Vaginal packing with antibacterial function as well as preparation method and application of vaginal packing
By using microencapsulation technology of components such as dihydroquercetin in vaginal tamponization, the anaerobic bacteria proliferation problem caused by vaginal tamponization is solved, and the antibacterial and sustained release effects are achieved, and vaginal health is maintained.
Patent Information
- Application Number
- CN202510800333.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-06-16
- Publication Date
- 2025-08-22
AI Technical Summary
Vaginal tamponade leads to a closed anaerobic environment, leading to proliferation of anaerobic bacteria, and may cause gynecological diseases.
Antibacterial agents composed of dihydroquercetin, citric acid, galactose oligosaccharide, isomaltose oligosaccharide, sodium lactate, sodium hyaluronate and chitosan are used to wrap ingredients through microencapsulation technology to form antibacterial microcapsules, which are combined to the vagina to fill the body, regulate the vaginal microenvironment, and inhibit the growth of anaerobic bacteria.
Effectively inhibit the growth of anaerobic bacteria, maintain the acidic environment of the vagina, promote local drug absorption, achieve sustained release effect, reduce stimulation, and enhance antibacterial performance.
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Figure CN120514901A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of vaginal packing, and in particular to a vaginal packing with antibacterial function, a preparation method thereof, and an application thereof. Background Art
[0002] Vaginal packing involves inserting gauze or cotton wool into the vagina. By contacting and compressing the wound, it reduces bleeding and absorbs blood. Compared to traditional vaginal packing, vaginal packing offers advantages such as adequate absorption, no leakage, and hemostatic properties. Furthermore, it does not interfere with clothing or exercise. However, the internal use of vaginal packing also makes it more likely that the vagina will create a closed, oxygen-free, or hypoxic environment, leading to the emergence and proliferation of anaerobic bacteria, potentially causing varying degrees of gynecological problems for the user. Summary of the Invention
[0003] The problem solved by the present invention is how to solve the problem that vaginal packing forms a closed anaerobic and anoxic environment in the vagina, leading to the emergence and large-scale proliferation of anaerobic bacteria.
[0004] In order to solve the above problems, the present invention provides a vaginal packing with antibacterial function and a preparation method and application thereof.
[0005] In a first aspect, the present invention provides a vaginal packing with antibacterial function, comprising dihydroquercetin, citric acid, galacto-oligosaccharide, isomalto-oligosaccharide, sodium lactate, sodium hyaluronate and chitosan.
[0006] Optionally, the composition comprises, by weight, 1 to 3 parts of dihydroquercetin, 0.5 to 2 parts of citric acid, 2 to 5 parts of galacto-oligosaccharide, 2 to 5 parts of isomalto-oligosaccharide, 1 to 3 parts of sodium lactate, 5 to 10 parts of sodium hyaluronate and 3 to 5 parts of chitosan.
[0007] In a second aspect, the present invention provides a method for preparing the vaginal packing with antibacterial function as described above, comprising the following steps: S1: Dissolve chitosan in acetic acid solution and stir, adjust the pH to 5-6, and obtain a first solution; sequentially add sodium hyaluronate, galacto-oligosaccharide, isomalto-oligosaccharide, sodium lactate, and citric acid to the first solution, and stir to mix evenly to obtain a second solution; dissolve dihydroquercetin in ethanol and then drip into the second solution, avoiding precipitation during the dripping process, to obtain a core material solution; S2: dissolving the microcapsule embedding matrix in deionized water and stirring to obtain a wall material solution; S3: dripping the core material solution into the wall material solution through a syringe pump to obtain droplets, and simultaneously applying ultrasonic high-frequency vibration above 20kHz or applying an electrostatic voltage of 10 to 15kV to make the droplets uniform; S4: placing the droplets in a solidification bath to form antibacterial microcapsules; S5: The vaginal packing with antibacterial function further includes a main body, and the antibacterial microcapsules are combined with the main body.
[0008] Optionally, combining the antibacterial microcapsules with the body includes: mixing the antibacterial microcapsules with an adhesive and spraying the mixture on the surface of the body.
[0009] Optionally, combining the antibacterial microcapsules with the body includes: mixing and pressing the antibacterial microcapsules with the constituent materials of the body, so that the antibacterial microcapsules are filled in the body.
