Female antibacterial gel and preparation method thereof
By combining a multi-layered hydrogel substrate with thermosensitive polymers and natural plant extracts, this design solves the problems of poor sustained-release effect and microecological disruption in existing gynecological gels, achieving highly efficient drug controlled release and antibacterial effects, and is suitable for the treatment and care of vaginal inflammation.
Patent Information
- Application Number
- CN202511396955.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-28
- Publication Date
- 2025-12-26
AI Technical Summary
Existing gynecological gels have poor sustained-release effects and may disrupt the vaginal microecological balance, leading to secondary infections and aggravated inflammation.
A sustained-release system is constructed using a multi-layered hydrogel substrate, combined with thermosensitive polymers and natural plant extracts, including Cnidium monnieri extract and Helichrysum fusiforme extract. The multi-layered hydrogel design achieves controlled drug release and antibacterial effects.
It improves the sustained-release effect of the drug, reduces irritation to the vaginal environment, avoids antibiotic resistance, and enhances the treatment effect on vaginal inflammation. It is suitable for daily care and inflammation treatment.
Smart Images
Figure CN121197288A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of gynecological gels, in particular to a gynecological bacteriostatic gel and a preparation method thereof. BACKGROUND
[0002] Gynecological inflammation, such as vaginitis, cervicitis, etc., is a very common disease in the female population. In the clinical treatment of such diseases, topical drug delivery formulations play a key role, among which suppositories, creams and gels are widely used. The gel dosage form can be well attached to the surface of the vaginal mucosa due to its excellent mucosal adhesion, thereby prolonging the contact time of the drug with the lesion; it has sustained release properties, which can make the drug release continuously and stably, maintain an effective drug concentration; it is relatively convenient and comfortable to use, and is more easily accepted by patients, so it has gradually become a research hotspot in this field.
[0003] Then, according to the characteristics of the vagina itself, the gel drug used in the prior art has poor sustained release effect, or the selected excipients have irritant properties, which may destroy the balance of the vaginal microecosystem. There is a complex and subtle microbial community in the vagina, which maintains a specific ecological balance and plays an important protective role in the health of the female reproductive system. Once the gel destroys this microecological balance, it may cause a series of adverse consequences, such as a decrease in the number of beneficial bacteria in the vagina and a large number of harmful bacteria, thereby increasing the risk of women being infected with other gynecological diseases, and even possibly leading to an exacerbation of the original inflammation. SUMMARY
[0004] To solve the above problems, the present application provides a gynecological bacteriostatic gel and a preparation method thereof, which uses natural plant extracts as effective components and combines gel hierarchical structures with sustained release effects to improve the sustained release effect and bacteriostatic and bactericidal effect in drug delivery, and reduce the risk of secondary exacerbation of inflammation caused by drug intervention.
[0005] To achieve the above purpose, the technical solution adopted by the present application is as follows:
[0006] In a first aspect, the present application provides a bacteriostatic gel for women, comprising the following components by weight: 97-99% of a base material and 1-3% of an effective component; the effective component comprises the following components by weight: 0.3-0.9% of Cnidium monnieri extract, 0.1-0.4% of Anthemis nobilis extract, 0.1-0.3% of Sophora flavescens extract, 0.1-0.3% of Nelumbo nucifera extract, 0.1-0.4% of Camellia sinensis extract, 0.1-0.3% of Psidium guajava leaf extract, and 0.1-0.3% of Angelica gigas Nakai extract; the base material comprises a first layer of hydrogel, a second layer of hydrogel, and a third layer of hydrogel, the first layer of hydrogel is not loaded with the effective component, the second layer of hydrogel is loaded with the effective component, and the third layer of hydrogel is loaded with a temperature-sensitive polymer.
[0007] In some specific implementations, the skeleton of the first layer of hydrogel mainly comprises carboxymethyl chitosan, and the skeleton of the second layer of hydrogel mainly comprises a temperature-sensitive polymer, which is a polyacrylamide derivative.
[0008] In some specific implementations, the effective component comprises the following components by weight: 0.5% of Cnidium monnieri extract, 0.2% of Anthemis nobilis extract, 0.2% of Sophora flavescens extract, 0.2% of Nelumbo nucifera extract, 0.2% of Camellia sinensis extract, 0.2% of Psidium guajava leaf extract, and 0.1% of Angelica gigas Nakai extract.
[0009] In some specific implementations, the polyacrylamide derivative comprises any one of poly(N-isopropyl acrylamide) block, N,N-diethyl acrylamide.
[0010] In some specific implementations, the polyacrylamide derivative comprises poly(N-isopropyl acrylamide) block, and the poly(N-isopropyl acrylamide) block comprises a first block and a second block; the first block is poly N-isopropyl acrylamide, and the second block is polyethylene glycol.
