A sustained-release gynecological antibacterial gel and preparation method thereof

Abstract

The invention relates to the technical field of medical gel preparation, in particular to a sustained-release gynecological antibacterial gel and a preparation method thereof. The gel mainly consists of a thermosensitive gel matrix, a first functional component and a second functional component, wherein the thermosensitive gel matrix is ​​prepared from poloxamer and arabinoxylan; the first functional component is prepared from silver dihydrogen citrate and citric acid, and the second functional component is prepared from cinnamaldehyde and oregano oil; the thermosensitive gel matrix is ​​prepared by mixing poloxamer and arabinoxylan, so that the functional components can be adhered to the surface thereof, and the functional components are allowed to be combined with the inner surface of a female vagina, and slowly released, thereby prolonging the time in the female vagina; the first functional component and the second functional component are mixed, so as to improve the overall antibacterial effect, and at the same time, the pH value of the mixed solution can be kept in a weak acid state, and the pH value thereof is 4.5-6, so that the pH value of the female vagina is not damaged, and the female vaginal health is beneficial.

Description

Technical Field

[0001] The invention relates to the technical field of medical gel preparation, in particular to a sustained-release gynecological antibacterial gel and a preparation method thereof. Background Art

[0002] The female vaginal environment is very complex and is very easy to be infected by pathogenic bacteria and cause related diseases. There are often a variety of aerobic and anaerobic bacteria and other microorganisms coexisting in the female vagina, which are interdependent and mutually restricted, thus forming a relatively stable microecological environment. Studies have shown that when pathogenic bacteria invade the vaginal environment, the bacteria will multiply rapidly, destroying the acidic microenvironment in the vaginal environment, causing symptoms such as itching and fishy odor, and may further cause vaginal diseases such as bacterial vaginitis and yeast infection. At the same time, there is a certain possibility of causing urinary tract infection. Female genital care products are a kind of maintenance liquid used by women on a daily basis. Its main function is to inhibit pathogenic bacteria, clean the vaginal environment, and adjust pH.

[0003] At present, there are many varieties and formulas of gynecological antibacterial gels on the market. Generally, they are Chinese herbal medicine extract antibacterial gels, including ginseng, sophora flavescens, scutellaria baicalensis, phellodendron chinense, aloe vera, etc. Western medicine antibacterial gels include guanidines, cationic antibacterial agents, chlorhexidine acetate, chlorhexidine gluconate, benzalkonium chloride, etc., and the matrix of the gel is generally carbomer. However, when these traditional antibacterial gels are injected into the vagina and encounter salt and electrolytes in the human body, they tend to become thin immediately and cannot adhere well to the vaginal epithelial cells, resulting in them being easily naturally discharged before they have time to stay on the inner wall of the vagina to play an antibacterial role, resulting in low efficacy and poor therapeutic effect of gynecological gels. There are various microorganisms in nature, and some microorganisms entering the body will have a greater impact on the internal environment of the human body, and even cause various infectious diseases; therefore, how to overcome the above-mentioned technical problems and defects has become a key issue that needs to be solved. Summary of the invention

[0004] The object of the present invention is to overcome the defects described in the background technology, thereby providing a sustained-release gynecological antibacterial gel and a preparation method thereof.

[0005] To achieve the above-mentioned purpose, the technical scheme of the present invention is: a sustained-release gynecological antibacterial gel, which is mainly composed of a thermosensitive gel matrix, a first functional component and a second functional component, wherein the thermosensitive gel matrix is ​​prepared from 2-8 parts of poloxamer and 5-15 parts of arabinoxylan; the first functional component is prepared from 12-22 parts of silver dihydrogen citrate and 2-8 parts of citric acid, and the second functional component is prepared from 4-12 parts of cinnamaldehyde and 2-6 parts of oregano oil, and the mass ratio of the thermosensitive gel matrix, the first functional component and the second functional component is 4-6:(5-8):(3-5).

[0006] Furthermore, the poloxamer is a mixture of poloxamer 188 and poloxamer 407, and the weight ratio of poloxamer 188 to poloxamer 407 is 1:(2-4).

[0007] Furthermore, the concentration of the silver dihydrogen citrate is 0.05-0.5 mg / ml.

