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CN103110572A - Gynecological antimicrobial gel recipe and preparation method thereof - Google Patents

Gynecological antimicrobial gel recipe and preparation method thereof Download PDF

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Publication number
CN103110572A
CN103110572A CN2012105563210A CN201210556321A CN103110572A CN 103110572 A CN103110572 A CN 103110572A CN 2012105563210 A CN2012105563210 A CN 2012105563210A CN 201210556321 A CN201210556321 A CN 201210556321A CN 103110572 A CN103110572 A CN 103110572A
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Prior art keywords
chitosan
iodine
gel
purified water
standby
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CN103110572B (en
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黄昌平
郑茂鑫
聂开品
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GUIZHOU YANGSHENG MEDICAL INSTRUMENT CO Ltd
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GUIZHOU YANGSHENG MEDICAL INSTRUMENT CO Ltd
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Abstract

The invention discloses a gynecological antimicrobial gel recipe and a preparation method thereof. A gel takes chitosan-iodine as a main active ingredient and comprises raw materials of chitosan-iodine, glacial acetic acid, polysorbate-20, glycerin, potassium iodate, chitosan, hydroxyethyl cellulose and purified water. The preparation method comprises the following steps of: (1) weighing according to the recipe for standby; (2) adding the glacial acetic acid, the polysorbate-20, the glycerin and part of the purified water into the chitosan-iodine to be fully and uniformly mixed, and completely dissolving for standby; (3) taking a small amount of purified water to dissolve the potassium iodate, adding the dissolved potassium iodate into standby materials to be mixed, and stirring uniformly; (4) adding the chitosan according to the raw material mass ratio, and stirring to dissolve the chitosan; and (5) adding the hydroxyethyl cellulose according to the raw material mass ratio, adding the residual purified water to 100% and slowly stirring to form the gel. The gel has the advantages of good stability, excellent sterilization effect and convenience in use; and the processed gel can be used for treating colpitis mycotica, mixed vaginitis and the like as well as chronic cervicitis.