[0011] In a second aspect, a preparation method of the female bacteriostatic gel is provided, and the method comprises the following steps: S1. preparing an oxidized dextran solution with a concentration of 10 wt% and a carboxymethyl chitosan solution with a concentration of 2 wt%, and mixing the oxidized dextran solution and the carboxymethyl chitosan solution at a volume ratio of (0.5-1.5):(1.5:0.5) to obtain a first layer of hydrogel; S2. preparing a carboxymethyl chitosan solution with a concentration of 2 wt% and a main component solution with a concentration of 5 wt%, mixing the carboxymethyl chitosan solution and the main component solution to obtain a first mixed solution, and mixing the first mixed solution and the oxidized dextran solution with a concentration of 10 wt% at an equal volume to prepare a second layer of hydrogel; S3. preparing a temperature-sensitive polymer solution, mixing the temperature-sensitive solution and the oxidized dextran solution to obtain a second mixed solution, and mixing the second mixed solution and the first mixed solution at an equal volume to prepare a third layer of hydrogel; and S4. combining the first layer of hydrogel, the second layer of hydrogel and the third layer of hydrogel to obtain the female bacteriostatic gel.
[0012] In some specific implementations, the main component solution is prepared by dissolving Cnidium monnieri extract 0.5%, Pyrethrum extract 0.2%, Sophora flavescens extract 0.2%, Lotus leaf extract 0.2%, tea leaf extract 0.2%, Psidium guajava leaf extract 0.2%, and Angelica gigas Nakai extract 0.1% in deionized water at a mass-volume ratio of 1:2 to obtain the main component solution.
[0013] In some specific implementations, the temperature-sensitive polymer solution is prepared by dissolving poly(N-isopropyl acrylamide) block in deionized water at a mass-volume ratio of 1:20 to obtain the temperature-sensitive polymer solution.
[0014] In some specific implementations, the method further comprises: dissolving a bisulfite-polyethylene glycol, N-isopropyl acrylamide and azobisisobutyronitrile in 1,4-dioxane and performing a cyclic deoxygenation treatment, and then performing a vacuum drying after sedimentation in n-hexane to obtain the poly(N-isopropyl acrylamide) block.
[0015] In some specific implementations, the cyclic deoxygenation treatment comprises three groups of cyclic treatment processes, and each group of the cyclic treatment processes comprises, in sequence, a freezing treatment, a vacuum treatment and a thawing treatment.
[0016] The technical scheme provided in the application provides a bacteriostatic gel for women and a preparation method thereof, is specially designed for the health of the private parts of women, can efficiently kill pathogenic bacteria, repair mucosa, and maintain the microecological balance of the vagina. The gel is composed of 97-99% of a multi-layer structure base material and 1-3% of natural plant effective components. The effective components contain seven natural ingredients such as Cnidium monnieri extract, Italian wax chrysanthemum extract, and Sophora flavescens root extract, which synergistically play the roles of broad-spectrum sterilization, anti-inflammatory and itching relief, and mucosa repair, and are especially suitable for the treatment of gynecological inflammation such as vaginitis and vulvitis. The natural ingredients are compounded and the intelligent slow-release technology is used to avoid the risk of antibiotic resistance and microbial imbalance, gently improve the problems such as itching, odor, and abnormal secretion of the private parts, and have the functions of efficient antibiosis, mucosa repair, and microecological regulation, and are suitable for daily care and inflammation treatment scenes. The gel is suitable for: auxiliary treatment of HPV infection, radical treatment of bacterial vaginitis, preventive care of recurrent vaginitis, and anti-infection protection after gynecological surgery. Comprehensive repair: has multiple functions of sterilization, anti-virus, anti-inflammatory, and mucosa repair.
[0017] And by configuring the base material with a multi-layer structure and adding the hydrogel with temperature-sensitive polymer in the base material, the loading and slow-release control effect of the effective components are realized, especially with high temperature responsiveness and pH responsiveness, thereby improving the medicinal effect of the bacteriostatic gel for women as a whole. And by compounding the functional agents, the application range of the antibacterial agent can be improved and multiple functional use scenes can be increased, which has higher efficient antibacterial property, broad-spectrum practicality, and environmental friendliness compared with the prior art. BRIEF DESCRIPTION OF DRAWINGS
[0018] In order to more clearly illustrate the technical scheme in the application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the application, and other drawings can be obtained by those skilled in the art without creative labor.
[0019] Figure 1 It is a preparation method flow chart of the bacteriostatic gel for women provided in the application.
[0020] Figure 2 It is a preparation method flow chart of the polyacrylamide derivative provided in the application.
[0021] Figure 3 It is the first schematic diagram of the experimental results provided in the application.
[0022] Figure 4 It is the second schematic diagram of the experimental results provided in the application.
[0023] Figure 5 It is the third schematic diagram of the experimental results provided in the application. DETAILED DESCRIPTION
[0024] In order to make the objectives, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below. If specific conditions are not indicated in the embodiments, the conventional conditions or the conditions suggested by the manufacturers are adopted. If the reagents or instruments used are not indicated by the manufacturers, they are all conventional products that can be purchased in the market. The embodiments described below are part of the embodiments of the present application, but not all the embodiments. All other embodiments obtained by those skilled in the art without creative efforts on the basis of the embodiments in the present application all fall within the scope of protection of the present application.
[0025] In one specific embodiment of the present application, a bacteriostatic gel for women is provided, the components of which include 97% to 99% of a base material and 1% to 3% of an effective component by weight. Among them, the base material is the gel structure loaded with the effective component in the embodiment, and the effective component is the composition that produces a direct bacteriostatic effect.
