Biological vaginal lotion and preparation method thereof

Abstract

The invention discloses a biological vaginal lotion, which integrates the biological surface activity function of sophorolipid, the repair activity of tabasheer extract and the micro-ecological regulation function of probiotics, and adopts an independent packaging technology to guarantee the activity of the probiotics, thereby providing the vaginal lotion with the functions of cleaning, resisting bacteria, resisting inflammation, repairing mucous membranes and regulating micro-ecology. The problems that in the prior art, probiotics are poor in stability, single in function and insufficient in use convenience are solved, and wide market application prospects are achieved.

Description

Technical Field

[0001] The invention belongs to the field of personal care and gynecological medicine, and particularly relates to a vaginal wash based on natural bioactive ingredients. Background Art

[0002] Vaginitis, bacterial infections, and microbiome imbalance are common health issues for women. Existing vaginitis washes often rely on synthetic antimicrobial agents (such as chlorhexidine), which can be highly irritating, disrupt microbiome balance, and have limited effectiveness against drug-resistant bacteria. Furthermore, traditional surfactants (such as sodium lauryl sulfate) may disrupt the vaginal mucosal barrier or inhibit the colonization of probiotics.

[0003] Probiotics in traditional lotions are often inactivated due to pH fluctuations, moisture content, and storage conditions, resulting in limited microecological restoration effectiveness. Furthermore, probiotics may interact with surfactants or other antimicrobial ingredients, reducing their activity. Summary of the Invention

[0004] In order to solve the above technical problems, the present invention provides a biological vaginal wash that "has the functions of cleaning, antibacterial, anti-inflammatory, mucosal repair and microecological regulation", and improves its activity and ease of use through "probiotic independent packaging" technology.

[0005] The technical solution of the present invention is: a biological vaginal wash and a preparation method thereof, comprising a wash body and an independent probiotic package, wherein the wash body contains sophorolipids (0.5%-5%), bamboo yellow extract (0.1%-3%), a moisturizer (0.05%-5%), a pH regulator, and the balance is water (pure water or deionized water).

[0006] Furthermore, the sophorolipid is preferably a complex sophorolipid. As a natural biosurfactant, the sophorolipid has a broad-spectrum antibacterial activity (inhibiting Escherichia coli, Staphylococcus aureus and Candida albicans) and has almost no irritation to the vaginal mucosa. It is used for cleaning, antibacterial and promoting the penetration of active ingredients.

[0007] The bamboo yellow extract contains hypocrellin A, polysaccharides and triterpenoid compounds, and has antioxidant, anti-inflammatory and collagen production-promoting effects, and is used to repair vaginal mucosal damage and delay tissue aging.

[0008] Furthermore, the content of hypocrellin A in the bamboo yellow extract is ≥0.5%.

[0009] The moisturizing agent is sodium hyaluronate (0.05%-0.5%) or glycerin (1%-5%), which is used to enhance the moisturizing property of the mucous membrane.

[0010] The pH regulator is lactic acid or citric acid, which is used to adjust the pH value of the lotion to 3.5-4.5.

[0011] The probiotics are preferably of the genus Lactobacillus, such as one or more combinations of Lactobacillus rhamnosus, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus acidophilus, Lactobacillus animalis, and Lactobacillus plantarum.

[0012] Furthermore, the Lactobacillus rhamnosus strain preservation information is: Preservation classification name: Lactobacillus rhamnosus Lactobacillus rhamnosus , deposit number: CGMCCNo.34707, deposit date: May 29, 2025, deposit unit: General Microbiology Center of China Culture Collection Administration, deposit unit address: No. 3, Yard 1, Beichen West Road, Chaoyang District, Beijing.

[0013] The independent probiotic package further comprises a probiotic protective agent, which is a combination of trehalose, gelatin or sodium alginate and chitosan, and is used to improve the survival rate of the probiotics in the washing solution.

[0014] Furthermore, the probiotic independent package is an independent package for one-time use, wherein the bacterial content is a viable bacterial count ≥ 1×10 9 CFU / time.

[0015] Furthermore, the vertical packaging technology is as follows:

[0016] 1. Independent packaging: Probiotics are packaged in single-dose bags (such as aluminum foil bags) or soluble capsules using freeze-drying packaging technology or microencapsulation technology; Each time the probiotics are used, the probiotics in the independent package are added to the biological washing liquid and mixed to avoid premature exposure to pH or moisture.

[0017] 2. Packaging materials: Use "semipermeable biocompatible materials" (such as calcium alginate, chitosan) or "degradable polymers" (such as PLA, PVA) as microcapsule wall materials.

[0018] 3. Storage conditions: The independently packaged probiotics must be stored at a low temperature (4-8°C) and away from light to maintain the activity of the live bacteria; The biological lotion body can be stored at room temperature and mixed with the probiotic independent package when used.