Description

A kind of gynaecologic antibiotic gel formula and preparation method thereof
Technical field
The present invention relates to medical dressing, particularly contain the dressing of chitosan iodine, specifically, relate to gynaecologic antibiotic gel.
Background technology
Iodine is used for the body sterilization history of existing 150 years, but the dissolubility in water is very little due to iodine, only has 1.315 * 10 under 25 ℃ -3Mol/L, can not be made into aqueous formulation and use, at room temperature easily distillation, content are unstable, to the mucocutaneous shortcoming such as irritant, have limited its extensive use.At present, widely used povidone iodine class disinfectant is take organic polymer or surfactant as carrier mostly, by network structure or the micelle that forms between carrier molecule, with the conformational effect in electronics and space with iodine " constraint " in wherein, thereby change the free state of iodine in general Operand, make its stability and bactericidal action enhancing, zest and xanthochromia reduction.But original micelle power can be destroyed after dilution for the finished product of this class take surfactant as carrier, makes the stability decreases of active iodine, thereby affect its sterilization effect.At present, most widely used povidone iodine class disinfectant is the povidone iodine complex in China, is recorded in version " two ones of Chinese pharmacopoeia in 2010.But polyvidone is less to the dissolubility of iodine, and molecular weight large (can up to 70000), more difficult being biodegradable, and life-time service can produce harmful effect to environment.In addition, itself there is no bactericidal action polyvidone, just forms micelle as a kind of surface activity carrier, improves the stability of iodine molecule.
Chitosan (chitosan) is the unique positively charged side chain polysaccharide of occurring in nature, has antibioticly, and antitumor strengthens the functions such as immunity, has good biocompatibility, and nonirritant, has no side effect, due to 2-NH 2Existence, chitosan has certain bacteria resistance function, but bacteriostasis property is limited, and is subject to the impact of the conditions such as chitosan molecule amount, deacetylation.Chitosan is a kind of macromolecular compound of biological property excellence, and after absorption iodine, the heat stability of iodine improves greatly, and is the same with other povidone iodine, and shell iodine can discharge elemental iodine, thereby has strong sterilization.This finished product is nontoxic, good stability, nonirritant.Bibliographical information has been arranged the sterilization effect of chitosan iodine (" laboratory observation of chitosan iodine liquid bactericidal effect ", Hengyang Medical College's journal (medicine) 05 phase in 2000), its chitosan raw material used is water-soluble chitosan.
In Chinese patent database, relate to the patent application of chitosan making gynaecologic antibiotic gel preparation few, No. 201010563054.0 " a kind of gel preparation and preparation technologies thereof that are used for the treatment of the gynaecopathias such as cervical erosion ", No. 201110031716.4 " a kind of washing-free puerpera perineum medical-care gel and preparation method thereof ", No. 201210135254.5 " Chitosangynaecologicsuppository antibacterial gel and preparation method thereof " are only arranged, but there is no the patent application of making the gynaecologic antibiotic gel preparation of chitosan iodine.
Summary of the invention
The purpose of this invention is to provide a kind of good stability, the gynaecologic antibiotic gel formula that bactericidal effect is good makes it the health service into the mankind.
Another purpose of the present invention is to provide the preparation method of above-mentioned gynaecologic antibiotic gel, enables to realize clinical practical application.
The gynaecologic antibiotic gel that the inventor provides, take chitosan iodine as main active, its raw materials quality formula is as follows:
Chitosan iodine 0.2%~5%
Glacial acetic acid 0.1%~2.5%
Tween-20 0.6%~15%
Glycerol 0.5%~12.5%
Potassium iodate 0.005%~0.125%
Chitosan 0.3%~2.4%
Hydroxyethyl-cellulose 1.5%~6.5%
Purified water adds to 100%.
The raw material preferred mass formula of above-mentioned gynaecologic antibiotic gel is as follows:
Chitosan iodine 2%
Glacial acetic acid 0.5%
Tween-20 3%
Glycerol 2.5%
Potassium iodate 0.025%
Chitosan 0.5%
Hydroxyethyl-cellulose 2.25%
Purified water adds to 100%.
Above-mentioned chitosan iodine is that water-insoluble chitosan and iodine get through complexation reaction preparation.
Above-mentioned Polysorbate-2, glycerol, potassium iodate, hydroxy ethyl fiber, purified water all meet the requirement of the Pharmacopoeia of the People's Republic of China.
The preparation method of the gynaecologic antibiotic gel that the inventor provides comprises the following steps:
1. according to the weighing of raw materials quality formula, standby;
2. add glacial acetic acid, Tween-20, glycerol, partial purification water to stir in chitosan iodine, make dissolving fully, standby;
3. the purified water that takes a morsel dissolving potassium iodate, and join in standby material and mix, stir;
4. add chitosan according to the raw materials quality formula, stir and make the chitosan dissolving;
5. add hydroxyethyl-cellulose according to the raw materials quality formula, and add to 100% with remaining purified water, slowly stir and make into gel, and get final product.
The inventor points out: the chitosan iodine in gynaecologic antibiotic gel mainly plays effect antibiotic and the promotion wound healing, glacial acetic acid is used for regulating pH value, and play collaborative solubilizing effect, Tween-20 mainly plays solubilization, glycerol plays blending and moisture-keeping function, potassium iodate plays stabilizer function, and chitosan and hydroxyethyl-cellulose have been all the effects that increases viscosity, and purified water is diluent.Gynaecologic antibiotic gel has the high-efficiency broad spectrum bactericidal action, to gram positive bacterias such as staphylococcus aureus, staphylococcus epidermidis, beta hemolytic streptococcus, bacillus subtilises, to gram negative bacterias such as escherichia coli, Pseudomonas aeruginosa, Diplococcus gonorrhoeae, to funguses such as Candida albicans, acrothesium floccosum, trichophyton, to acid-fast bacillis such as mycobacterium tuberculosis, infusorian etc. all there is extremely strong killing action.
The gynaecologic antibiotic gel that the inventor provides has good biocompatibility, to the vaginal mucosa nonirritant, and has stronger adhesiveness, and after the injection vagina, the energy secure adhesion in vaginal wall, slowly discharges sterilization component; Wherein contained constituent of chitosan has repair to the vaginal mucosa of damage.
Gynaecologic antibiotic gel of the present invention has good stability, and the advantage that bactericidal effect is good, easy to use can be used for treating colpitis mycotica due to the cause pathogeny imcrobe infections such as antibacterial, mycete, infusorian, Combination vaginitis etc. and chronic cervicitis after processing.
The specific embodiment
Describe the specific embodiment of the present invention in detail by the following example
EXAMPLE lAccording to the weighing of following raw materials according quality formula: chitosan iodine 0.2g, glacial acetic acid 0.1g, Tween-20 0.6g, glycerol 0.5g, potassium iodate 0.005g, chitosan 0.8g, hydroxyethyl-cellulose 2.4g adds purified water to 100g.Add glacial acetic acid, Tween-20, glycerol, partial purification water to stir in chitosan iodine, make dissolving fully, standby; The purified water that takes a morsel afterwards dissolving potassium iodate, and join in standby material and mix, stir; Add again the recipe quantity chitosan, stir and make the chitosan dissolving; Add at last the recipe quantity hydroxyethyl-cellulose, add remaining purified water to 100g, slowly stir and make into gel, namely get the gynaecologic antibiotic gel finished product.
Embodiment 2According to the weighing of following raw materials according quality formula: chitosan iodine 2g, glacial acetic acid 0.5 g, Tween-20 3g, glycerol 2.5g, potassium iodate 0.025g, chitosan 0.5g, hydroxyethyl-cellulose 2.25g adds purified water to 100g.Method for making obtains the gynaecologic antibiotic gel finished product with embodiment 1.
Embodiment 3According to the weighing of following raw materials according quality formula: chitosan iodine 5g, glacial acetic acid 2.5 g, Tween-20 15g, glycerol 12.5g, potassium iodate 0.125g, chitosan 2.4g, hydroxyethyl-cellulose 6.5g, purified water adds to 100g.Method for making obtains the gynaecologic antibiotic gel finished product with embodiment 1.

