CN113908206A - Preparation method and application of gynecological antibacterial gel - Google Patents
Preparation method and application of gynecological antibacterial gel Download PDFInfo
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- CN113908206A CN113908206A CN202111197390.2A CN202111197390A CN113908206A CN 113908206 A CN113908206 A CN 113908206A CN 202111197390 A CN202111197390 A CN 202111197390A CN 113908206 A CN113908206 A CN 113908206A
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Classifications
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- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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Abstract
The invention discloses a preparation method and application of gynecological antibacterial gel, wherein a homocarrier dispersion solution and a silver nitrate solution are added into a reducing agent aqueous solution at one time, and nano silver particles are obtained after centrifugation, standing, washing and drying; sequentially adding the nano silver particles into an aqueous solution mixed with propylene glycol, carbomer, a viscosity regulator and triethanolamine, and sequentially adding allantoin, a solubilizer, gamma-polyglutamic acid and a seaweed extract to obtain a solution D; adding the solution D into mother liquor containing water, suspension stabilizer, dispersant, soybean isoflavone, fructus Cnidii extract, radix rehmanniae Preparata extract, herba Leonuri and radix Sophorae Flavescentis extract, and mixing to obtain gynecological antibacterial gel; the gynecological antibacterial gel is applied to sterilization of female gynecological inflammation.
Description
Technical Field
The invention relates to the field of sterilization and disinfection, and in particular relates to a preparation method and application of gynecological antibacterial gel.
Background
Gynecological diseases threaten female health in daily life, and have bad influence on female work and life. The common gynecological diseases include bacterial vaginitis, senile vaginitis, chronic cervicitis, etc. Bacterial vaginitis is mostly seen in women before childbearing age, senile vaginitis is often seen in women after menopause, the clinical symptoms of the bacterial vaginitis are vaginal dryness or yellow secretion outflow, and congestion or bleeding of vaginal mucosa is detected in severe cases. Chronic cervicitis is mostly caused by incomplete treatment of acute cervicitis and reinfection after pathogen hiding. Cervical erosion is one of the manifestations of chronic cervicitis, and the main pathogenic bacteria are staphylococcus, escherichia coli and anaerobe. When inflammation occurs, the activity of metalloproteinase (MMP) on the cervical erosion surface is enhanced, and the growth factor and the new tissue are damaged by the high activity.
Antibiotics and antihistamines are mostly adopted for gynecological diseases, but antibiotics are abused to cause a lot of side effects, so that drug resistance is generated and vaginal dysbacteriosis can be caused. Antihistamines can cause vaginal dryness and significant reduction in secretions.
The gynecological antibacterial gel at present comprises traditional Chinese medicine type gel, western medicine type gel and nano-silver gel, the traditional Chinese medicine type gel has slow effect and is easy to relapse, the western medicine type gel has quick curative effect but is easy to generate drug resistance and relapse, and the gynecological antibacterial gel can damage liver, kidney and hematopoietic system.
The nano-silver gel has high curative effect and relatively few side effects, but the existing nano-silver gel has poor stability, the nano-silver and other components can interact with each other, and the nano-silver sterilization effect is mostly reduced, so that the sterilization effect is poor in persistence; the viscosity of the existing nano-silver gynecological gel is larger along with the change of air temperature, and the gel viscosity is reduced to be aqueous in summer, so that the skin feeling is influenced, and the use feeling of the product is poorer; the existing nano-silver gynecological gel and traditional Chinese medicine components are compounded to achieve a good sterilization effect, the gel not only has a good gynecological sterilization effect, but also has the curative effects of other compounded traditional Chinese medicines, but actually, the effects of a plurality of traditional Chinese medicine extracts, the traditional Chinese medicine extracts and the nano-silver can be mutually offset, and some of the traditional Chinese medicine extracts and the nano-silver can even cause the nano-silver sterilization effect to completely disappear. Therefore, the development of a stable gynecological antibacterial gel with multiple medical effects is urgently needed.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides gynecological antibacterial gel with multiple medical effects.
In order to solve the technical problems, the invention adopts the technical scheme that:
a preparation method of gynecological antibacterial gel comprises the following steps:
s1 preparation of nano silver particle raw material: respectively preparing a solution A and a solution with a carrier, wherein the specific preparation process comprises the following steps:
according to the mass fraction, 0.8-1.5 parts of carbon oxynitride and 600 parts of pure water are fully dispersed to prepare dispersion liquid with the carrier;
dissolving 4-4.5 parts of silver nitrate in 80-100 parts of pure water by mass, and then adding ammonium hydroxide to adjust the pH value to 7-8 to prepare a solution A;
s2 preparation of nano silver particles: according to the mass fraction, 10-15 parts of reducing agent and 9000-11000 parts of pure water are uniformly mixed at the temperature of 5-10 ℃, then the solution A obtained from the carrier dispersion liquid obtained from S1 and the solution A obtained from S1 are sequentially added, after uniform mixing, a solution B is prepared, then the solution B is centrifuged and stood to obtain a supernatant and a precipitate, and then the precipitate is washed by the pure water; repeating the centrifuging, standing and washing processes until the pH value of the supernatant is neutral, and stopping the reaction to obtain a final precipitate; freeze-drying the final precipitate to obtain nano silver particles;
s3 preparation of gynecological antibacterial gel raw material: respectively preparing a solution D and a mother solution, wherein the specific preparation process comprises the following steps:
according to the mass fraction, respectively adding 10-15 parts of suspension stabilizer and 2-5 parts of dispersing agent into 1000 parts of pure water at the rotating speed of 1000-1500rpm, fully and uniformly mixing, respectively adding 2-4 parts of soybean isoflavone, 3-5 parts of fructus cnidii extract, 2-3 parts of prepared rehmannia root extract, 2-4 parts of motherwort and 1-2 parts of radix sophorae flavescentis extract, and fully and uniformly mixing to obtain mother liquor;
according to the mass fraction, at the rotating speed of 3000rpm of 2000-170 portions of 140-170 portions of carbomer is added into a solution containing 9000 portions of purified water and 70-100 portions of propylene glycol and is fully and uniformly mixed, then 20-30 portions of viscosity regulator are added and are uniformly mixed, 35-45 portions of triethanolamine are added and are uniformly mixed, and the solution C is obtained after standing and vacuum defoaming for 1-5 hours; then adding the 1.2-1.5 parts of nano silver particles into the solution C at the rotating speed of 6000-; finally, respectively adding 30-40 parts of allantoin, 70-100 parts of solubilizer, 5-7 parts of gamma-polyglutamic acid and 3-6 parts of seaweed extract, and uniformly mixing to obtain a solution D;
preparation of S4 gynecological antibacterial gel: and adding the mother liquor obtained in the step S3 into the solution D obtained in the step S3, uniformly mixing, adjusting the pH value to 3.5-4.0, and aging for 60-180min to obtain the gynecological antibacterial gel.
