CN104922722A - Preparation method of absorbable degradatable starch hemostatic material - Google Patents
Preparation method of absorbable degradatable starch hemostatic material Download PDFInfo
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- CN104922722A CN104922722A CN201410097478.0A CN201410097478A CN104922722A CN 104922722 A CN104922722 A CN 104922722A CN 201410097478 A CN201410097478 A CN 201410097478A CN 104922722 A CN104922722 A CN 104922722A
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Abstract
The invention relates to an absorbable degradatable starch hemostatic material. Involved starch is modified starch and includes one or more of carboxymethyl starch and hydroxypropyl starch. The starch hemostatic material includes one or more forms of hemostatic micro-particles, a hemostatic membrane and a hemostatic sponge. The preparation method includes processes of inactivating and devirusing, and the purposes comprise that the prepared hemostatic material is safe and effective and has an excellent hemostatic effect and generates no heat source reaction in clinical application. The preparation method also includes a granulating process of the hemostatic particles and a vacuum freeze-drying process of other forms of hemostatic materials. The prepared hemostatic material has excellent biocompatibility, can be absorbed and degraded in vivo, is non-toxic, has no stimulation, has flexible forms, can be directly used in various complicated bloody wound surfaces, absorbs moisture in blood, aggregates coagulation factors, platelets, fibrous protein sources and red corpuscles in the blood to the wound surfaces, and plays roles in closing hemostasis, preventing tissue adhesion and promoting tissue healing.
Description
Technical field
The present invention relates to medical art, be specifically related to a kind of to there is excellent biocompatibility, Absorbable rod, degraded, nontoxic, the preparation method of starch hemostatic material that has no side effect.
Background technology
Various wound hemostasis is in medical industry and the focus of medical circle research.Also be the therapeutic process of doctor's emphasis in various wound and operation process, use and have that biology mixes, the hemostatic material of absorbable and degradable is safe and effective in the hemostasis of various wound surface, easy to use have bright prospects, benefits the nation and the people, the major issue of healthy human.
Conventional at present hemostatic material such as collagen protein sponge, gelfoam, regenerated fiber hemostatic gauze etc. have been applied for many years clinical, but different materials has different hemostatic mechanisms and corresponding advantage and limitation, and especially pure Animal by-product has higher risk.
Starch is green plants, the polymeric carbohydrate formed through photosynthesis, is a kind of a kind of desirable biomaterial having nontoxic, degradable, can biological mix.Modified starch hemostasia products can adopt different dosage forms according to different wound surface in clinical practice, can not limit by wound surface, reaches best haemostatic effect.
As modified starch, ative starch is not also had at present directly to carry out without deactivation and the ative starch of removing virus the starch that degeneration just can be used for using in body, potential risks can be there are in the hemostasia products of non-deactivation and removal virus in hemostasis, as bacterial endotoxin exceedes human body tolerance range, can heat source response be there is, serious untoward reaction may be caused to cause operative failure and cause the risk of malpractice.So particularly important for reduction product risks with this process of removal virus to the deactivation of the virus of its starch before degeneration.
Summary of the invention
One object of the present invention is for providing a kind of preparation method of absorbable and degradable starch hemostatic material, and the starch hemostatic material utilizing the method to prepare has without bacterial endotoxin, without the advantage such as thermal source, quick-acting haemostatic powder, absorbable and degradable, bio-compatible be good.And technology of preparing is stablized, preparation process is pollution-free, without noxious emission, be with a wide range of applications.
The preparation method of absorbable and degradable starch hemostatic material of the present invention is realized by following steps:
(1) before degeneration, deactivation carried out to ative starch and remove the process of virus;
(2) starch of deactivation and removal virus is carried out degeneration;
(3) methods such as boiling, suspension, spraying one or more combination of the starch after degeneration are adopted to prepare small porous particle;
(4) film series products is prepared by one or more combination of the starch after degeneration or with the vacuum drying method of the combined employing of other biomaterial;
(5) by one or more combination of the starch after distortion or prepare with the method for the combined employing vacuum lyophilization of other biomaterial and go back sponge products;
In the process, the ative starch of step (1) be corn starch, potato starch, Maninot esculenta crantz. and other starch one or more.The deactivation of step (1) and the processing method of removal virus comprise the one in following methods:
Method one, to be mixed by ative starch fully stir with 75% ethanol, form emulsus (30-60 rev/min of stirring, is no less than 30 minutes action time) and taken off by ethanol, washing, washing employing purified water, washing times is no less than 3 times.