[0026] Among them, the bacteriostatic gel in the prior art also adopts the above structure. The base material as the main structure of drug delivery achieves the delivery of the drug by loading the effective component, and achieves the sustained release effect of the release of the effective component under specific conditions.
[0027] However, it is different from the prior art in that, considering the complex vaginal environment, and the secondary infection caused by the fluctuation of the vaginal flora due to the stimulation of the drug and the stimulation of the base material in the drug delivery, and the drug resistance of the conventional antibiotic drugs. The bacteriostatic gel for women provided in the embodiment uses natural plant extracts as the effective component, reduces the stimulation of the drug to the vaginal environment and the drug resistance easily produced by the antibiotic drugs, and improves the overall sustained release effect of the drug by constructing a new loading structure, thereby improving the medicinal effect of the bacteriostatic gel for women as a whole.
[0028] Specifically, the effective component in the embodiment includes the following components by weight: Cnidium extract 0.3% to 0.9%, Italian wax chrysanthemum extract 0.1% to 0.4%, Sophora flavescens root extract 0.1% to 0.3%, lotus leaf extract 0.1% to 0.3%, tea leaf extract 0.1% to 0.4%, guava leaf extract 0.1% to 0.3%, and Korean angelica extract 0.1% to 0.3%.
[0029] The Cnidium monnieri extract as a bactericidal extract has direct killing ability against common pathogens in gynecology (such as trichomonas and epidermophyton), and its antihistamine property can quickly relieve vulvar itching. The Helichrysum italicum extract has anti-inflammatory repair, antioxidant, and mucosal healing promoting technical effects, and its antioxidant capacity can reduce mucosal oxidative damage caused by chronic inflammation. The Sophora flavescens root extract has broad-spectrum antibacterial, pH regulating, and damp-heat inflammation relieving technical effects, and in this embodiment, the Sophora flavescens root extract is combined with Cnidium monnieri to cover a wider spectrum of pathogens (such as Gardnerella and Candida), and its alkaloid component can quickly neutralize alkaline secretions and restore the lactobacillus dominant environment. The Nelumbo nucifera leaf extract has oil control, bacteriostasis, antioxidant, and mucosal barrier repair medicinal effects, it can stimulate the generation of collagen and elastic fibers, enhance the elasticity of the vaginal wall, and is especially suitable for postpartum or menopausal women with increased mucosal fragility; and it can also inhibit lipid peroxidation and reduce the production of inflammatory secretions. The Psidium guajava leaf extract has antioxidant, anti-inflammatory, astringent, and mast cell degranulation inhibiting effects, it can inhibit mast cell degranulation and relieve acute itching caused by contact dermatitis or chemical irritation, and its tannic acid component can also reduce the exudation of mucosal erosion and promote wound dryness and healing. The Angelica gigantea extract has the technical effects of regulating hormone balance, promoting blood circulation, and antibacterial repair, and through the degradation of androgen receptor protein by praeruptorin, it can improve the excessive secretion of sebum related to high androgen, promote postpartum uterine contraction, repair childbirth damage, and relieve pelvic congestion pain.
[0030] In this embodiment, the above effective components are all extracts of natural plants, which are more gentle than the antibiotics used in the prior art, can reduce the stimulation to the vaginal environment, and thus avoid the influence and damage of vaginal flora. Moreover, the effective components can also avoid the problem of antibiotic resistance, thereby improving the effect of the drug.
[0031] Moreover, the combined effect of the effective components provided in this embodiment is not simply bacteriostasis. Through the combination of the above effective components, different situations can be correspondingly solved. Specifically, the combination of Cnidium monnieri extract, Sophora flavescens extract, and Psidium guajava leaf extract can be used for rapid acute symptom control and for relieving acute symptoms. The combination of Nelumbo nucifera extract, Helichrysum italicum extract, and Angelica gigantea extract can support long-term tissue repair and avoid the problem of repeated infection caused by bacterial damage to the tissue. The combination of Sophora flavescens extract and tea leaf extract can inhibit harmful bacteria and create a living environment for lactobacillus, thereby allowing the vaginal microbial system to be reformed and reconstructed, and reducing the risk of re-infection.
[0032] From the above, the effective component of the women's bacteriostatic gel provided in the embodiment adopts various natural plant extracts and can improve the realization of the bactericidal effect based on the combined compounding idea.
[0033] The substrate in the embodiment is used to load, deliver and release the effective component in the area. Because the vagina is long and narrow and the flora environment is complex, if the sustained-release effect is poor or uncontrollable, the effective component will not be released at the target point, resulting in poor bacteriostatic effect.
[0034] Therefore, according to the scene characteristics in the embodiment, the substrate adopts a multilayer structure of hydrogel, and each layer of hydrogel has a controlled release effect. Specifically, the substrate in the embodiment includes a first layer of hydrogel, a second layer of hydrogel and a third layer of hydrogel. The first layer of hydrogel does not load the effective component, the second layer of hydrogel loads the effective component, and the third layer of hydrogel loads a temperature-sensitive polymer.