Further, in S1, the specific preparation method of the oxidized carbon nitride is as follows:
the method comprises the following steps: charging 4X 10 by mass fraction into a reaction vessel4-9×104Mixing the acid solution and cooling to below 10 ℃; then respectively adding 1 × 103-1.5×103Part of graphite-phase carbon nitride and 0.5X 103-1.5×103The oxidation promoter is added and fully stirred to ensure that the oxidation promoter is uniformly dispersedHomogenizing; finally, adding 1-5 parts of oxidation stabilizer, and fully stirring to uniformly disperse the oxidation stabilizer to obtain a solution E;
step two: keeping the temperature below 10 ℃, and adding 3X 10 to the solution E obtained in the first step according to mass fraction3-5×103Potassium ferrate is added and fully stirred for 1.5 to 2 hours; then heating to 25-35 ℃, adding 2X 103-4X 103 parts of potassium ferrate, and fully stirring for 2-3 h; finally, heating to 45-50 ℃ and stirring for 1.5-2h to obtain a solution F;
step three: centrifuging and standing the solution F obtained in the step two to obtain a supernatant and a precipitate, and then washing the precipitate with pure water; repeating the centrifuging, standing and washing processes until the pH value of the supernatant is 6.5-7.5, and obtaining final precipitate;
step four: freeze-drying the final precipitate obtained in the third step by a vacuum freeze dryer to obtain graphite oxide phase carbon nitride;
in the first step, the mixed acid solution is a mixed solution of sulfuric acid and hydrochloric acid, wherein the mass ratio of the sulfuric acid to the hydrochloric acid is 30:1-70: 1;
in the first step, the oxidation stabilizer is a mixture of periodic acid and citric acid, wherein the mass ratio of the periodic acid to the citric acid is 1:2-2: 1;
in the first step, the oxidation promoter is at least one of sodium nitrate and potassium nitrate.
Further, in S3, the dispersant is at least one of polyvinyl alcohol 1788 and polyvinyl alcohol 2488.
Further, in S2, the reducing agent is at least one of potassium citrate and sodium citrate.
Further, in S3, the viscosity modifier is at least one of methyl monoethanolamide palmitate and methyl monoethanolamide laurate.
Further, in S3, the solubilizer is at least one of polyoxyethylene lauryl ether, polyoxyethylene polyoxypropylene lauryl glycol ether, and polyoxyethylene hydrogenated castor oil.
Further, in S3, the suspension stabilizer is at least one of instant xanthan gum and instant hydroxypropyl methylcellulose.
Based on the same inventive concept, the application also provides an application of another gynecological antibacterial gel prepared by the preparation method, and the gynecological antibacterial gel is applied to sterilization of female gynecological inflammation.
The gynecological antibacterial gel does not contain hormone components, and the main components of the gynecological antibacterial gel are nano silver particles, plant extracts and natural products. The nano silver does not belong to antibiotics and has no drug resistance.
Wherein the plant extract comprises soybean isoflavone, fructus Cnidii extract, radix rehmanniae Preparata extract, herba Leonuri extract, and radix Sophorae Flavescentis extract. The soybean isoflavone has the effects of regulating female endocrine, regulating menstrual period, delaying aging and the like; fructus Cnidii extract is commonly used for treating infertility due to cold womb; the radix rehmanniae Preparata extract has effects of nourishing yin and tonifying blood; the sophora flavescens extract has the effects of killing parasites and relieving itching, and is commonly used for treating pruritus vulvae, leukorrhagia, eczema, pruritus vulvae, swelling of vulvae and other symptoms; the herba Leonuri extract has effects of promoting blood circulation, promoting estrus, removing blood stasis and relieving pain; the natural product comprises gamma-polyglutamic acid, seaweed extract, and allantoin. The gamma-polyglutamic acid (gamma-PGA) is a homopolymerized amino acid formed by polymerizing L-glutamic acid and D-glutamic acid through gamma-glutamine bond, has a special three-dimensional lattice structure, has extremely strong 5000 times of water absorption and moisture retention capacity, forms a layer of biological protective film on the surface of an external vagina, can well maintain the normal environment in the vagina and promotes the propagation of lactobacillus. The seaweed extract has effects of scavenging free radicals, resisting oxidation, preventing dryness of skin and mucosa, and nourishing female private parts. Allantoin has anti-inflammatory and antipruritic effects. The three natural products are matched for use, can deeply nourish the private cells of the female, improve the dryness symptom, enhance the good elasticity of the vaginal wall, prevent relaxation, dryness and aging and improve the quality of sexual life.