[0010] Optionally, the microcapsule embedding matrix is a sodium alginate solution with a concentration of 2%-3%, or the microcapsule embedding matrix is a mixed solution of equal volumes of a sodium alginate solution with a concentration of 2%-3% and a gelatin solution with a concentration of 1%-2%.
[0011] Optionally, in S2, the microcapsule embedding matrix is dissolved in deionized water at 55-65° C. and stirred for more than 1 hour to obtain a wall material solution.
[0012] Optionally, the curing bath includes CaCl2, wherein the concentration of CaCl2 is 2%-5%.
[0013] Optionally, placing the droplets in a solidification bath includes: placing the droplets in a solidification bath for solidification for 15 to 25 minutes, washing with a phosphate buffered saline solution, and drying to form powdered antibacterial microcapsules.
[0014] In a third aspect, the present invention provides a use of the vaginal packing with antibacterial function as described above in the preparation of vaginal drug delivery agents or tampons.
[0015] The beneficial effects of the vaginal packing with antibacterial function of the present invention, its preparation method and application are as follows: dihydroquercetin is a natural flavonoid compound that can damage bacterial cell membranes and bind to peptidoglycan synthase (such as PBP2a) of Gram-positive bacteria (such as Staphylococcus aureus), interfering with cell wall cross-linking to inhibit cell wall synthesis, destroying bacterial cell structure and function, and interfering with bacterial metabolism and gene expression. Dihydroquercetin can also downregulate the agr system of Staphylococcus aureus, degrade exopolysaccharides (such as PIA), inhibit biofilm formation of Pseudomonas aeruginosa and Candida albicans, and has strong antibacterial function against Gram-positive bacteria and fungi (such as Candida albicans); chitosan binds to the mucus layer (negatively charged mucin) through electrostatic interaction, prolonging the retention of dihydroquercetin at the absorption site. Chitosan interacts with cell membrane phospholipids (through hydrophobic forces and hydrogen bonds), temporarily increasing membrane fluidity and promoting the passive diffusion of hydrophobic dihydroquercetin. Therefore, the addition of chitosan, a penetration enhancer, promotes dihydroquercetin absorption by the vaginal mucosa, enhancing its synergy. Sodium hyaluronate improves the solubility and stability of dihydroquercetin, enhancing its absorption efficiency and further improving its antibacterial properties. Sodium hyaluronate is also highly hydrophilic and rapidly absorbs and swells upon contact with water, forming a more stable gel layer. This delays the burst release of the composition, controls the release schedule, and achieves sustained release, thus stably regulating the vaginal microenvironment. Furthermore, the surface activity of sodium hyaluronate reduces the interfacial tension between water molecules and the vaginal packing, accelerating water penetration and increasing the packing's fluid absorption rate. Citric acid, as an organic acid, regulates vaginal pH, maintaining an acidic environment and inhibiting the overgrowth of harmful bacteria. Galacto-oligosaccharide is a prebiotic. Mixing galacto-oligosaccharide with chitosan can form a composite adsorption material that can absorb vaginal secretions and provide prebiotic support. Galacto-oligosaccharide and sodium lactate work synergistically to promote the colonization of lactic acid bacteria and regulate the microecology. Mixing isomalt oligosaccharide with chitosan can also form an adsorption material for absorbing secretions and providing prebiotic support. Sodium lactate has antibacterial properties and synergistic prebiotic functions to maintain an acidic environment and regulate pH. As a metabolite of the natural vaginal microbiome, it is relatively mild. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Figure 1 The figure is a flow chart of a method for preparing a vaginal packing with antibacterial function according to an embodiment of the present invention. DETAILED DESCRIPTION
[0017] To make the above-mentioned objects, features, and advantages of the present invention more clearly understood, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. Although certain embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be construed as being limited to the embodiments described herein. Instead, these embodiments are provided to provide a more thorough and complete understanding of the present invention. It should be understood that the drawings and embodiments of the present invention are for illustrative purposes only and are not intended to limit the scope of protection of the present invention.
[0018] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meanings as those commonly understood by those skilled in the art to which the present invention belongs. The terms used in the present invention description are only for the purpose of describing specific embodiments and are not intended to limit the present invention; The term "including" and its variations used in this document are open inclusions, that is, "including but not limited to"; the term "based on" means "at least partially based on"; the term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one other embodiment"; the term "some embodiments" means "at least some embodiments"; the term "optionally" means "optional embodiments". The relevant definitions of other terms will be given in the following description. It should be noted that the concepts of "first" and "second" mentioned in the present invention are used to distinguish different objects, rather than to describe a specific order or a primary and secondary relationship. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise specified, "multiple" means two or more.