[0008] Furthermore, the concentration of the citric acid is 0.02-0.5 mol / l.

[0009] Furthermore, the concentration of the cinnamaldehyde is 0.08-0.32 mg / l.

[0010] Furthermore, the concentration of the oregano oil is 0.3-0.63 mg / l.

[0011] Furthermore, the volume ratio of the cinnamaldehyde to the oregano oil is 2-3:1.

[0012] Furthermore, a method for preparing a sustained-release gynecological antibacterial gel comprises the following steps:

[0013] 1) Take poloxamer and arabinoxylan, add deionized water, and stir for 20-30 minutes at 20-25°C to fully dissolve them as a thermosensitive gel matrix;

[0014] 2) silver dihydrogen citrate and citric acid are weighed and stirred at 20-25° C. for 20-30 minutes to mix them evenly to form a first functional component mixed solution;

[0015] 3) Measure cinnamaldehyde and oregano oil and stir at 20-25° C. for 20-30 minutes to mix them evenly to form a second functional component mixed solution;

[0016] 4) slowly adding the first functional component mixed solution to the second functional component mixed solution, the flow rate of the first functional component mixed solution is 1 ml / min, and the stirring speed is 1200 r / min; after complete mixing, continue stirring for 20-30 min to prepare a functional component mixed solution;

[0017] 5) Mix the thermosensitive gel matrix and the mixed solution of the functional components evenly at low temperature to obtain the product.

[0018] The beneficial effects of the sustained-release gynecological antibacterial gel and the preparation method thereof of the present invention are as follows:

[0019] 1. The sustained-release gynecological antibacterial gel of the present invention and its preparation method are prepared by mixing poloxamer and arabinoxylan to form a thermosensitive gel matrix. The arabinoxylan gel has a porous structure, a water environment and dietary fiber properties, which can make the functional components adhere to its surface and embed the functional components; the functional components are provided with mannose-specific adhesins or other adhesion mechanisms, thereby allowing the functional components to bind to the inner surface of the female vagina and be slowly released, thereby prolonging the time in the female vagina. At the same time, the arabinoxylan gel can also be degraded by bacteria in the vaginal microbiome to maintain vaginal health; the poloxamer acts as an emulsifier and stabilizer to uniformly emulsify and stabilize the oily materials in the formula in the gel, and acts as a sustained-release material to undergo phase change at human body temperature, thereby having strong adhesion to the vagina and having a sustained-release effect on the antibacterial compound. This allows the antibacterial gel to stay in the vagina for a long time, has good compatibility with the vaginal mucosa, is non-irritating, and can also increase skin permeability, which helps deep sterilization; poloxamer and arabinoxylan are combined within a suitable content range to form a paste-like gel that has a sustained-release effect and can adjust the phase change temperature to adapt to the human body temperature, stay in the vagina for a long time, and can exert good antibacterial properties.

[0020] 2. The sustained-release gynecological antibacterial gel and preparation method thereof of the present invention are prepared by slowly dropping a mixed solution of a first functional component into a mixed solution of a second functional component. In the presence of citric acid and a citrate radical, the first functional component is acidic. When mixed with the second functional component, the second functional component solution is compounded with citric acid, thereby improving the overall antibacterial effect. At the same time, the pH value of the mixed solution can be kept weakly acidic, with a pH value of 4.5-6, which will not damage the pH value of the female vagina and is beneficial to the health of the female vagina. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is the in vitro release kinetics curve of the sustained-release gynecological antibacterial gel; DETAILED DESCRIPTION

[0022] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. In the absence of conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other.

[0023] An embodiment of the present invention provides a sustained-release gynecological antibacterial gel, which is mainly composed of a thermosensitive gel matrix, a first functional component and a second functional component. The thermosensitive gel matrix is ​​prepared from 2-8 parts of poloxamer and 5-15 parts of arabinoxylan; the first functional component is prepared from 12-22 parts of silver dihydrogen citrate and 2-8 parts of citric acid, and the second functional component is prepared from 4-12 parts of cinnamaldehyde and 2-6 parts of oregano oil. The mass ratio of the thermosensitive gel matrix, the first functional component and the second functional component is 4-6:(5-8):(3-5).

