CN108158995A - A kind of gynaecology's anti-bacteria foaming agent containing chitosan and preparation method thereof - Google Patents
A kind of gynaecology's anti-bacteria foaming agent containing chitosan and preparation method thereof Download PDFInfo
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
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Abstract
The present invention relates to a kind of gynaecology's anti-bacteria foaming agents containing chitosan and preparation method thereof, belong to field of medicaments.The gynaecology for containing chitosan is made with anti-bacteria foaming agent by the raw material of following weight parts：0.5 2 parts of chitosan quaternary ammonium salt, 15 parts of chitosan, 0.5 2 parts of Sodium Hyaluronate, 1,3 0.5 1 parts of butanediol, 0.01 1 parts of oat beta glucan, natural 0.2 2 parts of lactic acid, 25 parts of glycerine, 0.04 1 parts of foaming agent, 75 105 parts of purified water.Between each component in terms of anti-vaginitis pathogenic bacteria there is significant synergistic effect, there is good antimicrobial effect.Its irritation for vagina is small, the reparation for the treatment of and the vagina mucosa surface of a wound suitable for gynaecological imflammations such as vaginitis, cervicitises.
Description
Technical field
The present invention relates to a kind of gynaecology's anti-bacteria foaming agents containing chitosan and preparation method thereof, belong to field of medicaments.
Background technology
Gynaecological imflammation is a kind of common disease and frequently-occurring disease, is due to outer damage or sense including vaginitis, cervicitis etc.
Dye, the inflammation that pathogen bacteria is caused to be invaded and is formed.Gynaecological imflammation perplexs a kind of common disease of vast female patient.For
The treatment of gynaecological imflammation class mainly by local administration, is removed or is killed pathogen, restore normal microenvironment, repairs impaired
Tissue, so as to reach curative effect.Vagina mucosa administration has the history of last 100 years, and there are many excellent compared with traditional oral medicine
Point is effective sustained drug release system, not only can with local application, can also systemic medication, drug glued by vagina
Film local administration can improve local drug concentration, give full play to curative effect of medication, avoid general action；Drug is glued by vagina
The absorption of film plays general action, can improve bioavilability to avoid the first pass effect of hepar of drug, reduce toxic side effect,
Avoid the gastrointestinal reaction of some drugs.
Gynaecology is commonly used in the treatment of various gynecology colpitis, cervicitis with foaming agent, and foaming agent can make drug in vagina
It is inside uniformly distributed, comes into full contact with, absorb rapidly, good effect, antibacterial anti-inflammatory effect is good, and dosage with vagina mucosa wrinkle wall
It is small, it is possible to reduce side effect.At present, Chinese patent application CN106727319A discloses a kind of gynaecology's foaming agent and its preparation side
Method, gynaecology's foaming agent be prepared by chitosan or chitosan derivatives, acetic acid, glycerine, more alveolitoid surfactants and water and
Into；CN101380447A discloses a kind of for treating chitose foaming agent of gynecological disease and preparation method thereof, which gathers
Sugarwhips agent is by chitosan, mannan-oligosaccharides, benzalkonium chloride, aloe, oil of zedoary turmeric, triclosan, polyethylene glycol 400,12
Made of sodium alkyl sulfate, tween, triethanolamine, the third butane and purified water；CN100396290C discloses gynecological external use antibacterial
Foaming agent, the foaming agent are by Nano silver solution, lauryl sodium sulfate, glycerine, tween, sapn, polyvinylpyrrolidone, thin
What lotus brain, propellant and purified water were prepared.
The prior art is defective, such as has used the propellants such as the third butane, and propellant can generate vagina mucosa certain
Irritation；It is added to benzalkonium chloride, nano silver etc. and not only stimulates skin, injure private parts but also there are security risks to body
Antimicrobial component.Effect of the various disinfectants of the prior art in terms for the treatment of and prevention is also preferable not to the utmost, and therefore, having must
Research and develop a kind of gynaecology's anti-bacteria foaming agent of safety and environmental protection.