[0019] In response to the problems existing in the above-mentioned related technologies, the embodiments of the present invention provide a vaginal packing with antibacterial function, a preparation method and application thereof.
[0020] An embodiment of the present invention provides a vaginal packing with antibacterial function, comprising dihydroquercetin, citric acid, galacto-oligosaccharide, isomalto-oligosaccharide, sodium lactate, sodium hyaluronate and chitosan.
[0021] In this embodiment, dihydroquercetin (DHQ) is a natural flavonoid compound that can damage bacterial cell membranes and bind to peptidoglycan synthases (such as PBP2a) of Gram-positive bacteria (such as Staphylococcus aureus), interfering with cell wall cross-linking and thereby inhibiting cell wall synthesis, destroying bacterial cell structure and function, and interfering with bacterial metabolism and gene expression. Dihydroquercetin can also downregulate the accessory gene regulator (AGR) of Staphylococcus aureus. Chitosan (CS) binds to the mucus layer (negatively charged mucin) through electrostatic interaction, prolongs the retention time of dihydroquercetin at the absorption site, increases the local concentration gradient, and interacts with cell membrane phospholipids (through hydrophobic forces and hydrogen bonds), temporarily increasing membrane fluidity and promoting the passive diffusion of hydrophobic dihydroquercetin. Therefore, the addition of chitosan, a penetration enhancer, can promote the absorption of dihydroquercetin by the vaginal mucosa and enhance the efficacy of the combination. Hyaluronic acid (HYALURONATE) improves the solubility and stability of dihydroquercetin, enhancing its absorption efficiency and further enhancing its antibacterial properties. Sodium hyaluronate is also highly hydrophilic. When exposed to water, it rapidly absorbs and swells, forming a more stable gel layer. This delays the burst release of the composition, controls the release rate, and achieves sustained release. It can also stabilize and regulate the vaginal microenvironment. The surface activity of sodium hyaluronate can reduce the interfacial tension between water molecules and the vaginal packing, accelerating water penetration and enhancing fluid absorption. Citric acid (CA), as an organic acid, can regulate vaginal pH, maintain an acidic environment, and inhibit the overgrowth of harmful bacteria. Galactooligosaccharides (GOS) are prebiotics. When mixed with chitosan, GOS forms a composite adsorbent that absorbs vaginal secretions and provides prebiotic support. GOS also works synergistically with sodium lactate to promote lactic acid bacteria colonization and regulate the microecology. Isomalto-oligosaccharides (IMO) mixed with chitosan can also form an adsorbent material for absorbing secretions and providing prebiotic support. Sodium lactate (Na-Lactate) has antibacterial properties and synergizes with prebiotics to maintain an acidic environment and regulate pH. As a metabolite of the natural vaginal microbiome, it is relatively mild.
[0022] The accessory gene regulator (agr) system of Staphylococcus aureus consists of two bidirectional transcription units: agrBDCA (regulatory module) and RNAIII (effector molecule). The agr system is a typical quorum sensing (QS) system that regulates virulence factor expression, biofilm formation, and environmental adaptation. Activation and inhibition of this system directly influence bacterial pathogenicity, making it an important target for antimicrobial drug development and infection control.
[0023] Specifically, vaginal packing can be gauze or cotton pads inserted into the vagina after vaginal and cervical surgery to compress the wound and reduce bleeding. It can also be vaginal suppositories or tampons. Dihydroquercetin, citric acid, galacto-oligosaccharides, isomaltooligosaccharides, sodium lactate, sodium hyaluronate, and chitosan can be dissolved in a solvent to obtain a composition solution, which can be evenly sprayed on the outer surface of the vaginal suppository or tampon. Alternatively, the vaginal suppository or tampon can be soaked in the composition solution to absorb the composition.
[0024] Specifically, dihydroquercetin can be dissolved in an organic phase such as 50% (volume fraction) ethanol or 30%-50% (volume fraction) propylene glycol, citric acid, galacto-oligosaccharides, isomalto-oligosaccharides, sodium lactate, sodium hyaluronate and chitosan are dissolved in water, and then the aqueous solution is mixed with the organic phase solution, wherein the volume ratio of the aqueous solution to the organic phase solution is 6:4 to 8:2 to obtain a composition solution.