[0024] A method for preparing a sustained-release gynecological antibacterial gel comprises the following steps:

[0025] 1) Take poloxamer and arabinoxylan, add deionized water, and stir for 20-30 minutes at 20-25°C to fully dissolve them as a thermosensitive gel matrix;

[0026] 2) silver dihydrogen citrate and citric acid are weighed and stirred at 20-25° C. for 20-30 minutes to mix them evenly to form a first functional component mixed solution;

[0027] 3) Measure cinnamaldehyde and oregano oil and stir at 20-25° C. for 20-30 minutes to mix them evenly to form a second functional component mixed solution;

[0028] 4) slowly adding the first functional component mixed solution to the second functional component mixed solution, the flow rate of the first functional component mixed solution is 1 ml / min, and the stirring speed is 1200 r / min; after complete mixing, continue stirring for 20-30 min to prepare a functional component mixed solution;

[0029] 5) Mix the thermosensitive gel matrix and the mixed solution of the functional components evenly at low temperature to obtain the product.

[0030] In the embodiment of the present invention, in step 1), the thermosensitive gel matrix is ​​prepared from poloxamer and arabinoxylan, and the thermosensitive gel matrix prepared from poloxamer and arabinoxylan is configured in a suitable ratio to form a gel having a good sustained release effect and being able to adjust the phase transition temperature, and being adapted to the human body temperature and being able to stay in the vagina for a long time. The arabinoxylan gel has a porous structure, a water environment and dietary fiber properties, which can make the functional components adhere to its surface and embed the functional components; the functional components have mannose-specific adhesins or other adhesion mechanisms, thereby allowing the functional components to bind to the inner surface of the female vagina, slowly release, and prolong the time in the female vagina. At the same time, the arabinoxylan gel can also be degraded by bacteria in the vaginal microbiome to maintain vaginal health; poloxamer acts as an emulsifier and stabilizer, uniformly emulsifies and stabilizes the oily materials in the formula in the gel, and acts as a sustained release material, which undergoes phase change at human body temperature, has strong adhesion to the vagina, and has a sustained release effect on the antibacterial compound. Thereby, the antibacterial gel can stay in the vagina for a long time, has good compatibility with the vaginal mucosa, is non-irritating, and can also increase skin permeability, which helps deep sterilization; poloxamer and arabinoxylan are combined within a suitable content range to form a paste-like gel with a sustained-release effect and the ability to adjust the phase change temperature to adapt to the human body temperature, and can stay in the vagina for a long time, while being able to exert good antibacterial properties.

[0031] Preferably, the ratio of poloxamer to arabinoxylan is 2-8:5-15; at this appropriate ratio, the gel has good stability and vaginal wall adhesion, and can release the first functional component and the second functional component at a reasonable rate to achieve a stable and significant antibacterial effect. More preferably, the ratio of poloxamer to arabinoxylan is 5:10;

[0032] Preferably, the poloxamer is a mixture of poloxamer 188 and poloxamer 407, and the weight ratio of poloxamer 188 to poloxamer 407 is 1:(2-4); poloxamer 407 is odorless, tasteless, easily soluble in water, acid, and alkali, and stable to metal ions. It has a special reverse thermal gelation effect, that is, it is liquid at low temperature and becomes a gel at body temperature. It has low toxicity, low irritation, and good biocompatibility; poloxamer 188 is easily soluble in water, has strong surface activity and gelation. It can effectively improve the dissolution rate of poorly soluble drugs. Poloxamer 188 is both fat-soluble and water-soluble. It can be dissolved with the aqueous phase and uniformly dispersed in the lipophilic polycaprolactone in a molecular state, forming a uniform porous structure on the surface of the microspheres. In addition, the addition of poloxamer 188 also improves the release of the drug, thereby increasing the effective therapeutic concentration of the drug; however, when the amount of poloxamer 407 used is less than 2 parts, the gel state is unstable and easily diluted; when the amount of poloxamer 407 used is greater than 4 parts, the drug release rate is low, the effective therapeutic concentration of the drug is low, and its therapeutic effect is poor.

[0033] In the embodiment of the present invention, in step 2), the concentration of silver dihydrogen citrate is 0.05-0.5 mg / ml; preferably, the concentration of silver dihydrogen citrate is 0.25 mg / ml.

