CN102688182A - Vagina pH buffer antibacterial gel and preparation method thereof - Google Patents
Vagina pH buffer antibacterial gel and preparation method thereof Download PDFInfo
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- CN102688182A CN102688182A CN2012101807841A CN201210180784A CN102688182A CN 102688182 A CN102688182 A CN 102688182A CN 2012101807841 A CN2012101807841 A CN 2012101807841A CN 201210180784 A CN201210180784 A CN 201210180784A CN 102688182 A CN102688182 A CN 102688182A
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Abstract
The invention provides vagina pH buffer antibacterial gel, a preparation method thereof, and a using method thereof. The gel mainly comprises the components of polycarbophil, carbomer, ethylenediamine tetraacetic acid disodium, chitosan, glycerol, triethanolamine, methyl parahydroxybenzoats and deionized water. By using the weak acidity of polycarbophil and the antibacterial performance of chitosan, the gel can eliminate the source of recurrence of vagina inflammatory diseases and recovers the self-cleaning ability of the vagina. The gel is free from antigen performance, allergy and irritation, and convenient to use, and tissue reaction is avoided.
Description
Technical field
The present invention relates to a kind of vagina pH value buffering antibacterial gel and preparation method thereof.
Background technology
All vaginitiss all are by certain pathogen, cause such as infection such as trichomonal vaginitis, Candida albicans, streptococcus.But under normal situation, the vagina pH value is in 3.8-4.4, can suppress the breeding and the growth of these pathogens, promptly has self-purification function, even thereby infected above-mentioned these pathogens, can not cause inflammation yet.But in case vaginal environment is destroyed, pH value is unbalance, and these pathogens will be bred in a large number, cause inflammation.Thereby, the treatment vaginitis, must balance in environment, recover the pH value of vagina, fundamentally eliminate the living environment of pathogen.But present treatment is to rely on Drug therapy merely mostly, no matter is oral antibiotic; Still suppository class vaginal suppository class, or vaginal lotion class is if use separately; Can kill pathogenic bacterium, this treatment is " curing the symptoms, not the disease ", though inflammation has been alleviated; But in case discontinue medication, remaining pathogen will soon be bred in a large number, makes the inflammation recurrence.Partly patient is eased owing to vaginal symptoms after treating or eliminates, and disease is not thoroughly cured as yet, and when the pH value of vagina changed, vaginitis will recur once more.
Existingly be used to treat colpitic method or medicine, be easy to generate drug resistance and symptomatic treatment just.Fundamentally do not solve the root of vaginitis recurrence.The vaginitis easy relapse is largely gone on the market because the destruction of the unbalance and intravaginal environment of pH value.
Polycarbophil has more stable faintly acid and to the good adhesion of mucosa, processes gel preparation and be used for intravaginal, can make the intravaginal pH value be in normal level, makes the antibacterial that causes inflammation lose the environment of growth, effectively prevention of inflammation recurrence.Polycarbophil is applied to the clinical luxuriant and rich with fragrance gel of the fragrant plant that the grand production of Hainan emperor is arranged at present; Main component is Polycarbophil, only is used for cushioning and the balance vagina PH value; Do not add antimicrobial component; Still need cooperate with antibiotic and antifungal drug treatment, medicine is treated repeatedly and must be brought drug resistance and big side effect.
Summary of the invention
The present invention provides a kind of vagina pH value buffering antibacterial gel and preparation method thereof.
PH value buffering antibacterial gel of the present invention comprises following component, by weight percentage:
Said chitosan is a water-soluble chitosan.
Polycarbophil used in the present invention is produced by U.S. promise reputation company (Noveon.Inc), and its model is AA-1.
Utilize the anti-microbial property of Polycarbophil faintly acid and chitosan to solve the root of colpitis easy relapse, recover the vagina self-purification function.
Chitosan is a kind of natural bioactive material, the natural biological antibacterial, has no drug resistance, and it is worthy of note especially to contain amino (NH in the solution after the dissolving
2+), these are amino through combining negatron to suppress antibacterial.
Carbomer is produced by Nanjing WeiEr chemical engineering Co., Ltd, and its physico-chemical parameter satisfies the accurate word (2005) of Soviet Union's medicine No. 428401.