[0035] During use, the women's bacteriostatic gel can directly kill the pathogenic bacteria of bacterial vaginitis, and has auxiliary inhibitory effect on HPV virus. The antioxidant and bacteriostatic properties of tea extract and guava leaf extract can further enhance the ability to remove harmful microorganisms. The first layer of hydrogel of the substrate does not contain effective components and can be used as a "physical barrier" to reduce direct irritation of the sensitive mucosa by subsequent effective components, especially suitable for scenarios such as postoperative gynecological surgery and acute inflammation of the mucosa, to improve safety and comfort. The effective component is wrapped in the second layer of hydrogel and can be slowly released through the swelling and penetration of the gel to avoid dilution or discharge of the effective component in a short period of time, so that the bacteriostatic and anti-inflammatory components can have a sustained effect (such as maintaining an effective concentration for 6-8 hours) at the lesion site, improving the treatment effect on vaginitis and vulvitis and reducing the inconvenience of "frequent medication". The third layer (loaded with temperature-sensitive polymer): temperature response, locking the affected area. The temperature-sensitive polymer will undergo a phase change (such as from liquid to gel) when it comes into contact with the body temperature of the vagina (about 37°C), forming a "closed layer" to lock the effective component of the second layer in the lesion area, further reducing the loss of components, and at the same time, it can isolate external pollutants (such as bacteria caused by underwear friction), creating a "closed and clean" environment for mucosa repair, meeting the needs of "postoperative anti-infection" and "mucosa repair".
[0036] The skeleton of the first layer of hydrogel and the second layer of hydrogel mainly includes carboxymethyl chitosan, the skeleton of the second layer of hydrogel mainly includes a temperature-sensitive polymer, and the temperature-sensitive polymer is a polyacrylamide derivative.
[0037] Further, the polyacrylamide derivative includes any one of poly(N-isopropyl acrylamide) block, N,N-diethyl acrylamide.
[0038] It is known that the microenvironment for bacterial infection has a specific micro-acidic feature, accompanied by temperature rise. Therefore, in order to achieve the technical effect of controllable slow release of the substrate in the embodiment, a multi-layer hydrogel structure is adopted, and a temperature-sensitive polymer is introduced into the hydrogel, which can cause chemical collapse and physical shrinkage of the hydrogel network structure under the lower pH and higher temperature in the bacterial infection microenvironment, so that the hydrogel realizes the controlled release of the drug under the double stimulation of pH and temperature.
[0039] Among them, the first layer and the second layer structure of the hydrogel are taken as the skeleton of oxidized dextran and carboxymethyl chitosan, and the controlled release of the drug is realized through the pH response characteristics of itself. The non-uniform distribution of polyacrylamide derivatives in the hydrogel can induce asymmetric shrinkage of the double-layer hydrogel when the temperature rises, so as to cause the shrinkage and deformation of the hydrogel, thereby producing a double response effect. The female bacteriostatic gel in the embodiment has a more efficient slow release effect and a more controllable slow release effect.
[0040] Among them, in order to further improve the slow release effect, the polyacrylamide derivative is improved in the embodiment to have better drug loading effect and more stable slow release effect.
[0041] Specifically, the polyacrylamide derivative in the embodiment is preferably poly(N-isopropyl acrylamide) block.
[0042] Among them, the poly(N-isopropyl acrylamide) block includes a first block and a second block; the first block is poly N-isopropyl acrylamide, which is used to impart hydrophobicity and temperature sensitivity to the polymer. The second block is polyethylene glycol, which is used to impart hydrophilicity and biocompatibility to the polymer. And an acid ester is arranged between the A block and the B block. In an acidic environment, the acid ester bond is unstable and prone to breakage. The effective components are loaded into the third layer hydrogel containing the polymer, which rapidly converts into a hydrogel solid implant in situ under the stimulation of the temperature of the vaginal environment, thereby realizing precise drug targeted delivery. At the same time, the orthoester bond in the hydrogel polymer chain breaks in a weak acid environment, and the gel network gradually collapses and degrades, thereby realizing stable and long-lasting release of the effective components.
[0043] Referring to Figure 1 , the female bacteriostatic gel is also provided a preparation method, including the following steps:
[0044] Step S11. Prepare an oxidized dextran solution with a concentration of 10wt% and a carboxymethyl chitosan solution with a concentration of 2wt%, and mix the oxidized dextran solution and the carboxymethyl chitosan solution in a volume ratio of (0.5-1.5):(1.5:0.5) to obtain a first layer of hydrogel.
[0045] Step S12. Prepare a carboxymethyl chitosan solution with a concentration of 2wt% and a main component solution with a concentration of 5wt%, mix the carboxymethyl chitosan solution and the main component solution to obtain a first mixed solution, and mix the first mixed solution and an oxidized dextran solution with a concentration of 10wt% in equal volume to prepare a second layer of hydrogel.
[0046] In this embodiment, the main component solution is a solution containing active ingredients, and the preparation method is as follows: dissolve Cnidium monnieri extract 0.5%, Italian wax chrysanthemum extract 0.2%, Sophora flavescens extract 0.2%, Lotus leaf extract 0.2%, tea leaf extract 0.2%, Psidium guajava leaf extract 0.2%, and Angelica gigas Nakai extract 0.1% in deionized water in a mass-volume ratio of 1:2 to obtain the main component solution.