[0034] Specifically, in step 2), the concentration of citric acid is 0.02-0.5 mol / l, preferably, the concentration of citric acid is 0.25 mol / l. In the presence of citric acid, the pH value of silver dihydrogen citrate is always acidic, maintaining its stability and prolonging its efficacy.

[0035] In the embodiment of the present invention, in step 3), the concentration of cinnamaldehyde is 0.08-0.32 mg / l, and the preferred concentration of cinnamaldehyde is 0.2 mg / l.

[0036] Specifically, in step 3), the concentration of oregano oil is 0.3-0.63 mg / l, preferably, the concentration of oregano oil is 0.5 mg / l; by compounding cinnamaldehyde and oregano oil, the antibacterial property thereof is improved;

[0037] Preferably, the volume ratio of cinnamaldehyde to oregano oil is 2-3:1. Experiments show that the antibacterial effect of cinnamaldehyde and oregano oil in combination is comparable to that of antibiotics, and has an antibacterial effect that cannot be replaced by antibiotics.

[0038] In the embodiment of the present invention, in step 4), the first functional component mixed solution is slowly added dropwise to the second functional component mixed solution. In the presence of citric acid and citrate, the first functional component is acidic. Therefore, when mixed with the second functional component, the second functional component solution is compounded with citric acid, thereby improving the overall antibacterial effect and keeping the pH value of the mixed solution at a weak acidic level.

[0039] In the embodiment of the present invention, in step 5), the thermosensitive gel matrix and the mixed solution of the functional components are mixed evenly at low temperature, so that the thermosensitive gel matrix embeds the functional components, thereby making the functional components adhere to the thermosensitive gel matrix.

[0040] Embodiment 1

[0041] A sustained-release gynecological antibacterial gel mainly consists of a thermosensitive gel matrix, a first functional component and a second functional component. The thermosensitive gel matrix is ​​prepared from 5 parts of poloxamer and 10 parts of arabinoxylan, wherein the poloxamer is poloxamer 188; the first functional component is prepared from 17 parts of silver dihydrogen citrate and 5 parts of citric acid, wherein the concentration of the silver dihydrogen citrate is 0.25 mg / ml, and the concentration of the citric acid is 0.2 mol / l; the second functional component is prepared from 8 parts of cinnamaldehyde and 4 parts of oregano oil, wherein the concentration of the cinnamaldehyde is 0.2 mg / l, the concentration of the oregano oil is 0.46 mg / l, and the volume ratio of cinnamaldehyde to oregano oil is 2:1.

[0042] A method for preparing a sustained-release gynecological antibacterial gel comprises the following steps:

[0043] 1) Take poloxamer and arabinoxylan, add deionized water, and stir for 20-30 minutes at 20-25°C to fully dissolve them as a thermosensitive gel matrix;

[0044] 2) silver dihydrogen citrate and citric acid are weighed and stirred at 20-25° C. for 20-30 minutes to mix them evenly to form a first functional component mixed solution;

[0045] 3) Measure cinnamaldehyde and oregano oil and stir at 20-25° C. for 20-30 minutes to mix them evenly to form a second functional component mixed solution;

[0046] 4) slowly adding the first functional component mixed solution to the second functional component mixed solution, the flow rate of the first functional component mixed solution is 1 ml / min, and the stirring speed is 1200 r / min; after complete mixing, continue stirring for 20-30 min to prepare a functional component mixed solution;

[0047] 5) Mix the thermosensitive gel matrix and the mixed solution of the functional components evenly at low temperature to obtain the product.

[0048] Embodiment 2

[0049] A sustained-release gynecological antibacterial gel mainly consists of a thermosensitive gel matrix, a first functional component and a second functional component. The thermosensitive gel matrix is ​​prepared from 5 parts of poloxamer and 9 parts of arabinoxylan, wherein the poloxamer is poloxamer 188; the first functional component is prepared from 16 parts of silver dihydrogen citrate and 8 parts of citric acid, wherein the concentration of the silver dihydrogen citrate is 0.3 mg / ml, and the concentration of the citric acid is 0.05 mol / l; the second functional component is prepared from 8 parts of cinnamaldehyde and 3 parts of oregano oil, wherein the concentration of the cinnamaldehyde is 0.2 mg / l, the concentration of the oregano oil is 0.6 mg / l, and the volume ratio of cinnamaldehyde to oregano oil is 3:1.

