CN100453122C - Hemostatic micro-granules and its prepn. method - Google Patents
Hemostatic micro-granules and its prepn. method Download PDFInfo
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- CN100453122C CN100453122C CNB2006100536809A CN200610053680A CN100453122C CN 100453122 C CN100453122 C CN 100453122C CN B2006100536809 A CNB2006100536809 A CN B2006100536809A CN 200610053680 A CN200610053680 A CN 200610053680A CN 100453122 C CN100453122 C CN 100453122C
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Abstract
A superfine styptic powder is the micron-class porous spherical particles. It is prepared from the potato starch through gelatinizing, regulating pH=8-10, emulsifying by span 80, dispersing in paraffin wax oil, cross-linking with epichlorohydrin, separating by ethyl acetate, washing with absolute alcohol, dewatering, baking, loading in sprayer, and sterilizing by epoxy ethane.
Description
(1) technical field
The present invention relates to a kind of medical hemostatic micro-granules and preparation method thereof.
(2) background technology
The local hemostasis material is extremely important, and as the injured rescue of the emergency treatment of daily sudden accident, particularly war, hospital all usually will use the local hemostasis material in to patient's wound hemostasis.To the hemorrhage main employing binder compressing of extremity bleeding part, discover recently and use the field operations dressing of the new hemostatic mechanism that is different from direct compressing can reduce severe haemorrhage at present.Before the ideal institute dressing should have that cost is low, good stability, easy to use, characteristics such as haemostatic effect is good, can form simultaneously moistening, heat insulation environment with prevention bacterial invasion and absorption wound exudate and pollutant, and remove and be unlikely to destroy new epithelize and blood crusts from wound easily.Use collagen-based composite, fibrin product, chitosan and zeolite that more general bleeding-stopping dressing has traditional alginate, collagen and occurs recently at present.The Taehocomd that Linz, AUT city HafsLund Nycomed pharmaceuticals develops can absorb blood stanching of wound surface agent, Gelfix hemostatic material and Surgieel regenerated cellulose hemostatic material etc.Its haemostatic effect has all fully been verified in surgical operation and zoopery.Simultaneously, experiment in vitro has also been proved its good anthemorrhagic performance.But its medicinal ingredient mainly is thrombin of beef that extracts etc. in animal body, dangerous.
Surgical hemostasis is one of core of surgical technic, and good hemostatic technique is the key that guarantees that operation is successful.Along with of the raising of various countries' medical circle to hemostatic material anthemorrhagic performance and the requirement of full peace property, seek the good biomaterial of occurring in nature, develop haemostatic effect better, have no side effect, nonirritant, be easy to the bleeding-stopping dressing of machine-shaping, imperative.
(3) summary of the invention
Task of the present invention is to utilize the agricultural product potato starch to extract micropore polysaccharide to prepare hemostatic micro-granules, this hemostatic micro-granules good biocompatibility, have no side effect, haemostatic effect is good, is applicable to the large tracts of land oozing of blood, the deep is hemorrhage and operation technique is difficult to reach the hemorrhage of position.The present invention also provides the preparation method of this hemostatic micro-granules.
The medicinal ingredient of the hemostatic micro-granules provided by the invention spheroidal particle that 30～98 microns surface band micropore is arranged that to be the micropore polysaccharide that extracts from potato starch form after crosslinked.
The preparation method of hemostatic micro-granules of the present invention:
1) produce starch solution: get the potato starch of constant weight unit, add 10～50 times of distilled water, the starch solution after the stirring is fully adjusted pH to 8.0～10.0 with NaOH solution; Perhaps, drip NaOH solution in the starch solution after the gelatinizing fully, adjust pH to 8.0～10.0 the constant temperature gelatinizing in 50～70 ℃ of temperature water-baths of the starch solution behind the adding distil water;
2) produce paraffin oil-starch mixed solution: get span80 emulsifying agent, liquid paraffin, mix, in 50～70 ℃ of thermostat water baths, stirred 5-30 minute, join then in the starch solution of step 1), stirring and evenly mixing 5-30 minute, the envelope-bulk to weight ratio of paraffin oil and potato starch, ml/g is 25～200: 1; The weight ratio of span80 emulsifying agent and potato starch, g/g is 0.1～2.5: 1;
3) crosslinking Treatment: add the chloropropylene oxide of certain volume unit in above-mentioned paraffin oil-starch mixed solution, stirring reaction 1～10 hour, the ratio of chloropropylene oxide and the volume weight of potato starch, ml/g is 0.05～2.5: 1;
4) preparation hemostatic micro-granules: above-mentioned product standing demix, take off a layer milky white liquid, add ethyl acetate, addition is 4～5 times of lower floor's milky white liquid, stirs; Standing demix takes off a layer milky white liquid again, adds the dehydrated alcohol of 2～3 times of primary liquid, restir, and vacuum filtration to moisture content is drained then, and the pressed powder drying that obtains, screening back packing promptly obtain product.