Invention content
In view of the deficiencies of the prior art, the present invention provides a kind of gynaecology's anti-bacteria foaming agent containing chitosan, the antibacterial
Foaming agent can make drug be evenly distributed in vaginal wall, kill bacterium rapidly, and safe ready is administered.Contain in the anti-bacteria foaming agent
There are many drug component as its active constituent, there is significant collaboration in terms of anti-vaginitis pathogenic bacteria wherein between each component
Effect, has the function of good antimicrobial effect.Its irritation for vagina is small, suitable for gynaecological imflammations such as vaginitis, cervicitises
Treatment.
The purpose of the present invention is achieved through the following technical solutions：
A kind of gynaecology's anti-bacteria foaming agent containing chitosan, the gynaecology containing chitosan with anti-bacteria foaming agent by
The raw material of following weight parts is made：0.5-2 parts of chitosan quaternary ammonium salt, 1-5 parts of chitosan, 0.5-2 parts of Sodium Hyaluronate, 1,3- fourth
0.5-1 parts of glycol, 0.01-1 parts of avenabeta glucosan, natural lactic acid 0.2-2 parts, 2-5 parts of glycerine, 0.04-1 parts of foaming agent is pure
Change 75-105 parts of water.
The deacetylation of the chitosan or chitosan quaternary ammonium salt is 90-98%；Point of chitosan or chitosan quaternary ammonium salt
Son amount range is 5000~250,000.
The molecular weight ranges of the avenabeta glucosan are 20,000~150,000.The foaming agent is alkyl phenol polyoxyethylene ether.
The foaming agent has good permeability, is conducive to the cell wall that chitosan and its derivative penetrates bacterium, so as to sterilizing
To synergistic effect.
Preferably, the gynaecology containing chitosan is made with anti-bacteria foaming agent by the raw material of following weight parts：Shell gathers
Sugared quaternary ammonium salt 1-1.5 parts, 2-4 parts of chitosan, 1-1.5 parts of Sodium Hyaluronate, 0.7-0.9 parts of 1,3-BDO, oat β-Portugal gathers
It is 0.09-0.5 parts sugared, natural lactic acid 0.8-1.5 parts, 2.5-4 parts of glycerine, 0.1-0.7 parts of foaming agent, 85-95 parts of purified water.
It is highly preferred that the gynaecology containing chitosan is made with anti-bacteria foaming agent by the raw material of following weight parts：Shell
1.2 parts of glycan quaternary ammonium salt, 3 parts of chitosan, 1.2 parts of Sodium Hyaluronate, 0.8 part of 1,3-BDO, 0.3 part of avenabeta glucosan,
Natural 1.1 parts of lactic acid, 3 parts of glycerine, 0.4 part of foaming agent, 90 parts of purified water.
The gynaecology containing chitosan is used for anti-bacteria foaming agent in the present invention：Treat vulvitis, vaginitis, cervicitis, palace
Neck is rotten to the corn, repairs cervical mucosa, vagina mucosa.
The effect of each raw material that the present invention uses is as follows：
Chitosan is inhibited to the growth of various bacteria, shows the feature of similar antibiotic.Chitosan is to table
The experimental strains such as skin staphylococcus, staphylococcus aureus, Escherichia coli, pseudomonas aeruginosa, Candida albicans have
There are inhibiting effect or even the Candida albicans for being difficult to inhibit to general antibiotic also to have inhibiting effect.Macromolecular chitosan passes through
The interaction of the positive charge of the institute's band of itself and the negative electrical charge entrained by microbial cell film destroys the original knot of bacteria cell wall
Structure causes the leakage of cell component and plays antibacterial action.And the chitosan of small molecule, it is intracellular with the moon by penetrating into
The large biological molecule of ion occurs similar to " flocculation " effect, to upset the normal physiological function of cell, the biosynthesis of blocking dna,
Breeding and growth so as to inhibit bacteria.As main disinfection component, it is proportionally added into mixture, it is therefore an objective to pass through it
Characteristic assists polyhexamethylene guanide, the residual bacterial do not killed completely is made to lose vitality, so as to reach enhancing sterilization effect.
