CN101564557B - Method for preparing antibiosis self-expanding material of one-off cervix dilator - Google Patents

Method for preparing antibiosis self-expanding material of one-off cervix dilator Download PDF

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CN101564557B
CN101564557B CN200910039678.XA CN200910039678A CN101564557B CN 101564557 B CN101564557 B CN 101564557B CN 200910039678 A CN200910039678 A CN 200910039678A CN 101564557 B CN101564557 B CN 101564557B
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polyvinyl alcohol
chitosan
antibiosis
self
cervix
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CN101564557A (en
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曾戎
唐云华
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Dongguan Kewei Medical Instrument Co Ltd
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Dongguan Kewei Medical Instrument Co Ltd
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Abstract

The invention relates to a method for preparing an antibiosis self-expanding material of a one-off cervix dilator. The method comprises the steps of: mixing chitosan or chitosan derivative with polyvinyl alcohol solution; carrying out cross-linking to form compound gel; and carrying out washing, drying, mould-pressing and shaping to obtain polyvinyl alcohol-chitosan or polyvinyl alcohol-chitosan derivative compound compressed sponge which has not only excellent water-absorbing expandability, wet mechanical strength and biological compatibility but also antibiosis and inflammation-diminishing effects. The polyvinyl alcohol- chitosan or polyvinyl alcohol-chitosan derivative compound compressed sponge can be used for preparing antibiosis one-off cervix dilator and can alleviate pain of patients in operation as well as reduce operation difficulty and occurrence of operation complicating diseases.