[0025] Specifically, galacto-oligosaccharides are composed of a smaller number of monosaccharide molecules (usually 2-10) linked by glycosidic bonds and are short-chain carbohydrates. Isomalto-oligosaccharides are composed of a smaller number of monosaccharide molecules (usually 2-10) linked by glycosidic bonds and are short-chain carbohydrates.
[0026] Optionally, the composition comprises, by weight, 1 to 3 parts of dihydroquercetin, 0.5 to 2 parts of citric acid, 2 to 5 parts of galacto-oligosaccharide, 2 to 5 parts of isomalto-oligosaccharide, 1 to 3 parts of sodium lactate, 5 to 10 parts of sodium hyaluronate and 3 to 5 parts of chitosan.
[0027] In this optional embodiment, the content of citric acid and sodium lactate can synergistically maintain a slightly acidic pH of 4.5-5.5, maintain an acidic environment to inhibit pathogens, and avoid excessive acidification to damage the mucosa; the content of oligosaccharides and oligosaccharides can balance prebiotics and osmotic pressure.
[0028] Specifically, dihydroquercetin, citric acid, galactoligosaccharides, isomaltooligosaccharides, sodium lactate, sodium hyaluronate and chitosan are dissolved to prepare a composition solution or coated with microencapsulation technology, with the weight fractions of dihydroquercetin 1% to 3%, citric acid 0.5% to 2%, galactoligosaccharides 2% to 5%, isomaltooligosaccharides 2% to 5%, sodium lactate 1% to 3%, sodium hyaluronate 5% to 10%, and chitosan 3% to 5%.
[0029] Another embodiment of the present invention provides a method for preparing the vaginal packing with antibacterial function as described above, comprising the following steps: S1: Dissolve chitosan in acetic acid solution and stir, adjust the pH to 5-6, and obtain a first solution; sequentially add sodium hyaluronate, galacto-oligosaccharide, isomalto-oligosaccharide, sodium lactate, and citric acid to the first solution, and stir to mix evenly to obtain a second solution; dissolve dihydroquercetin in ethanol and then drip into the second solution, avoiding precipitation during the dripping process, to obtain a core material solution; S2: dissolving the microcapsule embedding matrix in deionized water and stirring to obtain a wall material solution; S3: dripping the core material solution into the wall material solution through a syringe pump to obtain droplets, and simultaneously applying ultrasonic high-frequency vibration above 20kHz or applying an electrostatic voltage of 10 to 15kV to make the droplets uniform; S4: The droplets are placed in a solidification bath to form antibacterial microcapsules; S5: The vaginal packing with antibacterial function further includes a main body, and the antibacterial microcapsules are combined with the main body.
[0030] In the present embodiment, oligogalactose is wrapped in microcapsules by microencapsulation technology, which can protect oligogalactose from the external environment and improve its release efficiency. Oligomeric isomaltose is wrapped by microencapsulation technology, and its stability and release efficiency can also be improved. Microcapsules can gradually release active ingredients within 4-6 hours, achieve sustained release, and avoid stimulation or waste caused by sudden release of ingredients. Microencapsulation technology can shield the light / oxygen / humidity sensitive ingredient dihydroquercetin, prevent dihydroquercetin from inactivation during processing or storage, and protect dihydroquercetin activity. Microencapsulation technology can solve the differences in the physicochemical properties of multiple components and integrate the compatibility of multiple components.
[0031] Specifically, the preparation method of the vaginal packing with antibacterial function comprises the following steps: S1: Chitosan was dissolved in a 1% acetic acid solution and stirred at 50°C until clear. Excess acetic acid was neutralized with a NaOH solution and the pH was adjusted to 5.5 to obtain a first solution. Sodium hyaluronate, galacto-oligosaccharide, isomaltooligosaccharide, sodium lactate, and citric acid were sequentially added to the first solution and stirred and dissolved in a 40°C water bath to obtain a second solution. Dihydroquercetin was dissolved in a small amount of ethanol and then slowly added dropwise to the second solution to avoid precipitation during the addition process to obtain a core material solution. S2: Dissolve the microcapsule embedding matrix in deionized water, stir at 60°C for 1 hour, and filter to remove impurities to obtain a wall material solution; S3: The core material solution is dripped into the wall material solution through a syringe pump at a flow rate of 0.5-1 mL / min to obtain droplets, and at the same time, 20kHz ultrasonic high-frequency vibration or 10 to 15kV electrostatic voltage is applied to make the droplets uniform; S4: The droplets are placed in a solidification bath to form antibacterial microcapsules with a diameter of 100-300 μm; S5: The vaginal packing with antibacterial function further comprises a body, ie, a matrix material, and the antibacterial microcapsules are combined with the body.