Gelatinization time in the step 1) of the present invention is 1～10 minute.
Advantage of the present invention is:
The micropore polysaccharide that from potato starch, extracts, one of formation has the surface of 30-98 micron to have the spheroidal particle (being called for short the MPH hemostatic micro-granules) of micropore after passing through technical finesse such as crosslinked grade, nontoxic, have no side effect, good biocompatibility, the composition that does not contain any animal sources or humanized, and be aseptic packaging.This granule makes the blood fast dewatering after being directly used in the active hemorrhage position, thereby thrombin, erythrocyte and platelet are concentrated, and promotes the clot of instantaneity to form, can be hemorrhage at the trunk that 1 minute inner control comprises tremulous pulse.
The effect of hemostatic micro-granules possess hydrophilic property molecule filter screen of the present invention.By assembling the solid constituent in the blood,, around granule, form a kind of colloidal mixture, thereby quickened natural coagulation process as plasma proteins such as platelet, erythrocyte, albumin, thrombin and Fibrinogens.Anastalsis took place in several minutes usually.Its degradation process in vivo begins after hemostasis takes place, and multiple factor is depended in its absorption, comprises the dosage of use and the position of use.When being used for soft tissue, hemostatic micro-granules is absorbed in a couple of days fully, without any tissue reaction.
The interaction property of product of the present invention is pure physical property, and this material has very high Absorption to liquid, and the absorption of the moisture in the blood is caused hematoblastic concentrating, and strengthens its coagulation speed and agglutinability; Water sorption equally also reduces the liquid volume of wound site fast, helps accumulative generation.After the imbibition, peripheral vessels is formed certain pressure and promotes hemostasis; The suction back forms waterproof gel shape, shutoff wound.This polysaccharide microgranule can promote solidifying of blood simultaneously, and electron scanning confirms that also fibrin sticks to around the microgranule.The polysaccharide microgranule can be very fast resolved into maltose and glucose by intravital amylase and PYRASE, can not become the cradle of infection, do not cause adhesion yet.
The MPH hemostatic micro-granules can be used for various surgical operations as a kind of auxiliary hemostasis device.When in that pressurization, ligation or other routine operation are invalid maybe can not implement the time, can help to control the hemorrhage of blood capillary, vein and tremulous pulse.
Compare with Fibrin Glue, chemosynthesis glue, have haemostatic effect more efficiently, be particularly useful for the large tracts of land oozing of blood, the hemorrhage and operation technique in deep is difficult to reach the hemorrhage of position.
(4) specific embodiments
Further specify the present invention below by example, but invention is not limited thereto.
Embodiment 1:
1) produce starch solution:
Accurately take by weighing edible Rhizoma Solani tuber osi (Rhizoma Solani tuber osi) starch 4.0g with electronic balance, measure 40～200ml distilled water with graduated cylinder, mix homogeneously in the 250ml beaker;
In above-mentioned starch solution, drip the NaOH solution of 1mol/L, observe in pH value of solution=8.0～10.0 scopes with the pH reagent paper;
2) produce paraffin oil-starch mixed solution:
The above-mentioned starch solution that mixes up pH value, disperse with span80 emulsifying and paraffin oil, promptly accurately get span80 emulsifying agent 0.4～10.0g with electronic balance, measure liquid paraffin 100～1200ml with graduated cylinder, join in the ground flask, stirring rod is installed, the ground flask is placed 50～70 ℃ thermostat water bath, begin to stir, mixing speed is about 500rpm; After stirring 5～30min, add the starch solution of above-mentioned preparation, continue to stir 5～30min;
3) crosslinking Treatment:
Measure chloropropylene oxide 0.2～8.0ml with pipet, add in paraffin oil-starch mixed solution, (the optimization time is 2～4h) to stirring reaction 1～10h;
4) hemostatic micro-granules:
Above-mentioned product is poured in the 1000ml beaker, leaves standstill, about 2h, treat the solution layering after, upper solution is toppled over, the milky white liquid A of lower floor continues to employ;
In lower floor's milky white liquid, add ethyl acetate, separatory, addition approximately is 4～5 times of lower floor's milky white liquid, stirs with Glass rod, pours in the 1000ml separatory funnel and leaves standstill separatory, takes off a layer milky white liquid B;
Add dehydrated alcohol among the milky white liquid B of lower floor behind separatory, addition is 2～3 times of the milky white liquid B of lower floor, stirs with Glass rod, and sand core funnel is connected with vacuum pump, and the startup water pump is poured solution into the sand core funnel sucking filtration, drains to moisture;
The pressed powder that sucking filtration obtains takes out and places culture dish, places 40 ℃ Constant Temp. Oven to dry on culture dish;
Get the pressed powder after the oven dry, the sub-sieve screening with 30.8～98 μ m is product.