[0019] Preparation method

[0020] S1 Preparation of Sophorolipids: Candida bombicola is used to ferment vegetable oils (such as coconut oil) and sugars (such as glucose), and purified sophorolipids are obtained through physical extraction processes (centrifugation and membrane filtration); Control fermentation conditions (temperature 30-35°C, pH 5.5-6.5) to improve yield and antibacterial activity.

[0021] S2 Preparation of Bamboo Yellow Extract: After the bamboo shoots were crushed, they were reflux-extracted twice with an ethanol-water mixed solvent (volume ratio 1:1), and the extracts were combined and concentrated to a solid content of 5%-10%; Or use ultrasonic-assisted extraction technology to shorten the extraction time and retain the active ingredients.

[0022] S3 preparation of the main body of the lotion: Mix sophorolipids, bamboo extract, moisturizer and pH regulator in proportion, add purified water or deionized water and stir until uniform; High-pressure homogenization (pressure 50-100 MPa) to ensure stable dispersion of ingredients; After sterilization, aseptically fill into sealed containers for storage.

[0023] S4 preparation of probiotics independent packs: The probiotics are mixed with the protective agent in proportion, and made into freeze-dried powder by "freeze drying" or dry powder by "low temperature spray drying"; The lyophilized powder or dry powder is divided into individual packages (such as aluminum foil bags or soluble capsules), vacuum-sealed and stored at low temperature. Beneficial effects

[0024] (1) Synergistic effects of multiple biological activities: Sophora biosurfactants are mildly cleansing and antibacterial; bamboo extracts are antioxidant, anti-inflammatory and can repair mucosa; probiotics regulate microecological balance and inhibit the colonization of pathogens.

[0025] (2) Independent packaging of probiotics: Through independent packaging technology, the interaction between probiotics and other ingredients of the lotion is avoided, and the activity stability is improved; use on demand, reduce the risk of contamination, and enhance user experience.

[0026] (3) Microecological repair function: Probiotics and lactic acid jointly maintain the acidic environment of the vagina (pH 3.8-4.5), promoting the colonization rate of lactobacilli to increase by more than 35%; inhibiting the excessive reproduction of harmful yeasts (such as Candida albicans), and the effect is equivalent to that of antifungal drugs.

[0027] (4) Environmental friendliness: Sophorolipids are 100% biodegradable, bamboo extract is renewable, and probiotics are natural microorganisms, which are in line with the concept of green chemistry.

[0028] (5) Safety and applicability: In vitro tests have shown that it is non-toxic to vaginal epithelial cells (cell survival rate >95%); it is suitable for sensitive skin, postoperative care and long-term use. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a flow chart of the preparation method of the present invention. DETAILED DESCRIPTION

[0030] In order to make the purpose and advantages of the present invention more clearly understood, the present invention is further described below in conjunction with embodiments and experimental examples. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0031] Please refer to the attached Figure 1 The preferred embodiment of the present invention is described below. Figure 1 For the purpose of simplifying the process flow chart, the basic process of the present invention is only illustrated in a schematic manner, and therefore only the processes related to the present invention are shown. It should be understood by those skilled in the art that these embodiments are only used to explain the technical principles of the present invention and are not intended to limit the scope of protection of the present invention. Example

[0032] Washing solution: 1000 mL Complex sophorolipids: 30 g; Bamboo yellow extract (10% solid content): 20 g; Lactic acid (85%): 2.5 g (adjust pH to 4.2); Sodium hyaluronate: 3g; Purified water: Make up to 1000 mL.

[0033] After mixing evenly, perform high-pressure homogenization (pressure 80 MPa, 1 time), sterilize the washing solution, and aseptically fill it into a sealed container for storage.

[0034] Probiotics for one dose, individually packaged: 1.5g / bag Probiotics (1×10 9 CFU): 0.5g; Lactobacillus rhamnosus (5×10 8 CFU); Lactobacillus gasseri (3×10 8 CFU); Lactobacillus crispatus (2×10 8 CFU); Protective agent (trehalose, gelatin): 1g.

[0035] Freeze-dry and pack into aluminum foil bags or soluble capsules, vacuum seal and refrigerate at 4℃.

[0036] experiment

[0037] 1. Probiotics independent packaging activity test Individually packaged probiotics were stored at 4°C and room temperature (25°C) as experimental groups 1 and 2, respectively. Non-individually packaged probiotic solutions were stored at 4°C as the control group. The plate count method (GB 4789.3-2022) was used for testing at 0, 30, 60, and 90 days of storage. The experimental results are shown in Table 1:

[0038] Conclusion: The decline in viable bacterial count of independently packaged probiotics at 4°C was significantly less than that of the unpackaged group (P<0.01). The activity of independently packaged probiotics stored at room temperature was still better than that of the unpackaged group (P<0.05), indicating that encapsulation technology effectively delayed inactivation.

