 g of osthole was not added and 704 g of purified water was added.

[0087] The inhibition zone diameter of Candida albicans was 14.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the inhibition zone diameter of Escherichia coli was 12.1 mm;

[0088] The inhibition zone diameter of Staphylococcus aureus was 13.4 mm.

[0089] Comparative Example 4

[0090] The difference from Example 1 was that 2 g of xanthan gum was not added and 702 g of purified water was added.

[0091] The inhibition zone diameter of Candida albicans was 17.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the inhibition zone diameter of Escherichia coli was 14.1 mm;

[0092] The inhibition zone diameter of Staphylococcus aureus was 15.3 mm.

[0093] Comparative Example 5

[0094] The difference from Example 1 was that 9 of Kochia scoparia saponin was not added and 709 g of purified water was added;

[0095] The inhibition zone diameter of Candida albicans was 15.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the inhibition zone diameter of Escherichia coli was 12.1 mm;

[0096] The inhibition zone diameter of Staphylococcus aureus was 13.5 mm.

[0097] Comparative Example 6

[0098] The difference from Example 1 was that 35 of seabuckthorn seed oil was not added and 735 g of purified water was added;

[0099] The inhibition zone diameter of Candida albicans was 17.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the inhibition zone diameter of Escherichia coli was 14.1 mm;

[0100] The inhibition zone diameter of Staphylococcus aureus was 15.3 mm.

[0101] Comparative Example 7

[0102] It is different from Example 1 in that 15 g of panthenol is not added, and 715 g of purified water is added;

[0103] The diameter of the inhibition zone against Candida albicans is 17.4 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the diameter of the inhibition zone against Escherichia coli is 13.8 mm;

[0104] The diameter of the inhibition zone against Staphylococcus aureus is 15.0 mm.

[0105] Comparative Example 8

[0106] It is different from Example 1 in that 30 g of bletilla striata gum is not added, and 730 g of purified water is added.

[0107] The diameter of the inhibition zone against Candida albicans is 17.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the diameter of the inhibition zone against Escherichia coli is 14.3 mm;

[0108] The diameter of the inhibition zone against Staphylococcus aureus is 15.0 mm.

[0109] Comparative Example 9

[0110] It is different from Example 1 in that 12 g of polygonatum polysaccharide is not added, and 712 g of purified water is added;

[0111] The diameter of the inhibition zone against Candida albicans is 17.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the diameter of the inhibition zone against Escherichia coli is 14.1 mm;

[0112] The diameter of the inhibition zone against Staphylococcus aureus is 15.3 mm.

[0113] Comparative Example 10

[0114] It is different from Example 1 in that 50 g of lactic acid bacteria metabolites is not added, and 750 g of purified water is added; the diameter of the inhibition zone against Candida albicans is 16.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the diameter of the inhibition zone against Escherichia coli is 13.1 mm;

[0115] The diameter of the inhibition zone against Staphylococcus aureus is 14.1 mm.

[0116] Comparative Example 11

[0117] It is different from Example 1 in that 0.8 g of nano-zinc oxide is not added, and 700.8 g of purified water is added;

[0118] The diameter of the inhibition zone against Candida albicans is 16.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the diameter of the inhibition zone against Escherichia coli is 13.2 mm;

[0119] The inhibition zone diameter of Staphylococcus aureus is 14.1 mm.

[0120] Comparative Example 12

[0121] The difference from Example 1 is that 1.5 g of gallic acid is not added, and 701.5 g of pure water is added;

[0122] The inhibition zone diameter of Candida albicans is 16.8 ± 0.6 mm (cultured for 24 hours, agar diffusion method); the inhibition zone diameter of Escherichia coli is 13.2 mm;

[0123] The inhibition zone diameter of Staphylococcus aureus is 14.5 mm.

[0124] Comparative Example 13

[0125] The difference from Example 1 is that 1.5 g of thymol is not added, and 701.5 g of pure water is added;

[0126] The inhibition zone diameter of Candida albicans is 16.7 ± 0.6 mm (cultured for 24 hours, agar diffusion method);

[0127] The inhibition zone diameter of Escherichia coli is 13.1 mm;

[0128] The inhibition zone diameter of Staphylococcus aureus is 14.1 mm.

[0129] Comparative Example 14

[0130] The difference from Example 1 is that 0.1 g of vitamin E is not added, and 700.1 g of pure water is added.

[0131] The inhibition zone diameter of Candida albicans is 16.7 ± 0.6 mm (cultured for 24 hours, agar diffusion method);

[0132] The inhibition zone diameter of Escherichia coli is 13.1 mm;

[0133] The inhibition zone diameter of Staphylococcus aureus is 14.1 mm.

[0134] Papaya extract contains papain and polyphenols, which can gently decompose the biological membrane, enhance the permeability of other ingredients, and have anti-inflammatory and antibacterial effects at the same time. The volatile oil of wild chrysanthemum is rich in camphor and cineole, which can quickly inhibit pathogens such as Staphylococcus aureus, and the effect takes effect rapidly. Osthole is a natural coumarin compound, which can specifically kill Candida albicans and trichomonas, and is not likely to induce drug resistance. Saponins of Kochia scoparia play a broad-spectrum antibacterial role by destroying the cell membrane of microorganisms, and have less impact on lactic acid bacteria compared with chemically synthesized agents. Sea buckthorn seed oil and panthenol synergistically repair the mucosal barrier, reduce inflammatory reactions, and lower the risk of repeated infections. Metabolites of lactic acid bacteria (such as lactic acid, bacteriocin) maintain the acidic environment of the vagina, selectively inhibit pathogenic bacteria, and directly supplement the substances required by the microecology. Nano-zinc oxide and gallic acid physically adsorb pathogens and destroy their biological membranes. The slow release of zinc ions prolongs the action time, and gallic acid inhibits the formation of biofilms of drug-resistant bacteria. Polygonatum polysaccharide and Bletilla striata gum form a physical protective layer to reduce pathogen adhesion. At the same time, the immune regulation of polysaccharides enhances local defense.