Description

The preparation method that is used for the antibiosis self-expanding material of one-off cervix dilator
Technical field
The present invention relates to the medical macromolecular materials field, refer in particular to a kind of preparation method of the antibiosis self-expanding material for one-off cervix dilator.
Background technology
Cervical dilator is a kind of department of obstetrics and gynecology, family planning section medical surgical instrument commonly used.On the one hand, artificial abortion operation or in order to reduce the complication that some high risk pregnancy causes and to reduce perinatal mortality rate and the induced labor operation implemented, need the cervix uteri connective tissue effectively to soften and to expand; On the other hand, as Wicresoft of a kind of gynecological Clinics and Practices technology, the various operations of hysteroscope operation and mediation thereof are because its non-incision, wound are little, retain uterus, do not affect Function of Ovary, preserve quality of life, without the complication of opening abdomen, hospital stays is short, post-operative recovery is fast, and the advantages such as good operation effect are that the gynaecopathia diagnosis and treatment bring great convenience, and cervix dilating is extremely important to carrying out smoothly the hysteroscope operation.The cervical dilator of traditional use is the dilator bar of the different-diameter made by metal or rigid plastics clinically, mode cervix dilating with the rigid expansion of physics, this mode often causes operating time longer, cause larger pain to the patient, and easily cause vulneratio uteri, embryo damage and the untoward reaction such as hemorrhage.
For the slow expansion that realizes cervix uteri, alleviate patient's misery, reduce the generation of operating difficulty and complication, the slow expanding one-off cervix dilator bar that people utilize the imbibition characteristic of the medical macromolecular materials that biocompatibility is good to make to have the self-expanding performance.The medical macromolecular materials of application comprise [1. Liu Hibisci Mutabilis, the Xu Jine such as natural seaweed, gelatin, hydrophilic polyurethane compressed sponge, polyvinyl formal compressed sponge, the observation of Sargassum dilator bar to non-gravid woman's cervical dilatation effect, the Qingdao medical and health, 36 (3): 166-167 (2004).2. Chinese patent CN 2061461U: cervix dilating embolus made of gelatin; 3. United States Patent (USP): Osmoticcervical dilator, No.4467806.).But these self-expanding medical macromolecular materials still come with some shortcomings, for example Sargassum dilator bar, gelatin dilator bar are after cervix uteri place absorb body fluids expands, and intensity decreases, may fracture and Fragmentation Phenomena when taking out.Besides, existing self-expanding material lacks antibacterial and anti-inflammation functions, owing to often there being some conditioned pathogen to exist in the cervical canal of normal women, and many patients' endocervix organizes and often have the damage brought because of inflammation or operation, therefore prevent the infection in the cervical dilatation operation very important.
Polyvinyl alcohol is a kind of hydrophilic synthesized polymer material that has good biocompatibility and have no side effect, and has water suction self-expanding performance, and abroad existing polyvinyl formal compressed sponge is for the product of one-off cervix dilator bar.Chitosan is as a kind of natural cationic polysaccharide, not only there is hypotoxicity, good biocompatibility and biodegradability, and chitosan and derivant thereof have broad-spectrum antiseptic and antiinflammation preferably, effectively the microbial growths such as anti-bacteria, fungus, prevent traumatic infection.Chinese patent CN1385216 discloses take a kind of biodegradable anti-inflammation hemostasia material compositions and the preparation method that chitosan is component.
Summary of the invention
The present invention is directed to the deficiencies in the prior art, main purpose is to provide a kind of preparation method of the antibiosis self-expanding material for one-off cervix dilator, make and take this antibiosis self-expanding material and not only there is good water swellability, hygrometric state mechanical strength and biocompatibility as one-off cervix dilator prepared by base material, and there is the effect of anti-inflammation.
To achieve these goals, the present invention adopts following technical scheme:
A kind of preparation method of the antibiosis self-expanding material for one-off cervix dilator comprises following concrete steps:
(1) prepare the mixed solution of polyvinyl alcohol and chitosan or chitosan derivatives;
(2) add chemical cross-linking agent in the mixed solution of step (1), be uniformly mixed, inject mould, standing and reacting, obtain polyvinyl alcohol-chitosan or polyvinyl alcohol-chitosan derivatives composite aquogel;
(3) gained composite aquogel water is cleaned, drying, compression molding obtains polyvinyl alcohol-chitosan or polyvinyl alcohol-chitosan derivatives compound compressed sponge.
Preferred version of the present invention is as follows:
The chitosan that the preferred deacetylation of described chitosan is 70%~100%, molecular weight is 2000~1,000,000.
The preferred carboxymethyl chitosan of described chitosan derivatives, sulfated chitosan and chitosan quaternary amine.
One or more in the preferred glutaraldehyde of described chemical cross-linking agent, formaldehyde, acetaldehyde, epoxychloropropane.
In the described mixed solution of step (1), the concentration of polyvinyl alcohol is 40~150g/L, and the mass ratio of chitosan or chitosan derivatives and polyvinyl alcohol is (0.1~20): 100.
In step (2), the standing and reacting temperature is room temperature to 60 ℃, dry preferably freeze drying in step (3).
