CN106075558A - Conservative restoration material and preparation method thereof after a kind of uterine cavity damage - Google Patents
Conservative restoration material and preparation method thereof after a kind of uterine cavity damage Download PDFInfo
- Publication number
- CN106075558A CN106075558A CN201610568051.3A CN201610568051A CN106075558A CN 106075558 A CN106075558 A CN 106075558A CN 201610568051 A CN201610568051 A CN 201610568051A CN 106075558 A CN106075558 A CN 106075558A
- Authority
- CN
- China
- Prior art keywords
- uterine cavity
- damage
- restoration material
- preparation
- conservative restoration
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0019—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0023—Polysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
- A61L26/008—Hydrogels or hydrocolloids
Abstract
The present invention relates to Conservative restoration material and preparation method thereof after a kind of uterine cavity damages; after the damage of this uterine cavity, Conservative restoration material is in terms of the percentage composition of raw material gross weight; it is made up of following raw material: the block copolymer of polyoxyethylene poly-oxygen propylene aether 5% 55%; sodium alginate 0.1% 3%; glycerol 1% 25%; polyhydric alcohol 5% 15%, remaining is pure water.Conservative restoration material after the uterine cavity damage that the present invention provides; unique properties; easy to use; it it is good, safe and nontoxic, the non-stimulated gel rubber material of a kind of biocompatibility; uterus wound surface can be covered rapidly and comprehensively under the fluid state of liquid by the temperature response performance of its uniqueness; and under body temperature, form firm gel state, thus wound surface is effectively isolated, effectively protect surgical wound surface.This gel rubber material, in uterine cavity injury protection, has high using value.
Description
Technical field
The present invention relates to Conservative restoration material and preparation method thereof after a kind of uterine cavity damages, belong to field of medicaments.
Background technology
Uterine cavity is a special environment, and uterine cavity damage brings more for child-bearing health and the physiological health of women
Impact.Relative to uterine cavity damage bring intrauterine adhesion, sterility and infertility and cause adnexa damage, more and more cause doctor
The attention of worker, the preventing and controlling about uterine cavity damage have become as prevention and the necessarily mistake of preventing and treating uterine cavity damage class operation
Journey.
Prevention work after damaging about uterine cavity at present, uses the measure such as gel rubber material or intrauterine contraceptive loop more clinically,
Wherein the most effective is that the anti-adhesion gel material of Film with Preventing Adhesion is filled cavity of uterus, prevents, and achieves certain
Curative effect.
It is known that uterine cavity environment is the environment of a Guan Bi, due to the effect of body of uterus smooth muscle, stick shape in Guan Bi
State, this results in common gel rubber material, after injecting in uterine cavity, it is impossible to even application is in uterine cavity damage surface, and additionally gel is solid
Some forms cause being combined with damage surface insecure, easily run off and cause action time the longest, thus affect clinical efficacy.
Summary of the invention
The present invention is directed to uterine cavity injury protection and a kind of repair materials irrigating use and preparation method thereof, this gel are provided
When material is below 30 DEG C, for having the colourless transparent liquid of good fluidity, when 30-37 DEG C, it is changed into firm gel
State.
After the uterine cavity damage that the present invention provides, Conservative restoration material (less than 30 DEG C) before use is for having good fluidity
Fluid state, treat uterine cavity damage time, by the perfusion of fluid, aqueous dressing can be made quickly to be distributed in whole uterus table
Face, and wound surface is effectively covered, liquid dressing, after carrying out heat exchange with human body, completes inversion of phases, is formed firm
Gel, thus formed on whole intrauterine surface and there is the gel layer of spacial framework, form persistently protection.
After the uterine cavity damage that the present invention provides, Conservative restoration materials'use is preposition in 2-8 DEG C of refrigerator, such temperature cold
Dressing is poured in impaired cavity of uterus, can promote that blood capillary shrinks, and reduces oozing of blood sepage;Concurrently form the solidifying of network structure
Glue, plays the effect being effectively isolated wound surface, it is to avoid contacting with each other of damaged tissues, can prevent the generation of intrauterine adhesion;Material group
Sodium alginate in Fen has the effect promoting the smooth healing of tissue;The gel formed can sustainable existence 10-in cavity of uterus
15 days, and moist environment can be kept, can promote that uterus wound surface forms the incrustation of softness, it is to avoid decrustation is hemorrhage.