[0050] The preparation method of a sustained-release gynecological antibacterial gel is the same as that in Example 1, and will not be further described herein.

[0051] Embodiment 3

[0052] A sustained-release gynecological antibacterial gel mainly consists of a thermosensitive gel matrix, a first functional component and a second functional component, wherein the thermosensitive gel matrix is ​​prepared from 7 parts of poloxamer and 10 parts of arabinoxylan, wherein the poloxamer is poloxamer 188; the first functional component is prepared from 13 parts of silver dihydrogen citrate and 6 parts of citric acid, wherein the concentration of the silver dihydrogen citrate is 0.4 mg / ml, and the concentration of the citric acid is 0.25 mol / l; the second functional component is prepared from 9 parts of cinnamaldehyde and 4 parts of oregano oil, wherein the concentration of the cinnamaldehyde is 0.15 mg / l, the concentration of the oregano oil is 0.35 mg / l, and the volume ratio of the cinnamaldehyde to the oregano oil is 2:1.

[0053] The preparation method of a sustained-release gynecological antibacterial gel is the same as that in Example 1, and will not be further described herein.

[0054] Embodiment 4

[0055] A sustained-release gynecological antibacterial gel mainly consists of a thermosensitive gel matrix, a first functional component and a second functional component. The thermosensitive gel matrix is ​​prepared from 7 parts of poloxamer and 8 parts of arabinoxylan, wherein the poloxamer is poloxamer 188 and poloxamer 407 configured at a weight ratio of 9:1; the first functional component is prepared from 19 parts of silver dihydrogen citrate and 3 parts of citric acid, wherein the concentration of the silver dihydrogen citrate is 0.1 mg / ml, and the concentration of the citric acid is 0.4 mol / l; the second functional component is prepared from 7 parts of cinnamaldehyde and 5 parts of oregano oil, wherein the concentration of the cinnamaldehyde is 0.25 mg / l, the concentration of the oregano oil is 0.45 mg / l, and the volume ratio of cinnamaldehyde to oregano oil is 2:1.

[0056] The preparation method of a sustained-release gynecological antibacterial gel is the same as that in Example 1, and will not be further described herein.

[0057] Embodiment 5

[0058] A sustained-release gynecological antibacterial gel mainly consists of a thermosensitive gel matrix, a first functional component and a second functional component. The thermosensitive gel matrix is ​​prepared from 7 parts of poloxamer and 9 parts of arabinoxylan, wherein the poloxamer is poloxamer 188 and poloxamer 407 configured at a weight ratio of 11:1; the first functional component is prepared from 14 parts of silver dihydrogen citrate and 7 parts of citric acid, wherein the concentration of the silver dihydrogen citrate is 0.2 mg / ml, and the concentration of the citric acid is 0.3 mol / l; the second functional component is prepared from 8 parts of cinnamaldehyde and 4 parts of oregano oil, wherein the concentration of the cinnamaldehyde is 0.15 mg / l, the concentration of the oregano oil is 0.45 mg / l, and the volume ratio of cinnamaldehyde to oregano oil is 3:1.

[0059] The preparation method of a sustained-release gynecological antibacterial gel is the same as that in Example 1, and will not be further described herein.

[0060] Comparative Example 1

[0061] A sustained-release gynecological antibacterial gel mainly consists of a thermosensitive gel matrix, a first functional component and a second functional component. The thermosensitive gel matrix is ​​prepared from 15 parts of poloxamer, wherein the poloxamer is poloxamer 188; the first functional component is prepared from 17 parts of silver dihydrogen citrate and 5 parts of citric acid, wherein the concentration of the silver dihydrogen citrate is 0.25 mg / ml, and the concentration of the citric acid is 0.2 mol / l; the second functional component is prepared from 8 parts of cinnamaldehyde and 4 parts of oregano oil, wherein the concentration of the cinnamaldehyde is 0.2 mg / l, the concentration of the oregano oil is 0.46 mg / l, and the volume ratio of cinnamaldehyde to oregano oil is 2:1.

[0062] The method for preparing a sustained-release gynecological antibacterial gel is different from that of Example 1 in that: poloxamer is added to deionized water and stirred at 20-25° C. for 20-30 minutes to fully dissolve it to serve as a thermosensitive gel matrix.