Accurately weighing is loaded on medicinal sprayer unit, airtight package, ethane via epoxyethane sterilization back warehouse-in.
Embodiment 2
1) produce gelatinization of starch solution:
Accurately take by weighing edible Rhizoma Solani tuber osi (Rhizoma Solani tuber osi) starch 4.0g with electronic balance, measure the 100ml distilled water with graduated cylinder, mix homogeneously in the 250ml beaker;
The above-mentioned beaker for preparing solution is placed 50 ℃ thermostat water bath, and heating in water bath keeps 5min, and continues slowly to use glass stirring rod agitating solution, is starchiness to solution, takes out beaker and is cooled to room temperature, promptly obtains gelatinizing starch solution completely;
In gelatinization of starch solution, drip the NaOH solution of 1mol/L, observe in pH value of solution=9.0 scopes with the pH reagent paper;
2) produce paraffin oil-starch mixed solution:
The above-mentioned gelatinization of starch solution that mixes up pH value, disperse with span80 emulsifying and paraffin oil, promptly accurately get span80 emulsifying agent 1.6g with electronic balance, measure liquid paraffin 400ml with graduated cylinder, join in three mouthfuls of ground flasks, stirring rod is installed, three mouthfuls of ground flasks are placed 65 ℃ thermostat water bath, begin to stir, mixing speed is 500rpm; After stirring 15min, add the gelatinization of starch solution of above-mentioned preparation, continue to stir 15min;
3) crosslinking Treatment:
Measure chloropropylene oxide 0.8ml with pipet, add in paraffin oil-starch mixed solution, the stirring reaction time is 2h;
4) hemostatic micro-granules:
Above-mentioned product is poured in the 1000ml beaker, leaves standstill 2h, treat the solution layering after, upper solution is toppled over, the milky white liquid A of lower floor continues to employ;
In lower floor's milky white liquid, add ethyl acetate, separatory, addition approximately is 4～5 times of lower floor's milky white liquid, stirs with Glass rod, pours in the 1000ml separatory funnel and leaves standstill separatory, takes off a layer milky white liquid B;
Add dehydrated alcohol among the milky white liquid B of lower floor behind separatory, addition is 2～3 times of the milky white liquid B of lower floor, stirs with Glass rod, and sand core funnel is connected with vacuum pump, and the startup water pump is poured solution into the sand core funnel sucking filtration, drains to moisture;
The pressed powder that sucking filtration obtains takes out and places culture dish, places 40 ℃ Constant Temp. Oven to dry on culture dish;
Get the pressed powder after the oven dry, the sub-sieve screening with 30.8～98 μ m is product.
Accurately weighing is loaded on medicinal sprayer unit, airtight package, ethane via epoxyethane sterilization back warehouse-in.
Claims (3)
1. hemostatic micro-granules is characterized in that: but described hemostatic micro-granules is applied to wound surface hemostatic degradation in vivo in the body, and the micropore polysaccharide that extracts from potato starch is through the spheroidal particle of 30～98 microns surface band micropore of crosslinked back formation.
2. the preparation method of hemostatic micro-granules according to claim 1 is characterized in that carrying out according to following processing step:
1) produce starch solution: get the potato starch of constant weight unit, add 10～50 times of distilled water, the starch solution after the stirring is fully adjusted pH to 8.0～10.0 with NaOH solution; Perhaps, drip NaOH solution in the starch solution after the gelatinizing fully, adjust pH to 8.0～10.0 the constant temperature gelatinizing in 50～70 ℃ of temperature water-baths of the starch solution behind the adding distil water;
2) produce paraffin oil-starch mixed solution: get span80 emulsifying agent, liquid paraffin, mix, in 50～70 ℃ of thermostat water baths, stirred 5-30 minute, join then in the starch solution of step 1), stir 5-30 and divide clock time, the envelope-bulk to weight ratio of paraffin oil and potato starch, ml/g is 25～200: 1; The weight ratio of span80 emulsifying agent and potato starch, g/g is 0.1～2.5: 1;
3) crosslinking Treatment: add the chloropropylene oxide of certain volume unit in above-mentioned paraffin oil-starch mixed solution, stirring reaction 1～10 hour, the ratio of chloropropylene oxide and the volume weight of potato starch, ml/g is 0.05～2.5: 1;
4) preparation hemostatic micro-granules: above-mentioned product standing demix, take off a layer milky white liquid, add ethyl acetate, separatory, addition is 4～5 times of lower floor's milky white liquid, stirs; Standing demix takes off a layer milky white liquid again, adds dehydrated alcohol and cleans, and addition is 2～3 times of lower floor's milky white liquid, restir, and vacuum filtration to moisture content is drained then, and the pressed powder drying that obtains, screening back packing promptly obtain product.
