CN118121537A - Efficient antibacterial gynecological gel and preparation method thereof - Google Patents

Efficient antibacterial gynecological gel and preparation method thereof Download PDF

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CN118121537A
CN118121537A CN202410292121.1A CN202410292121A CN118121537A CN 118121537 A CN118121537 A CN 118121537A CN 202410292121 A CN202410292121 A CN 202410292121A CN 118121537 A CN118121537 A CN 118121537A
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parts
weight
gel
gynecological
chinese herbal
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蒋洪凯
管明义
肖爽
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Jiangxi Baiquan Industrial Co ltd
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Abstract

The invention provides a high-efficiency antibacterial gynecological gel and a preparation method thereof, wherein the gynecological gel comprises, by weight, 40-60 parts of a composite gel matrix, 8-12 parts of poly-N-isopropyl acrylamide, 20-25 parts of a Chinese herbal medicine extract, 5-7 parts of o-cymene-5-ol, 8-10 parts of dipropylene glycol and 3-5 parts of dichlorobenzyl alcohol; the composite gel matrix consists of trehalose gel, bentonite and hydroxyethyl cellulose in a mass ratio of 1.5-2.5:1:3-5; the Chinese herbal medicine extract is prepared from 6-8 parts by weight of snow lotus herb, 5-7 parts by weight of radix stemonae, 5-7 parts by weight of radix sophorae flavescentis, 3-5 parts by weight of fructus cnidii, 3-5 parts by weight of phellodendron, 2-4 parts by weight of safflower, 1-3 parts by weight of gallnut and 1-3 parts by weight of motherwort. The gynecological gel disclosed by the invention has good biocompatibility, does not cause allergy or irritation reaction, can effectively treat gynecological inflammation, can be used for rechecking one month after stopping medicine for a patient, has no medicine dependence, remarkably reduces the recurrence rate after healing, can relieve discomfort, remarkably reduces irritation, and improves the use experience of the gynecological inflammation patient.

Description

Efficient antibacterial gynecological gel and preparation method thereof
Technical Field
The invention relates to the field of gynecological medicaments, in particular to a high-efficiency antibacterial gynecological gel and a preparation method thereof.
Background
Gynecological inflammation is a common disease of women, such as female vulvitis, vaginitis, cervicitis and the like, and once a plurality of patients are infected with vaginitis, the patients are frequently cleaned and treated by taking antibiotics, however, the frequent use of washing liquor for cleaning the vulva or vaginal irrigation can change the pH value of the vagina, destroy the ecological balance of the vagina and aggravate the illness state. In fact, the pathogens causing vaginitis, except bacteria, namely mould and trichomonas, for which general antibiotics have no therapeutic effect, on the contrary, the long-term abuse of antibiotics is liable to cause the pathogen to generate drug resistance, and especially the use of antibiotics aggravates the infection symptoms when the fungi are infected, about 90% of fungi in the extract of the infected vagina are candida albicans, while escherichia coli, staphylococcus aureus and candida albicans are common pathogens of bacterial vaginitis. The intravaginal exposure to pathogens such as bacteria can lead to damage to the vaginal mucosa, resulting in long disease treatment cycles or difficulty in eradication.
The gynecological external gel has the advantages of no adhesion with wound surfaces, effective blocking of bacteria and prevention of wound surface infection, is widely used for gynecological inflammation treatment, but most of the existing external gel medicines for treating gynecological inflammation are antibiotics, have great skin irritation, easily cause anaphylactic reaction, cause certain injury to organisms after long-time use, generate drug resistance, influence the exertion and treatment effect of drug effect, repeatedly respond to inflammation, hardly treat radically, have poor healing effect or easily relapse of most products on the market, and also have certain safety problems.
Therefore, it is necessary to develop a gynecological gel which is safe and efficient in bacteriostasis and is not easy to relapse in gynecological inflammation.
Disclosure of Invention
In view of the above, the invention provides a high-efficiency antibacterial gynecological gel and a preparation method thereof.
The technical scheme of the invention is realized as follows:
The high-efficiency antibacterial gynecological gel comprises, by weight, 40-60 parts of a composite gel matrix, 8-12 parts of poly-N-isopropyl acrylamide, 20-25 parts of a Chinese herbal medicine extract, 5-7 parts of o-cymene-5-ol, 8-10 parts of dipropylene glycol and 3-5 parts of dichlorobenzyl alcohol;
the composite gel matrix consists of trehalose gel, bentonite and hydroxyethyl cellulose in a mass ratio of 1.5-2.5:1:3-5;
the Chinese herbal medicine extract is prepared from 6-8 parts by weight of snow lotus herb, 5-7 parts by weight of radix stemonae, 5-7 parts by weight of radix sophorae flavescentis, 3-5 parts by weight of fructus cnidii, 3-5 parts by weight of phellodendron, 2-4 parts by weight of safflower, 1-3 parts by weight of gallnut and 1-3 parts by weight of motherwort.
Further, the gel comprises, by weight, 50 parts of a composite gel matrix, 10 parts of poly-N-isopropyl acrylamide, 23 parts of a Chinese herbal medicine extract, 6 parts of cymene-5-ol, 9 parts of dipropylene glycol and 4 parts of dichlorobenzyl alcohol.