[0063] Comparative Example 2

[0064] A sustained-release gynecological antibacterial gel mainly consists of a thermosensitive gel matrix and a first functional component, wherein the thermosensitive gel matrix is ​​prepared from 5 parts of poloxamer and 10 parts of arabinoxylan, wherein the poloxamer is poloxamer 188; and the first functional component is prepared from 24 parts of silver dihydrogen citrate and 10 parts of citric acid, wherein the concentration of the silver dihydrogen citrate is 0.25 mg / ml, and the concentration of the citric acid is 0.2 mol / l.

[0065] The method for preparing a sustained-release gynecological antibacterial gel is different from that of Example 1 in that: there is no need to prepare a mixed solution of the second functional component.

[0066] Comparative Example 3

[0067] A sustained-release gynecological antibacterial gel mainly consists of a thermosensitive gel matrix and a second functional component, wherein the thermosensitive gel matrix is ​​prepared from 5 parts of poloxamer and 10 parts of arabinoxylan, wherein the poloxamer is poloxamer 188; the second functional component is prepared from 22 parts of cinnamaldehyde and 12 parts of oregano oil, wherein the concentration of cinnamaldehyde is 0.2 mg / l, the concentration of oregano oil is 0.46 mg / l, and the volume ratio of cinnamaldehyde to oregano oil is 2:1.

[0068] The method for preparing a sustained-release gynecological antibacterial gel is different from that of Example 1 in that: there is no need to prepare a mixed solution of the first functional component.

[0069] Comparative Example 4

[0070] A sustained-release gynecological antibacterial gel mainly consists of a thermosensitive gel matrix and a second functional component, wherein the thermosensitive gel matrix is ​​prepared from 5 parts of poloxamer and 10 parts of arabinoxylan, wherein the poloxamer is poloxamer 188; the second functional component is prepared from 16 parts of cinnamaldehyde, 8 parts of oregano oil and 10 parts of citric acid, wherein the concentration of cinnamaldehyde is 0.2 mg / l, the concentration of oregano oil is 0.46 mg / l, and the volume ratio of cinnamaldehyde to oregano oil is 2:1.

[0071] The method for preparing a sustained-release gynecological antibacterial gel is different from that of Example 1 in that: there is no need to prepare a mixed solution of the first functional component.

[0072] Experimental Example 1

[0073] Sustained release effect measurement:

[0074] The test samples are: the antibacterial gel of Example 1 and the antibacterial gels of Comparative Examples 1-4;

[0075] The detection method is as follows: 10 ml of the test samples of Example 1 and Comparative Examples 1-4 are respectively measured and placed in dialysis bags with a capacity of 1 L and a molecular weight cutoff of 1000, and then the dialysis bags are placed in 100 ml of deionized water at a temperature of 36-37° C. The concentration of silver ions in the deionized water at different times is measured to determine the sustained release ability of the gel.

[0076] Test results such as Figure 1 As shown;

[0077] The release time of the antibacterial gel in comparative example 1 is the shortest, which is only 180 min. The release time of the antibacterial gel in Example 1 is the longest, which is 300 min. The release times of the antibacterial gels in comparative examples 2, 3 and 4 are similar, but all exceed 240 min. The thermosensitive gel matrix of the antibacterial gel in comparative example 1 is prepared from 15 parts of poloxamer; the difference between the antibacterial gels in comparative examples 2, 3 and 4 and in Example 1 is that the thermosensitive gel matrix is ​​prepared from 5 parts of poloxamer and 10 parts of arabinoxylan, and the total weight is the same, but the sustained release The time is longer than that of the antibacterial gel prepared by pure poloxamer. It can be seen that the thermosensitive gel matrix prepared by compounding poloxamer and arabinoxylan can better prolong the sustained-release performance of the gel and increase its release time. The release rates of the antibacterial gels in Comparative Example 2, Comparative Example 3, Comparative Example 4 and Example 1 are all over 95%, while the release rate of Comparative Example 1 is about 90%. It can be seen that the thermosensitive gel matrix prepared by compounding poloxamer and arabinoxylan can not only better prolong the sustained-release performance of the gel and prolong its release time, but also increase its Ag + release rate.