According to the preparation method, the carbon oxynitride is used as the same carrier material of the nano silver, so that the stability and the dispersibility of the nano silver can be effectively improved, and the yield and the antibacterial effect of nano silver particles are further improved. In the subsequent preparation process of the gynecological antibacterial gel, the suspension stabilizer and the viscosity regulator are added in two steps, so that the suspension stabilizer and the viscosity regulator are not interfered with each other and are cooperated with each other, and the yield of the gynecological antibacterial gel is improved.
The plant extracts and natural products in the existing gynecological antibacterial gel have the phenomenon of mutual offset or hedonic effect, so that the problem can be effectively solved by the special formula provided by the application. For example, the bactericidal ability of nano-silver can be reduced after the radix sophorae flavescentis extract and the fructus cnidii extract are added, and the bactericidal ability of nano-silver can be improved by adding a proper amount of soybean isoflavone and seaweed extract. Meanwhile, the sophora flavescens extract and the fructus cnidii extract can kill trichomonads, so that the trichomonad killing capability of the nano-silver is further enhanced.
The gynecological antibacterial gel disclosed by the invention is added with various natural products and plant extracts, so that the plant extracts are low in solubility in an aqueous solution, and are easy to separate out after being dissolved and placed, and the effect is seriously influenced. In order to keep the plant extract stable in the system, a suspension stabilizer is added, so that the plant extract particles can be stably and uniformly dispersed and suspended in the whole hydrogel system, the plant extract is prevented from precipitating, and the whole gel is uniform. The multiple plant extracts have interaction, and after the dispersing agent is added, each component can play a role, and the function is not greatly reduced due to the polymerization of the multiple components. (for example, the flavone in the radix sophorae flavescentis and the coumarin in the fructus cnidii have obvious effects, and the dispersing agent is added to enable the flavone and the coumarin to play original properties) and the gynecological antibacterial gel disclosed by the invention to adjust the pH to be close to the original pH value of the vagina, so that the vaginal dysbacteriosis can be prevented, and the female reproductive health can be protected.
The invention uses the viscosity regulator, and the viscosity change is very small at 5-50 ℃, so the product has good temperature resistance and no obvious abnormal feeling when in use.
The gynecological antibacterial gel is detected by a third-party detection mechanism, and the inactivation rate of the gynecological antibacterial gel to HPV (human papillomavirus) is higher than 99.99889%; multiple global skin irritation tests with an average integral (irritation index) of 0; the stimulation test of the vaginal mucosa shows that the vaginal mucosa is basically intact, and congestion, edema and other abnormal manifestations are not seen.
Compared with the prior art, the invention has the beneficial effects that: the gynecological antibacterial gel and the carrier nano-silver component can rapidly and directly kill bacteria such as corynebacterium, staphylococcus aureus and the like, fungi such as candida albicans and the like, and viruses such as Human Papilloma Virus (HPV) and the like. While the nano silver kills bacteria, silver ions in the solution are also bonded to biomolecules of the bacterial corpse and deposited in the bacterial corpse. The silver "stored" in the bacteria can be released again, and the process can be explained by the shift of the chemical reaction equilibrium, so that the next generation of drug resistance can not survive. The nano silver particles are easy to agglomerate in aqueous solution, and the carbon oxynitride is used as a substrate material of the same carrier, silver ions can be carried on nodes of a single-layer six-membered ring network structure of the silver ions, and the nano microcrystal grows in situ from quantum dots, so that the agglomeration of the nano silver particles is obviously inhibited, the nano silver particles are stably suspended in the solution, and the specific surface area of the nano silver particles is further increased. The gynecological antibacterial gel can reduce the release speed of the nano silver, so that the gynecological antibacterial gel can keep good bactericidal performance for a long time and has better safety compared with nano silver particles. The plant extract and natural product have effects of caring female private parts, relieving itching and diminishing inflammation. The gynecological antibacterial gel forms a layer of protective film in private parts, and the components can be gradually released, so that the antibacterial effect is durable, and the gynecological antibacterial gel has no drug resistance. The use and operation are simple, and the administration is convenient; has no obvious overflow and discomfort during use, and reduces the pain and inconvenience of the medicine to patients.
Detailed Description
Preparation of carbon oxynitride: carbon oxynitride prepared according to the preparation method of claim 2 of the present application was used in the following examples 1, 2 and 3 and comparative examples 1, 2 and 3
The method comprises the following steps: 60g of 98% concentrated sulfuric acid and 2g of concentrated hydrochloric acid are mixed and then poured into a reaction bottle, and the reaction bottle is placed into an ice water bath to be cooled to 6 ℃. Adding 1g of graphite-phase carbon nitride and 1g of sodium nitrate into a reaction bottle, and fully stirring for 25 minutes to uniformly disperse the graphite-phase carbon nitride and the sodium nitrate; finally, 0.001g of periodic acid and 0.002g of citric acid are added and stirred for 10min to obtain a solution E.
Step two: keeping the temperature of the ice-water bath at 10 ℃, and slowly adding 4g of potassium ferrate into the solution E to avoid generating bubbles. Stirring was continued for 2 h. Continuously adding 3g of potassium ferrate in portions, keeping the temperature at 30 ℃ and stirring for 2 h. Heating to 45 ℃, and stirring for 2h to obtain a solution F.
