CN103333261B - A kind of hemostatic starch and preparation method thereof - Google Patents
A kind of hemostatic starch and preparation method thereof Download PDFInfo
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- CN103333261B CN103333261B CN201310166694.1A CN201310166694A CN103333261B CN 103333261 B CN103333261 B CN 103333261B CN 201310166694 A CN201310166694 A CN 201310166694A CN 103333261 B CN103333261 B CN 103333261B
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Abstract
The present invention relates to a kind of hemostatic starch and application thereof, this hemostatic starch is by modified starch of the prior art sex change being finally prepared from through ultrasonication again.This hemostatic starch soaking effect is excellent, safety, stable, is a kind of biocompatibility, the hemostatic starch that can be directly used in the blood surface of a wound.
Description
Technical field
The present invention relates to starch of a kind of hemostasis and preparation method thereof, particularly a kind of biocompatibility, the hemostatic starch that can be directly used in the blood surface of a wound and preparation method thereof.
Background technology
Hemorrhage is the phenomenon the most easily occurred in accident and medical procedure, and the life security of a large amount of hemorrhage entail dangers to people, therefore needs to stop blooding in time for the hemorrhage surface of a wound.
Along with the development of medical science, hemostatic material is of a great variety, and with regard to biocompatibility, conventional biocompatible hemostatic material has: the gelatin class hemostatic materials such as absorbability gelatine starch, collagen protein starch; SURGICEL, oxidized regenerated cellulose class hemostatic material; The natural biological polysaccharide hemostatic materials etc. such as chitosan/chitin kind, starch polysaccharide.
Content of the present invention relates to the hemostatic material of starch polysaccharide, and the patent application that this field is relevant is as follows:
CN200710141944.0 denaturated starch absorbable hemostatic material and preparation method thereof, CN200710199682.3 biocompatibility modified starch starch, the modified starch material that CN200810032631.6 biocompatible hemostatic, anti, promoting healing, surgery are closed, modified starch that CN200810033239.3 is biocompatibility pre-gelatinized and preparation method thereof, CN200810009706.9 denaturated starch absorbable hemostatic material and preparation method thereof, CN200910045995.2 biocompatible hemostatic and promotion knitting material and preparation method thereof.
Above 6 patent applications, described content is roughly the same, is same applicant or contriver.The purposes of partially denaturing starch in hemostasis is disclosed in above-mentioned patent, and propose several specific modified starch, as the modified starch of cationic starch, epichlorohydrin cross-linked starch, carboxymethyl starch, hydroxyethylamyle, pre-gelatinized, the hydroxypropyl Staragel 90V, vinylformic acid-carboxymethyl starch graft copolymer etc. of pre-gelatinized, but its specific nature and detailed applications are not described.
Applicant has carried out systematic study to above-mentioned all kinds of modified starch, and find that the modified starch water absorbent rate in above-mentioned patent application is low, unstable properties, can not meet the demand of clinical hemostasis.Therefore applicant has carried out following process to modified starch of the prior art: modified starch of the prior art is carried out sex change again and be prepared into modified starch after repeatedly sex change, and carry out supersound process in the process.Supersound process is the method processed modified starch that this area is commonly used, known in prior art: ultrasonic wave not only can fast reaction speed, and improve reaction yield, the reaction that some can also be made to be difficult to carry out is achieved.Applicant with ultrasonic modified starch is processed after, surprised discovery, it can also improve water absorbent rate and the rate of water absorption of modified starch.Applicant is through repeatedly repeating experimental studies have found that, the hemostatic starch obtained by the technical scheme of the application, can significantly be improved its water-absorbent, have fabulous application prospect.Applicant has also filtered out preferred processing parameter by experiment simultaneously, and its preparation is more stable, and safety more benefits suitability for industrialized production.
Summary of the invention
An object of the present invention is to provide a kind of new hemostatic starch, this material good water absorption, safety, stable performance, overcome modified starch water-absorbent in prior art low, the shortcomings such as preparation is unstable.