Require in the method to carry out limit test of microbe to ative starch randomization, after washing, resampling does following inspection.
(1) limit test of microbe is carried out to the goods after washing.
(2), within baterial endotoxin test should be limited in 5EU/ml, as touched the mark after washing, by the requirement preparing hemostatic material, degeneration is carried out to ative starch.
Method two, ative starch is carried out irradiation sterilization dosage at 3-18KGY, the starch after sterilizing carries out washing the virus and impurity of removing deactivation, and washing temperature controls at 20 DEG C-40 DEG C, and water quality is purified water, adopt suspend, the method such as centrifugal, precipitation.
Ative starch randomization carries out limit test of microbe in the method, carries out sterility test after irradiation sterilization, checks endotoxin situation simultaneously, wash after the above results record with tiny electrolytic cell instrument.Sampling check after washing, endotoxin should control within 5EU/ml, increases washing times if not up to standard, as the starch viral with removal to deactivation up to standard carries out degeneration by the different hemostatic material of preparation.
Above preparation method be pretreatment to various hemostatic material, to obtain the modified starch raw material of safe and reliable hemostasia products.
In the process, deactivation and the starch of removing virus are carried out degeneration by step (2), the mode of its degeneration including, but not limited to:
(1) physical modification pre-gelatinized starch, irradiated starch, ion modified starch etc.
(2) chemical modification enzymatic starch, Oxytarch, esterification starch, etherification starch, graft starch, crosslinked starch etc.
(3) enzyme process degeneration bio-modification starch and various enzyme treated starch etc.
(4) composite starch adopts the modified starch that two or more processing method obtains, as oxidative crosslinked starch, esterified and cross-linked starch etc.
The degeneration of starch can adopt Dry process, wet method degeneration, extruding degeneration etc.Above-mentioned modified starch can select potato starch, corn starch, tapioca, rice starch, wheaten starch etc.
In the process, one or more combination of the starch after degeneration adopts the methods such as boiling, suspension, spraying to prepare small porous particle by step (3).
In the process, ultrasound wave homogenizing is carried out in the combination that modified starch is obtained one or more modified starches by step (4), using the assembly after homogenizing as carrier, be mixed in proportion with viral the chitosan of removal or other materials, homogenizing again, carries out vacuum drying and namely obtains all size Antiadhesive film.
In the process, step (5) modified starch is obtained one or more modified starches must combine carry out ultrasound wave homogenizing after carry out emulsifying, emulsifying temperature is at 40 DEG C-80 DEG C, add appropriate emulsifying agent when needing, the assembly cool to room temperature after emulsifying carries out vacuum lyophilization and namely obtains various sthptic sponge product.
Accompanying drawing explanation
Fig. 1 is hemostatic micro-granules scanning electron microscope diagram
Fig. 2 is sthptic sponge scanning electron microscope diagram
Detailed description of the invention
The preparation method of absorbable and degradable starch hemostatic material of the present invention is realized by following steps:
(1) before degeneration, deactivation carried out to ative starch and remove the process of virus;
(2) starch of deactivation and removal virus is carried out degeneration;
(3) methods such as boiling, suspension, spraying one or more combination of the starch after degeneration are adopted to prepare small porous particle;
(4) film series products is prepared by one or more combination of the starch after degeneration or with the vacuum drying method of the combined employing of other biomaterial;
(5) by one or more combination of the starch after distortion or prepare with the method for the combined employing vacuum lyophilization of other biomaterial and go back sponge products;
In the process, the ative starch of step (1) be corn starch, potato starch, Maninot esculenta crantz. and other starch one or more.The deactivation of step (1) and the processing method of removal virus comprise the one in following methods:
Method one, ative starch mixed with 75% ethanol and fully stirs, form emulsus (30-60 rev/min of stirring, be no less than 30 minutes action time) ethanol is taken off, washing, washing adopts purified water, washing times is no less than 3 times, can according to the viral level determination washing times of deactivation.
Require in the method to carry out limit test of microbe to ative starch randomization, after washing, resampling does following inspection.
(1) limit test of microbe is carried out to the goods after washing.
(2), within baterial endotoxin test should be limited in 5EU/ml, as touched the mark after washing, by the requirement preparing hemostatic material, degeneration is carried out to ative starch.
Method two, ative starch is adopted Co 60 or other rays for irradiation, virus in starch is carried out deactivation, the amount of the bacterial endotoxin after irradiation intensity detects according to ative starch is determined, irradiation sterilization dosage is usually at 3-18KGY, starch after sterilizing carries out washing the virus and impurity of removing deactivation, washing temperature controls at 20 DEG C-40 DEG C, and water quality is purified water, adopt suspend, the method such as centrifugal, precipitation.