[0039] 2. Antibacterial performance test Escherichia coli (ATCC 25922), Staphylococcus aureus (ATCC 6538), and Candida albicans (ATCC 10231) strains were tested using the inhibition zone method (referring to General Chapter 1104 of the 2020 edition of the Chinese Pharmacopoeia, Part IV) and the minimum inhibitory concentration (MIC) using the broth microdilution method (CLSI M27-A protocol). Wash solution concentration: 1% (v / v); The experimental results are shown in Table 2:

[0040] Control experiment: Compared with existing products (such as Jieeryin wash), the diameter of the inhibition zone of the wash of the present invention against Candida albicans is increased by 20% (P<0.05).

[0041] 3. Mucosal repair effect (animal experiment) Female SD rats (weighing 200-250g) were used to establish a vaginal mucosal injury model using mechanical injury. The wash solution of the present invention served as the experimental group, and normal saline served as the control group (administered once daily for 7 consecutive days). Inflammation scores (0-4 points) and collagen expression levels (ELISA) were assessed. The experimental results are shown in Table 3:

[0042] Conclusion: The lotion of the present invention significantly reduced the inflammation score (P<0.01) and promoted collagen synthesis (P<0.05), and its repair effect was better than that of the control group.

[0043] 4. In vitro cytotoxicity assay The cell viability of human vaginal epithelial cells was tested by MTT assay using the original solution of the present invention (100% concentration); dilutions of the solution (1%, 5%, 10%, and 20% v / v, diluted in sterile PBS); negative control: sterile PBS; positive control: 1% sodium dodecyl sulfate (SDS, a known cytotoxic substance); The experimental results are shown in Table 4:

[0044] Conclusion: The RGR of the lotion of the present invention to vaginal epithelial cells is ≥95.8% within the concentration range of 1%-100%.

[0045] 5. Pregnancy safety test Experimental Methods: Twenty New Zealand white rabbits, 5-7 days of gestation, were randomly divided into two groups. The experimental group received daily vaginal instillation with the original solution of the present invention (5 mL / time), while the control group received daily vaginal instillation with normal saline. The pregnancy abortion rate, fetal malformation rate, fetal weight, and organ development were observed. The experimental results are shown in Table 5:

[0046] Conclusion: The lotion of the present invention has no adverse effects on pregnant animals and fetuses.

[0047] 6. pH stability (direct test): after 6 months of storage at room temperature, the pH fluctuation range is <0.3 (initial pH=4.2).

[0048] Thus far, the technical solutions of the present invention have been described in conjunction with the preferred embodiments shown in the accompanying drawings. However, it will be readily understood by those skilled in the art that the scope of protection of the present invention is clearly not limited to these specific embodiments. Without departing from the principles of the present invention, those skilled in the art may make equivalent changes or substitutions to the relevant technical features, and the technical solutions after such changes or substitutions will fall within the scope of protection of the present invention.

Claims

1. A biological vaginal wash, characterized in that: The invention comprises a lotion body and an independent probiotic package. The lotion body contains sophorolipids (0.5%-5%), bamboo yellow extract (0.1%-3%), moisturizer (0.05%-5%), pH regulator, and the balance is water (purified water or deionized water).

2. The washing liquid according to claim 1, characterized in that The sophorolipid is a complex sophorolipid.

3. The washing liquid according to claim 1, characterized in that The content of hypocrellin A in the bamboo yellow extract is ≥0.5%.

4. The washing liquid according to claim 1, characterized in that The moisturizing agent is sodium hyaluronate (0.05%-0.5%) or glycerin (1%-5%).

5. The washing liquid according to claim 1, characterized in that The pH regulator is lactic acid or citric acid, which is used to adjust the pH value of the lotion to 3.5-4.

5.

6. The washing liquid according to claim 1, characterized in that The probiotics are of the genus Lactobacillus and are packaged in a single-dose package by freeze-drying technology or microencapsulation. The number of viable bacteria in the single dose is ≥ 1×10 9 CFU / time.

7. The washing liquid according to claim 1, characterized in that The probiotic independent package adopts semi-permeable biocompatible materials (such as calcium alginate, chitosan) or degradable polymers (such as PLA, PVA) as microcapsule wall materials.

8. The washing liquid according to claim 1, characterized in that The independent probiotic package further comprises a probiotic protective agent, which is a combination of trehalose, gelatin or sodium alginate and chitosan.

9. A method for preparing the lotion according to any one of claims 1 to 8, comprising the steps of fermenting sophorolipids, extracting active ingredients from bamboo biosurfactants, mixing and preparing the lotion body, and preparing independent probiotic packages.

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