Another object of the present invention is the preparation method providing described hemostatic starch, the object of the invention is to be achieved through the following technical solutions:
A preparation method for hemostatic starch, is characterized in that: comprise the following steps:
1) modified starch raw material is carried out etherificate, crosslinked, esterification and repeatedly makes new modified starch after sex change,
2) wash, dry, obtain hemostatic starch.
Preferably, the modified starch raw material in step 1 is one or more the combination in pre-gelatinized starch, denaturated starch by acid, dextrin, Sumstar 190, esterification starch, etherification starch, cross-linking starch, graft starch, composite modified starch.
Preferably, before step 1, or add sonicating step afterwards.
Preferably, power during supersound process is 450W-600W.
Preferably, sonication treatment time is 3-7min.
Preferably, ultrasound treatment patterns is effect 2s interval 2s.
The purposes of the hemostatic starch that another Technical Design of the present invention is prepared by method of the present invention:
The hemostatic material of the blood surface of a wound is had for the preparation of people, Mammals, birds, Reptilia.
The blood surface of a wound is had or for the hemostatic material under surgical operation, emergency care of trauma, laryngoscope, endoscope, chamber mirror for the preparation of body surface, in-vivo tissue organ and body cavity inner tissue or organ.
For the preparation of the material promoting organization healing.
Preferably, described tissue comprises sub-dermal soft tissue, muscle tissue, osseous tissue, cerebral tissue, nervous tissue, liver,kidney,spleen.
For the preparation of in the material that its hetero-organization or organ of preventing the tissue of wound or organ and surrounding stick together.
Applicant, after having carried out a series of conditional filtering test, finds that method of the present invention has following characteristics:
Beneficial effect of the present invention:
1. the kind of method of the present invention to modified starch has no requirement, in prior art, the conventional modified starch seen may be used to present method, its water absorbent rate of the hemostatic starch prepared and rate of water absorption all far above modified starch starch of the prior art, have obvious performance advantage.Such as compared with control group, water absorbent rate on average improves more than 30%, and rate of water absorption improves more than 1 times, has obvious performance advantage.
2. before ultrasonic step can be positioned at modified starch denaturation process, among or afterwards, as long as employ ultrasonic step in the preparation whole process of modified starch, all can improve water absorbent rate and the rate of water absorption of the new modified starch of acquisition.
3. the present invention is by carrying out sex change again to existing modified starch, and ultrasonication in addition, break up the structure of starch molecule further, significantly improve its water absorbing properties, and filter out preferred processing parameter by great many of experiments, make the hemostatic starch prepared on water absorbing properties, be better than like product of the prior art, have broad application prospects.Prepared by hemostatic starch of the present invention convenient, preparation is more stable, safety, more benefits suitability for industrialized production.
Embodiment
Below in conjunction with embodiment, the present invention is further described in detail, the embodiment provided only in order to illustrate the present invention, instead of in order to limit the scope of the invention.
Embodiment 1:
Hydroxypropyl Staragel 90V is carried out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly makes new modified starch after sex change, again this modified starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 450w power effect 3min (effect 2s interval 2s).With ethanol wash, dry, obtain hemostatic starch 1.
Embodiment 2:
Hydroxypropyl Staragel 90V slurry (ice bath) is placed in ultrasonic cell disruptor, with 450w power effect 3min (effect 2s interval 2s).With ethanol wash, dry, then carry out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly make new modified starch after sex change, with ethanol wash, dry, namely obtain hemostatic starch 2.
Embodiment 3:
Hydroxyethylamyle is carried out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly makes new modified starch after sex change, again this modified starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 450w power effect 3min (effect 2s interval 2s).With ethanol wash, dry, obtain hemostatic starch 3.
Embodiment 4:
Hydroxyethylamyle slurry (ice bath) is placed in ultrasonic cell disruptor, with 450w power effect 3min (effect 2s interval 2s).With ethanol wash, dry, then carry out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly make new modified starch after sex change, with ethanol wash, dry, namely obtain hemostatic starch 4.