[0032] Optionally, the step of bonding the antibacterial microcapsules to the body includes: mixing the antibacterial microcapsules with an adhesive and spraying the mixture on the surface of the body.
[0033] Specifically, the mass ratio of antibacterial microcapsules to adhesive is approximately 1:2. The adhesive can be medical-grade sodium carboxymethyl cellulose. When the vaginal packing is a tampon, the antibacterial microcapsule loading on the tampon surface is 5 to 10 mg / tampon. A step-by-step drying process, with a gradual cooling from 50°C to 30°C, can be used to minimize wall cracking.
[0034] Specifically, the antibacterial microcapsules can be dispersed in a 2% (w / v) hydroxyethyl cellulose gel solution, with a mass ratio of about 1:2, and then sprayed onto the surface of the tampon. The antibacterial microcapsules are then fixed to the tampon surface using ultraviolet curing (365 nm, 10 min).
[0035] Specifically, adhesives can be selected from commonly used suppository bases such as polyethylene glycol 4000 and polyethylene glycol 400. Polyethylene glycol 4000 provides high adhesion and cures at low temperatures. Polyethylene glycol 400 lowers the melting point and improves fluidity. Plasticizers such as glycerin can also be added to adjust flexibility and prevent cracking. The ratio of polyethylene glycol 4000 to polyethylene glycol 400 can be adjusted as needed, as this ratio affects viscosity and curing time. For example, a ratio of 8:2 results in a melting point of approximately 50-55°C.
[0036] Specific operation steps: first prepare a body without microcapsules, spray polyethylene glycol 4000 (10% solution) onto the surface of the body (spray gun pressure 0.2-0.5 MPa), immediately sprinkle antibacterial microcapsules, and gently press to embed the antibacterial microcapsules into the body.
[0037] Optionally, the step of combining the antibacterial microcapsules with the body includes: mixing and pressing the antibacterial microcapsules with the constituent materials of the body so that the antibacterial microcapsules are filled in the body.
[0038] Specifically, when the vaginal packing is a tampon, the antibacterial microcapsules are mixed with cotton fiber slurry during the tampon pressing process and integrated through a wet molding process. Pressure must be controlled to prevent the antibacterial microcapsules from rupturing. The antibacterial microcapsule loading of the tampon is 3-8% (mass fraction). Sodium lactate is esterified with cotton fibers and fixed to the tampon, which improves the stability of the sodium lactate and enhances its antibacterial effect. The main body of the tampon can be made of pure cotton or viscose fibers, maintaining water absorption while being able to load liposomes.
[0039] Specifically, the antibacterial microcapsules can be added to molten polyethylene glycol 4000 or polyethylene glycol 400 in advance (the volume fraction of the antibacterial microcapsules is 5%-20%), and stirred at a low speed (200-500 rpm) to disperse the antibacterial microcapsules. A homogenizer (10,000 rpm, 30s) can be used for a short treatment to ensure uniform distribution; then, the mixture is mixed with the main body material, which is beneficial to the uniformity and curing ability of the combination of the antibacterial microcapsules and the main body material.
[0040] Optionally, the microcapsule embedding matrix is a 2%-3% sodium alginate solution or a 2%-3% sodium alginate solution mixed with a 1%-2% gelatin solution in equal volumes.
[0041] In this optional embodiment, the microcapsule embedding matrix prepared by mixing equal volumes of 2%-3% sodium alginate solution and 1%-2% gelatin solution has stronger mechanical strength.
[0042] Optionally, in step S2, the microcapsule embedding matrix is dissolved in deionized water at 55-65° C. and stirred for more than 1 hour to obtain a wall material solution.
[0043] Optionally, the curing bath includes CaCl2, wherein the concentration of CaCl2 is 2%-5%.
[0044] Specifically, sodium alginate forms antibacterial microcapsules through ionic cross-linking.
