CN102144988A - Chitosan cervix uteri anti-microbial membrane and preparation method thereof - Google Patents

Chitosan cervix uteri anti-microbial membrane and preparation method thereof Download PDF

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Publication number
CN102144988A
CN102144988A CN2011100625023A CN201110062502A CN102144988A CN 102144988 A CN102144988 A CN 102144988A CN 2011100625023 A CN2011100625023 A CN 2011100625023A CN 201110062502 A CN201110062502 A CN 201110062502A CN 102144988 A CN102144988 A CN 102144988A
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chitosan
cervix uteri
percent
uterus
film
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黄昌平
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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 chitosan cervix uteri anti-microbial membrane and a preparation method thereof. The chitosan cervix uteri anti-microbial membrane has a structure of a circular plate, bulged flangings are formed at the periphery of the circular plate, and a convex body is arranged in the center of the reverse side of the circular plate. The chitosan cervix uteri anti-microbial membrane is prepared from the following raw materials in percentage by mass: 0.5 to 5.0 percent of chitosan iodine, 2.0 to 10.0 percent of polysorbate-20, 0.1 to 2.0 percent of acetic acid, 0.1 to 5.0 percent of hydroxypropyl methyl cellulose, 1.0 to 10.0 percent of gelatin, 1.0 to 10.0 percent of glycerol and the balance of purified water. The chitosan cervix uteri anti-microbial membrane is prepared from novel biological materials synthesized by the chitosan and derivatives thereof by processes of freezing, vacuum drying and the like according to characteristics of human anatomy, pathology, physiology and the like, has a shape of a thin curved surface, and can be in full fit with pathological tissue, absorb wound exudate and eliminate necrotic tissue by being attached to cervix uteri surfaces outside uterine cavities, so that wounds are drained fully; and sterilizing inflammation-diminishing active factors are released in a sustained way at the targeting position to promote wound union effectively. The chitosan cervix uteri anti-microbial membrane is suitable for patients who suffer from gynecological cervical diseases.

