CN103110572B - Gynecological antimicrobial gel recipe and preparation method thereof - Google Patents
Gynecological antimicrobial gel recipe and preparation method thereof Download PDFInfo
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- CN103110572B CN103110572B CN201210556321.0A CN201210556321A CN103110572B CN 103110572 B CN103110572 B CN 103110572B CN 201210556321 A CN201210556321 A CN 201210556321A CN 103110572 B CN103110572 B CN 103110572B
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- chitosan
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- 238000002360 preparation method Methods 0.000 title claims abstract description 14
- 230000000845 anti-microbial effect Effects 0.000 title abstract 2
- 229920001661 Chitosan Polymers 0.000 claims abstract description 47
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 40
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims abstract description 26
- 239000011630 iodine Substances 0.000 claims abstract description 25
- 229910052740 iodine Inorganic materials 0.000 claims abstract description 25
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 23
- 239000008213 purified water Substances 0.000 claims abstract description 19
- 239000002994 raw material Substances 0.000 claims abstract description 17
- JLKDVMWYMMLWTI-UHFFFAOYSA-M potassium iodate Chemical compound [K+].[O-]I(=O)=O JLKDVMWYMMLWTI-UHFFFAOYSA-M 0.000 claims abstract description 15
- 239000001230 potassium iodate Substances 0.000 claims abstract description 15
- 229940093930 potassium iodate Drugs 0.000 claims abstract description 15
- 235000006666 potassium iodate Nutrition 0.000 claims abstract description 15
- 238000003756 stirring Methods 0.000 claims abstract description 15
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims abstract description 13
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims abstract description 13
- 229920001213 Polysorbate 20 Polymers 0.000 claims abstract description 13
- 229960000583 acetic acid Drugs 0.000 claims abstract description 13
- 239000012362 glacial acetic acid Substances 0.000 claims abstract description 13
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims abstract description 13
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims abstract description 13
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims abstract description 13
- 229940071826 hydroxyethyl cellulose Drugs 0.000 claims abstract description 12
- 238000005303 weighing Methods 0.000 claims abstract description 6
- 239000000463 material Substances 0.000 claims abstract description 4
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 claims description 23
- 230000003115 biocidal effect Effects 0.000 claims description 20
- PNDPGZBMCMUPRI-UHFFFAOYSA-N iodine Chemical compound II PNDPGZBMCMUPRI-UHFFFAOYSA-N 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 3
- 238000000746 purification Methods 0.000 claims description 3
- 238000006243 chemical reaction Methods 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 7
- 230000001954 sterilising effect Effects 0.000 abstract description 6
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 6
- 206010046914 Vaginal infection Diseases 0.000 abstract description 4
- 201000008100 Vaginitis Diseases 0.000 abstract description 2
- 230000008901 benefit Effects 0.000 abstract description 2
- 206010008323 cervicitis Diseases 0.000 abstract description 2
- 201000003988 chronic cervicitis Diseases 0.000 abstract description 2
- 235000011187 glycerol Nutrition 0.000 abstract 2
- 229940068977 polysorbate 20 Drugs 0.000 abstract 2
- 239000004480 active ingredient Substances 0.000 abstract 1
- 229940045110 chitosan Drugs 0.000 abstract 1
- 229960005150 glycerol Drugs 0.000 abstract 1
- 230000000844 anti-bacterial effect Effects 0.000 description 9
- CPKVUHPKYQGHMW-UHFFFAOYSA-N 1-ethenylpyrrolidin-2-one;molecular iodine Chemical class II.C=CN1CCCC1=O CPKVUHPKYQGHMW-UHFFFAOYSA-N 0.000 description 4
- 239000000693 micelle Substances 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 229920000153 Povidone-iodine Polymers 0.000 description 2
- 239000000645 desinfectant Substances 0.000 description 2
- 238000001879 gelation Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 210000004877 mucosa Anatomy 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 229960001621 povidone-iodine Drugs 0.000 description 2
- 239000004094 surface-active agent Substances 0.000 description 2
- 241000304886 Bacilli Species 0.000 description 1
- 244000063299 Bacillus subtilis Species 0.000 description 1
- 235000014469 Bacillus subtilis Nutrition 0.000 description 1
- GAWIXWVDTYZWAW-UHFFFAOYSA-N C[CH]O Chemical group C[CH]O GAWIXWVDTYZWAW-UHFFFAOYSA-N 0.000 description 1
- 241000222122 Candida albicans Species 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 241000187479 Mycobacterium tuberculosis Species 0.000 description 1
- 241000588652 Neisseria gonorrhoeae Species 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 241000191963 Staphylococcus epidermidis Species 0.000 description 1
- 241000194017 Streptococcus Species 0.000 description 1
- 241000223238 Trichophyton Species 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 239000013011 aqueous formulation Substances 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 229940095731 candida albicans Drugs 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 230000006196 deacetylation Effects 0.000 description 1
- 238000003381 deacetylation reaction Methods 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000004821 distillation Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 230000003628 erosive effect Effects 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 230000009931 harmful effect Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000002949 hemolytic effect Effects 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000002085 irritant Substances 0.000 description 1
- 231100000021 irritant Toxicity 0.000 description 1
- 230000002147 killing effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 229920000620 organic polymer Polymers 0.000 description 1
- 210000002640 perineum Anatomy 0.000 description 1
- -1 plays solubilization Substances 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 230000003381 solubilizing effect Effects 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 210000001215 vagina Anatomy 0.000 description 1
- 230000029663 wound healing Effects 0.000 description 1
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
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 has the history of 150 years for body sterilization, but because the dissolubility of iodine in water is very little, at 25 ℃, only has 1.315 * 10
-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 that to take organic polymer or surfactant be carrier mostly, by the network structure or the micelle that form between carrier molecule, with the conformational effect in electronics and space by iodine " constraint " in wherein, thereby change the free state of iodine in general Operand, its stability and bactericidal action enhancing, zest and xanthochromia are reduced.But this class be take the finished product that surfactant is carrier, and after dilution, original micelle power can be destroyed, makes the stability decreases of active iodine, thereby affect its sterilization effect.At present, in China, most widely used povidone iodine class disinfectant is povidone iodine complex, is recorded in bis-of version < < 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, life-time service can produce harmful effect to environment.In addition, itself there is no bactericidal action polyvidone, just as a kind of surface activity carrier, forms micelle, improves the stability of iodine molecule.