Step three: the solution F was centrifuged at 10000rpm for 60 min. Standing for layering for 20min to obtain supernatant and precipitate, and pouring out the supernatant. Washing the precipitate with 50g of pure water, and repeating the above centrifuging, standing and washing processes until the pH value of the supernatant is 7.0 to obtain 2.95g of final precipitate.
Step four: and (4) freeze-drying the final precipitate obtained in the third step by using a vacuum freeze dryer to obtain 0.78g of graphite oxide phase carbon nitride.
The materials used in the following examples and comparative examples, unless otherwise specified, were all commercially available products, and the product specifications of cnidium monnieri (fructus cnidii) extract, rehmanniae radix preparata extract, leonurus japonicus extract, and sophora flavescens extract were 10:1 water-soluble type.
Example 1
S1 preparation of nano silver particle raw material: respectively preparing a solution A and a solution with a carrier, wherein the specific preparation process comprises the following steps:
according to the mass fraction, 1.0g of carbon oxynitride and 550g of pure water are stirred for 15min, then dispersed for 40min by using an ultrasonic dispersion machine, and after full dispersion, the dispersion liquid with the carrier is prepared;
dissolving 4g of silver nitrate in 80g of pure water according to mass fraction, and then adding ammonium hydroxide to adjust the pH value to 7 to obtain a solution A;
s2 preparation of nano silver particles:
according to the mass fraction, 15g of potassium citrate and 11000g of pure water are uniformly mixed in an ice-water bath at the temperature of 5 ℃, then the solution A obtained from S1 and the carrier dispersion liquid and the solution A obtained from S1 are sequentially added, the mixture is fully and uniformly mixed by stirring for 20min and ultrasonic treatment for 30min to obtain a solution B, then the solution B is centrifuged at the rotating speed of 6000rpm for 30min and is kept stand for 30min to obtain a supernatant and a precipitate, and then the precipitate is washed by the pure water; repeating the centrifuging, standing and washing processes until the pH value of the supernatant is neutral, and stopping the reaction to obtain a final precipitate; freeze-drying the final precipitate to obtain nano silver particles;
s3 preparation of gynecological antibacterial gel raw material: respectively preparing a solution D and a mother solution, wherein the specific preparation process comprises the following steps:
according to the mass fraction, 15g of xanthan gum and 4g of polyvinyl alcohol 2488 are respectively added into 1000g of pure water at the rotating speed of 1000-1500rpm, the mixture is stirred at a high speed for 50min, after the mixture is fully mixed uniformly, 4g of soybean isoflavone, 3g of fructus cnidii extract, 3g of prepared rehmannia root extract, 2g of motherwort and 1g of radix sophorae flavescentis extract are respectively added, and the mother liquor is obtained after the mixture is fully mixed uniformly;
adding 150g of carbomer into a solution containing 9000g of purified water and 100g of propylene glycol at the rotating speed of 2000rpm according to mass fraction, stirring for 30min, mixing uniformly, adding 20g of methyl palmitoglycolate monoethanolamide, mixing uniformly, adding 40g of triethanolamine, mixing uniformly, standing for 30min, and defoaming in vacuum for 1h to obtain a solution C; then adding the 1.2g of nano silver particles into the solution C at the rotating speed of 6000, stirring for 60min and uniformly mixing; finally, 30g of allantoin, 70g of polyoxyethylene polyoxypropylene lauryl glycol ether, 5g of gamma-polyglutamic acid and 3g of seaweed extract are respectively added, stirred for 20min and uniformly mixed to obtain a solution D;
preparation of S4 gynecological antibacterial gel:
and adding the mother solution obtained in the step S3 into the solution D obtained in the step S3, stirring for 15min, uniformly mixing, adjusting the pH value to 3.5, and aging for 60 to obtain the gynecological antibacterial gel.
Example 2
S1 preparation of nano silver particle raw material: respectively preparing a solution A and a solution with a carrier, wherein the specific preparation process comprises the following steps:
according to the mass fraction, 0.9g of carbon oxynitride and 500g of pure water are stirred for 10min, then dispersed for 30min by using an ultrasonic dispersion machine, and after full dispersion, the dispersion liquid with the carrier is prepared;
dissolving 4.5g of silver nitrate in 80g of pure water according to mass fraction, and then adding ammonium hydroxide to adjust the pH value to 7 to prepare a solution A;
s2 preparation of nano silver particles:
according to the mass fraction, 10g of potassium citrate and 11000g of pure water are uniformly mixed in an ice-water bath at the temperature of 5 ℃, then the solution A obtained from S1 and the carrier dispersion liquid and the solution A obtained from S1 are sequentially added, the mixture is fully and uniformly mixed by stirring for 20min and ultrasonic treatment for 40min to obtain a solution B, then the solution B is centrifuged at the rotating speed of 6000rpm for 30min and is kept stand for 30min to obtain a supernatant and a precipitate, and then the precipitate is washed by the pure water; repeating the centrifuging, standing and washing processes until the pH value of the supernatant is neutral, and stopping the reaction to obtain a final precipitate; freeze-drying the final precipitate to obtain nano silver particles;
s3 preparation of gynecological antibacterial gel raw material: respectively preparing a solution D and a mother solution, wherein the specific preparation process comprises the following steps:
according to the mass fraction, under the rotating speed of 1000-1500rpm, respectively adding 8g of instant xanthan gum, 4g of instant hydroxypropyl methylcellulose and 3g of polyvinyl alcohol 1788 into 1000g of pure water, stirring at a high speed for 50min, fully and uniformly mixing, respectively adding 2g of soybean isoflavone, 3g of fructus cnidii extract, 2.5g of prepared rehmannia root extract, 2g of motherwort and 1g of radix sophorae flavescentis extract, and fully and uniformly mixing to obtain mother liquor;
adding 140g of carbomer into a solution containing 9000g of purified water and 100g of propylene glycol at the rotating speed of 2000rpm according to mass fraction, stirring for 30min, mixing uniformly, adding 20g of methyl palmitoglycolate monoethanolamide, mixing uniformly, adding 35g of triethanolamine, mixing uniformly, standing for 30min, and defoaming in vacuum for 1h to obtain a solution C; then adding the 1.5g of nano silver particles into the solution C at the rotating speed of 6000, stirring for 60min and uniformly mixing; finally, 40g of allantoin, 20g of polyoxyethylene lauryl ether, 30g of polyoxyethylene polyoxypropylene lauryl glycol ether, 40g of polyoxyethylene hydrogenated castor oil, 7g of gamma-polyglutamic acid and 3g of seaweed extract are respectively added, stirred for 20min and uniformly mixed to obtain a solution D;
preparation of S4 gynecological antibacterial gel:
and adding the mother solution obtained in the step S3 into the solution D obtained in the step S3, stirring for 15min, uniformly mixing, adjusting the pH value to 4.0, and aging for 60min to obtain the gynecological antibacterial gel.