3. the preparation method of hemostatic micro-granules according to claim 2 is characterized in that the gelatinization time in step 1) is 1～10 minute.
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| CN100453122C true CN100453122C (en) | 2009-01-21 |
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| CN101121041A (en) * | 2007-08-09 | 2008-02-13 | 美国淀粉医疗公司 | Denaturated starch absorbable hemostatic material and preparation method thereof |
| CN102406956B (en) * | 2011-03-09 | 2013-09-25 | 天津爱勒易医药材料有限公司 | Starch hemostatic microsphere and preparation method thereof |
| CN102139123B (en) * | 2011-03-25 | 2013-07-17 | 杜宝堂 | Method for preparing intra-operative hemostatic material by cross emulsification of plant starch |
| CN102302796B (en) * | 2011-09-08 | 2015-04-15 | 江苏天麟生物医药科技有限公司 | Absorptive hemostatic biological material and preparation method thereof |
| CN104274486A (en) * | 2013-09-03 | 2015-01-14 | 江西丽华鑫朗药业科技有限公司 | Composite biodegradable styptic powder prepared by sodium hyaluronate |
| CN104225662B (en) * | 2014-09-28 | 2016-03-23 | 沈丽青 | Hemostasia products and preparation method thereof |
| CN104606723B (en) * | 2014-12-12 | 2017-06-16 | 重庆联佰博超医疗器械有限公司 | Absorbability starch hemostatic powder and preparation method thereof, application |
| CN105688265A (en) * | 2016-01-22 | 2016-06-22 | 青岛中腾生物技术有限公司 | Absorbable hemostatic material as well as preparation method and use thereof |
| CN105597143B (en) * | 2016-02-01 | 2018-12-18 | 山东省药学科学院 | A kind of method that pure water mutually prepares styptic powder |
| CN105920662A (en) * | 2016-05-25 | 2016-09-07 | 重庆联佰博超医疗器械有限公司 | Absorbable wound buffer dressing |
| CN105920661A (en) * | 2016-05-25 | 2016-09-07 | 重庆联佰博超医疗器械有限公司 | Absorbable wound buffering dressing |
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| CN107802881A (en) * | 2016-12-07 | 2018-03-16 | 海南美享医药科技有限公司 | A kind of plant polysaccharide with anastalsis and preparation method thereof |
| CN106955375A (en) * | 2016-12-07 | 2017-07-18 | 凯文蔡司淀粉科技有限公司 | A kind of medical treatment device for including plant polysaccharide stopped blooding for Minimally Invasive Surgery |
| CN108434510B (en) * | 2018-05-23 | 2021-03-02 | 宁波宝亭生物科技有限公司 | Preparation method of modified starch hemostatic microspheres |
| CN108815564A (en) * | 2018-07-25 | 2018-11-16 | 青岛琛蓝海洋生物工程有限公司 | A kind of starch base styptic powder and preparation method thereof |
| CN110665049B (en) * | 2019-10-25 | 2022-02-01 | 石家庄亿生堂医用品有限公司 | Method for preparing hemostatic starch microspheres by ultrasonic |
| CN112843324A (en) * | 2021-01-13 | 2021-05-28 | 山东省药学科学院 | Preparation method of rapidly degradable hemostatic powder |
| CN115154645B (en) * | 2022-08-23 | 2023-09-26 | 赛克赛斯生物科技股份有限公司 | Antibacterial hemostatic material, preparation method and application thereof, and medical material |
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Assignee: Hangzhou Singclean Medical Products Co., Ltd. Assignor: Shen Jing Contract record no.: 2010330001603 Denomination of invention: Hemostatic micro-granules and its prepn. method Granted publication date: 20090121 License type: Exclusive License Open date: 20070418 Record date: 20100809 |
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Effective date of registration: 20160830 Address after: 311215, No. 10, East (125) Street, Xiasha economic and Technological Development Zone, Hangzhou, Zhejiang Patentee after: Hangzhou Singclean Medical Products Co., Ltd. Address before: 311402 Gaoqiao Industrial Park (Hefeng), Fuyang, Zhejiang Patentee before: Shen Jing |