Further, the preparation method of the trehalose comprises the following steps: crushing and sieving the cleaned and dried kelp, adding a compound biological enzyme consisting of cellulose and pectase in a mass ratio of 1:2-3, reacting to obtain an enzymolysis liquid, inoculating lactobacillus in a volume ratio of 5% -8% of the enzymolysis liquid for mixed fermentation, centrifuging the fermentation liquid, collecting supernatant, precipitating with 60% v/v ethanol, and drying the precipitate to obtain the trehalose gel.
Further, the preparation method of the Chinese herbal medicine extract comprises the following steps: pulverizing herba Saussureae Involueratae, radix Stemonae, radix Sophorae Flavescentis, fructus Cnidii, cortex Phellodendri, carthami flos, galla chinensis and herba Leonuri, mixing, soaking in 80-90% v/v ethanol solution of 6-8 times weight for 1-3 hr, extracting the soaked Chinese herbal medicines with microwave for 2 times at 50-60deg.C for 10-20 min each time, filtering, concentrating the extractive solution under reduced pressure, drying, and pulverizing into granule.
Further, the gynecological gel also comprises 0.5-1.5 parts of water-soluble vitamin E and 1-3 parts of beta-glucan.
A preparation method of high-efficiency antibacterial gynecological gel comprises the following steps:
s1, dissolving poly-N-isopropyl acrylamide in water, then adding Chinese herbal medicine extract particles, o-cymene-5-alcohol, dipropylene glycol and dichlorobenzyl alcohol, carrying out ultrasonic treatment at 25-35 ℃ for 40-50 minutes for coating, and evaporating a solvent to obtain microcapsules;
S2, uniformly dispersing the composite gel matrix in water, soaking for 12-20 hours to obtain a swelling solution, uniformly stirring, adding the microcapsules in the S1, performing ultrasonic dispersion for 30-40 minutes, and uniformly stirring;
s3, continuously adding the water-soluble vitamin E and the beta-glucan, and continuously stirring to obtain the target gynecological gel.
Compared with the prior art, the invention has the beneficial effects that:
1. The gynecological gel disclosed by the invention has good biocompatibility, does not cause allergy or irritation reaction, has strong adhesiveness, prolongs the action time of the gel, is favorable for releasing and absorbing antibacterial components, continuously repairing inflammation, promoting tissue healing, reducing recurrence rate, relieving discomfort and improving the use experience of gynecological inflammation patients.
2. According to the invention, the poly-N-isopropyl acrylamide is selected as a thermosensitive material to encapsulate antibacterial components to prepare the microcapsule, so that the stability can be improved, active components are protected, degradation is avoided, slow release and long-acting effects are realized, and the low-dose medicine is used for efficiently treating gynecological inflammation. The poly-N-isopropyl acrylamide is water-soluble at the temperature lower than 32 ℃, and is converted from water-soluble to insoluble once the temperature exceeds 36 ℃, so that the microcapsule is dissolved or contracted to release the drug, thereby realizing the release of antibacterial components under the stimulation of body temperature, improving the local treatment effect of the drug in vagina, ensuring the release of the drug at proper time and position, increasing the drug effect and reducing the side effect.
3. According to the invention, the trehalose gel, bentonite and hydroxyethyl cellulose in specific proportions are selected to cooperatively improve the viscosity, stability and release characteristics of antibacterial components of the gynecological gel, so that better treatment effect and use experience are achieved. The trehalose gel can increase the viscosity and adhesiveness of gynecological gel, improve the stability and adhesiveness of the gel, and the bentonite can increase the viscosity of gynecological gel and improve the rheological property of gynecological gel, has a certain adsorption capacity, is favorable for stabilizing and transferring antibacterial components, has good moisturizing performance, can help to maintain the moisture balance of vaginal mucosa, and reduces the discomfort of dryness.
4. The Chinese herbal medicine extracts of the snow lotus herb, the radix stemonae, the radix sophorae flavescentis, the fructus cnidii, the cortex phellodendri, the safflower, the gallnut and the motherwort not only can promote the healing of inflammatory tissues, but also can help to stimulate the generation of cytokines and growth factors, regulate inflammatory reaction, promote tissue repair and regeneration, reduce the influence of gynecological inflammation on tissue structures, balance the immune state of vagina and be beneficial to restoring normal physiological states.
Detailed Description
In order to better understand the technical content of the present invention, the following provides specific examples to further illustrate the present invention.
The experimental methods used in the embodiment of the invention are conventional methods unless otherwise specified.
Materials, reagents, and the like used in the examples of the present invention are commercially available unless otherwise specified.
Example 1
The high-efficiency antibacterial gynecological gel comprises, by weight, 50 parts of a composite gel matrix, 10 parts of poly-N-isopropyl acrylamide, 23 parts of a Chinese herbal medicine extract, 6 parts of o-cymene-5-ol, 9 parts of dipropylene glycol, 4 parts of dichlorobenzyl alcohol, 1 part of water-soluble vitamin E and 2 parts of beta-glucan, wherein the composite gel matrix consists of, by mass, 2:1:4 trehalose gum, bentonite and hydroxyethyl cellulose, and the Chinese herbal medicine extract is prepared from 7 parts of saussurea involucrata, 6 parts of radix stemonae, 6 parts of radix sophorae flavescentis, 4 parts of fructus cnidii, 4 parts of phellodendron, 3 parts of safflower, 2 parts of Chinese gall and 2 parts of motherwort.