[0047] Step S13. Prepare a temperature-sensitive polymer solution, mix the temperature-sensitive solution and the oxidized dextran solution to obtain a second mixed solution, and mix the second mixed solution and the first mixed solution in equal volume to prepare a third layer of hydrogel.
[0048] In this embodiment, the temperature-sensitive polymer is preferably poly(N-isopropyl acrylamide) block. As for the secondary polymer, a corresponding synthesis method is provided in this embodiment, please refer to Figure 2 , which comprises the following steps:
[0049] Step S21. Mix the dithioester-polyethylene glycol, N-isopropyl acrylamide, and azobisisobutyronitrile in a weight ratio of 1:10:15 to obtain a mixed component.
[0050] Step S22. Dissolve the mixed component in 1,4-dioxane in a mass-volume ratio of 5:4, and perform a cyclic deoxygenation treatment, and then perform a stirring reaction at 80°C for 10h.
[0051] In this embodiment, the cyclic deoxygenation treatment comprises three sets of cyclic treatment processes, and each set of the cyclic treatment processes comprises freezing treatment, vacuum treatment, and thawing treatment in sequence.
[0052] Step S23. After the reaction is completed, perform sedimentation in n-hexane, and obtain poly(N-isopropyl acrylamide) block powder under vacuum drying conditions.
[0053] Step S14. Combining the first layer hydrogel, the second layer hydrogel and the third layer hydrogel to obtain the antibacterial gel for women.
[0054] Embodiment 1
[0055] The embodiment of the present application provides an antibacterial gel for women, which is composed of 97% of a base material and 3% of an effective component. The effective component comprises the following components according to the total weight: 1.0% of Cnidium monnieri extract, 0.4% of Anthemis nobilis extract, 0.3% of Sophora flavescens extract, 0.3% of Nelumbo nucifera extract, 0.4% of Camellia sinensis extract, 0.3% of Psidium guajava leaf extract and 0.3% of Angelica gigas Nakai extract. The base material comprises poly(N-isopropyl acrylamide) block, wherein the poly(N-isopropyl acrylamide) block comprises a first block and a second block; the first block is poly N-isopropyl acrylamide, and the second block is polyethylene glycol and is connected by an acid ester bond.
[0056] The embodiment of the present application also provides a preparation method of the antibacterial gel for women, which comprises the following steps:
[0057] Synthesis of poly(N-isopropyl acrylamide) block:
[0058] Step S11. Mixing 0.1 g of disulfide-polyethylene glycol, 1 g of N-isopropyl acrylamide and 1.5 g of azobisisobutyronitrile to obtain a mixed component.
[0059] Step S12. Dissolving the mixed component in 2.5 ml of 1,4-dioxane, and after three cycles of freezing-vacuum-thawing deoxygenation, stirring at 80°C for 10 h.
[0060] Step S13. After the reaction is completed, sedimentation is performed in n-hexane, and poly(N-isopropyl acrylamide) block powder is obtained under vacuum drying conditions.
[0061] Preparation of the antibacterial gel for women:
[0062] Step S21. Dissolving 1 g of oxidized dextran in 10 mL of deionized water to prepare a 10 wt% oxidized dextran solution, dissolving 0.2 g of carboxymethyl chitosan in 10 mL of deionized water to prepare a 2 wt% carboxymethyl chitosan solution, mixing the two solutions at a ratio of 0.5:1.5 and pouring into a mold to prepare a first layer hydrogel without loading drugs.
[0063] Step S21. 1 g of oxidized dextran was dissolved in 10 mL of deionized water to prepare a 10 wt% oxidized dextran solution, 0.2 g of carboxymethyl chitosan and 0.5 g of the active component were dissolved in 10 mL of deionized water to prepare a 5 wt% active component solution and a 2 wt% carboxymethyl chitosan solution, respectively; 0.05 mL of the main component solution and 1 mL of the carboxymethyl chitosan solution were mixed, deionized water was added to keep the solution volume at 2 mL, and then mixed with the same volume of the oxidized dextran solution, and then poured into a mold with a thickness of 1 mm to prepare the second layer of the drug-loaded hydrogel.
[0064] Step S23. 0.5 g of poly(N-isopropyl acrylamide) block was dissolved in 10 mL of deionized water to prepare a 5 wt% poly(N-isopropyl acrylamide) block solution, 2 g of oxidized dextran was dissolved in 10 mL of deionized water to prepare a 20 wt% oxidized dextran solution, the poly(N-isopropyl acrylamide) block solution and the oxidized dextran solution were mixed in different volume ratios of 0.5:1.0, and then deionized water was added to keep the solution volume at 2 mL; then the mixed solution of the poly(N-isopropyl acrylamide) block and the oxidized dextran was mixed with the same volume of the mixed solution of the main component and the carboxymethyl chitosan, and then poured into a mold with a thickness of 1 mm to prepare the third layer of the hydrogel.
[0065] Step S24. The first layer of the hydrogel, the second layer of the hydrogel, and the third layer of the hydrogel were combined to obtain the antibacterial gel for women.