Example 3
S1 preparation of nano silver particle raw material: respectively preparing a solution A and a solution with a carrier, wherein the specific preparation process comprises the following steps:
according to the mass fraction, 1.2g of carbon oxynitride and 500g of pure water are stirred for 13min, then dispersed for 40min by using an ultrasonic dispersion machine, and after full dispersion, the dispersion liquid with the carrier is prepared;
dissolving 4.3g of silver nitrate in 90g of pure water according to mass fraction, and then adding ammonium hydroxide to adjust the pH value to 8 to prepare a solution A;
s2 preparation of nano silver particles:
according to the mass fraction, 5g of sodium citrate, 5g of potassium citrate and 11000g of pure water are uniformly mixed in an ice-water bath at 10 ℃, then the solution A obtained from S1 and the carrier dispersion liquid and the solution A obtained from S1 are sequentially added, the mixture is fully and uniformly mixed by stirring for 30min and ultrasonic treatment for 40min to obtain a solution B, then the solution B is centrifuged for 30min at the rotating speed of 6000rpm and is kept stand for 30min to obtain a supernatant and a precipitate, and then the precipitate is washed by the pure water; repeating the centrifuging, standing and washing processes until the pH value of the supernatant is neutral, and stopping the reaction to obtain a final precipitate; freeze-drying the final precipitate to obtain nano silver particles;
s3 preparation of gynecological antibacterial gel raw material: respectively preparing a solution D and a mother solution, wherein the specific preparation process comprises the following steps:
respectively adding 4g of instant xanthan gum, 8g of instant hydroxypropyl methylcellulose and 2g of polyvinyl alcohol 1788 into 1000g of pure water at the rotating speed of 1500rpm by mass percent, stirring at a high speed for 50min, fully and uniformly mixing, respectively adding 4g of soybean isoflavone, 3g of fructus cnidii extract, 2g of prepared rehmannia root extract, 3g of motherwort and 2g of radix sophorae flavescentis extract, and fully and uniformly mixing to obtain mother liquor;
according to the mass fraction, 155g of carbomer is added into a solution containing 9000g of purified water and 90g of propylene glycol at the rotating speed of 2500rpm, the mixture is stirred for 30min and is fully and uniformly mixed, then 20g of methyl monoethanolamide palmitate and 10g of methyl monoethanolamide are added and are uniformly mixed, 38g of triethanolamine is added and is uniformly mixed, and the solution C is obtained after standing for 30min and vacuum defoaming for 1 h; then adding the 1.4g of nano silver particles into the solution C at the rotating speed of 7000rpm, stirring for 60min and uniformly mixing; finally, respectively adding 35g of allantoin, 50g of polyoxyethylene polyoxypropylene lauryl glycol ether, 40g of polyoxyethylene hydrogenated castor oil, 6g of gamma-polyglutamic acid and 5g of seaweed extract, stirring for 20min, and uniformly mixing to obtain a solution D;
preparation of S4 gynecological antibacterial gel:
and adding the mother solution obtained in the step S3 into the solution D obtained in the step S3, stirring for 15min, uniformly mixing, adjusting the pH value to 4.0, and aging for 60min to obtain the gynecological antibacterial gel.
Comparative example 1
1)1.0g of carbon oxynitride and 550g of pure water were stirred for 15 minutes, and then dispersed for 40 minutes using an ultrasonic disperser to obtain the supported dispersion A.
2) Dissolving 4g of silver nitrate in 80g of pure water, adding ammonium hydroxide to adjust the pH value to 7-8 to prepare a solution B
3) Keeping the temperature of the ice-water bath at 5 ℃, and uniformly mixing 15g of potassium citrate and 11000g of pure water. Adding the carrier dispersion liquid A and the solution B in sequence, and stirring for 20min. Then ultrasonic treatment is carried out for 30min to prepare a solution C.
4) Centrifuging the solution C at 6000rpm for 30min, standing for layering for 30min, and pouring out the supernatant. Pure water was added to the lower precipitate to wash ten times until the solution was neutral. And then putting the sample into a vacuum freeze dryer for freeze drying to obtain the nano silver particles.