The preparation method of the gynecological gel comprises the following steps:
S1, preparing trehalose glue: crushing and sieving cleaned and dried kelp, adding a compound biological enzyme consisting of cellulose and pectase in a mass ratio of 1:2.5, reacting to obtain an enzymolysis liquid, inoculating lactobacillus in a volume ratio of 7% of the enzymolysis liquid for mixed fermentation, centrifuging the fermentation liquid, collecting supernatant, precipitating with 60% v/v ethanol, and drying the precipitate to obtain trehalose gel;
S2, preparing a Chinese herbal medicine extract: pulverizing herba Saussureae Involueratae, radix Stemonae, radix Sophorae Flavescentis, fructus Cnidii, cortex Phellodendri, carthami flos, galla chinensis and herba Leonuri, mixing, soaking in 85% v/v ethanol solution 7 times of the weight for 2 hr, microwave extracting the soaked Chinese herbal medicines for 2 times at 55deg.C for 15min each time, filtering, concentrating the extractive solution under reduced pressure, drying, and pulverizing into granule;
s3, dissolving poly-N-isopropyl acrylamide in water, then adding Chinese herbal medicine extract particles, o-cymene-5-alcohol, dipropylene glycol and dichlorobenzyl alcohol, carrying out ultrasonic treatment at 30 ℃ for 45min for coating, and evaporating the solvent to obtain microcapsules;
S4, uniformly dispersing the composite gel matrix in water, soaking for 15 hours to obtain a swelling solution, uniformly stirring, adding the microcapsules in the S3, performing ultrasonic dispersion for 35 minutes, uniformly stirring, continuously adding the water-soluble vitamin E and the beta-glucan, and continuously stirring to obtain the target gynecological gel.
Example 2
The high-efficiency antibacterial gynecological gel comprises, by weight, 40 parts of a composite gel matrix, 8 parts of poly-N-isopropyl acrylamide, 20 parts of a Chinese herbal medicine extract, 5 parts of o-cymene-5-ol, 8 parts of dipropylene glycol, 3 parts of dichlorobenzyl alcohol, 0.5 part of water-soluble vitamin E and 1 part of beta-glucan, wherein the composite gel matrix consists of trehalose gum, bentonite and hydroxyethyl cellulose in a mass ratio of 1.5:1:3, and the Chinese herbal medicine extract is prepared from 6 parts of snow lotus herb, 5 parts of radix stemonae, 5 parts of radix sophorae flavescentis, 3 parts of fructus cnidii, 3 parts of phellodendron, 2 parts of safflower, 1 part of Chinese gall and 1 part of motherwort.
The preparation method of the gynecological gel comprises the following steps:
S1, preparing trehalose glue: crushing and sieving cleaned and dried kelp, adding a compound biological enzyme consisting of cellulose and pectase in a mass ratio of 1:2.5, reacting to obtain an enzymolysis liquid, inoculating lactobacillus in a volume ratio of 7% of the enzymolysis liquid for mixed fermentation, centrifuging the fermentation liquid, collecting supernatant, precipitating with 60% v/v ethanol, and drying the precipitate to obtain trehalose gel;
S2, preparing a Chinese herbal medicine extract: pulverizing herba Saussureae Involueratae, radix Stemonae, radix Sophorae Flavescentis, fructus Cnidii, cortex Phellodendri, carthami flos, galla chinensis and herba Leonuri, mixing, soaking in 85% v/v ethanol solution 7 times of the weight for 2 hr, microwave extracting the soaked Chinese herbal medicines for 2 times at 55deg.C for 15min each time, filtering, concentrating the extractive solution under reduced pressure, drying, and pulverizing into granule;
s3, dissolving poly-N-isopropyl acrylamide in water, then adding Chinese herbal medicine extract particles, o-cymene-5-alcohol, dipropylene glycol and dichlorobenzyl alcohol, carrying out ultrasonic treatment at 30 ℃ for 45min for coating, and evaporating the solvent to obtain microcapsules;
S4, uniformly dispersing the composite gel matrix in water, soaking for 15 hours to obtain a swelling solution, uniformly stirring, adding the microcapsules in the S3, performing ultrasonic dispersion for 35 minutes, uniformly stirring, continuously adding the water-soluble vitamin E and the beta-glucan, and continuously stirring to obtain the target gynecological gel.