Embodiment 5:
Carboxymethyl starch is carried out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly makes new modified starch after sex change, again this modified starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 450w power effect 3min (effect 2s interval 2s).With ethanol wash, dry, obtain hemostatic starch 5.
Embodiment 6:
Carboxymethyl starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 450w power effect 3min (effect 2s interval 2s).With ethanol wash, dry, then carry out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly make new modified starch after sex change, with ethanol wash, dry, namely obtain hemostatic starch 6.
Embodiment 7:
Cationic starch is carried out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly makes new modified starch after sex change, again this modified starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 450w power effect 3min (effect 2s interval 2s).With ethanol wash, dry, obtain hemostatic starch 7.
Embodiment 8:
Cationic starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 450w power effect 3min (effect 2s interval 2s).With ethanol wash, dry, then carry out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly make new modified starch after sex change, with ethanol wash, dry, namely obtain hemostatic starch 8.
Embodiment 9:
Hydroxypropyl Staragel 90V is carried out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly makes new modified starch after sex change, again this modified starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 600w power effect 7min (effect 2s interval 2s).With ethanol wash, dry, obtain hemostatic starch 9.
Embodiment 10:
Hydroxypropyl Staragel 90V slurry (ice bath) is placed in ultrasonic cell disruptor, with 600w power effect 7min (effect 2s interval 2s).With ethanol wash, dry, then carry out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly make new modified starch after sex change, with ethanol wash, dry, namely obtain hemostatic starch 10.
Embodiment 11:
Hydroxyethylamyle is carried out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly makes new modified starch after sex change, again this modified starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 600w power effect 7min (effect 2s interval 2s).With ethanol wash, dry, obtain hemostatic starch 11.
Embodiment 12:
Hydroxyethylamyle slurry (ice bath) is placed in ultrasonic cell disruptor, with 600w power effect 7min (effect 2s interval 2s).With ethanol wash, dry, then carry out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly make new modified starch after sex change, with ethanol wash, dry, namely obtain hemostatic starch 12.
Embodiment 13:
Carboxymethyl starch is carried out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly makes new modified starch after sex change, again this modified starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 600w power effect 7min (effect 2s interval 2s).With ethanol wash, dry, obtain hemostatic starch 13.
Embodiment 14:
Carboxymethyl starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 600w power effect 7min (effect 2s interval 2s).With ethanol wash, dry, then carry out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly make new modified starch after sex change, with ethanol wash, dry, namely obtain hemostatic starch 14.
Embodiment 15:
Cationic starch is carried out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly makes new modified starch after sex change, again this modified starch slurry (ice bath) is placed in ultrasonic cell disruptor, with 600w power effect 7min (effect 2s interval 2s).With ethanol wash, dry, obtain hemostatic starch 15.
Embodiment 16:
Cationic starch slurry (ice bath) is placed in ultrasonic cell disruptor, 600w power effect 7min (effect 2s interval 2s).With ethanol wash, dry, then carry out etherificate, crosslinked, esterification through the chemical reagent such as propylene oxide, phosphoric acid and repeatedly make new modified starch after sex change, with ethanol wash, dry, namely obtain hemostatic starch 16.
The experimental design of embodiment 17 control group
According to the embodiment 1,3 of patent cn200710199682.3, the method for 4,5, prepares hemostatic starch A, C, D, E respectively, and as a control group, concrete steps are as follows:
By 2g pre-gelatinized hydroxypropyl Staragel 90V 51# as in 30ml water, constantly stir, make starch granules fully swelling and be scattered in water, forming uniform suspension, then use ethanol wash, dry, obtain hemostatic starch A.
By 2g carboxymethyl starch 66# as in 30ml water, constantly stir, make starch granules fully swelling and be scattered in water, forming uniform suspension, then pouring in container, then use ethanol wash, dry, obtain hemostatic starch C.