Description

A kind of chitosan uterus-neck antibiotic film and preparation method thereof
Technical field
The present invention relates to contain the pharmaceutical product of organic effective ingredient, specifically, relate to the pharmaceutical product that contains chitin, also relate to its preparation method.
Background technology
40% the women of child-bearing age suffer from cervicitis, and the treatment of cervicitis is based on topical therapeutic, and wherein naturopathy is first-selected, the unsatisfactory curative effect of Drug therapy, supplementary means often.Existing naturopathy means comprise Leep cutter, freezing, half-light infrared ray condense therapy, micro-wave therapeutic etc.The curative effect of naturopathy is mostly satisfied, but because when the removing cervix uteri festers tissue, formed a wound surface, generally needs could heal in about 2 months fully, by uterus neck special physiological structure and the particularity of above-mentioned cervix uteri inflammatory wound surface, clinical medicine or the material that does not also have the above-mentioned cervix uteri wound repair of being specifically designed to of a kind of satisfaction at present.
Relating to the application part for the treatment of cervicitis in the Chinese patent literature has: No. 00221307.9 " cervix uteri chitosan complex film ", 03277446.X number " cervix uteri biomembrane ", No. 200310106404.0 " chitosan uterus-neck antibiotic film ", No. 200420078791.1 " uterus-neck antibiotic biomembrane ", No. 200820035427.5 " vagina uterus-neck antibiotic film ", No. 200820137801.2 " chitosan uterus-neck antibiotic film " and No. 200920071352.0 " preventing and treating the diaphragm diaphragm of cervical erosion " etc., these patented technologies all have certain effect.But certain structures is unreasonable, the use inconvenience that has, and what have also needs to use attached apparatus.
Summary of the invention
The purpose of this invention is to provide a kind of chitosan uterus-neck antibiotic film, to solve the defective of existing treatment gynaecopathia technology, its existing protection wound surface, anti-inflammation have the effect that promotes wound healing again.
Another purpose of the present invention provides the preparation method of above-mentioned antibacterial film, makes the antibacterial film product that provides can produce and be applied to clinical.
The chitosan uterus-neck antibiotic film that the inventor provides has following structure: it has a disk, the peripheral bossed flange of this disk, and there is a convex shape at its center, back side; It is made by the following raw materials according component and by following quality proportioning:
Figure BSA00000451564200021
The diameter and the woman vagina of above-mentioned disk are suitable, are 10~35mm; The flange height is lower than 2mm; The convex shape height is 1~5mm.
The preparation method of the chitosan uterus-neck antibiotic film that the inventor provides may further comprise the steps: the gelatin that (1) takes by weighing said ratio adds and to be equipped with in the stirred vessel of purified water, sets bath temperature 60 ℃ of heating, and insulated and stirred 4h makes its dissolving; (2) continue to stir 2h behind the hydroxypropyl emthylcellulose of adding said ratio, make its dissolving; (3) glycerol of adding said ratio mixes; (4) stirring is cooled to about 30 ℃ it, can annotate film with the chitosan iodine solution mix homogeneously for preparing; (5) behind the notes film mould is put into freeze dryer, behind-50 ℃ of freezing 4h, remove lid, continue freezing 2h again, enter lyophilisation; (6) after lyophilisation, under aseptic condition, from freeze dryer, take out, divide the box of packing into, add outer package, sterilization obtains the chitosan uterus-neck antibiotic film product.
The using method of chitosan uterus-neck antibiotic film is: clamp convex shape by the gynaecologist with special-purpose long forceps diaphragm is sent on the cervix uteri, and head into a band wire cotton balls and play fixation.
The inventor points out: the antibacterial action of chitosan uterus-neck antibiotic film is embodied in following 4 aspects:
1. chitosan has bactericidal action, and under acid condition, the amino in the chitosan molecule has positive charge, becomes NH 3+Absorption has the antibacterial of negative charge, make the negative charge skewness on bacteria cell wall and the cell membrane, synthesizing of interference cell wall, break the synthetic and dissolution equilibrium of cell wall under naturalness, make cell wall trend towards dissolving, thin fertile film is not because of bearing the osmotic pressure deformation fracture, content such as water, the protein etc. of cell ooze out, and bacterolysis take place and death.
2. the carrier low molecular chitosan of product is the derivant that derives from the tegument polysaccharide, and degraded to low-molecular-weight (mean molecule quantity<10000), natural degradation speed than existing like product is faster, and noresidue in environment is a kind of antiinflammatory antibacterial of environment-friendly type.Compare with antibiotics, can not produce drug resistance.
3. chitosan further improves the stability of product of the present invention to the existing ligand complex of iodine, again micelle power and physisorption are arranged; And still have certain viscosity through the low-molecular weight chitoglycan that degraded obtains, and can play certain slow releasing function to iodine, have than like product and more stablize persistent antiinflammatory bactericidal effect.
4. because low molecular chitosan has the favorable tissue compatibility, to the skin nonirritant, human body is had no side effect, its toxicity is also far below cationic surfactant, therefore product of the present invention is a carrier with it, and is lower than the zest and the toxicity of existing like product.
The present invention has the following advantages:
1. chitosan uterus-neck antibiotic film is by chitosan and the synthetic novel biomaterial of derivant thereof, and according to features such as human dissection, pathology, physiology, form through technology manufacturings such as lyophilisation, be shaped as the thin type curved face type, outside cavity of uterus (cervix uteri face) applied in suction, and this product can be fitted by tissue abundant and pathological changes, absorbs wound exudate, remove slough, make the abundant drain of wound surface; At targeting moiety, slow release bactericidal antiphlogistic active factors promotes the healing of wound surface effectively simultaneously.
2. product has the protection wound surface, and anti-inflammation promotes the effect of wound healing.The energy anti-inflammation is eliminated the tissue that rots and is absorbed sepage, promotion cervicitis wound healing; Can eliminate the postoperative edema wound of physics, softening incrustation, reduce hemorrhage, keep wound moistening, promote the granulation growth, protect newborn epithelial tissue, control cervical canal cylindrical epithelium turns up.
3. chitosan uterus-neck antibiotic film can be fed through cervix uteri with film by the conical convex shape that vaginal speculum is clamped film with special-purpose long forceps of gynecological, product is applied ointment or plaster on the cervix uteri surface, make film effectively contact or cover with wound surface, make things convenient for the gynecologist to manipulate, need not to use extra administration device, the patient is caused unnecessary loss, avoid the administration device material environment damage.
4. the present invention adopts advanced nanometer lyophilized formulations technology to make membrane material be the porous spongy organizational structure by to the screening of prescription and the optimization of technology, and the complete material that makes of smooth surface has good adhesiveness and flexibility.
Description of drawings
Fig. 1 is the structural representation of uterus-neck antibiotic film of the present utility model, and Fig. 2 is the front view in uterus-neck antibiotic film front, and Fig. 3 is the front view at the uterus-neck antibiotic film back side.1 is disk among the figure, and 2 is flange, and 3 is convex shape.
The specific embodiment
Embodiment
Get chitosan iodine 20g, Tween-20 60g, acetic acid 10g, hydroxypropyl emthylcellulose 10g, gelatin 50g, glycerol 50g and purified water 800mL, altogether the 1000g material;
The gelatin adding is equipped with in the stirred vessel of purified water, sets bath temperature, dissolve about insulated and stirred 4h 60 ℃ of heating; Continue to stir about 2h after then adding hydroxypropyl emthylcellulose, make its dissolving; Adding recipe quantity glycerol again mixes; Afterwards, stirring is cooled to about 30 ℃ material, can annotate film with the chitosan iodine solution mix homogeneously for preparing; At last, behind the notes film mould is put into freeze dryer, behind-50 ℃ of freezing 4h, remove lid, continue freezing 2h again, enter lyophilisation; After lyophilisation, under aseptic condition, from machine, take out, divide the box of packing into, add outer package, sterilization obtains the chitosan uterus-neck antibiotic film product.