Example 3
The high-efficiency antibacterial gynecological gel comprises, by weight, 60 parts of a composite gel matrix, 12 parts of poly-N-isopropyl acrylamide, 25 parts of a Chinese herbal medicine extract, 7 parts of o-cymene-5-ol, 10 parts of dipropylene glycol, 5 parts of dichlorobenzyl alcohol, 1.5 parts of water-soluble vitamin E and 3 parts of beta-glucan, wherein the composite gel matrix consists of 2.5:1:5 trehalose gum, bentonite and hydroxyethyl cellulose, and the Chinese herbal medicine extract is prepared from 8 parts of snow lotus herb, 7 parts of radix stemonae, 7 parts of radix sophorae flavescentis, 5 parts of fructus cnidii, 5 parts of phellodendron, 4 parts of safflower, 3 parts of Chinese gall and 3 parts of motherwort.
The preparation method of the gynecological gel comprises the following steps:
S1, preparing trehalose glue: crushing and sieving cleaned and dried kelp, adding a compound biological enzyme consisting of cellulose and pectase in a mass ratio of 1:2.5, reacting to obtain an enzymolysis liquid, inoculating lactobacillus in a volume ratio of 7% of the enzymolysis liquid for mixed fermentation, centrifuging the fermentation liquid, collecting supernatant, precipitating with 60% v/v ethanol, and drying the precipitate to obtain trehalose gel;
S2, preparing a Chinese herbal medicine extract: pulverizing herba Saussureae Involueratae, radix Stemonae, radix Sophorae Flavescentis, fructus Cnidii, cortex Phellodendri, carthami flos, galla chinensis and herba Leonuri, mixing, soaking in 85% v/v ethanol solution 7 times of the weight for 2 hr, microwave extracting the soaked Chinese herbal medicines for 2 times at 55deg.C for 15min each time, filtering, concentrating the extractive solution under reduced pressure, drying, and pulverizing into granule;
s3, dissolving poly-N-isopropyl acrylamide in water, then adding Chinese herbal medicine extract particles, o-cymene-5-alcohol, dipropylene glycol and dichlorobenzyl alcohol, carrying out ultrasonic treatment at 30 ℃ for 45min for coating, and evaporating the solvent to obtain microcapsules;
S4, uniformly dispersing the composite gel matrix in water, soaking for 15 hours to obtain a swelling solution, uniformly stirring, adding the microcapsules in the S3, performing ultrasonic dispersion for 35 minutes, uniformly stirring, continuously adding the water-soluble vitamin E and the beta-glucan, and continuously stirring to obtain the target gynecological gel.
Example 4
The high-efficiency antibacterial gynecological gel comprises, by weight, 50 parts of a composite gel matrix, 10 parts of poly-N-isopropyl acrylamide, 23 parts of a Chinese herbal medicine extract, 6 parts of o-cymene-5-ol, 9 parts of dipropylene glycol, 4 parts of dichlorobenzyl alcohol, 1 part of water-soluble vitamin E and 2 parts of beta-glucan, wherein the composite gel matrix consists of, by mass, 2:1:4 trehalose gum, bentonite and hydroxyethyl cellulose, and the Chinese herbal medicine extract is prepared from 7 parts of saussurea involucrata, 6 parts of radix stemonae, 6 parts of radix sophorae flavescentis, 4 parts of fructus cnidii, 4 parts of phellodendron, 3 parts of safflower, 2 parts of Chinese gall and 2 parts of motherwort.
The preparation method of the gynecological gel comprises the following steps:
s1, preparing trehalose glue: crushing and sieving cleaned and dried kelp, adding composite biological enzyme consisting of cellulose and pectase in a mass ratio of 1:2, reacting to obtain enzymolysis liquid, inoculating lactobacillus in a volume ratio of 5% to the enzymolysis liquid for mixed fermentation, centrifuging the fermentation liquid, collecting supernatant, precipitating with 60% v/v ethanol, and drying the precipitate to obtain trehalose gel;
S2, preparing a Chinese herbal medicine extract: pulverizing herba Saussureae Involueratae, radix Stemonae, radix Sophorae Flavescentis, fructus Cnidii, cortex Phellodendri, carthami flos, galla chinensis and herba Leonuri, mixing, soaking in 80% v/v ethanol solution 6 times of the weight for 1 hr, microwave extracting the soaked Chinese herbal medicines for 2 times at 50deg.C for 10min each time, filtering, concentrating the extractive solution under reduced pressure, drying, and pulverizing into granule;
S3, dissolving poly-N-isopropyl acrylamide in water, then adding Chinese herbal medicine extract particles, o-cymene-5-alcohol, dipropylene glycol and dichlorobenzyl alcohol, carrying out ultrasonic treatment at 25 ℃ for 40min for coating, and evaporating the solvent to obtain microcapsules;
S4, uniformly dispersing the composite gel matrix in water, soaking for 12 hours to obtain a swelling solution, uniformly stirring, adding the microcapsules in the S3, performing ultrasonic dispersion for 30 minutes, uniformly stirring, continuously adding the water-soluble vitamin E and the beta-glucan, and continuously stirring to obtain the target gynecological gel.