The technical scheme is that Conservative restoration material after a kind of uterine cavity damage, with former
The percentage composition meter of material gross weight, is made up of following raw material:
The block copolymer 5%-55% of polyoxyethylene poly-oxygen propylene aether, modified sodium alginate 0.1%-3%, glycerol 1%-
25%, polyhydric alcohol 5%-15%, remaining is pure water.
On the basis of technique scheme, the present invention can also do following improvement.
Further, during the block copolymer of described polyoxyethylene poly-oxygen propylene aether is poloxamer188 or PLURONICS F87
One or both mixture.Buy from Xi'an Tian Zheng pharmaceutic adjuvant company limited.
Further, the mixture of one or more during described polyhydric alcohol is glycerol, propylene glycol, mannitol.
The present invention also provides for the preparation method of Conservative restoration material after a kind of uterine cavity as above damages, including:
1) under 0 DEG C of ice bath, by block copolymer and the sodium alginate mixing of polyoxyethylene poly-oxygen propylene aether, pure water is added
Carry out swelling, be dissolved into solution;
2) to 1) solution that obtains adds polyhydric alcohol, under agitation it is added dropwise over glycerol, obtains mixed liquor;
3) by mixed liquor under 0 DEG C of condition of ice bath, vacuum outgas, obtain transparent settled solution;
4) by 3) the transparent settled solution 0.22-0.45 μm filtering with microporous membrane that obtains, maintain cold-aseptic filling in container
In, high pressure steam sterilization, obtain Conservative restoration material after uterine cavity damage.
On the basis of technique scheme, the present invention can also do following improvement.
Further, 3) in, the vacuum of described vacuum outgas is-20kPa, and degassing is to bubble-free in mixed liquor.
Further, 4) in, described low temperature is 0-5 DEG C.
Further, 4) in, described container includes that clamped bottle, cillin bottle, inoculated fill one or more in emitter, institute
The specifications and models stating container include: 0.5ml, 1.0ml, 2.0ml, 3.0ml, 5.0ml, 10ml.
Further, 4) in, described high pressure steam sterilization is 100kPa, temperature 115 DEG C, sterilizing 15min.
The invention has the beneficial effects as follows:
1, the phase in version system that controlled by variations in temperature of Conservative restoration material and function after the uterine cavity damage that the present invention provides
Property regulation component composition.Being the liquid with good fluidity less than (less than 30 DEG C) in the suitable temperature ranges of body temperature, can
Realize by the conversion of liquid to gel state under body temperature, when i.e. temperature is increased to 30-37 DEG C, solidification can be changed into by flowable state
Gel state.
2, Conservative restoration material after the uterine cavity damage that the present invention provides, unique properties, easy to use, it is a kind of bio-compatible
The gel rubber material that property is good, safe and nontoxic, non-stimulated, the temperature response performance of its uniqueness can be right under the fluid state of liquid
Uterus wound surface covers rapidly and comprehensively, and forms firm gel state under body temperature, thus is effectively isolated by wound surface,
Effectively protect surgical wound surface.This gel rubber material, in uterine cavity injury protection, has high using value.
3, the present invention uses linear polymeric material, polyhydric alcohol by hydrogen bond action, hands in conjunction with certain polyol structure
Locking that interaction and being formed varies with temperature and the temperature sensitivity system of release hydrone ability, thus reach in default temperature
The specific physical effect converted to gel state by liquid in the range of degree.The gel state of the gel rubber material that the present invention provides and solution state
Conversion process there is reversibility, therefore in hot weather, storage or transportation in can be solid-state, as long as before use
It is placed under low temperature and changes into liquid.