Chitosan (chitosan) is the unique positively charged side chain polysaccharide of occurring in nature, has antibacterially, 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, 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.The sterilization effect of chitosan iodine (the laboratory observation > > of < < chitosan iodine liquid bactericidal effect that had bibliographical information, 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 by the patent application of chitosan making gynaecologic antibiotic gel preparation few, only there is No. 201010563054.0 < < gel preparation and preparation technology > > thereof who is used for the treatment of the gynaecopathias such as cervical erosion, a 201110031716.4 number < < washing-free puerpera perineum medical-care gel and preparation method thereof > >, 201210135254.5 number < < Chitosangynaecologicsuppository antibacterial gel and preparation method thereof > >, but there is no the patent application of making gynaecologic antibiotic gel preparation of chitosan iodine.
Summary of the invention
The object 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 object 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 inventor provides, 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%.
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 obtain through complex reaction preparation.
Above-mentioned Polysorbate-2, glycerol, potassium iodate, hydroxy ethyl fiber, purified water all meet the requirement of < < Pharmacopoeia of People's Republic of China > >.
The preparation method of the gynaecologic antibiotic gel that inventor provides, comprises the following steps:
1. according to the weighing of raw materials quality formula, standby;
2. in chitosan iodine, add glacial acetic acid, Tween-20, glycerol, partial purification water to stir, make to dissolve completely, standby;
3. the purified water that takes a morsel is dissolved potassium iodate, and joins in standby material and mix, and stirs;
4. according to raw materials quality formula, add chitosan, stir chitosan is dissolved;
5. according to raw materials quality formula, add hydroxyethyl-cellulose, and add to 100% by remaining purified water, slowly stir and make into gel, obtain.
Inventor points out: the chitosan iodine in gynaecologic antibiotic gel mainly plays effect antibacterial and 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 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. is all had to extremely strong killing action.
The gynaecologic antibiotic gel that inventor provides has good biocompatibility, to vaginal mucosa nonirritant, and has stronger adhesiveness, and after injection vagina, 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
By the following example, describe the specific embodiment of the present invention in detail
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.In chitosan iodine, add glacial acetic acid, Tween-20, glycerol, partial purification water to stir, make to dissolve completely, standby; The purified water that takes a morsel is afterwards dissolved potassium iodate, and joins in standby material and mix, and stirs; Add again recipe quantity chitosan, stir chitosan is dissolved; Finally add recipe quantity hydroxyethyl-cellulose, add remaining purified water to 100g, slowly stir and make into gel, obtain 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, with embodiment 1, obtains gynaecologic antibiotic gel finished product.
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, with embodiment 1, obtains gynaecologic antibiotic gel finished product.
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. the 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 obtain through complex 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. in chitosan iodine, add glacial acetic acid, Tween-20, glycerol, partial purification water to stir, make to dissolve completely, standby;
3. the purified water that takes a morsel is dissolved potassium iodate, and joins in standby material and mix, and stirs;
4. according to raw materials quality formula, add chitosan, stir chitosan is dissolved;
5. according to raw materials quality formula, add hydroxyethyl-cellulose, and add to 100% by remaining purified water, slowly stir and make into gel, obtain.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201210556321.0A CN103110572B (en) | 2012-12-20 | 2012-12-20 | Gynecological antimicrobial gel recipe and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210556321.0A CN103110572B (en) | 2012-12-20 | 2012-12-20 | Gynecological antimicrobial gel recipe and preparation method thereof |
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| CN103110572A CN103110572A (en) | 2013-05-22 |
| CN103110572B true CN103110572B (en) | 2014-07-16 |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103405382B (en) * | 2013-08-15 | 2015-07-01 | 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)
| 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 |
-
2012
- 2012-12-20 CN CN201210556321.0A patent/CN103110572B/en active Active
Patent Citations (2)
| 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 |
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