The healing of the surface of a wound or wound is very important for patient, and wound mainly includes platelet aggregation, blood coagulates
Gu, fibrin formation, inflammatory reaction generation, matrix variation, cell Proliferation and regeneration, repair of damaged tissues and remodeling waited
Journey.Chitosan can promote the regeneration of epithelial cell, be proliferated to promote wound healing by mediated cell, pass through mild acute inflammation
Property reaction a large amount of polymorphonuclear cell and macrophage is attracted to remove fragment of tissue and blood clot.Chitosan can promote fiber finer
The migration of born of the same parents has stroma cell chemotactic, migration, activation, and accelerates cell Proliferation and tissue remodeling process, promotes skin
Tissue repair.The catabolite N-acetyl-glucosamine (NAG) of chitosan repairs the scar of tissue extremely important.Make as vagina
Externally used antimicrobial agent and surface of a wound care agent, although chitosan have in terms of the wound repair (such as in wound repair and nursing) compared with
Good effect, but in terms of antibiotic property, apparent deficiency, especially this form of washing lotion, are rinsed especially in terms of pathogenic bacteria are killed
Vagina when, active ingredient in washing lotion intravaginal retention time is short, effective concentration is low, a kind of ingredient of chitosan alone,
For in the serious and treatment of intractable gynecological disease, antibacterial action Shortcomings.
The water solubility of chitosan quaternary ammonium salt is got well than chitin and chitosan, can preferably play the work(of chitosan
Effect.Chitosan quaternary ammonium salt not only has the property of typical quaternary ammonium salt, such as bacteria resistance and moisture absorbability and moisture retentivity, and maintains
The performances such as the original good film forming of chitosan, flocculability, biocompatibility and biodegradation, are preferably utilized chitosan
Biological activity；Chitosan quaternary ammonium salt has pathogenic microorganism very strong thermophilic film property, adsorbs, merges with membranous structure, changes it
Permeability causes its content to leak and causes its death；Have broad-spectrum antiseptic, antiviral activity, pathogenic microorganism is not easy to produce it
Raw drug resistance.
Sodium Hyaluronate is the sodium-salt form of hyaluronic acid, and hyaluronic acid is a kind of acid mucopolysaccharide, is that tissue is consolidated
A kind of ingredient having, unique molecular structure and physicochemical property show a variety of important physiological functions in body, such as moisten
Sliding joint adjusts the permeability of vascular wall, regulatory protein matter, Water-Electrolyte diffusion and operating, promotes wound healing etc..It is particularly heavy
It wants, hyaluronic acid has special water retention, is the substance that moisture retention is best in presently found nature, is referred to as
Ideal natural moisturizing factor (Natural moisturizing factor, NMF), such as：2% pure hyaluronic acid is water-soluble
Liquid energy firmly holds 98% moisture, and special water retention can significantly improve the dry and astringent disease of woman vagina, and married woman is because of the moon
Road secretion substantially reduces and easily becomes the gynecologic miscellaneous diseases such as vaginal dryness.Hyaluronic acid is a kind of multi-functional matrix, transparent
Matter acid (sodium hyaluronate) HA is distributed widely in partes corporis humani position.Its medial vagina also contains a large amount of hyaluronic acid with cervical skin,
Changing in ripe and ageing process also with the content of hyaluronic acid and metabolism, it can improve skin-nourishing metabolism,
Make skin it is tender, it is smooth, increase elasticity, prevent aging.It is good skin penetration enhancer again while moisturizing.
Avenabeta glucosan is a kind of smaller short chain glucan of relative molecular mass, the variation model of relative molecular mass
Enclose is 5300~257200.Beta glucan is different from most of moisturizer, soft skin agent, it is to act on cellular and molecular level
On, and the surface of skin is not acted on, it is really from the interior active matter for changing skin.Avenabeta glucosan its possess
Excellent senile-resistant efficacy can smooth fine wrinkles, improve skin elasticity, improve dermatoglyph degree；With unique straight chain
Molecular structure imparts good Transdermal absorption performance；Promote fibroblast synthesis collagen, promote wound healing, control
Bacterium infection processed, makes infection face restore as early as possible, repairs impaired skin.