Ative starch randomization carries out limit test of microbe in the method, carries out sterility test after irradiation sterilization, checks endotoxin situation simultaneously, wash after the above results record with tiny electrolytic cell instrument.Sampling check after washing, endotoxin should control within 5EU/ml, increases washing times if not up to standard, as the starch viral with removal to deactivation up to standard carries out degeneration by the different hemostatic material of preparation.
Above preparation method be pretreatment to various hemostatic material, to obtain the modified starch raw material of safe and reliable hemostasia products.
In the process, deactivation and the starch of removing virus are carried out degeneration by step (2), the mode of its degeneration including, but not limited to:
(1) physical modification pre-gelatinized starch, irradiated starch, ion modified starch etc.
(2) chemical modification enzymatic starch, Oxytarch, esterification starch, etherification starch, graft starch, crosslinked starch etc.
(3) enzyme process degeneration bio-modification starch and various enzyme treated starch etc.
(4) composite starch adopts the modified starch that two or more processing method obtains, as oxidative crosslinked starch, esterified and cross-linked starch etc.
The degeneration of starch can adopt Dry process, wet method degeneration, extruding degeneration etc.Above-mentioned modified starch can select potato starch, corn starch, tapioca, rice starch, wheaten starch etc.
In the process, one or more combination of the starch after degeneration adopts the methods such as boiling, suspension, spraying to prepare small porous particle by step (3).
Described boiling is with special boiling granulator; it the method for starch vacuum is made to produce boiling effect when negative pressure; water for injection is atomized; be sprayed on the starch of boiling; the granule of starch is made to be bonded to granule through the water of spraying; by regulate droplet size control starch microparticles particle diameter, drying porous-starch microgranule.
Described suspension is that starch is mixed into emulsion with water for injection in proportion, the method that this emulsion is sprayed is sprayed in the closed storehouse of 50 DEG C-80 DEG C, and suitably enters emulsion that negative pressure makes to spray into and to suspend and dry.
In the process, ultrasound wave homogenizing is carried out in the combination that modified starch is obtained one or more modified starches by step (4), using the assembly after homogenizing as carrier, be mixed in proportion with viral the chitosan of removal or other materials, homogenizing again, carries out vacuum drying and namely obtains all size Antiadhesive film.
The preparation method of film product comprises: be coated in by mixed liquor coating machine on polytetrafluoro flat board and carry out vacuum drying, and the temperature of vacuum drier is set in 45 DEG C of-65 DEG C of scopes and carries out vacuum, and vacuum is advisable not make mixed liquor bubble, shape film-forming products.
In the process, step (5) modified starch is obtained one or more modified starches must combine carry out ultrasound wave homogenizing after carry out emulsifying, emulsifying temperature is at 40 DEG C-80 DEG C, add appropriate emulsifying agent when needing, the assembly cool to room temperature after emulsifying carries out vacuum lyophilization and namely obtains various sthptic sponge product.
The manufacturing process of sthptic sponge product comprises: the mixed liquor fill of starch and water for injection is carried out lyophilizing in lyophilizing mould, is frozen into by mixed liquor solid-state, generally at-32 DEG C in 6 hours--and 42 DEG C of insulation 4-6 hour, start vacuum operation.Make it distil by the speed of rising per hour 2 DEG C the temperature in freeze dryer simultaneously, can vacuum operation be stopped when temperature is raised to 30 DEG C, starch sponge molding.
Embodiment 1:
The preparation of small porous particle hemostatic micro-granules: ultrasound wave homogenizing is carried out in the combination of one or more modified starches of modified starch, is undertaken the assembly after homogenizing seething with excitement, suspends, the method such as spraying makes small porous particle, obtain small porous particle styptic powder.
Fig. 1 is the scanning electron microscope diagram sheet of how empty hemostatic micro-granules, and as shown in the figure, gained small porous particle particle size range of the present invention is between 30-300nm, and microparticle surfaces hole distribution is even.
Embodiment 2:
The preparation of sthptic sponge: after the combination of one or more modified starches of modified starch being carried out excusing from death ripple homogenizing, then add appropriate water for injection, then homogenizing.Homogenizing temperature is at 40 DEG C-80 DEG C, and homogenizing time is no less than 60 minutes and carries out vacuum operation, finally carries out vacuum lyophilization, obtains sthptic sponge.