[0078] Experimental Example 2

[0079] Antibacterial performance test: According to the method of the "Technical Specification for Disinfection" of the Ministry of Health in 2017, the antibacterial gels prepared in Examples 1-5 of the present invention and the sustained-release microemulsion thermosensitive antibacterial gels prepared in Comparative Examples 1-4 were tested for their microbial bactericidal effects.

[0080] The test item is the bactericidal rate, and the test bacteria include Staphylococcus aureus ATCC6538, Candida albicans ATCC10231, Trichomonas vaginalis and Neisseria gonorrhoeae.

[0081] Test method: 40 ml of the antibacterial gel prepared in Examples 1-5 and the antibacterial gel prepared in Comparative Examples 1-4 were measured and divided into 4 portions, each 10 ml. The antibacterial gel was used to act on Staphylococcus aureus for 3 minutes, on Candida albicans for 8 minutes, and on Trichomonas vaginalis and Neisseria gonorrhoeae for 10 minutes. The test results are shown in Table 1:

[0082] Table 1 Antibacterial performance test results

[0083]

[0084]

[0085] As can be seen from the above table, the gynecological antibacterial gels of Examples 1-5 of the present invention have good antibacterial effects on Staphylococcus aureus ATCC6538, Candida albicans ATCC10231, Trichomonas vaginalis and Neisseria gonorrhoeae, with a sterilization rate of more than 98%. The bactericidal effect of comparative examples 1-4 is poor, because: the thermosensitive gel matrix in comparative example 1 is prepared only by poloxamer, lacks arabinoxylan, resulting in a short sustained release time and greatly weakened antibacterial effect; in comparative example 2, there is only the first functional component, although the weight of the first functional component is the same as the total weight of the first functional component and the second functional component in Example 1, but due to the lack of the cooperation of the second functional component, its antibacterial effect is greatly weakened; in comparative example 3, there is only the second functional component, although the weight of the second functional component is the same as the total weight of the first functional component and the second functional component in Example 1, but due to the lack of the cooperation of the first functional component, its antibacterial effect is greatly weakened; in comparative example 3, there is only the second functional component and citric acid, citric acid can be compounded with the second functional component to improve its antibacterial performance, but due to the lack of dihydrogen silver citrate in the first functional component, its bactericidal ability is greatly weakened. It can be seen from comparative examples 2-4 that the bactericidal effect of the first functional component and the second functional component after compounding is much greater than the bactericidal performance of the single functional component, from which it can be seen that the first functional component and the second functional component have a synergistic effect.

[0086] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0087] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A sustained-release gynecological antibacterial gel, characterized in that: The gel consists of a thermosensitive gel matrix, a first functional component and a second functional component, wherein the thermosensitive gel matrix is ​​prepared from 5 parts of poloxamer 188 and 10 parts of arabinoxylan; the first functional component is prepared from 17 parts of silver dihydrogen citrate and 5 parts of citric acid, wherein the concentration of silver dihydrogen citrate is 0.25 mg / mL; the concentration of citric acid is 0.2 mol / L; the second functional component is prepared from 8 parts of cinnamaldehyde and 4 parts of oregano oil, wherein the concentration of cinnamaldehyde is 0.2 mg / L, the concentration of oregano oil is 0.46 mg / L, and the volume ratio of cinnamaldehyde to oregano oil is 2:1; the antibacterial gel is prepared according to the following steps: 1) Poloxamer 188 and arabinoxylan are added to deionized water and stirred at 20-25°C for 20-30 minutes to fully dissolve them as a thermosensitive gel matrix; 2) silver dihydrogen citrate and citric acid are weighed and stirred at 20-25° C. for 20-30 minutes to mix them evenly to form a first functional component mixed solution; 3) Measure cinnamaldehyde and oregano oil and stir at 20-25° C. for 20-30 minutes to mix them evenly to form a second functional component mixed solution; 4) slowly adding the first functional component mixed solution to the second functional component mixed solution, the flow rate of the first functional component mixed solution is 1 mL / min, and the stirring speed is 1200 r / min; after complete mixing, continue stirring for 20-30 min to prepare a functional component mixed solution; 5) Mix the thermosensitive gel matrix and the mixed solution of the functional components evenly at low temperature to obtain the product.

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