Claims (3)

1. chitosan uterus-neck antibiotic film, it is characterized in that it has following structure: it has a disk, the peripheral bossed flange of this disk, there is a convex shape at its center, back side; It is made by the following raw materials according component and by following mass fraction proportioning:
Figure FSA00000451564100011
2. chitosan uterus-neck antibiotic film as claimed in claim 1 is characterized in that the diameter of described disk and woman vagina are suitable, is 10~35mm; The flange height is lower than 2mm; The convex shape height is 1~5mm.
3. the method for preparing the described chitosan uterus-neck antibiotic film of claim 1, its feature may further comprise the steps: (1) takes by weighing the gelatin adding according to said ratio and is equipped with in the stirred vessel of purified water, sets bath temperature 60 ℃ of heating, and insulated and stirred 4h makes its dissolving; (2) continue to stir 2h behind the hydroxypropyl emthylcellulose of adding said ratio, make its dissolving; (3) glycerol of adding said ratio mixes; (4) stirring is cooled to about 30 ℃ it, can annotate film with the chitosan iodine solution mix homogeneously for preparing; (5) behind the notes film mould is put into freeze dryer, behind-50 ℃ of freezing 4h, remove lid, continue freezing 2h again, enter lyophilisation; (6) after lyophilisation, under aseptic condition, from freeze dryer, take out, divide the box of packing into, add outer package, sterilization obtains the chitosan uterus-neck antibiotic film product.
CN2011100625023A 2011-03-16 2011-03-16 Chitosan cervix uteri anti-microbial membrane and preparation method thereof Pending CN102144988A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102961331A (en) * 2012-12-20 2013-03-13 贵州扬生医用器材有限公司 Iodine-chitosan solution formula and preparation method thereof
CN103110976A (en) * 2012-12-20 2013-05-22 贵州扬生医用器材有限公司 Skin antimicrobial gel recipe and preparation method thereof
CN103110572A (en) * 2012-12-20 2013-05-22 贵州扬生医用器材有限公司 Gynecological antimicrobial gel recipe and preparation method thereof
CN103110536A (en) * 2012-12-20 2013-05-22 贵州扬生医用器材有限公司 Tooth-cleaning antimicrobial gel recipe and preparation method thereof
CN103110609A (en) * 2012-12-20 2013-05-22 贵州扬生医用器材有限公司 Film coating agent for treating dental ulcer and preparation method thereof
CN105727348A (en) * 2016-04-11 2016-07-06 上海济国医疗科技有限公司 Antibacterial film, preparing method and antibacterial repairing dressing

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1543982A (en) * 2003-11-20 2004-11-10 杨玉民 Chitose antibacterial film of uterine neck
CN101507731A (en) * 2008-10-30 2009-08-19 杨玉民 Chitosan uterus-neck antibiotic film and preparation method thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1543982A (en) * 2003-11-20 2004-11-10 杨玉民 Chitose antibacterial film of uterine neck
CN101507731A (en) * 2008-10-30 2009-08-19 杨玉民 Chitosan uterus-neck antibiotic film and preparation method thereof

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102961331A (en) * 2012-12-20 2013-03-13 贵州扬生医用器材有限公司 Iodine-chitosan solution formula and preparation method thereof
CN103110976A (en) * 2012-12-20 2013-05-22 贵州扬生医用器材有限公司 Skin antimicrobial gel recipe and preparation method thereof
CN103110572A (en) * 2012-12-20 2013-05-22 贵州扬生医用器材有限公司 Gynecological antimicrobial gel recipe and preparation method thereof
CN103110536A (en) * 2012-12-20 2013-05-22 贵州扬生医用器材有限公司 Tooth-cleaning antimicrobial gel recipe and preparation method thereof
CN103110609A (en) * 2012-12-20 2013-05-22 贵州扬生医用器材有限公司 Film coating agent for treating dental ulcer and preparation method thereof
CN103110572B (en) * 2012-12-20 2014-07-16 贵州扬生医用器材有限公司 Gynecological antimicrobial gel recipe and preparation method thereof
CN103110536B (en) * 2012-12-20 2014-11-26 贵州扬生医用器材有限公司 Tooth-cleaning antimicrobial gel recipe and preparation method thereof
CN105727348A (en) * 2016-04-11 2016-07-06 上海济国医疗科技有限公司 Antibacterial film, preparing method and antibacterial repairing dressing

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Application publication date: 20110810