By 3g crosslinked carboxymethyl fecula 66#
+as in 30ml water, constantly stir, make starch granules fully swelling and be scattered in water, forming uniform suspension, then pouring in container, then use ethanol wash, dry, obtain hemostatic starch D.
By 3g hydroxyethylamyle 88# modified starch as in 30ml water, constantly stir, make starch granules fully swelling and be scattered in water, forming uniform suspension, then use ethanol wash, dry, obtain hemostatic starch E.
The water absorbent rate of embodiment 18 hemostatic starch and the detection of rate of water absorption
Starch water absorbent rate adopts centrifugal determination, is about to about 0.025g starch as in 2ml water, and balance 10min, then puts into whizzer, and under 500rpm rotating speed, take out after centrifugal 10 minutes, weigh and calculate raffinate amount, each sample test removes mean value 6 times.
The rate of water absorption of starch is observed by German Dataphysics company OCA40Micro video contact angle measuring instrument.
Experimental result: the hemostatic starch A that the 16 kinds of hemostatic starchs obtained by embodiment 1-16 method and embodiment 17 control group are obtained, its water absorbent rate of C, D, E and rate of water absorption contrast as shown in the table:
Table 1
Interpretation:
Following conclusion can be drawn by above experimental data:
1. the kind of method of the present invention to modified starch has no requirement, in prior art, the conventional modified starch seen may be used to present method, its water absorbent rate of the hemostatic starch prepared and rate of water absorption all far above modified starch starch of the prior art, have obvious performance advantage.Such as compared with control group, water absorbent rate on average improves more than 30%, and rate of water absorption improves more than 1 times, has obvious performance advantage.
2. before ultrasonic step can be positioned at modified starch denaturation process, among or afterwards, as long as employ ultrasonic step in the preparation whole process of modified starch, all can improve water absorbent rate and the rate of water absorption of the new modified starch of acquisition.
Embodiment 19 modified starch hemostatic starch is to the haemostatic effect of liver Hemorrhage Model
Test method:
Cut liver placenta percreta area 1.5cm × 2.5cm in pig liver surface scalpel, Wound depth is 0.25cm, makes the hemorrhage surface of a wound, and the hemostatic starch of employing has: hemostatic starch 1-90, and the hemostatic starch that control group adopts has hemostatic starch A, C, D, E.
Respectively the above-mentioned surface of a wound is stopped blooding.After hemorrhage, be placed on by hemostatic starch immediately on wound and also exert pressure on starch with medical surgical gloves or hemostatic gauze, gloves or gauze are unclamped after 1 ~ 2min by blocking blood flow gently, observe haemostatic effect, gloves and gauze whether adhesion starch and sludged blood, cause again hemorrhage when opening.Without the need to modified starch starch is taken away or removed after hemostasis, but do suitably to infiltrate with physiological saline and rinse.
Test-results:
Hemostatic starch 1-16 haemostatic effect is fine, and easy to use.All hemostatic starchs is sucked blood immediately after meeting blood and is formed the starch-sludged blood colloid of viscosity with blood, within 1 minute, all can effectively control the hemorrhage of the liver surface of a wound, and hemostatic starch A, C, D, E more than 1.5 minutes, the time just can Bleeding control.Hemostatic starch 1-90 and liver wound tissue tight adhesion, promote blood coagulation, the gauze dressing of sludged blood and pressing does not stick together, and can not cause again hemorrhage.
Claims (11)
1. a preparation method for hemostatic starch, is characterized in that: comprise the following steps:
1) modified starch raw material is carried out etherificate, crosslinked, esterification and repeatedly makes new modified starch after sex change,
2) wash, dry, obtain hemostatic starch,
In step 1) before, among or add sonicating step afterwards.
2. preparation method as claimed in claim 1, is characterized in that: the modified starch raw material in step 1 is one or more the combination in pre-gelatinized starch, denaturated starch by acid, dextrin, Sumstar 190, esterification starch, etherification starch, cross-linking starch, graft starch, composite modified starch.