No. the 428401st, the accurate word (2005) of table 1 Soviet Union's medicine
The pH value of vagina pH value buffering antibacterial gel according to the invention is 3.8-4.4, has powerful pH buffer capacity, can help the intravaginal environment to recover the pH balance rapidly.The present invention has acid prescription, helps promoting the vagina self purification, and the rejection condition pathogenic bacterium reduce diseased plant crowd's assembly.Vagina pH value buffering antibacterial gel of the present invention is a kind of high-moisture bioadhesive gel based on Polycarbophil, and is hydrophilic and water insoluble.But this gel tight adhesion forms the moistening film of one deck on the vaginal epithelial cell surface, for vaginal mucosa is replenished large quantity of moisture.Safeguard that vagina is natural moist, protection vaginal walls elasticity.The Polycarbophil that the present invention adopted can form hydrogen bond with the mucin of vagina epithelium tissue, produce stronger mucus gel networks, thereby tight adhesion is in the vaginal wall epithelial cell.The normal vaginal epithelial cell update cycle is 3 days, and when the vaginal epithelial cell apoptosis came off, this gel just can come off thereupon, useful effect 72 hours.Chitosan used in the present invention belongs to non-stripping property antibacterial, can not induce to produce the drug resistance bacterium, and pure natural biological product, degradable is nontoxic, non-stimulated, have no drug resistance.
The method for preparing of vagina pH value buffering antibacterial gel of the present invention comprises the steps:
(1) take by weighing Polycarbophil and carbomer by proportioning, add in the glycerol that takes by weighing by proportioning, dispersed with stirring to pasty state obtains the glycerol pasty liquid;
(2) take by weighing chitosan by proportioning, add in the deionized water, add disodiumedetate, methyl parahydroxybenzoate, stir and make each components dissolved, obtain chitosan solution;
(3) chitosan solution is added in the glycerol pasty liquid, stir, its pH is transferred to 3.8-4.4, obtain the gel of Polycarbophil and chitosan with triethanolamine solution;
(4) stop to stir discharging;
(5) fill;
(6) aseptic process.
PH value buffering antibacterial gel of the present invention has following advantage:
1. regulate the vagina pH value: make vagina recover normal PH.Environment in repairing.
2. no antigen: be the polysaccharide composition, no protein, no immunoreation;
3. do not have allergy, non-stimulated: Polycarbophil is safe to human body;
4. easy to use: sterile product cooperates vaginal administration device to use;
5. inorganization reaction.
The specific embodiment
Embodiment 1
Above-mentioned percent is percetage by weight.
Take by weighing Polycarbophil and carbomer by proportioning, add in the glycerol that takes by weighing by proportioning, dispersed with stirring to pasty state obtains the glycerol pasty liquid; Take by weighing carboxymethyl chitosan by proportioning, add in the deionized water, add disodiumedetate, stir and make the extremely clarification of each components dissolved, obtain the carboxymethyl chitosan sugar juice; The carboxymethyl chitosan sugar juice is added in the glycerol pasty liquid, stir, its pH is transferred to 3.8-4.4, get the gel of Polycarbophil and carboxymethyl chitosan with triethanolamine solution; Stop to stir discharging; Fill; Obtain pH value buffering antibacterial gel of the present invention after the aseptic process.
Embodiment 2
Take by weighing Polycarbophil and carbomer by proportioning, add in the glycerol that takes by weighing by proportioning, dispersed with stirring to pasty state obtains the glycerol pasty liquid; Take by weighing carboxymethyl chitosan by proportioning, add in the deionized water, add EDTA-2na, stir and make the extremely clarification of each components dissolved, obtain the carboxymethyl chitosan sugar juice; The carboxymethyl chitosan sugar juice is added in the glycerol pasty liquid, stir, its pH is transferred to 3.8-4.4, get the gel of Polycarbophil and carboxymethyl chitosan with triethanolamine solution; Stop to stir discharging; Fill; Obtain pH value buffering antibacterial gel of the present invention after the aseptic process.
Embodiment 3
Above-mentioned percent is percetage by weight.
Take by weighing Polycarbophil and carbomer by proportioning, add in the glycerol that takes by weighing by proportioning, dispersed with stirring to pasty state obtains the glycerol pasty liquid; Take by weighing chitosan by proportioning, add in the deionized water, add EDTA-2na, stir and make the extremely clarification of each components dissolved, obtain chitosan solution; Chitosan solution is added in the glycerol pasty liquid, stir, its pH is transferred to 3.8-4.4, get the gel of Polycarbophil and chitosan with triethanolamine solution; Stop to stir discharging; Fill; Obtain vagina PH value buffering antibacterial gel of the present invention after the aseptic process.Anti-(pressing down) bacterium rate detects
According to GB15979-2002 three embodiment of the present invention are resisted the test of (pressing down) bacterium; Three result of the tests are referring to table 2-4; Vagina pH value buffering antibacterial gel of the present invention effect 2 minutes, 5 minutes, 10 minutes, 20 minutes and staphylococcus aureus; Escherichia coli and Candida albicans, its killing rate is all greater than 50%, and product has antibacterial action.
Table 2 embodiment 1 bacteriostatic experiment result
Table 3 embodiment 2 bacteriostatic experiment results
Table 4 embodiment 3 bacteriostatic experiment results
Local irritation detects
Purpose: estimate pH value buffering antibacterial gel zest
Method: act on rabbit vagina with pH value buffering antibacterial gel (hereinafter to be referred as gel), observe its zest to the damaged vaginal mucosa of rabbit complete sum.