4, the present invention is with the block copolymer of linear polymeric material polyoxyethylene poly-oxygen propylene aether and by monosaccharide aldehydic acid line
Property the polysaccharide that is polymerized based on, in liquid linear polymeric system solution, by certain order, by regulation concentration
And the change of the interpolation speed of strict polyhydric alcohol, and formed and reach the material behavior that expection requires, during material is made
Be applied to low temperature swelling re-dissolved technology, the locking of gelation hydrone, solve lock-in techniques, cold-aseptic filling technique, and high pressure steam
Vapour sterilization process technology so that it is become the dressing applied that really can be used for solving uterine cavity damage problem.
Detailed description of the invention
Principle and feature to the present invention are described below, and example is served only for explaining the present invention, is not intended to limit
Determine the scope of the present invention.
Embodiment 1
1) Conservative restoration material prescription after uterine cavity damage: in terms of mass fraction, kg/kg, %
2) preparation method of Conservative restoration material after uterine cavity damage:
A, under 0 DEG C of ice bath, by the block copolymer of polyoxyethylene poly-oxygen propylene aether and sodium alginate mixing, add pure water
Carry out swelling, be dissolved into solution;
B, in the solution that A obtains add polyhydric alcohol, be under agitation added dropwise over glycerol, obtain mixed liquor;
C, by mixed liquor under 0 DEG C of condition of ice bath ,-20kPa vacuum outgas, to bubble-free in mixed liquor, obtains transparent clear
Clear solution;
D, the transparent settled solution 0.22-0.45 μm filtering with microporous membrane that C is obtained, maintain 0-5 DEG C of cold-aseptic filling in
In container, described container includes that clamped bottle, cillin bottle, inoculated fill one or more in emitter, the specification type of described container
Number include: 0.5ml, 1.0ml, 2.0ml, 3.0ml, 5.0ml, 10ml, 100kPa, 115 DEG C of high pressure steam sterilization 15min, obtain palace
Conservative restoration material after the damage of chamber.Embodiment 2
1) Conservative restoration material prescription after uterine cavity damage: in terms of mass fraction, kg/kg, %
2) after uterine cavity damages, Conservative restoration material preparation method is with embodiment 1.
Embodiment 3
1) Conservative restoration material prescription after uterine cavity damage: in terms of mass fraction, kg/kg, %
2) after uterine cavity damages, Conservative restoration material preparation method is with embodiment 1.
Embodiment 4
1) Conservative restoration material prescription after uterine cavity damage: in terms of mass fraction, kg/kg, %
2) after uterine cavity damages, Conservative restoration material preparation method is with embodiment 1.
Embodiment 5
1) Conservative restoration material prescription after uterine cavity damage: in terms of mass fraction, kg/kg, %
2) after uterine cavity damages, Conservative restoration material preparation method is with embodiment 1.
The rabbit that after the uterine cavity damage of present invention embodiment 1 preparation, uterine cavity is damaged by Conservative restoration material is tested,
Repair materials is taken out from the refrigerator of 2-8 DEG C, is now fluid state, fluid perfusion is applied in impaired intrauterine, liquid
Uterus wound surface is covered rapidly and comprehensively in 1min by material, and the dressing of low temperature promotes wound healing, reduces oozing of blood, liquid dressing
After carrying out heat exchange with human body, complete inversion of phases, form firm gel state, thus wound surface is effectively isolated, prevention
Intrauterine adhesion, the gel of formation is energy sustainable existence 15 days in cavity of uterus, and can keep moist environment, promote uterus wound surface shape
Become soft incrustation, it is to avoid decrustation is hemorrhage.
With reference to the cytotoxicity grade scale GB/T14233.2-2005 of medical material, prepared by testing example 1-5
Conservative restoration material after uterine cavity damage, result display cytotoxicity is maintained at 1 grade, protects after the uterine cavity damage that the present invention provides is described
Protecting repair materials is good, safe and nontoxic, the non-stimulated gel rubber material of a kind of biocompatibility.
In a word, after the uterine cavity damage that the present invention provides, Conservative restoration material can facilitate and is coated on vulneratio uteri uniformly
Face, can firmly be combined on vulneratio uteri face again, keeps apart impaired uterus wound surface, has promotion healing simultaneously, reduces and ooze
Go out, prevent decrustation hemorrhage etc. acts on, and treats and prevents and have positive meaning after damaging uterine cavity.