Example 5
The high-efficiency antibacterial gynecological gel comprises, by weight, 50 parts of a composite gel matrix, 10 parts of poly-N-isopropyl acrylamide, 23 parts of a Chinese herbal medicine extract, 6 parts of o-cymene-5-ol, 9 parts of dipropylene glycol, 4 parts of dichlorobenzyl alcohol, 1 part of water-soluble vitamin E and 2 parts of beta-glucan, wherein the composite gel matrix consists of, by mass, 2:1:4 trehalose gum, bentonite and hydroxyethyl cellulose, and the Chinese herbal medicine extract is prepared from 7 parts of saussurea involucrata, 6 parts of radix stemonae, 6 parts of radix sophorae flavescentis, 4 parts of fructus cnidii, 4 parts of phellodendron, 3 parts of safflower, 2 parts of Chinese gall and 2 parts of motherwort.
The preparation method of the gynecological gel comprises the following steps:
S1, preparing trehalose glue: crushing and sieving cleaned and dried kelp, adding composite biological enzyme consisting of cellulose and pectase in a mass ratio of 1:3, reacting to obtain enzymolysis liquid, inoculating lactobacillus with a volume ratio of 8% to the enzymolysis liquid for mixed fermentation, centrifuging the fermentation liquid, collecting supernatant, precipitating with 60% v/v ethanol, and drying the precipitate to obtain trehalose gel;
S2, preparing a Chinese herbal medicine extract: pulverizing herba Saussureae Involueratae, radix Stemonae, radix Sophorae Flavescentis, fructus Cnidii, cortex Phellodendri, carthami flos, galla chinensis and herba Leonuri, mixing, soaking in 90% v/v ethanol solution 8 times of the total weight for 3 hr, microwave extracting for 3 times at 60deg.C for 20min each time, filtering, concentrating the extractive solution under reduced pressure, drying, and pulverizing into granule;
S3, dissolving poly-N-isopropyl acrylamide in water, then adding Chinese herbal medicine extract particles, o-cymene-5-alcohol, dipropylene glycol and dichlorobenzyl alcohol, carrying out ultrasonic treatment at 35 ℃ for 50min for coating, and evaporating the solvent to obtain microcapsules;
S4, uniformly dispersing the composite gel matrix in water, soaking for 20 hours to obtain a swelling solution, uniformly stirring, adding the microcapsules in the S3, performing ultrasonic dispersion for 40 minutes, uniformly stirring, continuously adding the water-soluble vitamin E and the beta-glucan, and continuously stirring to obtain the target gynecological gel.
Comparative example 1
The difference from example 1 is that: the raw materials are different in dosage; the other points are the same as in example 1.
The high-efficiency antibacterial gynecological gel comprises, by weight, 30 parts of a composite gel matrix, 15 parts of poly-N-isopropyl acrylamide, 30 parts of a Chinese herbal medicine extract, 3 parts of o-cymene-5-ol, 7 parts of dipropylene glycol, 2 parts of dichlorobenzyl alcohol, 2 parts of water-soluble vitamin E and 4 parts of beta-glucan, wherein the composite gel matrix consists of 4 parts of saussurea involucrata, 8 parts of radix stemonae, 8 parts of radix sophorae flavescentis, 7 parts of fructus cnidii, 2 parts of amur corktree bark, 1 part of safflower, 4 parts of gallnut and 4 parts of motherwort according to the mass ratio of 1:1:2.
Comparative example 2
The difference from example 1 is that: lack of poly N-isopropyl acrylamide; the other points are the same as in example 1.
The high-efficiency antibacterial gynecological gel comprises, by weight, 50 parts of a composite gel matrix, 23 parts of a Chinese herbal medicine extract, 6 parts of o-cymene-5-ol, 9 parts of dipropylene glycol, 4 parts of dichlorobenzyl alcohol, 1 part of water-soluble vitamin E and 2 parts of beta-glucan, wherein the composite gel matrix is composed of trehalose gum, bentonite and hydroxyethyl cellulose in a mass ratio of 2:1:4, and the Chinese herbal medicine extract is prepared from 7 parts of snow lotus herb, 6 parts of radix stemonae, 6 parts of radix sophorae flavescentis, 4 parts of fructus cnidii, 4 parts of phellodendron, 3 parts of safflower, 2 parts of gallnut and 2 parts of motherwort.
The preparation method of the gynecological gel comprises the following steps:
S1, preparing trehalose glue: crushing and sieving cleaned and dried kelp, adding a compound biological enzyme consisting of cellulose and pectase in a mass ratio of 1:2.5, reacting to obtain an enzymolysis liquid, inoculating lactobacillus in a volume ratio of 7% of the enzymolysis liquid for mixed fermentation, centrifuging the fermentation liquid, collecting supernatant, precipitating with 60% v/v ethanol, and drying the precipitate to obtain trehalose gel;
S2, preparing a Chinese herbal medicine extract: pulverizing herba Saussureae Involueratae, radix Stemonae, radix Sophorae Flavescentis, fructus Cnidii, cortex Phellodendri, carthami flos, galla chinensis and herba Leonuri, mixing, soaking in 85% v/v ethanol solution 7 times of the weight for 2 hr, microwave extracting the soaked Chinese herbal medicines for 2 times at 55deg.C for 15min each time, filtering, concentrating the extractive solution under reduced pressure, drying, and pulverizing into granule;
s3, uniformly dispersing the composite gel matrix in water, soaking for 15 hours to obtain a swelling solution, uniformly stirring, adding the Chinese herbal medicine extract in the S2, then adding the o-cymene-5-alcohol, the dipropylene glycol and the dichlorobenzyl alcohol, performing ultrasonic dispersion for 35 minutes, uniformly stirring, continuously adding the water-soluble vitamin E and the beta-glucan, and continuously stirring to obtain the target gynecological gel.