[0045] Optionally, step S4 includes: placing the droplets in a curing bath for curing for 15 to 25 minutes, rinsing with a phosphate buffered saline solution, and drying to form powdered antibacterial microcapsules.
[0046] Specifically, phosphate buffered saline (PBS), pH 7.4, was used to rinse to remove residual acetic acid and calcium ions.
[0047] Alternatively, vaginal packing can be sterilized using ethylene oxide gas (concentration 600 mg / L) at 50°C for 4 h to avoid high temperature destruction of the antibacterial microcapsules.
[0048] Another embodiment of the present invention provides a use of the above-mentioned vaginal packing with antibacterial function in the preparation of vaginal drug delivery agents or tampons.
[0049] The present invention is further described below with reference to specific embodiments.
[0050] Example 1: Preparation of a vaginal packing tampon with antibacterial function.
[0051] 1. Dissolve 30 mg of chitosan in 1 g of 1% acetic acid solution and stir at 50°C until clear. Neutralize excess acetic acid with NaOH and adjust the pH to 5.5 to obtain a first solution. Add 50 mg of sodium hyaluronate, 20 mg of galacto-oligosaccharide, 20 mg of isomaltooligosaccharide, 10 mg of sodium lactate, and 5 mg of citric acid to the first solution in sequence, and stir and dissolve in a 40°C water bath to obtain a second solution. Dissolve 10 mg of dihydroquercetin in 5 mL of ethanol and slowly drip into the second solution. Avoid precipitation during the dripping process to obtain a core material solution. 2. Dissolve sodium alginate in deionized water to a concentration of 2%, stir at 60°C for 1 hour, filter and remove impurities to obtain a wall material solution; 3. The core material solution is dripped into the wall material solution through a syringe pump at a flow rate of 1 mL / min to obtain droplets. At the same time, 20kHz ultrasonic high-frequency vibration or 10kV electrostatic voltage is applied to make the droplets uniform; 4. The droplets are placed in a solidification bath CaCl2 solution with a concentration of 2% to form antibacterial microcapsules with a diameter of 100-300 μm; 5. The antibacterial microcapsules were dispersed in 2% (w / v) hydroxyethyl cellulose glue, and the mass ratio of the antibacterial microcapsules to the hydroxyethyl cellulose was controlled to be approximately 1:2. The antibacterial microcapsules were sprayed on the surface of the tampon to bind the antibacterial microcapsules to the tampon. The antibacterial microcapsules were loaded on the surface of the tampon at 8 mg / tampon. The antibacterial microcapsules were fixed on the surface of the tampon by ultraviolet curing (365 nm, 10 min).
[0052] Tampons were sterilized with ethylene oxide gas (concentration 600 mg / L) at 50°C for 4 h.
[0053] Example 2: Preparation of a vaginal packing tampon with antibacterial function.
[0054] 1. Dissolve 50 mg of chitosan in 1 g of 1% acetic acid solution and stir at 50°C until clear. Neutralize the excess acetic acid with NaOH and adjust the pH to 5 to obtain a first solution. Add 100 mg of sodium hyaluronate, 50 mg of galacto-oligosaccharide, 50 mg of isomaltooligosaccharide, 30 mg of sodium lactate, and 20 mg of citric acid to the first solution in sequence, and stir and dissolve in a 40°C water bath to obtain a second solution. Dissolve 10 mg of dihydroquercetin in 5 mL of ethanol and slowly drip into the second solution to avoid precipitation during the dripping process to obtain a core material solution. 2. Dissolve sodium alginate in deionized water to a concentration of 3%, stir at 60°C for 1 hour, filter and remove impurities to obtain a wall material solution; 3. The core material solution is dripped into the wall material solution through a syringe pump at a flow rate of 0.5 mL / min to obtain droplets. At the same time, 20 kHz ultrasonic high-frequency vibration or 15 kV electrostatic voltage is applied to make the droplets uniform; 4. The droplets are placed in a solidification bath CaCl2 solution with a concentration of 5% to form antibacterial microcapsules with a diameter of 100-300 μm; 5. During the tampon pressing process, the antibacterial microcapsules are mixed with the cotton fiber slurry and integrated through a wet molding process. The pressure needs to be controlled to prevent the antibacterial microcapsules from breaking, and the antibacterial microcapsule loading of the tampon is controlled to 5% (mass fraction).