Fig. 2 is sthptic sponge scanning electron microscope diagram sheet, and freezing dry process maintains starch polymer structure, and the sponge Hole that can obtain porous form after drying is dendroid, and bore hole size is even.
Embodiment 3:
The preparation of sthptic sponge: modified starch is obtained one or more modified starches must combine carry out ultrasound wave homogenizing after carry out emulsifying, emulsifying temperature is at 40 DEG C-80 DEG C, add appropriate emulsifying agent when needing, the assembly cool to room temperature after emulsifying carries out vacuum lyophilization and namely obtains sthptic sponge.
Embodiment 4:
The preparation of sthptic sponge: modified starch is obtained one or more modified starches and obtain assembly and remove viral must being mixed in proportion (ratio mixed is that chitosan is within 1%-50%) by chitosan, fully stir, vacuum operation 2 hours, carries out vacuum lyophilization and namely obtains sthptic sponge.
Embodiment 5:
The preparation of Antiadhesive film: ultrasound wave homogenizing is carried out in combination modified starch being obtained one or more modified starches, viral that chitosan mixes with removal, the ratio of chitosan is greater than more than 60% of starch monomer or mixture, add the water for injection of 40 DEG C-60 DEG C, homogenizing again, vacuum operation 2 hours, carries out vacuum drying and namely obtains Antiadhesive film.
The Antiadhesive film of thickness at 0.2mm to 1mm all size can be prepared according to the requirement that product uses.
Embodiment 6:
The preparation of Antiadhesive film: ultrasound wave homogenizing is carried out in the combination of one or more modified starches of modified starch, be no less than the polylactic acid of 60% in proportion, poly-DL-lactic acid-co-glycolic acid carries out ultrasonic emulsification, and vacuum operation carries out vacuum drying in 2 hours again, obtains Antiadhesive film.
Thickness can be prepared according to the instructions for use of product and obtain Antiadhesive film at 0.2mm to 1mm all size.
Embodiment 7:
The preparation of Antiadhesive film: modified starch is obtained one or more modified starches and must combine and carry out ultrasound wave homogenizing, using the assembly after homogenizing as carrier, be mixed in proportion with hyaluronate sodium, chitosan, Rhizoma amorphophalli glucomannan, carry out microwave to be cross-linked, crosslinking time is no less than 4 hours, adopt dehydrated alcohol do cross-linking agent make its mix, vacuum drying, obtains Antiadhesive film.
Claims (10)
1. a preparation method for absorbable and degradable starch hemostatic material, comprises the following steps:
(1) carry out deactivation to starch and remove the process of virus, mixed with 75% ethanol by ative starch and fully stir, 30-60 rev/min is stirred 30 minutes, forms emulsus, takes off ethanol, then wash, and washing adopts purified water, and washing times is no less than 3 times;
(2) degeneration is carried out in deactivation and the starch of removing virus, the method for described degeneration is the one in etherificate, esterification, oxidation, crosslinked and complex denaturation;
(3) small porous particle is prepared in the starch employing boiling after degeneration, suspension process, wherein, described boiling process adopts boiling granulator, starch is produced boiling effect under negative pressure, water for injection is atomized, is injected on the starch of boiling, make the granule of starch be bonded to granule through the water of spraying, by regulate droplet size control starch microparticles particle diameter, drying porous-starch microgranule; Described suspension process is that starch is mixed into emulsion with water for injection in proportion, the method that this emulsion is sprayed is sprayed in the closed storehouse of 50 DEG C-80 DEG C, and carries out emulsion that Negative pressure makes to spray into and to suspend and dry, forms starch small porous particle.
2. a preparation method for absorbable and degradable starch hemostatic material, comprises the following steps:
(1) carry out deactivation to starch and remove the process of virus, mixed with 75% ethanol by ative starch and fully stir, 30-60 rev/min is stirred 30 minutes, forms emulsus, takes off ethanol, then wash, and washing adopts purified water, and washing times is no less than 3 times;
(2) degeneration is carried out in deactivation and the starch of removing virus, the method for described degeneration is the one in etherificate, esterification, oxidation, crosslinked and complex denaturation;
(3) be coated on polytetrafluoroethylene by the starch solution coating machine after degeneration and carry out vacuum drying treatment, the temperature of vacuum drier is set in 45 DEG C of-65 DEG C of scopes, forms starch film product.