Comparative example 3
The difference from example 1 is that: the composite gel matrix consists of trehalose gel, bentonite and hydroxyethyl cellulose according to the mass ratio of 1:1:2; the other points are the same as in example 1.
The high-efficiency antibacterial gynecological gel comprises, by weight, 50 parts of a composite gel matrix, 10 parts of poly-N-isopropyl acrylamide, 23 parts of a Chinese herbal medicine extract, 6 parts of o-cymene-5-ol, 9 parts of dipropylene glycol, 4 parts of dichlorobenzyl alcohol, 1 part of water-soluble vitamin E and 2 parts of beta-glucan, wherein the composite gel matrix consists of, by mass, 1:2 trehalose gum, bentonite and hydroxyethyl cellulose, and the Chinese herbal medicine extract is prepared from 7 parts of saussurea involucrata, 6 parts of radix stemonae, 6 parts of radix sophorae flavescentis, 4 parts of fructus cnidii, 4 parts of phellodendron, 3 parts of safflower, 2 parts of Chinese gall and 2 parts of motherwort.
Comparative example 4
The difference from example 1 is that: the Chinese herbal medicine extract is prepared from 5 parts of snow lotus herb, 4 parts of radix stemonae, 4 parts of radix sophorae flavescentis, 6 parts of fructus cnidii, 2 parts of amur corktree bark, 1 part of safflower, 4 parts of gallnut and 4 parts of motherwort; the other points are the same as in example 1.
The high-efficiency antibacterial gynecological gel comprises, by weight, 50 parts of a composite gel matrix, 10 parts of poly-N-isopropyl acrylamide, 23 parts of a Chinese herbal medicine extract, 6 parts of o-cymene-5-ol, 9 parts of dipropylene glycol, 4 parts of dichlorobenzyl alcohol, 1 part of water-soluble vitamin E and 2 parts of beta-glucan, wherein the composite gel matrix consists of 5 parts of saussurea involucrata, 4 parts of radix stemonae, 4 parts of radix sophorae flavescentis, 6 parts of fructus cnidii, 2 parts of amur corktree bark, 1 part of safflower, 4 parts of gallnut and 4 parts of motherwort according to the mass ratio of 2:1:4.
Comparative example 5
The difference from example 1 is that: absence of o-cymene-5-ol, dipropylene glycol and dichlorobenzyl alcohol; the other points are the same as in example 1.
The high-efficiency antibacterial gynecological gel comprises, by weight, 50 parts of a composite gel matrix, 10 parts of poly-N-isopropyl acrylamide, 23 parts of a Chinese herbal medicine extract, 1 part of water-soluble vitamin E and 2 parts of beta-glucan, wherein the composite gel matrix is composed of trehalose gum, bentonite and hydroxyethyl cellulose in a mass ratio of 2:1:4, and the Chinese herbal medicine extract is prepared from 7 parts of snow lotus herb, 6 parts of radix stemonae, 6 parts of radix sophorae flavescentis, 4 parts of fructus cnidii, 4 parts of phellodendron, 3 parts of safflower, 2 parts of gallnut and 2 parts of motherwort.
The preparation method of the gynecological gel comprises the following steps:
S1, preparing trehalose glue: crushing and sieving cleaned and dried kelp, adding a compound biological enzyme consisting of cellulose and pectase in a mass ratio of 1:2.5, reacting to obtain an enzymolysis liquid, inoculating lactobacillus in a volume ratio of 7% of the enzymolysis liquid for mixed fermentation, centrifuging the fermentation liquid, collecting supernatant, precipitating with 60% v/v ethanol, and drying the precipitate to obtain trehalose gel;
S2, preparing a Chinese herbal medicine extract: pulverizing herba Saussureae Involueratae, radix Stemonae, radix Sophorae Flavescentis, fructus Cnidii, cortex Phellodendri, carthami flos, galla chinensis and herba Leonuri, mixing, soaking in 85% v/v ethanol solution 7 times of the weight for 2 hr, microwave extracting the soaked Chinese herbal medicines for 2 times at 55deg.C for 15min each time, filtering, concentrating the extractive solution under reduced pressure, drying, and pulverizing into granule;
S3, dissolving the poly-N-isopropyl acrylamide in water, then adding the Chinese herbal medicine extract particles, carrying out ultrasonic treatment at 30 ℃ for 45min for coating, and evaporating the solvent to obtain microcapsules;
S4, uniformly dispersing the composite gel matrix in water, soaking for 15 hours to obtain a swelling solution, uniformly stirring, adding the microcapsules in the S3, performing ultrasonic dispersion for 35 minutes, uniformly stirring, continuously adding the water-soluble vitamin E and the beta-glucan, and continuously stirring to obtain the target gynecological gel.
In vitro bacteriostasis test
Bacterial species for in vitro bacteriostasis test: candida albicans (ATCC 10231), escherichia coli (ATCC 25922), staphylococcus aureus (ATCC 6538).