3. preparation method as claimed in claim 2, is characterized in that: power during supersound process is 450W-600W.
4. preparation method as claimed in claim 3, is characterized in that: sonication treatment time is 3-7min.
5. preparation method as claimed in claim 3, is characterized in that: ultrasound treatment patterns is effect 2s interval 2s.
6. the hemostatic starch that described in any one of claim 1-5, method prepares.
7. the purposes of the hemostatic starch of claim 6, its feature exists: the hemostatic material having the blood surface of a wound for the preparation of people, Mammals, birds, Reptilia.
8. the purposes of the hemostatic starch of claim 6, its feature exists: for the preparation of body surface, in-vivo tissue organ have the blood surface of a wound hemostatic material or for the hemostatic material under surgical operation, emergency care of trauma, laryngoscope, endoscope, chamber mirror.
9. the purposes of the hemostatic starch of claim 6, is characterized in that: for the preparation of the material promoting organization healing.
10. the purposes of the hemostatic starch of claim 9, is characterized in that: described tissue comprises sub-dermal soft tissue, muscle tissue, osseous tissue, cerebral tissue, nervous tissue, liver,kidney,spleen.
The purposes of the hemostatic starch of 11. claims 6, is characterized in that: the material sticked together for the preparation of its hetero-organization or organ of preventing the tissue of wound or organ and surrounding.
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| CN103265640B (en) * | 2013-05-08 | 2016-03-30 | 江苏德威兰医疗器械有限公司 | A kind of hemostatic starch and preparation method thereof |
| CN103265641B (en) * | 2013-05-08 | 2016-05-25 | 江苏德威兰医疗器械有限公司 | A kind of hemostatic starch and preparation method thereof |
| CN103570838B (en) * | 2013-10-17 | 2015-09-02 | 广州大学 | A kind of preparation method of composite modified high amylose starch |
| CN105770963A (en) * | 2014-12-23 | 2016-07-20 | 重庆联佰博超医疗器械有限公司 | Polysaccharide styptic powder, preparation method and applications thereof |
| CN105107006B (en) * | 2015-07-24 | 2018-02-16 | 成都仁天医疗器械有限公司 | A kind of degradable starch-based hemostatic material and its preparation method and application |
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| CN101497670A (en) * | 2008-01-29 | 2009-08-05 | 纪欣 | Biocompatibility pre-gelatinized modified starch and preparation thereof |
| CN101785873A (en) * | 2009-01-23 | 2010-07-28 | 纪欣 | Biocompatible bleed-stopping and bone healing promoting material and preparation method thereof |
| WO2011067403A1 (en) * | 2009-12-06 | 2011-06-09 | B. Braun Melsungen Ag | Starch derivative mixtures |
| CN103265641A (en) * | 2013-05-08 | 2013-08-28 | 江苏德威兰医疗器械有限公司 | Hemostasis starch and preparation method thereof |
| CN103265640A (en) * | 2013-05-08 | 2013-08-28 | 江苏德威兰医疗器械有限公司 | Hemostasis starch and preparation method thereof |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101497670A (en) * | 2008-01-29 | 2009-08-05 | 纪欣 | Biocompatibility pre-gelatinized modified starch and preparation thereof |
| CN101785873A (en) * | 2009-01-23 | 2010-07-28 | 纪欣 | Biocompatible bleed-stopping and bone healing promoting material and preparation method thereof |
| WO2011067403A1 (en) * | 2009-12-06 | 2011-06-09 | B. Braun Melsungen Ag | Starch derivative mixtures |
| CN103265641A (en) * | 2013-05-08 | 2013-08-28 | 江苏德威兰医疗器械有限公司 | Hemostasis starch and preparation method thereof |
| CN103265640A (en) * | 2013-05-08 | 2013-08-28 | 江苏德威兰医疗器械有限公司 | Hemostasis starch and preparation method thereof |
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