[0066] Example 2
[0067] The example of the present application provides an antibacterial gel for women, which is different from example 1 in that the example comprises the following components by weight: 98% base material and 2% active component, and the active component comprises the following components by weight: 0.8% Cnidium extract, 0.3% Italian wax chrysanthemum extract, 0.2% Sophora flavescens extract, 0.2% Lotus leaf extract, 0.3% tea leaf extract, 0.1% Psidium guajava leaf extract, and 0.1% Angelica acutiloba extract.
[0068] Example 3
[0069] The example of the present application provides an antibacterial gel for women, which is different from example 1 in that the example comprises the following components by weight: 98.4% base material and 1.6% active component, and the active component comprises the following components by weight: 0.5% Cnidium extract, 0.2% Italian wax chrysanthemum extract, 0.2% Sophora flavescens extract, 0.2% Lotus leaf extract, 0.2% tea leaf extract, 0.2% Psidium guajava leaf extract, and 0.1% Angelica acutiloba extract.
[0070] Example 4
[0071] The embodiment of the present application provides a bacteriostatic gel for women, which is different from the embodiment 1 in that the preparation of the bacteriostatic gel for women comprises the following steps:
[0072] Step S21. 1g of oxidized dextran is dissolved in 10mL of deionized water to prepare a 10wt% oxidized dextran solution, 0.2g of carboxymethyl chitosan is dissolved in 10mL of deionized water to prepare a 2wt% carboxymethyl chitosan solution, and the two solutions are mixed at a ratio of 1:1 and poured into a mold to prepare a first layer of hydrogel without loading drugs.
[0073] Step S21. 1g of oxidized dextran is dissolved in 10mL of deionized water to prepare a 10wt% oxidized dextran solution, 0.2g of carboxymethyl chitosan and 0.5g of active components are respectively dissolved in 10mL of deionized water to prepare a 5wt% active component solution and a 2wt% carboxymethyl chitosan solution; 0.05mL of the main component solution and 1mL of the carboxymethyl chitosan solution are mixed, deionized water is added to keep the solution volume at 2mL, and then mixed with the oxidized dextran solution at the same volume, and then poured into a mold with a thickness of 1mm to prepare a second layer of hydrogel loaded with drugs.
[0074] Step S23. 0.5g of poly(N-isopropyl acrylamide) block is dissolved in 10mL of deionized water to prepare a 5wt% poly(N-isopropyl acrylamide) block solution, 2g of oxidized dextran is dissolved in 10mL of deionized water to prepare a 20wt% oxidized dextran solution, the poly(N-isopropyl acrylamide) block solution and the oxidized dextran solution are mixed at different volume ratios of 1:1, and then deionized water is added to keep the solution volume at 2mL; then the mixed solution of poly(N-isopropyl acrylamide) and oxidized dextran and the mixed solution of the main component and carboxymethyl chitosan are mixed at the same volume and poured into a mold with a thickness of 1mm to prepare a third layer of hydrogel.
[0075] Step S24. The first layer of hydrogel, the second layer of hydrogel and the third layer of hydrogel are combined to obtain the bacteriostatic gel for women.
[0076] Embodiment 5
[0077] The embodiment of the present application provides a bacteriostatic gel for women, which is different from the embodiment 2 in that the preparation of the bacteriostatic gel for women comprises the following steps:
[0078] Step S21. 1g of oxidized dextran is dissolved in 10mL of deionized water to prepare a 10wt% oxidized dextran solution, 0.2g of carboxymethyl chitosan is dissolved in 10mL of deionized water to prepare a 2wt% carboxymethyl chitosan solution, and the two solutions are mixed at a ratio of 1:1 and poured into a mold to prepare a first layer of hydrogel without loading drugs.
[0079] Step S21. 1 g of oxidized dextran is dissolved in 10 mL of deionized water to prepare a 10 wt% oxidized dextran solution, 0.2 g of carboxymethyl chitosan is dissolved in 10 mL of deionized water to prepare a 2 wt% carboxymethyl chitosan solution, and 0.05 mL of the main component solution and 1 mL of the carboxymethyl chitosan solution are mixed, deionized water is added to keep the solution volume at 2 mL, and then the solution is mixed with the oxidized dextran solution in equal volume, and then poured into a mold with a thickness of 1 mm to prepare a second layer of hydrogel without loading drugs.
[0080] Step S23. 0.5 g of poly(N-isopropyl acrylamide) block is dissolved in 10 mL of deionized water to prepare a 5 wt% poly(N-isopropyl acrylamide) block solution, 2 g of oxidized dextran is dissolved in 10 mL of deionized water to prepare a 20 wt% oxidized dextran solution, and the poly(N-isopropyl acrylamide) block solution and the oxidized dextran solution are mixed in a volume ratio of 1:1, and then deionized water is added to keep the solution volume at 2 mL; then the mixed solution of poly(N-isopropyl acrylamide) block and oxidized dextran is mixed with the mixed solution of the main component and carboxymethyl chitosan in equal volume and poured into a mold with a thickness of 1 mm to prepare a third layer of hydrogel.