According to GB15979-2002 'Disposable hygienic product hygienic standard' annex C antibacterial property test method, the method specifically comprises the following steps: the test bacteria were washed with PBS for 24 hours to prepare a bacterial suspension (the required concentration is that 100. Mu.L of the suspension is dropped on a control sample, and the number of recovered bacteria is 1X 10 4~9×104 cfu/tablet). The sample pieces (50 px. Times.75 px) and the control pieces (the same size as the sample homogeneous material, but containing no antibacterial material, and having been subjected to sterilization treatment) were each 4 pieces. Taking the bacterial suspension, respectively dripping 100 mu L of the bacterial suspension on each tested sample piece and each control sample piece, uniformly coating, taking the bacterial suspension for 10min, respectively putting the sample pieces into a test tube containing 5mLPBS by using sterile forceps, fully and uniformly mixing the sample pieces for proper dilution, then taking 2-3 dilutions of the bacterial suspension, respectively sucking 0.5mL of the bacterial suspension, placing the bacterial suspension into two plates, pouring the bacterial suspension by using 5mL of nutrient agar culture medium cooled to 40-45 ℃, rotating the plates to ensure that the bacterial suspension is fully and uniformly, overturning the plates after agar solidification, culturing the plates at 35+/-2 ℃ for 48h, and counting viable bacteria colonies. The test was repeated 3 times and the bacteriostasis rate was calculated: bacteriostasis% = (average colony count of control sample-average colony count of tested sample)/average colony count of control sample x 100%.
The antibacterial effect test of E.coli, candida albicans and Staphylococcus aureus was carried out for the above examples 1-5 and comparative examples 1-5 for 10min, and the test results are shown in Table 1.
TABLE 1
Sample of Candida albicans antibacterial rate Coliform bacteria inhibition rate Antibacterial rate of staphylococcus aureus
Example 1 100% 100% 100%
Example 2 100% 100% 100%
Example 3 100% 100% 100%
Example 4 100% 100% 100%
Example 5 100% 100% 100%
Comparative example 1 93% 94% 91%
Comparative example 2 90% 91% 89%
Comparative example 3 85% 86% 83%
Comparative example 4 84% 85% 83%
Comparative example 5 83% 84% 82%
As can be seen from Table 1, the gynecological gel prepared by the invention can realize the release of active ingredients under the stimulation of body temperature, improves the local treatment effect of the medicine in vagina, increases the medicine effect, and has excellent antibacterial effect. Comparative example 1 is different from example 1 in that the amount of raw materials is different, and unsuitable raw material amounts cause a decrease in the bacteriostatic rate of gynecological gel. Comparative example 2 is different from example 1 in that the poly N-isopropyl acrylamide is absent, because the poly N-isopropyl acrylamide is used as a thermosensitive material to encapsulate antibacterial ingredients to prepare microcapsules, stability can be improved, active ingredients are protected, degradation is avoided, slow release is realized, long-acting effect is realized, low-dose medicine is realized to treat gynecological inflammation efficiently, the poly N-isopropyl acrylamide can realize release of active ingredients under body temperature stimulation, local treatment effect of medicine in vagina is improved, release of medicine in proper time and position is ensured, drug effect is increased, side effect is reduced, and antibacterial effect is reduced due to the fact that comparative example 2 lacks poly N-isopropyl acrylamide. The comparison example 3 is different from the example 1 in that the composite gel matrix is composed of trehalose gel, bentonite and hydroxyethyl cellulose in a mass ratio of 1:1:2, and the antibacterial effect is obviously reduced, and a large number of experiments show that if the composite gel matrix is not composed of trehalose gel, bentonite and hydroxyethyl cellulose in a mass ratio of 1:1:2, a certain matrix is replaced or a certain matrix is lacking, the antibacterial effect is reduced to different degrees. Comparative example 4 is different from example 1 in that the herbal extracts are prepared from 5 parts of snow lotus herb, 4 parts of stemona root, 4 parts of kuh-seng, 6 parts of cnidium fruit, 2 parts of phellodendron bark, 1 part of safflower, 4 parts of Chinese gall and 4 parts of motherwort, the antibacterial effect of which is obviously reduced, and the herbal extracts of snow lotus herb, stemona root, kuh-seng, cnidium fruit, phellodendron bark, safflower, chinese gall and motherwort of the present invention regulate inflammatory reaction, promote tissue repair and regeneration, and facilitate recovery of normal physiological state, and a large number of experiments show that if the weight parts and composition of the herbal extracts of the present invention (lack of a certain herbal extract or replace a certain herbal extract) are reduced to different extents. Comparative example 5 differs from example 1 in that the absence of o-cymene-5-ol, dipropylene glycol and dichlorobenzyl alcohol results in a decrease in the bacteriostatic effect of the gynecological gel, and experimental data indicate that the bacteriostatic effect of the gynecological gel is decreased to a different extent in the absence of or in place of a component of o-cymene-5-ol, dipropylene glycol and dichlorobenzyl alcohol.