It is a further object of the present invention to provide a kind of preparation method of gynaecology's anti-bacteria foaming agent containing chitosan, including
Following steps：
1) by the chitosan quaternary ammonium salt of formula ratio, avenabeta glucosan, Sodium Hyaluronate is added to a certain amount of purified water
In, it stirs to being completely dissolved, obtains mixed solution 1；
2) it by the chitosan of formula ratio and a certain amount of natural lactic acid, is added in the purified water of surplus, stirs to complete
Fully dissolved obtains mixed solution 2, then mixes solution 1 and solution 2, stirs evenly；
3) 1,3-BDO and glycerine of formula ratio are added in while stirring into the solution that step 2) prepares, is stirred evenly,
Then the natural lactic acid of surplus is added in, pH value is adjusted 4~6, stirs evenly；
4) foaming agent of formula ratio is eventually adding, is uniformly mixing to obtain foaming agent, i.e. gynaecology's anti-bacteria foaming agent.
The gynaecology of chitosan of the present invention has following technical advantage with anti-bacteria foaming agent：
(1) foaming agent of the present invention is in strong ionic, subacidity, and antibiotic property is strong, so as to cultivate beneficial bacterium, improve
Vaginal microenvironment effectively inhibits to be attached to the pathogenic bacteria of vaginal wall and cervical mucosa, restores vaginal pH, can be used as all kinds of vaginas
Inflammation, the treatment of cervicitis and the treatment of cervical erosion；And there is irritating solvent, surfactant and guarantor without other
The additives such as humectant, therefore there is no irritation to skin, it is safe.
(2) present invention is enhanced using avenabeta glucosan and Sodium Hyaluronate as moisturizer and skin penetration enhancer
The sterilizing ability of chitosan and its derivative, and play moisturizing and moist effect；In addition, oat beta-glucan can control
Bacterium infection promotes infection face to restore as early as possible, and Sodium Hyaluronate plays the role of repairing the surface of a wound；Therefore, the two is to vagina
The mucous membrane surface of a wound also has repair.(3) present invention is using chitosan, chitosan quaternary ammonium salt, avenabeta glucosan, Sodium Hyaluronate
Gynaecology's anti-bacteria foaming agent of chitosan is produced with foaming agent, each raw material complements each other, and plays the synergistic effect between raw material, makes
The bacteriostasis property of the present invention has reached most preferably, and with broad-spectrum antiseptic, anti-drug resistance；Meanwhile the invention avoids use spray
The irritation that agent generates vagina mucosa is penetrated, improves safety in utilization.
Specific embodiment
With reference to embodiment, the claim of the present invention is described in further detail, but do not formed pair
Any restrictions of the present invention.
Embodiment 1
A kind of gynaecology's anti-bacteria foaming agent containing chitosan, the gynaecology containing chitosan with anti-bacteria foaming agent by
The raw material of following weight parts is made：0.5 part of chitosan quaternary ammonium salt, 1 part of chitosan, 0.5 part of Sodium Hyaluronate, 1,3-BDO
0.5 part, 0.01 part of avenabeta glucosan, natural 0.2 part of lactic acid, 2 parts of glycerine, 0.04 part of foaming agent, 75 parts of purified water.
The deacetylation of the chitosan or chitosan quaternary ammonium salt is 90%；The molecular weight of chitosan or chitosan quaternary ammonium salt
It is 5000.The molecular weight of the avenabeta glucosan is 20,000.The foaming agent is alkyl phenol polyoxyethylene ether.
A kind of preparation method of gynaecology's anti-bacteria foaming agent containing chitosan, includes the following steps：
1) by the chitosan quaternary ammonium salt avenabeta glucosan of formula ratio, Sodium Hyaluronate is added to a certain amount of purified water
In, it stirs to being completely dissolved, obtains mixed solution 1；
2) it by the chitosan of formula ratio and a certain amount of natural lactic acid, is added in the purified water of surplus, stirs to complete
Fully dissolved obtains mixed solution 2, then mixes solution 1 and solution 2, stirs evenly；3) into the solution that step 2) prepares, side is stirred
1,3-BDO and glycerine that side adds in formula ratio are mixed, is stirred evenly, then adds in the natural lactic acid of surplus, pH value is adjusted and exists
4, it stirs evenly；
4) foaming agent of formula ratio is eventually adding, is uniformly mixing to obtain foaming agent, i.e. gynaecology's anti-bacteria foaming agent.