The invention has the advantages that polyvinyl alcohol-chitosan or the polyvinyl alcohol-chitosan derivatives composite aquogel of preparation chemical crosslinking, then through cleaning, dry, compression molding, make polyvinyl alcohol-chitosan or polyvinyl alcohol-chitosan derivatives compressed sponge, obtain a kind of antibiosis self-expanding material for one-off cervix dilator, it not only has good water swellability, hygrometric state mechanical strength and biocompatibility, and there is the effect of anti-inflammation, alternative existing self-expanding macromolecular material is for the preparation of the one-off cervix dilator bar with anti-microbial property, alleviate patient's misery in operation, reduce the generation of operating difficulty and complication.
The specific embodiment
Below in conjunction with specific embodiment, the invention will be further described.
Embodiment 1
(1) 4.0g polyvinyl alcohol and 0.4g chitosan (deacetylation 90%, molecular weight 20000) heating for dissolving, in the acetic acid,diluted of 80mL, are cooled to room temperature, obtain polyvinyl alcohol/chitosan mixed solution;
(2) glutaraldehyde solution that adds the 0.32mol/L of 20mL in the polyvinyl alcohol prepared in step (1)-chitosan mixed solution, fully stir, and in 60 ℃ of reactions 1 hour, standing 24 hours of room temperature, obtained crosslinked polyvinyl alcohol-chitosan plural gel.
(3) polyvinyl alcohol that obtains-chitosan plural gel water is fully cleaned, lyophilization, then compression molding obtains polyvinyl alcohol-chitosan compressed sponge rod.By after this compressed sponge rod water suction diameter expansion 300%, tensile strength is 1.8MPa, to staphylococcus aureus ATCC6538 bacteriostasis rate, is 90.4%, and stronger bacteriostasis is arranged, and can be used as the antibiosis self-expanding material of one-off cervix dilator.
Embodiment 2
(1) 10.0g polyvinyl alcohol and 2.0g chitosan (deacetylation 100%, molecular weight 5000) heating for dissolving, in the acetic acid,diluted of 80mL, are cooled to room temperature, obtain polyvinyl alcohol-chitosan mixed solution;
(2) glutaraldehyde solution that adds the 0.43mol/L of 20mL in the polyvinyl alcohol prepared in step (1)-chitosan mixed solution, fully stir, and in 50 ℃ of reactions 1 hour, standing 24 hours of room temperature, obtained crosslinked polyvinyl alcohol-chitosan plural gel.
(3) polyvinyl alcohol that obtains-chitosan plural gel water is fully cleaned, lyophilization, then compression molding obtains polyvinyl alcohol-chitosan compressed sponge rod.By after this compressed sponge rod water suction diameter expansion 300%, tensile strength is 2.1MPa, to staphylococcus aureus ATCC6538 bacteriostasis rate, is 92.1%, and stronger bacteriostasis is arranged, and can be used as the antibiosis self-expanding material of one-off cervix dilator.
Embodiment 3
(1) by 10.0g polyvinyl alcohol and 0.5g sulfated chitosan heating for dissolving in the water of 80mL, be cooled to room temperature, obtain polyvinyl alcohol-sulfated chitosan mixed solution;
(2) formalin that adds the 0.43mol/L of 20mL in the polyvinyl alcohol prepared in step (1)-sulfated chitosan mixed solution, fully stir, in 50 ℃ of reactions 2 hours, standing 24 hours of room temperature, obtained crosslinked polyvinyl alcohol-sulfated chitosan pluralgel.
(3) polyvinyl alcohol that obtains-sulfated chitosan pluralgel water is fully cleaned, lyophilization, then compression molding obtains polyvinyl alcohol-sulfated chitosan compressed sponge rod.By after this compressed sponge rod water suction diameter expansion 300%, tensile strength is 2.2MPa, to staphylococcus aureus ATCC6538 bacteriostasis rate, is 91.4%, and stronger bacteriostasis is arranged, and can be used as the antibiosis self-expanding material of one-off cervix dilator.
Embodiment 4
(1) by 10.0g polyvinyl alcohol and 1.0g carboxymethyl chitosan heating for dissolving in the water of 80mL, be cooled to room temperature, obtain polyvinyl alcohol-carboxymethyl chitosan mixed solution;
(2) glutaraldehyde solution that adds the 0.43mol/L of 20mL in the polyvinyl alcohol prepared in step (1)-carboxymethyl chitosan mixed solution, fully stir, and in 50 ℃ of reactions 24 hours, obtains crosslinked polyvinyl alcohol-carboxymethyl chitosan plural gel.
(3) polyvinyl alcohol that obtains-carboxymethyl chitosan plural gel water is fully cleaned, lyophilization, then compression molding obtains polyvinyl alcohol-carboxymethyl chitosan compressed sponge rod.By after this compressed sponge rod water suction diameter expansion 300%, tensile strength is 2.0MPa, to staphylococcus aureus ATCC6538 bacteriostasis rate, is 80.1%, and bacteriostasis is arranged, and can be used as the antibiosis self-expanding material of one-off cervix dilator.
Embodiment 5
(1) by 10.0g polyvinyl alcohol and 0.8g chitosan quaternary amine heating for dissolving in the water of 80mL, be cooled to room temperature, obtain polyvinyl alcohol-chitosan quaternary amine mixed solution;
(2) glutaraldehyde solution that adds the 0.43mol/L of 20mL in the polyvinyl alcohol prepared in step (1)-chitosan quaternary amine mixed solution, fully stir, and in 50 ℃ of reactions 24 hours, obtains crosslinked polyvinyl alcohol-chitosan quaternary amine pluralgel.
(3) polyvinyl alcohol that obtains-chitosan quaternary amine pluralgel water is fully cleaned, lyophilization, then compression molding obtains polyvinyl alcohol-chitosan quaternary amine compressed sponge rod.By after this compressed sponge rod water suction diameter expansion 300%, tensile strength is 2.2MPa, to staphylococcus aureus ATCC6538 bacteriostasis rate, is 95.0%, and stronger bacteriostasis is arranged, and can be used as the antibiosis self-expanding material of one-off cervix dilator.
To sum up each embodiment is known, polyvinyl alcohol-chitosan that the present invention is prepared or polyvinyl alcohol-chitosan derivatives compound compressed sponge not only has good water swellability, hygrometric state mechanical strength and biocompatibility, and there is the effect of anti-inflammation, alternative existing self-expanding macromolecular material, for the preparation of the one-off cervix dilator bar with anti-microbial property, alleviates the generation of patient's misery, minimizing operating difficulty and complication in operation.
The above, it is only preferred embodiment of the present invention, not technical scope of the present invention is imposed any restrictions, therefore any trickle modification, equivalent variations and modification that every foundation technical spirit of the present invention is done above embodiment all still belong in the scope of technical solution of the present invention.