[0055] Tampons were sterilized with ethylene oxide gas (concentration 600 mg / L) at 50°C for 4 h.
[0056] Example 3: Preparation of a vaginal packing tampon with antibacterial function.
[0057] 20 mg of dihydroquercetin was dissolved in 400 mL of 50% (volume fraction) ethanol, 10 mg of citric acid, 30 mg of galacto-oligosaccharide, 30 mg of isomaltooligosaccharide, 20 mg of sodium lactate, 80 mg of sodium hyaluronate, and 40 mg of chitosan were dissolved in 700 mL of deionized water, the ethanol solution and the aqueous solution were mixed to obtain a composite solution, the tampon body was immersed in the composite solution, and dried at 30°C.
[0058] Tampons were sterilized with ethylene oxide gas (concentration 600 mg / L) at 50°C for 4 h.
[0059] Comparative Example 1: Preparation of a comparative product tampon.
[0060] 1. Dissolve 20 mg of galacto-oligosaccharide, 20 mg of isomaltooligosaccharide, 10 mg of sodium lactate and 5 mg of citric acid in a 40°C water bath with stirring to obtain a core material solution; 2. Dissolve sodium alginate in deionized water to a concentration of 2%, stir at 60°C for 1 hour, filter and remove impurities to obtain a wall material solution; 3. The core material solution is dripped into the wall material solution through a syringe pump at a flow rate of 1 mL / min to obtain droplets. At the same time, 20kHz ultrasonic high-frequency vibration or 10kV electrostatic voltage is applied to make the droplets uniform; 4. The droplets are placed in a solidification bath of CaCl2 solution with a concentration of 2% to form microcapsules with a diameter of 100-300 μm; 5. The microcapsules were dispersed in 2% (w / v) hydroxyethyl cellulose glue, with the mass ratio of microcapsules to hydroxyethyl cellulose controlled at approximately 1:2. The solution was sprayed on the surface of the tampon to bind the microcapsules to the tampon. The microcapsule loading on the tampon surface was controlled to be 8 mg / tampon. The microcapsules were fixed to the surface of the tampon using ultraviolet curing (365 nm, 10 min).
[0061] Tampons were sterilized with ethylene oxide gas (concentration 600 mg / L) at 50°C for 4 h.
[0062] Comparative Example 2: Preparation of a comparative product tampon.
[0063] 10 mg of citric acid, 30 mg of galacto-oligosaccharide, 30 mg of isomaltooligosaccharide, and 20 mg of sodium lactate were dissolved in 1000 mL of deionized water to obtain a solution. The tampon was immersed in the solution and dried at 30°C.
[0064] Tampons were sterilized with ethylene oxide gas (concentration 600 mg / L) at 50°C for 4 h.
[0065] Effect embodiment Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans were determined in the use scenarios of the tampon products prepared in Example 1, Example 3 and Comparative Example 1 and Comparative Example 2. Four diabetic subjects were selected. Since the number of Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans may increase in diabetic subjects with vaginitis, it is convenient to determine the number and changes of Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans. The four subjects first used cotton swabs to scrape vaginal secretions. The four subjects were respectively inserted with tampons prepared in Example 1, Example 3 and Comparative Example 1 and Comparative Example 2. After 2 hours, they were taken out and secretions were scraped from the surface of the tampon using sterile tweezers. 10 μL of secretion was evenly spread on a glass slide, dried at room temperature, and Gram-stained (crystal violet → iodine solution → decolorizer → safranin, 30 seconds for each step). Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans on the slide were observed under a microscope (oil objective lens, 1000×). After Gram staining, Staphylococcus aureus appeared purple and had irregular grape-like clusters, Pseudomonas aeruginosa appeared red or pink and had slender straight rods, and Candida albicans had purple oval yeast cells with some visible pseudohyphae. The number of cells in each field of view was counted, and the statistical results are shown in Table 1.
[0066] Table 1 Statistics of bacterial species in the subjects' vagina before and after tampon insertion
[0067] As shown in Table 1, the vaginal packings with antibacterial properties of Examples 1 and 2 reduced the number of Staphylococcus aureus and Pseudomonas aeruginosa, exhibited antibacterial activity against these bacteria, and also had some antibacterial activity against Candida albicans. The tampons of Comparative Examples 1 and 2 had no antibacterial activity against Staphylococcus aureus, Pseudomonas aeruginosa, or Candida albicans.