Embodiment 2
A kind of gynaecology's anti-bacteria foaming agent containing chitosan, the gynaecology containing chitosan with anti-bacteria foaming agent by
The raw material of following weight parts is made：2 parts of chitosan quaternary ammonium salt, 5 parts of chitosan, 2 parts of Sodium Hyaluronate, 01 part of 1,3-BDO,
1 part of avenabeta glucosan, natural 2 parts of lactic acid, 5 parts of glycerine, 1 part of foaming agent, 105 parts of purified water.
The deacetylation of the chitosan or chitosan quaternary ammonium salt is 98%；The molecular weight of chitosan or chitosan quaternary ammonium salt
It is 250,000.The molecular weight of the avenabeta glucosan is 150,000.The foaming agent is alkyl phenol polyoxyethylene ether.
A kind of preparation method of gynaecology's anti-bacteria foaming agent containing chitosan, includes the following steps：
1) by the chitosan quaternary ammonium salt of formula ratio, avenabeta glucosan, Sodium Hyaluronate is added to
In a certain amount of purified water, stir to being completely dissolved, obtain mixed solution 1；
2) it by the chitosan of formula ratio and a certain amount of natural lactic acid, is added in the purified water of surplus, stirs to complete
Fully dissolved obtains mixed solution 2, then mixes solution 1 and solution 2, stirs evenly；
3) 1,3-BDO and glycerine of formula ratio are added in while stirring into the solution that step 2) prepares, is stirred evenly,
Then the natural lactic acid of surplus is added in, pH value is adjusted 6, stirs evenly；
4) foaming agent of formula ratio is eventually adding, is uniformly mixing to obtain foaming agent, i.e. gynaecology's anti-bacteria foaming agent.
Embodiment 3
A kind of gynaecology's anti-bacteria foaming agent containing chitosan, the gynaecology containing chitosan with anti-bacteria foaming agent by
The raw material of following weight parts is made：1 part of chitosan quaternary ammonium salt, 2 parts of chitosan, 1 part of Sodium Hyaluronate, 0.7 part of 1,3-BDO,
0.09 part of avenabeta glucosan, natural 0.8 part of lactic acid, 2.5 parts of glycerine, 0.1 part of foaming agent, 85 parts of purified water.
The deacetylation of the chitosan or chitosan quaternary ammonium salt is 92%；The molecular weight of chitosan or chitosan quaternary ammonium salt
It is 150,000.The molecular weight of the avenabeta glucosan is 80,000.The foaming agent is alkyl phenol polyoxyethylene ether.
A kind of preparation method of gynaecology's anti-bacteria foaming agent containing chitosan, includes the following steps：
1) by the chitosan quaternary ammonium salt of formula ratio, avenabeta glucosan, Sodium Hyaluronate is added to
In a certain amount of purified water, stir to being completely dissolved, obtain mixed solution 1；
2) it by the chitosan of formula ratio and a certain amount of natural lactic acid, is added in the purified water of surplus, stirs to complete
Fully dissolved obtains mixed solution 2, then mixes solution 1 and solution 2, stirs evenly；
3) 1,3-BDO and glycerine of formula ratio are added in while stirring into the solution that step 2) prepares, is stirred evenly,
Then the natural lactic acid of surplus is added in, pH value is adjusted 4.5, stirs evenly；
4) foaming agent of formula ratio is eventually adding, is uniformly mixing to obtain foaming agent, i.e. gynaecology's anti-bacteria foaming agent.