5) Taking 1000g of pure water, adding 15g of xanthan gum and 4g of polyvinyl alcohol 2488 at the rotation speed of 1500rpm, stirring at high speed for 50min, then adding 2-4g of soybean isoflavone, 3g of fructus cnidii extract, 5g of prepared rehmannia root extract, 2g of motherwort and 1g of radix sophorae flavescentis extract, and preparing mother liquor D.
6) 9000g of purified water and 100g of propylene glycol were added to 150g of carbomer at 2000rpm, and stirred for 30min after the addition. Adding 40g of triethanolamine, stirring for 30min, standing for 30min, and defoaming in vacuum for 1h to obtain a solution E. At 6000rpm, 1.2g of nano-silver particles were added to solution E and stirred for 60 min.
7) Adding allantoin 30g, polyoxyethylene polyoxypropylene lauryl glycol ether 70g, gamma-polyglutamic acid 5g, and Sargassum lobuli extract 3g sequentially, and stirring for 20min.
8) Adding the mother liquor D, stirring for 15min, adjusting pH to 3.5, aging for 60min, and making into gynecological antibacterial gel.
Comparative example 2
1)0.9g of carbon oxynitride and 500g of pure water were stirred for 10 minutes, and then dispersed for 30 minutes using an ultrasonic disperser to obtain the same carrier dispersion liquid A.
2) Dissolving 4.5g silver nitrate in 80g pure water, adding ammonium hydroxide to adjust pH to 7-8 to obtain solution B
3) Keeping the temperature of the ice water bath at 5-10 ℃, and uniformly mixing 10g of sodium citrate and 11000g of pure water. Adding the carrier dispersion liquid A and the solution B in sequence, and stirring for 20min. Then ultrasonic treatment is carried out for 40min to prepare a solution C.
4) Centrifuging the solution C at 6000rpm for 30min, standing for layering for 30min, and pouring out the supernatant. Pure water was added to the lower precipitate to wash ten times until the solution was neutral. And then putting the sample into a vacuum freeze dryer for freeze drying to obtain the nano silver particles.
5) Adding 1000g pure water at 1200rpm into 3g polyvinyl alcohol 1788, stirring at high speed for 50min, adding 2g soybean isoflavone, 3g fructus Cnidii extract, 5g radix rehmanniae Preparata extract, 2g herba Leonuri, and 1g radix Sophorae Flavescentis extract to obtain mother liquor D
6) 9000g of purified water and 100g of propylene glycol are taken, 140g of carbomer is added at the rotating speed of 2000rpm, stirring is carried out for 30min after the addition is finished, then 20g of palmitic acid methyl monoethanolamide is added, and stirring is continued for 20min. Adding 35g of triethanolamine, stirring for 30min, standing for 30min, and defoaming in vacuum for 1h to obtain a solution E. At 6000rpm, 1.5g of nano-silver particles were added to solution E and stirred for 60 min.
7) Adding allantoin 40g, polyoxyethylene lauryl ether 20g, polyoxyethylene polyoxypropylene lauryl glycol ether 30g, polyoxyethylene hydrogenated castor oil 40g, gamma-polyglutamic acid 7g, and Sargassum lobuli extract 3g, and stirring for 20min.
8) Adding the mother liquor D, stirring for 15min, adjusting pH to 3.5-4.0, aging for 60min, and making into gynecological antibacterial gel.
Comparative example 3
1)0.9g of carbon oxynitride and 500g of pure water were stirred for 10 minutes, and then dispersed for 30 minutes using an ultrasonic disperser to obtain the same carrier dispersion liquid A.
2) Dissolving 4.5g silver nitrate in 80g pure water, adding ammonium hydroxide to adjust pH to 7-8 to obtain solution B
3) Keeping the temperature of the ice water bath at 5-10 ℃, and uniformly mixing 10g of sodium citrate and 11000g of pure water. Adding the carrier dispersion liquid A and the solution B in sequence, and stirring for 20min. Then ultrasonic treatment is carried out for 40min to prepare a solution C.
4) Centrifuging the solution C at 6000rpm for 30min, standing for layering for 30min, and pouring out the supernatant. Pure water was added to the lower precipitate to wash ten times until the solution was neutral. And then putting the sample into a vacuum freeze dryer for freeze drying to obtain the nano silver particles.
5) Adding 8g instant xanthan gum and 4g instant hydroxypropyl methylcellulose into 1000g pure water at 1200rpm, stirring at high speed for 50min, adding 2g soybean isoflavone, 3g fructus Cnidii extract, 5g radix rehmanniae Preparata extract, 2g herba Leonuri, and 1g radix Sophorae Flavescentis extract, and making into mother liquor D
6) 9000g of purified water and 100g of propylene glycol are taken, 140g of carbomer is added at the rotating speed of 2000rpm, stirring is carried out for 30min after the addition is finished, then 20g of palmitic acid methyl monoethanolamide is added, and stirring is continued for 20min. Adding 35g of triethanolamine, stirring for 30min, standing for 30min, and defoaming in vacuum for 1h to obtain a solution E. At 6000rpm, 1.5g of nano-silver particles were added to solution E and stirred for 60 min.
7) Adding allantoin 40g, polyoxyethylene lauryl ether 20g, polyoxyethylene polyoxypropylene lauryl glycol ether 30g, polyoxyethylene hydrogenated castor oil 40g, gamma-polyglutamic acid 7g, and Sargassum lobuli extract 3g, and stirring for 20min.