3. a preparation method for absorbable and degradable starch hemostatic material, comprises the following steps;
(1) carry out deactivation to starch and remove the process of virus, mixed with 75% ethanol by ative starch and fully stir, 30-60 rev/min is stirred 30 minutes, forms emulsus, takes off ethanol, then wash, and washing adopts purified water, and washing times is no less than 3 times;
(2) degeneration is carried out in deactivation and the starch of removing virus, the method for described degeneration is the one in etherificate, esterification, oxidation, crosslinked and complex denaturation;
(3) method of vacuum lyophilization is adopted to prepare sponge products the starch after degeneration, the preparation method of described sponge products is, the mixed liquor fill of starch and water is carried out freezing in freezing mould, in 6 hours, mixed liquor is frozen into solid-state, at-32 DEG C--42 DEG C of insulation 4-6 hour, start application of vacuum, the temperature in freeze dryer are made described solid state sublimation by the speed of rising per hour 2 DEG C simultaneously, stop vacuum operation when temperature is raised to 30 DEG C, form starch sponge.
4. according to the method one of claims 1 to 3 Suo Shu, it is characterized in that: before degeneration, deactivation carried out to starch and remove the process of virus, the state that can be used in body can be reached, then carry out degeneration.
5. according to the method one of claims 1 to 3 Suo Shu, it is characterized in that: within the bacterial endotoxin of starch material is limited in 5EU/ml.
6. method according to claim 1, is characterized in that: hemostasis small porous particle particle diameter is between 60 order-200 orders, and its aperture 30-300nm and porosity are no less than in 60% scope.
7. method according to claim 3, is characterized in that: sthptic sponge is the spongy body with aperture, porosity and water absorption rate, by changing aperture and porosity reaches different water absorption rates.
8., according to a starch hemostatic material prepared by the method one of claims 1 to 3 Suo Shu, described starch hemostatic material is used for the hemostasis of tissue, comprises body surface, in-vivo tissue, intraluminal tissue and other the various hemostasis having blood wound.
9. starch hemostatic material according to claim 8, is characterized in that: sthptic sponge can be directly used in the hemostasis in blood wound surface and operation.
10. starch hemostatic material according to claim 8, is characterized in that: described starch hemostatic material has the effect promoting to organize healing acceleration.
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CN105056281A (en) * | 2015-07-09 | 2015-11-18 | 天津市长江医疗器械有限公司 | Starch sponge haemostatic material and preparation method thereof |
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CN107538873A (en) * | 2016-06-23 | 2018-01-05 | 吉林农业大学 | A kind of support carrier by the use of electroheating type teflon material as production starch film |
CN109125795A (en) * | 2018-10-18 | 2019-01-04 | 赛克赛斯生物科技股份有限公司 | A kind of polysaccharide hemostatic composition and the preparation method and application thereof |
CN111388745A (en) * | 2020-02-20 | 2020-07-10 | 北京爱特康医疗科技有限公司 | Composite starch hemostatic and preparation method thereof |
CN114191601A (en) * | 2021-11-25 | 2022-03-18 | 华南理工大学 | Starch gel hemostatic material based on 3D printing technology and preparation method and application thereof |
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CN105056282A (en) * | 2015-07-09 | 2015-11-18 | 天津市长江医疗器械有限公司 | Starch porous particle hemostasis material and preparation method thereof |
CN105056281A (en) * | 2015-07-09 | 2015-11-18 | 天津市长江医疗器械有限公司 | Starch sponge haemostatic material and preparation method thereof |
CN105107005A (en) * | 2015-07-09 | 2015-12-02 | 天津市长江医疗器械有限公司 | Starch film haemostasis material and preparation method thereof |
CN107538873A (en) * | 2016-06-23 | 2018-01-05 | 吉林农业大学 | A kind of support carrier by the use of electroheating type teflon material as production starch film |
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CN109125795A (en) * | 2018-10-18 | 2019-01-04 | 赛克赛斯生物科技股份有限公司 | A kind of polysaccharide hemostatic composition and the preparation method and application thereof |
CN109125795B (en) * | 2018-10-18 | 2021-06-15 | 赛克赛斯生物科技股份有限公司 | Polysaccharide hemostatic composition and preparation method and application thereof |
CN111388745A (en) * | 2020-02-20 | 2020-07-10 | 北京爱特康医疗科技有限公司 | Composite starch hemostatic and preparation method thereof |
CN114191601A (en) * | 2021-11-25 | 2022-03-18 | 华南理工大学 | Starch gel hemostatic material based on 3D printing technology and preparation method and application thereof |
CN114191601B (en) * | 2021-11-25 | 2022-05-24 | 华南理工大学 | Starch gel hemostatic material based on 3D printing technology and preparation method and application thereof |
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Application publication date: 20150923 |
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