[0135] This application provides lactic acid and antibacterial peptides through metabolites of lactic acid bacteria (rather than live bacteria), quickly acidifying the environment without disturbing the original flora. Polygonatum polysaccharide and Bletilla striata gum, as prebiotics, promote the colonization of native lactic acid bacteria, avoiding the "indiscriminate killing" problem of chemical bacteriostatic agents.

[0136] The volatile oil of wild chrysanthemum (small molecules are easy to absorb) and nano-zinc oxide (quick contact sterilization) achieve immediate effects, and synergize with slow-acting ingredients such as osthole. Sea buckthorn seed oil and vitamin E, as natural antioxidants, protect easily degradable ingredients (such as osthole); xanthan gum and Bletilla striata gum form a gel sustained-release system to prolong the action time of active ingredients.

[0137] Thymol (destroying cell membranes), gallic acid (inhibiting DNA gyrase), and osthole (interfering with mitochondrial function) have triple mechanisms to reduce the risk of drug resistance. Papaya extract decomposes the biofilm matrix, and nano-zinc oxide penetrates the membrane structure, solving the problem of the shelter of drug-resistant bacteria. This composition has three levels of action: "quick antibacterial - microecological regulation - mucosal repair", combining the immediacy of chemical drugs and the safety of traditional Chinese medicine, and is suitable for patients with repeated infections or antibiotic treatment failures.

[0138] In summary, the gynecological antibacterial composition of the present invention can be used for the private part cleaning and care of women, dealing with gynecological problems caused by Candida albicans infections, and is suitable for people with recurrent vaginitis and postpartum private part repair. It is recommended to use it 1 - 2 times a day for more than 7 consecutive days. Postpartum / menopausal women can use it to improve mucosal dryness and decreased elasticity.

[0139] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included in the protection scope of the present invention.

Claims

1. A gynecological antibacterial composition, characterized in that: By weight parts, it includes: 60 - 80 parts of purified water; 1 - 6 parts of papaya extract; 0.5 - 1 part of volatile oil of wild chrysanthemum; 0.3 - 0.5 part of osthole; 0.1 - 0.3 part of xanthan gum; 0.8 - 1 part of saponins of Kochia scoparia; 3 - 4 parts of seabuckthorn seed oil; 1 - 2 parts of panthenol; 2 - 4 parts of bletilla striata gum; 1 - 1.5 parts of polygonatum polysaccharide; 3 - 8 parts of lactic acid bacteria metabolites; 0.05 - 0.1 part of nano zinc oxide; 0.1 - 0.2 part of gallic acid; 0.1 - 0.2 part of thymol; 0.01 - 0.1 part of vitamin E.

2. The gynecological antibacterial composition according to claim 1, characterized in that: The particle size of nano zinc oxide is 30 - 50 nm; and / or, the enzyme activity of papaya extract ≥ 800 U / g; and / or, the unsaturated fatty acid content of seabuckthorn seed oil ≥ 70%; and / or, the eucalyptol content detected by GC of volatile oil of wild chrysanthemum ≥ 15%; 3. The preparation method of a gynecological antibacterial composition according to claim 1, characterized in that: The total saponin content of saponins of Kochia scoparia ≥ 80%; and / or, the polysaccharide content of polygonatum polysaccharide ≥ 90%; and / or, the source of lactic acid bacteria metabolites is the fermentation filtrate of Lactobacillus, and lactic acid ≥ 3 mg / g.

4. A method for preparing a gynecological antibacterial composition according to any one of claims 1-3, characterized in that: It includes the following steps: S1: Mix seabuckthorn seed oil, volatile oil of wild chrysanthemum, osthole, and vitamin E, and disperse them by water bath ultrasonic to obtain an oil phase; S2: Heat purified water to 45 - 50 °C, add bletilla striata gum to the purified water for pre - swelling, then add papaya extract, xanthan gum, and polygonatum polysaccharide, cool down to 38 °C, add panthenol and saponins of Kochia scoparia, and add nano zinc oxide after pre - dispersing it into a homogeneous slurry with 4 - 6% glycerol, and homogenize to form a stable water phase; S3: Drop the oil phase obtained in step S1 into the water phase obtained in step S2 at a speed of 0.5 - 1.5 mL / min, and at the same time, perform high - speed shear emulsification at 8000 - 10000 rpm for 5 - 10 min, and then perform shear emulsification at 3000 - 5000 rpm for 10 - 20 minutes to stabilize the emulsion; obtain a primary emulsion; S4: After the primary emulsion cools down to 30 °C, add lactic acid bacteria metabolites, gallic acid, and thymol, let it stand and age for 1.8 - 2.2 h, use 0.1 M lactic acid to adjust the pH to 4 - 5, filter through a 0.22 μm microporous filter membrane, detect the stability and then sterilize, and fill.

5. The preparation method of a gynecological antibacterial composition according to claim 4, characterized in that: In step S1, the temperature of water bath ultrasonic is 58 - 62 °C, and the time is 9 - 11 min; and / or, the homogenization in step S2 is at 5000 rpm for 10 minutes.

6. Use of the gynecological antibacterial composition prepared from the gynecological antibacterial composition described in claim 5 in the preparation of gynecological antibacterial drugs.

7. A gynecological lotion, characterized in that, It includes the gynecological antibacterial composition prepared from the gynecological antibacterial composition described in claim 5.