8) Adding the mother liquor D, stirring for 15min, adjusting pH to 3.5-4.0, aging for 60min, and making into gynecological antibacterial gel.
Gynecological antibacterial gel application
The gynecological antibacterial gel mainly comprises gel and a vaginal administration device. Information on vaginal drug delivery device: the disposable plastic pipe is composed of a pipe body, a piston, a push rod and a pipe cap, and is made of food-grade polypropylene (PP) and provided with disposable packages which are disposable. Taking 1 (6 g/piece) gynecological antibacterial gel in a supine position before sleeping at night, taking out a sterile cap of the pulp booster, slowly inserting into the vagina, and compressing the push rod pulp stock solution to be injected into the bottom of the vagina at one time.
Viscosity as a function of temperature for example 1 and comparative example 1
TABLE 1 TABLE of viscosity as a function of temperature for example 1 and comparative example 1
As can be seen from table 1, example 1 has a small change in viscosity with a change in temperature. This is because example 1 uses a viscosity modifier and comparative example 1 does not use a viscosity modifier.
Sterilization effect of example 2 and comparative example 2 on Staphylococcus aureus
TABLE 2 Sterilization Effect of example 2 and comparative example 2 on Staphylococcus aureus
As can be seen from table 2, example 2 using the suspension stabilizer exhibited a significantly better bactericidal effect than comparative example 2 not using the suspension stabilizer. The reason is that the gynecological antibacterial gel is not added with a suspension stabilizer, and some components in the plant extract have great influence on the nano-silver sterilizing capability under the condition of low silver ion concentration, so that the sterilizing effect is greatly reduced.
Stability test results of example 2 and comparative example 3
Table 3 table of stability test results of example 2 and comparative example 3
| Incubator at 54 ℃ for 14 days | Refrigerator at 5 deg.C for 30 days | ||
| Example 2 | Transparent and free of precipitate | Transparent and free of precipitate | |
| Comparative example 3 | Transparent and free of precipitate | Opaque with precipitates |
As can be seen from Table 3, in comparative example 3, no dispersant was added, and the gynecological gel became opaque with a small amount of precipitates after the product was cooled in a refrigerator at 5 ℃ for 30 days. As the plant extracts interact with each other, polymerization reaction occurs, and precipitation is generated.
New navigation detection vagina mucosa stimulation test of third-party detection mechanism
Materials and animals
1, sample: example 2 gynecological antibacterial gel
2, animal: new Zealand rabbits, available from Taiping Biotech, Inc. of Hunan.
And 3, environment: the temperature is 23-26 ℃, and the relative humidity is 54-58 percent
Two results
After the animals in the control combined experimental group are treated, the animals have no abnormality in food intake, water drinking, excrement and urine, behavioral activities and the like. After two groups of animals infected with the virus for 24 hours are respectively killed, the vaginal mucosa of all tested animals in the experimental group is observed by naked eyes to be basically intact, and congestion, edema and other abnormal manifestations are not seen; all the tested animals in the control group have intact vaginal mucosa and no obvious congestion, edema and other manifestations are seen. The pathological detection result shows that the vagina mucosa stimulation index of the tested animals in the experimental group is 0.45.
Multiple integral skin irritation test for new navigation detection of third-party detection mechanism
A material and animal
1, sample: example 2 gynecological antibacterial gel
2, animal: new Zealand rabbits, available from Taiping Biotech, Inc. of Hunan.
And 3, environment: the temperature is 23-26 ℃, and the relative humidity is 54-58%
Two methods
The detection basis is as follows: disinfection Specification (2002 edition) 2.3.3.3.3
Three results
The skin of the drug-coated area of all tested animals has no erythema, edema and other abnormalities within the observation period of 14d after the infection; the skin of the control area of the tested animal has no abnormal phenomenon in the observation period. The average integral of the stimulus response (stimulus index) per animal per day was 0.
Third party detection institution ENGELL detection of HPV Virus inactivation test
1 materials of the experiment
1.1 test sample: example 2
1.2 cells: 293FT cells were subcultured in this laboratory
1.3 Virus: human papillomavirus type 16 pseudovirus (HPV16PP) was prepared and stored in the laboratory
1.4 Experimental reagents: DMEM culture medium, fetal calf serum and other experimental reagents are provided by the laboratory
2 results of the experiment
The experiment detects the inactivation of gynecological antibacterial gel on HPV16 type pseudovirus at the cellular level. The detection result shows that the virus titer of the virus control group is 1.505 x 107ffu/ml, the titer of gynecological antibacterial gel of the detected sample is less than 1.67 x 102ffu/ml, and compared with a virus control group, the gynecological antibacterial gel has the advantages that the reduction of the titer of HPV16 pseudovirus under the condition of room temperature for 30 minutes is more than 4.95log, and the inactivation rate is more than 99.99889%.
EXAMPLE 1 Candida albicans Sterilization test
Example 1 gynecological antibacterial gel, pure water was added to dilute the gel to solutions of different silver ion concentrations, 5ppm, 10ppm, 25ppm, 50ppm, 100 ppm.
Candida albicans sterilization experiments show that the Candida albicans sterilization rate is 99.8% at the silver ion concentration of 5 ppm.
TABLE 4 fungicidal action of the fungicides on Candida albicans
In Table 4, parallel (R) and parallel (R) represent repeated experiments conducted in parallel.