Embodiment 4
A kind of gynaecology's anti-bacteria foaming agent containing chitosan, the gynaecology containing chitosan with anti-bacteria foaming agent by
The raw material of following weight parts is made：1.5 parts of chitosan quaternary ammonium salt, 4 parts of chitosan, 1.5 parts of Sodium Hyaluronate, 1,3-BDO
0.9 part, 0.5 part of avenabeta glucosan, natural 1.5 parts of lactic acid, 4 parts of glycerine, 0.7 part of foaming agent, 95 parts of purified water.
The deacetylation of wherein described chitosan or chitosan quaternary ammonium salt is 96%；Point of chitosan or chitosan quaternary ammonium salt
Son amount is 200,000.The molecular weight of the avenabeta glucosan is 120,000.The foaming agent is alkyl phenol polyoxyethylene ether.
The preparation method of gynaecology's anti-bacteria foaming agent containing chitosan, includes the following steps：
1) by the chitosan quaternary ammonium salt of formula ratio, avenabeta glucosan, Sodium Hyaluronate is added to
In a certain amount of purified water, stir to being completely dissolved, obtain mixed solution 1；
2) it by the chitosan of formula ratio and a certain amount of natural lactic acid, is added in the purified water of surplus, stirs to complete
Fully dissolved obtains mixed solution 2, then mixes solution 1 and solution 2, stirs evenly；
3) 1,3-BDO and glycerine of formula ratio are added in while stirring into the solution that step 2) prepares, is stirred evenly,
Then the natural lactic acid of surplus is added in, pH value is adjusted 5.5, stirs evenly；
34 are eventually adding the foaming agent of formula ratio, are uniformly mixing to obtain foaming agent, i.e. gynaecology's anti-bacteria foaming agent.
Embodiment 5
A kind of gynaecology's anti-bacteria foaming agent containing chitosan, the gynaecology containing chitosan with anti-bacteria foaming agent by
The raw material of following weight parts is made：1.2 parts of chitosan quaternary ammonium salt, 3 parts of chitosan, 1.2 parts of Sodium Hyaluronate, 1,3-BDO
0.8 part, 0.3 part of avenabeta glucosan, natural 1.1 parts of lactic acid, 3 parts of glycerine, 0.4 part of foaming agent, 90 parts of purified water.
The deacetylation of wherein described chitosan or chitosan quaternary ammonium salt is 96%；Point of chitosan or chitosan quaternary ammonium salt
Son amount is 180,000.The molecular weight of the avenabeta glucosan is 100,000.The foaming agent is alkyl phenol polyoxyethylene ether.
The preparation method of above-mentioned gynaecology's anti-bacteria foaming agent containing chitosan, includes the following steps：
1) by the chitosan quaternary ammonium salt of formula ratio, avenabeta glucosan, Sodium Hyaluronate is added to a certain amount of purified water
In, it stirs to being completely dissolved, obtains mixed solution 1；
2) it by the chitosan of formula ratio and a certain amount of natural lactic acid, is added in the purified water of surplus, stirs to complete
Fully dissolved obtains mixed solution 2, then mixes solution 1 and solution 2, stirs evenly；
3) 1,3-BDO and glycerine of formula ratio are added in while stirring into the solution that step 2) prepares, is stirred evenly,
Then the natural lactic acid of surplus is added in, pH value is adjusted 5.0, stirs evenly；
4) foaming agent of formula ratio is eventually adding, is uniformly mixing to obtain foaming agent, i.e. gynaecology's anti-bacteria foaming agent.
Comparative example 1
According to the anti-bacteria foaming agent that embodiment 5 is prepared, difference lies in do not contain avenabeta glucosan wherein.
Comparative example 2
According to the anti-bacteria foaming agent that embodiment 5 is prepared, difference lies in do not contain chitosan wherein.
Comparative example 3
The anti-bacteria foaming agent being prepared according to preparation process described in embodiment 1 in patent CN100396290C.
The bacteriostatic experiment of the anti-bacteria foaming agent of the invention containing chitosan of embodiment 6
It reports in the prior art, the pathogenic bacteria for causing the gynecological diseases such as vaginitis, cervical erosion are Candida albicans, large intestine
Bacillus, Gardnerella, gonococcus (take vagina in the sufferer that Gardnerella and gonococcus are made a definite diagnosis by certain gynaecologic hospital with sterile cotton
Secretion).This experiment is with above-mentioned four kinds of pathogenic bacteria, the antimicrobial spume of testing example 1-6 and the antibacterial of comparative example 1-3
The fungistatic effect of foam.