Clinical study
In 40 cases of patients with colpitis mycotica with clinical symptoms and clear examination, 20 patients (test group) are washed with warm boiled water every night, and the antibacterial gynecological gel in example 1 is applied to the outside and the depth of vagina. The results of the first review, and the second review after one month, were performed on 20 additional patients (control group) using a commercial baofukang gel (purchased from taihe county Hui Tang healthcare limited) continuously using one course of treatment (7 days) are shown in table 2.
The patient in turn evaluates the irritation and comfort of use. The testers score according to own feeling, and the scoring standard adopts 5 scores, wherein the irritation is calculated by the best score of 0 and the worst score of 5; comfort was calculated at 0 score worst, 5 score best, and finally the sensory effect scores of each group were recorded as average values, with the results shown in table 3.
TABLE 2
Sample of Effectiveness/example Invalidation/instance Effective rate of Recurrence rate
Example 1 19 1 95% 15.8%
Commercial products 16 4 80% 68.8%
TABLE 3 Table 3
Sample of Irritation (irritation) Comfort level
Example 1 1 5
Commercial products 3 3
As can be seen from tables 2 and 3, the gynecological gel of the invention has good biocompatibility, does not cause allergy or irritation reaction, can effectively treat gynecological inflammation, and compared with a control group, the gynecological gel has no drug dependence, obviously reduces recurrence rate after curing for one month, can relieve discomfort, obviously reduces irritation, and improves use experience of gynecological inflammation patients.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, alternatives, and improvements that fall within the spirit and scope of the invention.

Claims (6)

1. The high-efficiency antibacterial gynecological gel is characterized by comprising, by weight, 40-60 parts of a composite gel matrix, 8-12 parts of poly-N-isopropyl acrylamide, 20-25 parts of a Chinese herbal medicine extract, 5-7 parts of o-cymene-5-ol, 8-10 parts of dipropylene glycol and 3-5 parts of dichlorobenzyl alcohol;
the composite gel matrix consists of trehalose gel, bentonite and hydroxyethyl cellulose in a mass ratio of 1.5-2.5:1:3-5;
the Chinese herbal medicine extract is prepared from 6-8 parts by weight of snow lotus herb, 5-7 parts by weight of radix stemonae, 5-7 parts by weight of radix sophorae flavescentis, 3-5 parts by weight of fructus cnidii, 3-5 parts by weight of phellodendron, 2-4 parts by weight of safflower, 1-3 parts by weight of gallnut and 1-3 parts by weight of motherwort.
2. A high-efficiency bacteriostatic gynecological gel according to claim 1, which comprises, by weight, 50 parts of a composite gel matrix, 10 parts of poly-N-isopropyl acrylamide, 23 parts of a herbal extract, 6 parts of cymene-5-ol, 9 parts of dipropylene glycol, and 4 parts of dichlorobenzyl alcohol.
3. A highly effective bacteriostatic gynecological gel according to claim 1, wherein said trehalose gum is prepared by the steps of: crushing and sieving the cleaned and dried kelp, adding a compound biological enzyme consisting of cellulose and pectase in a mass ratio of 1:2-3, reacting to obtain an enzymolysis liquid, inoculating lactobacillus in a volume ratio of 5% -8% of the enzymolysis liquid for mixed fermentation, centrifuging the fermentation liquid, collecting supernatant, precipitating with 60% v/v ethanol, and drying the precipitate to obtain the trehalose gel.
4. The efficient bacteriostatic gynecological gel according to claim 1, wherein the preparation process of the herbal extract comprises the following steps: pulverizing herba Saussureae Involueratae, radix Stemonae, radix Sophorae Flavescentis, fructus Cnidii, cortex Phellodendri, carthami flos, galla chinensis and herba Leonuri, mixing, soaking in 80-90% v/v ethanol solution of 6-8 times weight for 1-3 hr, extracting the soaked Chinese herbal medicines with microwave for 2 times at 50-60deg.C for 10-20 min each time, filtering, concentrating the extractive solution under reduced pressure, drying, and pulverizing into granule.
5. A highly effective bacteriostatic gynecological gel according to claim 1, further comprising 0.5-1.5 parts of water-soluble vitamin E and 1-3 parts of beta-glucan.
6. The method for preparing the efficient antibacterial gynecological gel as claimed in claims 1-5, which is characterized by comprising the following steps:
s1, dissolving poly-N-isopropyl acrylamide in water, then adding Chinese herbal medicine extract particles, o-cymene-5-alcohol, dipropylene glycol and dichlorobenzyl alcohol, carrying out ultrasonic treatment at 25-35 ℃ for 40-50 minutes for coating, and evaporating a solvent to obtain microcapsules;
S2, uniformly dispersing the composite gel matrix in water, soaking for 12-20 hours to obtain a swelling solution, uniformly stirring, adding the microcapsules in the S1, performing ultrasonic dispersion for 30-40 minutes, and uniformly stirring;
s3, continuously adding the water-soluble vitamin E and the beta-glucan, and continuously stirring to obtain the target gynecological gel.
CN202410292121.1A 2024-03-14 2024-03-14 Efficient antibacterial gynecological gel and preparation method thereof Pending CN118121537A (en)

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