Claims (8)
1. The preparation method of the gynecological antibacterial gel is characterized by comprising the following steps:
s1 preparation of nano silver particle raw material: respectively preparing a solution A and a solution with a carrier, wherein the specific preparation process comprises the following steps:
according to the mass fraction, 0.8-1.5 parts of carbon oxynitride and 600 parts of pure water are fully dispersed to prepare dispersion liquid with the carrier;
dissolving 4-4.5 parts of silver nitrate in 80-100 parts of pure water by mass, and then adding ammonium hydroxide to adjust the pH value to 7-8 to prepare a solution A;
s2 preparation of nano silver particles: according to the mass fraction, 10-15 parts of reducing agent and 9000-11000 parts of pure water are uniformly mixed at the temperature of 5-10 ℃, then the solution A obtained from the carrier dispersion liquid obtained from S1 and the solution A obtained from S1 are sequentially added, the solution B is prepared after full and uniform mixing, then the solution B is centrifuged and stood to obtain supernatant and precipitate, and then the precipitate is washed by the pure water; repeating the centrifuging, standing and washing processes until the pH value of the supernatant is neutral, and stopping the reaction to obtain a final precipitate; freeze-drying the final precipitate to obtain nano silver particles;
s3 preparation of gynecological antibacterial gel raw material: respectively preparing a solution D and a mother solution, wherein the specific preparation process comprises the following steps:
according to the mass fraction, respectively adding 10-15 parts of suspension stabilizer and 2-5 parts of dispersing agent into 1000 parts of pure water at the rotating speed of 1000-1500rpm, fully and uniformly mixing, respectively adding 2-4 parts of soybean isoflavone, 3-5 parts of fructus cnidii extract, 2-3 parts of prepared rehmannia root extract, 2-4 parts of motherwort and 1-2 parts of radix sophorae flavescentis extract, and fully and uniformly mixing to obtain mother liquor;
according to the mass fraction, at the rotating speed of 3000rpm of 2000-170 portions of 140-170 portions of carbomer is added into a solution containing 9000 portions of purified water and 70-100 portions of propylene glycol and is fully and uniformly mixed, then 20-30 portions of viscosity regulator are added and are uniformly mixed, 35-45 portions of triethanolamine are added and are uniformly mixed, and the solution C is obtained after standing and vacuum defoaming for 1-5 hours; then adding the 1.2-1.5 parts of nano silver particles into the solution C at the rotating speed of 6000-; finally, respectively adding 30-40 parts of allantoin, 70-100 parts of solubilizer, 5-7 parts of gamma-polyglutamic acid and 3-6 parts of seaweed extract, and uniformly mixing to obtain a solution D;
preparation of S4 gynecological antibacterial gel: and adding the mother liquor obtained in the step S3 into the solution D obtained in the step S3, uniformly mixing, adjusting the pH value to 3.5-4.0, and aging for 60-180min to obtain the gynecological antibacterial gel.
2. The method according to claim 1, wherein in S1, the method for preparing the oxidized carbon nitride comprises:
the method comprises the following steps: charging 4X 10 by mass fraction into a reaction vessel4-9×104Mixing the acid solution and cooling to below 10 ℃; then respectively adding 1 × 103-1.5×103Part of graphite-phase carbon nitride and 0.5X 103-1.5×103The oxidation promoter is added and fully stirred to be uniformly dispersed; finally, adding 1-5 parts of oxidation stabilizer, and fully stirring to uniformly disperse the oxidation stabilizer to obtain a solution E;
step two: keeping the temperature below 10 ℃, and adding 3X 10 to the solution E obtained in the first step according to mass fraction3-5×103Potassium ferrate is added and fully stirred for 1.5 to 2 hours; then heating to 25-35 ℃, adding 2X 103-4X 103 parts of potassium ferrate, and fully stirring for 2-3 h; finally heating to 45-50 deg.C and stirring for 1.5-2h to obtain solutionF；
Step three: centrifuging and standing the solution F obtained in the step two to obtain a supernatant and a precipitate, and then washing the precipitate with pure water; repeating the centrifuging, standing and washing processes until the pH value of the supernatant is 6.5-7.5, and obtaining final precipitate;
step four: freeze-drying the final precipitate obtained in the third step by a vacuum freeze dryer to obtain graphite oxide phase carbon nitride;
in the first step, the mixed acid solution is a mixed solution of sulfuric acid and hydrochloric acid, wherein the mass ratio of the sulfuric acid to the hydrochloric acid is 30:1-70: 1;
in the first step, the oxidation stabilizer is a mixture of periodic acid and citric acid, wherein the mass ratio of the periodic acid to the citric acid is 1:2-2: 1;
in the first step, the oxidation promoter is at least one of sodium nitrate and potassium nitrate.
3. The method according to claim 1, wherein the dispersant is at least one of polyvinyl alcohol 1788 and 2488 in S3.
4. The method according to claim 1, wherein the reducing agent is at least one of potassium citrate and sodium citrate in S2.
5. The method according to claim 1, wherein the viscosity modifier is at least one of methyl monoethanolamide palmitate and methyl monoethanolamide laurate in S3.
6. The method according to claim 1, wherein in S3, the solubilizer is at least one of polyoxyethylene lauryl ether, polyoxyethylene polyoxypropylene lauryl glycol ether and polyoxyethylene hydrogenated castor oil.
7. The method according to claim 1, wherein the suspension stabilizer in S3 is at least one of instant xanthan gum and instant hydroxypropyl methylcellulose.
8. The use of a gynecological antiseptic gel prepared according to the preparation method of any one of claims 1 to 7, characterized in that the gynecological antiseptic gel is used for the sterilization of female gynecological inflammation.
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