Fungistatic effect is calculated with broth dilution method, the quality with MIC (minimal inhibitory concentration) for criterion fungistatic effect,
And using single chitosan quaternary ammonium saline solution as reference substance.
Bacteriostasis rate (%)=(positive control value-test value)/(positive control value-negative control value) × 100%
1 bacteriostatic test result of table
As can be seen from Table 1, the gynaecology containing chitosan described in 1-6 of the embodiment of the present invention with antimicrobial spume be respectively provided with compared with
Good fungistatic effect, in embodiment 1- embodiments 5, the fungistatic effect of embodiment 5 is preferable, that is, works as chitosan quaternary ammonium salt, chitosan,
When the weight ratio of avenabeta glucosan three is 1: 2.5: 0.25, anti-microbial property is most strong.It is of the present invention to contain chitosan
Gynaecology be above comparative example 3 with antimicrobial spume, with existing antimicrobial spume antibacterial aspect have significant advantage.
7 vagina multiple dosing irritation test of embodiment
Healthy female Japan large ear rabbit 28 is taken, be randomly divided into 7 groups, every group 4 and is marked, respectively blank control
Group, positive controls, 5 groups of 1 group-embodiment of embodiment.4 hours fasting for solids and liquids before and after the administration of each group rabbit, rabbit is lain on the back solid
Due on operating table, perineum and introitus are exposed, vagina is expanded with asoscope.Positive control medicine is given with vaginal administration device
(gynecological chitosan gel, Nanchang Hua Kang medical science and technologies Co., Ltd) 0.5g, embodiment 7-12 groups are respectively to 0.5g, blank control
Group gives 0.5g distilled water, one time a day, unclamps rabbit and puts back to rabbit-hutch within 15 minutes after administration.Successive administration 14 days, administration 24 is small every time
When after observe the variations of rabbit systemic conditions, (such as blood glues for vagina position, clinical manifestation (such as pain symptom) and vaginal fluid
Liquid) etc., animal dead situation after administration；Then rabbit is put to death with aeroembolism method (in administration 15 days), observes postmortem situation, taken out cloudy
Phenomena such as road, uterus, ovary tissue, warm water cleaning drug cut off tiling, and observation whether there is hyperemia, oedema, parallel Histopathology
It checks.Experimental result is shown in Table 2.
2 rabbit multiple dosing Vaginal irritation effects of table are tested
Claims (8)
1. a kind of gynaecology's anti-bacteria foaming agent containing chitosan, which is characterized in that it is made by the raw material of following weight parts：
0.5-2 parts of chitosan quaternary ammonium salt, 1-5 parts of chitosan, 0.5-2 parts of Sodium Hyaluronate, 0.5-1 parts of 1,3-BDO, oat β-Portugal
0.01-1 parts of glycan, natural lactic acid 0.2-2 parts, 2-5 parts of glycerine, 0.04-1 parts of foaming agent, 75-105 parts of purified water.
2. gynaecology's anti-bacteria foaming agent according to claim 1, which is characterized in that it is by the raw material system of following weight parts
：1-1.5 parts of chitosan quaternary ammonium salt, 2-4 parts of chitosan, 1-1.5 parts of Sodium Hyaluronate, 0.7-0.9 parts of 1,3-BDO, oat
0.09-0.5 parts of beta glucan, natural lactic acid 0.8-1.5 parts, 2.5-4 parts of glycerine, 0.1-0.7 parts of foaming agent, purified water 85-95
Part.
3. gynaecology's anti-bacteria foaming agent according to claim 1, which is characterized in that it is by the raw material system of following weight parts
：1.2 parts of chitosan quaternary ammonium salt, 3 parts of chitosan, 1.2 parts of Sodium Hyaluronate, 0.8 part of 1,3-BDO, avenabeta glucosan
0.3 part, natural 1.1 parts of lactic acid, 3 parts of glycerine, 0.4 part of foaming agent, 90 parts of purified water.