Claims (4)

1. a gynaecologic antibiotic gel, is characterized in that it take chitosan iodine as main active, and its raw materials quality formula is as follows:
Chitosan iodine 0.2%~5%
Glacial acetic acid 0.1%~2.5%
Tween-20 0.6%~15%
Glycerol 0.5%~12.5%
Potassium iodate 0.005%~0.125%
Chitosan 0.3%~2.4%
Hydroxyethyl-cellulose 1.5%~6.5%
Purified water adds to 100%.
2. gynaecologic antibiotic gel as claimed in claim 1 is characterized in that the raw materials quality formula of this gel is as follows:
Chitosan iodine 2%
Glacial acetic acid 0.5%
Tween-20 3%
Glycerol 2.5%
Potassium iodate 0.025%
Chitosan 0.5%
Hydroxyethyl-cellulose 2.25%
Purified water adds to 100%.
3. gynaecologic antibiotic gel as described in one of claim 1 or 2, is characterized in that described chitosan iodine is that water-insoluble chitosan and iodine get through complexation reaction preparation.
4. the method for preparing one of claim 1 or 2 described gynaecologic antibiotic gel, its feature comprises the following steps:
1. according to the weighing of raw materials quality formula, standby;
2. add glacial acetic acid, Tween-20, glycerol, partial purification water to stir in chitosan iodine, make dissolving fully, standby;
3. the purified water that takes a morsel dissolving potassium iodate, and join in standby material and mix, stir;
4. add chitosan according to the raw materials quality formula, stir and make the chitosan dissolving;
5. add hydroxyethyl-cellulose according to the raw materials quality formula, and add to 100% with remaining purified water, slowly stir and make into gel, and get final product.
CN201210556321.0A 2012-12-20 2012-12-20 Gynecological antimicrobial gel recipe and preparation method thereof Active CN103110572B (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103405382A (en) * 2013-08-15 2013-11-27 成都益贝乐医疗器械有限公司 Formula and preparation technology of chitosan-iodine suppository
CN103705535A (en) * 2013-12-27 2014-04-09 王东宇 Gynecological chitosan gel and preparation method thereof
CN105687233A (en) * 2014-11-26 2016-06-22 天津博克尼科技发展有限公司 Method for producing coco trimethyl ammonium chloride iodine complex gel

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102144988A (en) * 2011-03-16 2011-08-10 贵州扬生医用器材有限公司 Chitosan cervix uteri anti-microbial membrane and preparation method thereof
CN102764447A (en) * 2012-07-27 2012-11-07 武汉人福医疗用品有限公司 Hydrogel dressing and preparation process thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102144988A (en) * 2011-03-16 2011-08-10 贵州扬生医用器材有限公司 Chitosan cervix uteri anti-microbial membrane and preparation method thereof
CN102764447A (en) * 2012-07-27 2012-11-07 武汉人福医疗用品有限公司 Hydrogel dressing and preparation process thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103405382A (en) * 2013-08-15 2013-11-27 成都益贝乐医疗器械有限公司 Formula and preparation technology of chitosan-iodine suppository
CN103705535A (en) * 2013-12-27 2014-04-09 王东宇 Gynecological chitosan gel and preparation method thereof
CN105687233A (en) * 2014-11-26 2016-06-22 天津博克尼科技发展有限公司 Method for producing coco trimethyl ammonium chloride iodine complex gel

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