Test material: pH value buffering antibacterial gel sample (lot number 20110104), 3g/ prop up
Contrast: carbomer gel (not containing Polycarbophil and chitosan) (irritant test)
Experimental animal: 24 of white big ear rabbits.
Get 24 of healthy white rabbit, female, be divided into 4 groups of gel group, contrast complete vagina group and damaged vagina groups at random, 6 every group.Gel group and the complete vagina group of contrast are in the vagina 2cm place of each animal, with having slow respectively gel 1g, the carbomer gel 1g of injecting of the syringe of irritating the stomach syringe needle.Gel group and the damaged vagina group of contrast are inserted vagina 2cm with the circular file of the blunt circle of front end respectively in preceding 12 hours of administration, pass in and outs 5 times, rub and cause the vagina breakage, and degree of injury should be consistent.Afterwards more as stated above respectively at animal vagina injection testing gel and carbomer gel.Observed in per 30 minutes once, complementary testing gel and carbomer gel.Guarantee that contact 4 hours every day at least with vaginal mucosa.
Continuous 7 days.
Observe the animal pudendum after 7 days and have or not hyperemia, erythema, edema or secretions etc.
Put to death animal, win vagina, have or not irritative response symptoms such as hyperemia, erythema and edema with the clean back perusal of normal saline flushing mucosa.Carry out the zest evaluation.With 10% formalin fixed, dehydration, waxdip, embedding, section, HE dyeing, carry out pathological examination under the light microscopic afterwards.
The irritation test viewing duration, complete vagina group of gel and damaged vagina group diet, activity are all normal, the no phenomena of mortality.Smooth, the no edema of mucomembranous surface, petechia, ulcer or abnormal response.Damaged group has an animal a small amount of secretions, the reaction of vaginal mucosa irritation property to be arranged referring to table 5-7, and its average product score value was respectively 0 minute and 0.17 minute.Compare no significant difference with matched group.
Table 5 embodiment 1 vaginal mucosa irritation property result of the test
Table 6 embodiment 2 vaginal mucosa irritation property result of the tests
Table 7 embodiment 3 vaginal mucosa irritation property result of the tests
Annotate: 0 no erythema, edema, secretions
1 very slight erythema, edema (almost can not discover), secretions
2 slight erythema, edema (exposed region is apparently higher than the neighboring area), slight secretions
3 poison to severe erythema, edema (protruding about 1mm), moderate secretions
The serious erythema of 4-6, edema (protrusion is greater than 1mm), a large amount of secretions
Testing result: during the irritation test; Gel treated animal diet, activity are all normal, the no phenomena of mortality, and animal vaginal mucosa smooth surface is glossy; No edema, petechia, ulcer or paraplasm, reaction of vaginal mucosa irritation property and matched group comparing difference nonsignificance; The pathological examination result, the complete vagina group of gel, damaged vagina treated animal inner membrance are complete, and epithelium is high column, and no necrosis comes off and a large amount of inflammatory cells, and the minority animal inner membrance of damaged vagina group is the doll shape.There is limitation incomplete, above-mentioned two groups and corresponding matched group comparing difference nonsignificance.
Conclusion: gel is to the vaginal mucosa nonirritant.
Sensitization detects
Purpose: estimate pH value buffering antibacterial gel zest and anaphylaxis
Method: the Buehler method acts on the Cavia porcellus vagina, observes its anaphylaxis.
Experiment material: pH value buffering antibacterial gel embodiment 1 sample, 3g/ prop up; Embodiment 2 samples, 3g/ prop up; Embodiment 3 samples, 3g/ prop up.
Positive control (hypersensitive test) 2,4-dinitrochlorobenzene (chemical pure) Shanghai reagent one factory is mixed with 1% and 0.1% solution with acetone
Experimental animal: 80 of healthy guinea pigs, female, body weight 250～300g,
Test method: sensitization test (Buehler method);
Get 30 of Cavia porcelluss, female, after the laboratory nursing conformed in 3 days; Be divided into 3 groups at random; Respectively with having the syringe of irritating the stomach syringe needle, injected gel 1g, carbomer gel and positive group 1%2 for the Cavia porcellus vagina at the 0th, 7,14 day, 4-dinitrochlorobenzene 0.2ml gives once to induce; 1,24 hours, observes 3 groups of whole bodies and pudendum anaphylaxis situation.The 28th day, give experimental group booster dose 0.5g, repeat process of the test last time.In 24,48 h observation Cavia porcellus systemic anaphylaxis situation, put to death animal subsequently then, vertical face cuts vagina, behind normal saline flushing, observes the vaginal mucosa anaphylaxis.By the standards of grading scoring, calculate average anaphylaxis score value and sensitization rate (anaphylaxis number of animals/all animals number * 100%).