[0081] Step S24. The first layer of hydrogel, the second layer of hydrogel, and the third layer of hydrogel are combined to obtain the antibacterial gel for women.
[0082] Example 6
[0083] The embodiment of the present application provides an antibacterial gel for women, which is different from the embodiment 3 in that the preparation of the antibacterial gel for women comprises the following steps:
[0084] Step S21. 1 g of oxidized dextran is dissolved in 10 mL of deionized water to prepare a 10 wt% oxidized dextran solution, 0.2 g of carboxymethyl chitosan is dissolved in 10 mL of deionized water to prepare a 2 wt% carboxymethyl chitosan solution, and the two solutions are mixed in a volume ratio of 1:1 and poured into a mold to prepare a first layer of hydrogel without loading drugs.
[0085] Step S21. 1 g of oxidized dextran is dissolved in 10 mL of deionized water to prepare a 10 wt% oxidized dextran solution, 0.2 g of carboxymethyl chitosan and 0.5 g of effective components are respectively dissolved in 10 mL of deionized water to prepare a 5 wt% effective component solution and a 2 wt% carboxymethyl chitosan solution; 0.05 mL of the main component solution and 1 mL of the carboxymethyl chitosan solution are mixed, deionized water is added to keep the solution volume at 2 mL, and then the solution is mixed with the oxidized dextran solution in equal volume, and then poured into a mold with a thickness of 1 mm to prepare a second layer of hydrogel with loading drugs.
[0086] Step S23. 0.5 g of poly(N-isopropylacrylamide) block was dissolved in 10 mL of deionized water to prepare a 5 wt% poly(N-isopropylacrylamide) block solution, 2 g of oxidized dextran was dissolved in 10 mL of deionized water to prepare a 20 wt% oxidized dextran solution, the poly(N-isopropylacrylamide) block solution and the oxidized dextran solution were mixed in a volume ratio of 1:1, and then deionized water was added to keep the solution volume at 2 mL; the mixed solution of poly(N-isopropylacrylamide) block and oxidized dextran was mixed with the mixed solution of the main component and carboxymethyl chitosan in equal volume, and then poured into a mold with a thickness of 1 mm to prepare the third layer of hydrogel.
[0087] Step S24. The first layer of hydrogel, the second layer of hydrogel and the third layer of hydrogel were combined to obtain the antibacterial gel for women.
[0088] Experimental Example 1
[0089] The antibacterial ability of the antibacterial gel for women corresponding to Examples 1-6 was tested by the inhibition zone method. The antibacterial release experiment was performed by placing the antibacterial gel for women corresponding to Examples 1-6 on agar plates containing E. coli and S. aureus, respectively. The antibacterial release results can be seen in Figure 3
[0090] 200 μL of bacterial suspension with a concentration of 1×10 6 CFU / mL was uniformly coated on an LB nutrient agar plate using a sterile applicator. Three pieces of drug sensitivity paper were placed on each petri dish, and the antibacterial gel for women corresponding to Examples 1-6 was placed on the drug sensitivity paper. The petri dishes were incubated in a 37°C constant temperature incubator, and optical images were collected to observe the colony distribution.
[0091] Among them, Figures a-f are the experimental results of the antibacterial gel for women corresponding to Examples 1-6 on E. coli by the inhibition zone method, and Figures j-l are the experimental results of the antibacterial gel for women corresponding to Examples 1-6 on S. aureus by the inhibition zone method.
[0092] From the colony distribution in the multiple figures shown in Figure 4 It can be seen that the antibacterial gel for women provided in the present embodiment has a high antibacterial effect on E. coli and S. aureus, and the antibacterial effect of Examples 2, 3 and 6 is better, and the result of Example 6 is the best. Therefore, Example 6 is the optimal example.
[0093] Experimental Example 2
[0094] Referring to Figure 4 In order to further verify the pH responsiveness of the antibacterial gel for women, Examples 2, 3 and 6 were used as experimental examples to conduct degradation experiments at pH 7.4 and pH 5.5, and the pH responsiveness of the antibacterial gel for women in this embodiment was determined.
[0095] It can be seen that the antibacterial gel for women in this embodiment has excellent pH responsiveness. Under slightly acidic conditions, the dissociation of the Schiff base bond can be triggered to degrade the hydrogel. At the same time of degradation of the hydrogel, the polymer components and drugs in the hydrogel are released, so that the mass of the hydrogel is reduced. The difference in degradation curves of the hydrogel in different pH environments proves the pH responsiveness of the hydrogel. Figure 4
[0096] Example 3
[0097] In order to verify the temperature responsiveness of the antibacterial gel for women, Examples 3 and 6 were used as experimental examples to conduct shrinkage rate experiments at different temperatures, and the results are shown in Table 2. Figure 5 Table 2: Shrinkage rate verification results
[0098] As can be seen from the shrinkage rate, the shrinkage rates of the antibacterial gels for women corresponding to Examples 2 and 6 are 68% and 73% respectively, which proves that the temperature responsiveness of the hydrogel enables it to have the ability of asymmetric shrinkage.