The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all spirit in the present invention and
Within principle, any modification, equivalent substitution and improvement etc. made, should be included within the scope of the present invention.
Claims (8)
1. Conservative restoration material after a uterine cavity damage, it is characterised in that in terms of the percentage composition of raw material gross weight, by the most former
Material composition:
The block copolymer 5%-55% of polyoxyethylene poly-oxygen propylene aether, sodium alginate 0.1%-3%, glycerol 1%-25% are many
Unit alcohol 5%-15%, remaining is pure water.
Conservative restoration material after uterine cavity the most according to claim 1 damage, it is characterised in that described polyoxyethylene polyoxy third
The block copolymer of alkene ether is one or both the mixture in poloxamer188 or PLURONICS F87.
Conservative restoration material after uterine cavity the most according to claim 1 damage, it is characterised in that described polyhydric alcohol is the third three
The mixture of one or more in alcohol, propylene glycol, mannitol.
4. the preparation method of Conservative restoration material after the uterine cavity damage as described in claim 1-3 is arbitrary, it is characterised in that
Including:
1) under 0 DEG C of ice bath, by block copolymer and the sodium alginate mixing of polyoxyethylene poly-oxygen propylene aether, add pure water and carry out
Swelling, it is dissolved into solution;
2) to 1) solution that obtains adds polyhydric alcohol, under agitation it is added dropwise over glycerol, obtains mixed liquor;
3) by mixed liquor under 0 DEG C of condition of ice bath, vacuum outgas, obtain transparent settled solution;
4) by 3) the transparent settled solution 0.22-0.45 μm filtering with microporous membrane that obtains, maintain cold-aseptic filling in container, high
Pressure steam sterilization, obtains Conservative restoration material after uterine cavity damage.
Preparation method the most according to claim 4, it is characterised in that 3) in, the vacuum of described vacuum outgas is-
20kPa, degassing is to bubble-free in mixed liquor.
Preparation method the most according to claim 4, it is characterised in that 4) in, described low temperature is 0-5 DEG C.
Preparation method the most according to claim 4, it is characterised in that 4) in, described container includes clamped bottle, XiLin
Bottle, inoculated fill one or more in emitter, the specifications and models of described container include: 0.5ml, 1.0ml, 2.0ml, 3.0ml,
5.0ml、10ml。
Preparation method the most according to claim 4, it is characterised in that 4) in, described high pressure steam sterilization is 100kPa,
Temperature 115 DEG C, sterilizing 15min.
Priority Applications (1)
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CN201610568051.3A CN106075558A (en) | 2016-07-18 | 2016-07-18 | Conservative restoration material and preparation method thereof after a kind of uterine cavity damage |
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CN201610568051.3A CN106075558A (en) | 2016-07-18 | 2016-07-18 | Conservative restoration material and preparation method thereof after a kind of uterine cavity damage |
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CN201610568051.3A Pending CN106075558A (en) | 2016-07-18 | 2016-07-18 | Conservative restoration material and preparation method thereof after a kind of uterine cavity damage |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN109125814A (en) * | 2017-06-15 | 2019-01-04 | 上海微创医疗器械(集团)有限公司 | Antiadhesive film and preparation method thereof |
CN112190768A (en) * | 2020-10-20 | 2021-01-08 | 江苏山信药业有限公司 | Postoperative anti-adhesion gel for uterine cavity, preparation method and application thereof |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN109125814A (en) * | 2017-06-15 | 2019-01-04 | 上海微创医疗器械(集团)有限公司 | Antiadhesive film and preparation method thereof |
CN109125814B (en) * | 2017-06-15 | 2021-11-09 | 上海微创医疗器械(集团)有限公司 | Anti-adhesion membrane and preparation method thereof |
CN112190768A (en) * | 2020-10-20 | 2021-01-08 | 江苏山信药业有限公司 | Postoperative anti-adhesion gel for uterine cavity, preparation method and application thereof |
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