Sensitivity test is in observing time, and gel treated animal vagina does not have symptoms such as hyperemia, edema.The sensitization rate is 0%.Show that gel does not have sensitization to the Cavia porcellus vagina, does not see serious systemic anaphylaxis such as asthma, astasia or shock yet.
Result of the test is referring to table 8:
Table 8 local anaphylaxis result of the test
Annotate: sensitization rate 0-8% is no sensitization--a weak sensitization
9-28% is slight sensitization
29-64 is a moderate sensitization
65-80 is strong sensitization
81-100 is extremely strong sensitization
Testing result: during the sensitivity test, gel treated animal vagina does not have symptoms of allergic such as erythema or edema, and the sensitization rate is 0%, shows that gel does not have sensitization to the Cavia porcellus vagina, does not see serious systemic anaphylaxis such as asthma, astasia or shock yet.
Conclusion: gel does not have sensitization to vaginal mucosa.
Claims (2)
1. a vagina pH value buffering antibacterial gel is characterized in that comprising following component, by weight percentage:
Said chitosan is a water-soluble chitosan.
2. the method for preparing of the described vagina pH value buffering of claim 1 antibacterial gel is characterized in that comprising the steps:
(1) take by weighing Polycarbophil and carbomer by proportioning, add in the glycerol that takes by weighing by proportioning, dispersed with stirring to pasty state obtains the glycerol pasty liquid;
(2) take by weighing chitosan by proportioning, add deionized water, disodiumedetate, methyl parahydroxybenzoate, stir and make each components dissolved, obtain chitosan solution;
(3) chitosan solution is added in the glycerol pasty liquid, stir, its pH is transferred to 3.8-4.4, get the gel of Polycarbophil and chitosan with triethanolamine solution;
(4) stop to stir discharging;
(5) fill;
(6) aseptic process.
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| CN105362289A (en) * | 2015-10-24 | 2016-03-02 | 惠峪 | Vagina-retained boric acid preparation and preparation method thereof |
| CN105919926A (en) * | 2016-06-29 | 2016-09-07 | 江苏开源康达医疗器械有限公司 | Carbomer cervical gel and preparation method thereof |
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| CN106540046A (en) * | 2016-12-21 | 2017-03-29 | 甘起伍 | A kind of vagina antibiosis pharmaceutical gel |
| CN109793706A (en) * | 2019-03-20 | 2019-05-24 | 吉林省盛赛医药实业有限公司 | A kind of gynecological gel and preparation method thereof with carboxyl double ion biology crosslinking technological |
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| CN103908479A (en) * | 2014-04-29 | 2014-07-09 | 安徽徽科生物工程技术有限公司 | Medical hydrogel for treating gynecological diseases or skin diseases and application of medical hydrogel |
| CN103908479B (en) * | 2014-04-29 | 2017-06-06 | 安徽徽科生物工程技术有限公司 | For treating gynecological disease or dermopathic medical aquogel and its application |
| CN105362289B (en) * | 2015-10-24 | 2018-08-31 | 惠峪 | A kind of vaginal retention borate compounds and preparation method thereof |
| CN105362289A (en) * | 2015-10-24 | 2016-03-02 | 惠峪 | Vagina-retained boric acid preparation and preparation method thereof |
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| CN105919926B (en) * | 2016-06-29 | 2019-11-05 | 江苏开源康达医疗器械有限公司 | A kind of Carbomer cervical gel and preparation method thereof |
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| CN106540046A (en) * | 2016-12-21 | 2017-03-29 | 甘起伍 | A kind of vagina antibiosis pharmaceutical gel |
| CN109793706A (en) * | 2019-03-20 | 2019-05-24 | 吉林省盛赛医药实业有限公司 | A kind of gynecological gel and preparation method thereof with carboxyl double ion biology crosslinking technological |
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| WO2021036294A1 (en) * | 2019-08-28 | 2021-03-04 | 南京天朗制药有限公司 | Vaginal acid-base buffer gel and preparation method |
| CN110575431B (en) * | 2019-08-28 | 2021-08-03 | 南京天朗制药有限公司 | Vaginal acid-base buffer gel and preparation method thereof |
| CN112933109A (en) * | 2021-02-03 | 2021-06-11 | 湖南奥朗特医疗器械有限公司 | Vagina pH regulator and preparation method and application thereof |
| CN114230808A (en) * | 2021-12-20 | 2022-03-25 | 中国科学院重庆绿色智能技术研究院 | Preparation method of antibacterial gel with amino polyethylene glycol as gel matrix |
| CN114230808B (en) * | 2021-12-20 | 2024-04-16 | 中国科学院重庆绿色智能技术研究院 | Preparation method of antibacterial gel with amino polyethylene glycol as gel matrix |
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