[0099] In summary, the antibacterial gel for women and the preparation method thereof provided in the embodiments of the present application can realize the combination and compounding of various effective components with natural extracts to improve the antibacterial effect on gynecological diseases. By configuring a substrate with a multi-layer structure and adding a temperature-sensitive polymer hydrogel in the substrate, the loading and controlled release effect of the effective components can be achieved, especially with high temperature responsiveness and pH responsiveness, thereby improving the medicinal effect of the antibacterial gel for women as a whole. In addition, by compounding functional agents, the application range of the antibacterial agent can be improved and various functional use scenarios can be increased, which is more efficient, has a wide range of practicality and is environmentally friendly compared to the prior art.
[0100] The above only describes the preferred embodiments of the present application and is not intended to limit the present application. Any modification, equivalent replacement and improvement within the principles of the present application shall be included in the protection scope of the present application.
Claims
1. An antibacterial gel for feminine use, characterized in that, By weight parts including the following components: 97-99% base material and 1-3% effective components; the effective components include the following components by weight parts: Cnidium extract 0.3%-1.0%, Italian wax chrysanthemum extract 0.1%-0.4%, Sophora root extract 0.1%-0.3%, Lotus leaf extract 0.1%-0.3%, tea extract 0.1%-0.4%, guava leaf extract 0.1%-0.3%, Korean angelica extract 0.1%-0.3%; the base material includes a first layer of hydrogel, a second layer of hydrogel and a third layer of hydrogel, the first layer of hydrogel is not loaded with the effective components, the second layer of hydrogel is loaded with the effective components, and the third layer of hydrogel is loaded with a temperature-sensitive polymer.
2. The antimicrobial gel for female use according to claim 1, wherein The skeleton of the first layer of hydrogel and the second layer of hydrogel mainly includes carboxymethyl chitosan, and the skeleton of the second layer of hydrogel mainly includes a temperature-sensitive polymer, which is a polyacrylamide derivative.
3. The antimicrobial gel for female use according to claim 1, wherein The effective components include the following components by weight parts: Cnidium extract 0.5%, Italian wax chrysanthemum extract 0.2%, Sophora root extract 0.2%, Lotus leaf extract 0.2%, tea extract 0.2%, guava leaf extract 0.2%, Korean angelica extract 0.1%.
4. The antimicrobial gel for female use according to claim 1, wherein The polyacrylamide derivative includes any one of poly(N-isopropyl acrylamide) block, N,N-diethyl acrylamide.
5. The bacteriostatic gel for female use according to claim 4, wherein The polyacrylamide derivative includes poly(N-isopropyl acrylamide) block, and the poly(N-isopropyl acrylamide) block includes a first block and a second block; the first block is poly N-isopropyl acrylamide, and the second block is polyethylene glycol.
6. A method of preparing a bacteriostatic gel for feminine use according to any one of claims 1 to 5, wherein The following steps are included: S1. Prepare an oxidized dextran solution with a concentration of 10wt% and a carboxymethyl chitosan solution with a concentration of 2wt%, and mix the oxidized dextran solution with the carboxymethyl chitosan solution at a volume ratio of (0.5-1.5):(1.5:0.5) to obtain a first layer of hydrogel; S2. Prepare a carboxymethyl chitosan solution with a concentration of 2wt% and a main component solution with a concentration of 5wt%, mix the carboxymethyl chitosan solution and the main component solution to obtain a first mixed solution, and mix the first mixed solution with an oxidized dextran solution with a concentration of 10wt% at equal volume to prepare a second layer of hydrogel; S3. Prepare a temperature-sensitive polymer solution, mix the temperature-sensitive solution and the oxidized dextran solution to obtain a second mixed solution, and mix the second mixed solution with the first mixed solution at equal volume to prepare a third layer of hydrogel; S4. Combine the first layer of hydrogel, the second layer of hydrogel and the third layer of hydrogel to obtain the women's antibacterial gel.
7. A method of preparing a bacteriostatic gel for feminine use according to claim 6, wherein Prepare the main component solution, including: dissolve Cnidium extract 0.5%, Italian wax chrysanthemum extract 0.2%, Sophora root extract 0.2%, Lotus leaf extract 0.2%, tea extract 0.2%, guava leaf extract 0.2%, and Korean angelica extract 0.1% in deionized water at a mass-volume ratio of 1:2 to obtain the main component solution.
8. The method of making a bacteriostatic gel for feminine use according to claim 6, wherein, The method comprises: dissolving poly(N-isopropyl acrylamide) block in deionized water at a mass-volume ratio of 1:20 to obtain the temperature-sensitive polymer solution.
9. A method of preparing a bacteriostatic gel for feminine use according to claim 8, wherein The method further comprises: dissolving the bisulfite-polyethylene glycol, N-isopropyl acrylamide and azobisisobutyronitrile in 1,4-dioxane and performing a cyclic deoxygenation treatment, and then performing a vacuum drying after sedimentation in n-hexane to obtain the poly(N-isopropyl acrylamide) block.
10. A method of preparing a bacteriostatic gel for feminine use according to claim 9, wherein The cyclic deoxygenation treatment comprises three groups of cyclic treatment processes, and each group of the cyclic treatment processes comprises, in sequence, a freezing treatment, a vacuum treatment and a thawing treatment.