Claims (1)

1. the preparation method for the antibiosis self-expanding material of one-off cervix dilator, is characterized in that: comprise the following steps
(1) prepare the mixed solution of polyvinyl alcohol and chitosan derivatives, wherein 10.0g polyvinyl alcohol and 0.8g chitosan quaternary amine heating for dissolving, in the water of 80ml, are cooled to room temperature, obtain polyvinyl alcohol-chitosan quaternary amine mixed solution;
(2) to the glutaraldehyde solution that adds the 0.43mol/L of 20ml in the mixed solution of step (1), be uniformly mixed, inject mould, standing and reacting, in 50 ℃ of reactions 24 hours, obtain polyvinyl alcohol-chitosan quaternary amine composite aquogel;
(3) gained composite aquogel water is cleaned, lyophilization, compression molding obtains polyvinyl alcohol-chitosan quaternary amine compound compressed sponge.
CN200910039678.XA 2009-05-25 2009-05-25 Method for preparing antibiosis self-expanding material of one-off cervix dilator Active CN101564557B (en)

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Families Citing this family (12)

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Publication number Priority date Publication date Assignee Title
CN102921098A (en) * 2011-08-10 2013-02-13 辽宁爱母医疗科技有限公司 Application of water absorbing material to medical tract dilator
CN102921097A (en) * 2011-08-10 2013-02-13 史凤阳 Liquid absorbing expansion type tract dilator
CN103528474B (en) * 2013-05-17 2016-03-30 哈尔滨欧替药业有限公司 A kind of detection method for vaginal expansion plug
CN104558988A (en) * 2013-10-11 2015-04-29 上海工程技术大学 High-elasticity strong-hydroscopicity chitosan sponge allowing normal-temperature drying and preparation method thereof
CN104998298A (en) * 2015-06-16 2015-10-28 常州大学 Chitosan support achieving directional hole forming and preparation method of chitosan support
CN106137454B (en) * 2016-08-02 2018-01-09 青海省畜牧兽医科学院 A kind of component for cervical dilatation before ox embryo transfer
EP3522972A1 (en) * 2016-10-06 2019-08-14 MEDICEM Technology s.r.o. Combined osmotic and hydrogel cervical dilators and method of making same
CN107050502B (en) * 2016-12-20 2018-11-27 欣乐加生物科技有限公司 A kind of super water-absorbent macromolecule hydrogel dry glue sponge and its preparation method and application
CN210494864U (en) * 2017-03-28 2020-05-12 杭州爱光医疗器械有限公司 Disposable micro-noninvasive injection type cervical dilator
CN111195173A (en) * 2018-11-19 2020-05-26 江苏昌吉永生物科技股份有限公司 Injection type hemostatic applicator and preparation method thereof
CN110585570B (en) * 2019-09-17 2022-06-14 北京中杰瑞康科技有限公司 Liquid-absorbing expansion self-adaptive and antibacterial dilating cervical dilator and preparation method thereof
CN113119369B (en) * 2021-05-24 2022-10-21 爱光生物医药(南昌)有限公司 Method for forming inert end part of disposable cervical dilating rod

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