[0068] The sustained-release properties of the tampon products prepared in Example 1 and Comparative Example 1 were tested. The test method was as follows: immersion in simulated saline (37° C.) was used to detect the 24-hour release rate of citric acid. The citric acid release rate at each time period was statistically analyzed. The statistical results are shown in Table 2.
[0069] Table 2 Statistics of citric acid release rate
[0070] As can be seen from Table 2, compared with Comparative Example 1, the vaginal packing of Example 1 has a slower release rate of citric acid, which can achieve sustained release, delayed burst release, and achieve stable regulation of the vaginal microenvironment.
[0071] Although the present invention is disclosed as above, the protection scope of the present invention is not limited thereto. Those skilled in the art may make various changes and modifications without departing from the spirit and scope of the present invention, and these changes and modifications will fall within the protection scope of the present invention.
Claims
1. A vaginal packing with antibacterial function, characterized in that: Includes dihydroquercetin, citric acid, galacto-oligosaccharides, isomalto-oligosaccharides, sodium lactate, sodium hyaluronate and chitosan.
2. The vaginal packing with antibacterial function according to claim 1, characterized in that: Calculated by weight, the invention comprises 1 to 3 parts of dihydroquercetin, 0.5 to 2 parts of citric acid, 2 to 5 parts of galacto-oligosaccharide, 2 to 5 parts of isomalto-oligosaccharide, 1 to 3 parts of sodium lactate, 5 to 10 parts of sodium hyaluronate and 3 to 5 parts of chitosan.
3. A method for preparing a vaginal packing with antibacterial function according to claim 1 or 2, characterized in that: The following steps are involved: S1: dissolving chitosan in an acetic acid solution with stirring, adjusting the pH to 5-6, to obtain a first solution; sequentially adding sodium hyaluronate, galacto-oligosaccharide, isomalto-oligosaccharide, sodium lactate, and citric acid to the first solution, stirring and mixing uniformly, to obtain a second solution; dissolving dihydroquercetin in ethanol and then dripping it into the second solution, avoiding precipitation during the dripping process, to obtain a core material solution; S2: dissolving the microcapsule embedding matrix in deionized water and stirring to obtain a wall material solution; S3: dripping the core material solution into the wall material solution through a syringe pump to obtain droplets, and simultaneously applying ultrasonic high-frequency vibration above 20 kHz or applying an electrostatic voltage of 10 to 15 kV to make the droplets uniform; S4: placing the droplets in a solidification bath to form antibacterial microcapsules; S5: The vaginal packing with antibacterial function further includes a body, and the antibacterial microcapsules are combined with the body.
4. The method for preparing a vaginal packing with antibacterial function according to claim 3, characterized in that: The step of combining the antibacterial microcapsules with the main body comprises: mixing the antibacterial microcapsules with an adhesive and spraying the mixture on the surface of the main body.
5. The method for preparing a vaginal packing with antibacterial function according to claim 3, characterized in that: The step of combining the antibacterial microcapsules with the main body comprises: mixing and pressing the antibacterial microcapsules with the main body constituent materials, so that the antibacterial microcapsules are filled in the main body.
6. The method for preparing a vaginal packing with antibacterial function according to claim 3, characterized in that: The microcapsule embedding matrix is a sodium alginate solution with a concentration of 2%-3%, or the microcapsule embedding matrix is a mixed solution of equal volumes of a sodium alginate solution with a concentration of 2%-3% and a gelatin solution with a concentration of 1%-2%.
7. The method for preparing a vaginal packing with antibacterial function according to claim 3, characterized in that: In S2, the microcapsule embedding matrix is dissolved in deionized water at 55-65° C. and stirred for more than 1 hour to obtain the wall material solution.
8. The method for preparing a vaginal packing with antibacterial function according to claim 3, characterized in that: The curing bath includes CaCl2, wherein the concentration of CaCl2 is 2%-5%.
9. The method for preparing a vaginal packing with antibacterial function according to claim 3, characterized in that: Placing the droplets in a solidification bath comprises: solidifying the droplets in a solidification bath for 15 to 25 minutes, washing with a phosphate buffered saline solution, and drying to form powdered antibacterial microcapsules.
10. Use of the vaginal packing with antibacterial function according to claim 1 or 2 in the preparation of vaginal drug delivery agents or tampons.