4. according to claim 1-3 any one of them gynaecology anti-bacteria foaming agent, which is characterized in that the chitosan or shell gather
The deacetylation of sugared quaternary ammonium salt is 90-98%, and the molecular weight ranges of the chitosan or chitosan quaternary ammonium salt are 5000~250,000.
5. according to claim 1-3 any one of them gynaecology anti-bacteria foaming agent, which is characterized in that the avenabeta glucosan
Molecular weight ranges 20,000~150,000.
6. according to claim 1-3 any one of them gynaecology anti-bacteria foaming agent, which is characterized in that the foaming agent is alkyl
Phenol polyethenoxy ether.
7. a kind of preparation method according to claim 1-3 any one of them gynaecology anti-bacteria foaming agent, it is characterized in that including
Following steps：
1) by the chitosan quaternary ammonium salt of formula ratio, avenabeta glucosan, Sodium Hyaluronate is added in a certain amount of purified water,
Stirring obtains mixed solution 1 to being completely dissolved；
2) it by the chitosan of formula ratio and a certain amount of natural lactic acid, is added in the purified water of surplus, stirs to completely molten
Solution, obtains mixed solution 2, then mixes solution 1 and solution 2, stir evenly；
3) 1,3-BDO and glycerine of formula ratio are added in while stirring into the solution that step 2) prepares, is stirred evenly, then
The natural lactic acid of surplus is added in, pH value is adjusted 4~6, stirs evenly；
4) foaming agent of formula ratio is eventually adding, is uniformly mixing to obtain foaming agent, i.e. gynaecology's anti-bacteria foaming agent.
8. treatment vulvitis, vaginitis and uterine neck are being prepared according to claim 1-3 any one of them gynaecology antimicrobial spume
Purposes in the gynaecological imflammations drug such as inflammation.
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| CN109316444A (en) * | 2018-11-09 | 2019-02-12 | 南京道大药业有限公司 | A kind of antibacterial chitose foaming agent and preparation method thereof |
| CN113662998A (en) * | 2021-09-17 | 2021-11-19 | 中科卫康(广东)生物科技研究中心(有限合伙) | A pharmaceutical composition for treating vaginitis and gynecological inflammation, and its preparation method |
| CN113730433A (en) * | 2021-09-30 | 2021-12-03 | 湖南天根乐微君科技有限公司 | Gynecological gel and preparation method and application thereof |
| CN114452307A (en) * | 2020-11-10 | 2022-05-10 | 西安正浩生物制药有限公司 | Lactobacillus capsule with treatment and prevention effects on vaginitis and preparation method thereof |
| WO2022106536A1 (en) * | 2020-11-18 | 2022-05-27 | Lantmännen Oats AB | Anti-microbial skin-care composition comprising beta-glucan and natural oil |
| CN115152793A (en) * | 2022-07-25 | 2022-10-11 | 独春堂生物科技研究院(菏泽)有限公司 | Purifying agent for ICU ward purification and preparation method thereof |
| WO2022218487A1 (en) * | 2021-04-12 | 2022-10-20 | CIRQLE BIOMEDICAL CONTRACEPTION ApS | A vaginal contraceptive composition for reinforcement of the cervical mucus barrier properties |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109316444A (en) * | 2018-11-09 | 2019-02-12 | 南京道大药业有限公司 | A kind of antibacterial chitose foaming agent and preparation method thereof |
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| CN113662998A (en) * | 2021-09-17 | 2021-11-19 | 中科卫康(广东)生物科技研究中心(有限合伙) | A pharmaceutical composition for treating vaginitis and gynecological inflammation, and its preparation method |
| CN113730433A (en) * | 2021-09-30 | 2021-12-03 | 湖南天根乐微君科技有限公司 | Gynecological gel and preparation method and application thereof |
| CN115152793A (en) * | 2022-07-25 | 2022-10-11 | 独春堂生物科技研究院(菏泽)有限公司 | Purifying agent for ICU ward purification and preparation method thereof |
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Application publication date: 20180615 |