CN100444901C - Biologically expansive hemorrhage arresting sponge and its production process - Google Patents
Biologically expansive hemorrhage arresting sponge and its production process Download PDFInfo
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- CN100444901C CN100444901C CNB031355765A CN03135576A CN100444901C CN 100444901 C CN100444901 C CN 100444901C CN B031355765 A CNB031355765 A CN B031355765A CN 03135576 A CN03135576 A CN 03135576A CN 100444901 C CN100444901 C CN 100444901C
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- 238000004519 manufacturing process Methods 0.000 title claims description 17
- 208000032843 Hemorrhage Diseases 0.000 title 1
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- 108010035532 Collagen Proteins 0.000 claims abstract description 27
- 229920001436 collagen Polymers 0.000 claims abstract description 26
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 20
- 238000005516 engineering process Methods 0.000 claims abstract description 19
- 238000004080 punching Methods 0.000 claims abstract description 15
- 239000007788 liquid Substances 0.000 claims abstract description 12
- 108091005804 Peptidases Proteins 0.000 claims abstract description 6
- 241000282894 Sus scrofa domesticus Species 0.000 claims description 17
- 238000000855 fermentation Methods 0.000 claims description 15
- 230000004151 fermentation Effects 0.000 claims description 15
- 241000282898 Sus scrofa Species 0.000 claims description 13
- 230000001954 sterilising effect Effects 0.000 claims description 13
- 238000004659 sterilization and disinfection Methods 0.000 claims description 10
- 239000004365 Protease Substances 0.000 claims description 5
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 claims description 5
- 239000002994 raw material Substances 0.000 claims description 5
- 230000018044 dehydration Effects 0.000 claims description 4
- 238000006297 dehydration reaction Methods 0.000 claims description 4
- 239000006260 foam Substances 0.000 claims description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 3
- 238000000748 compression moulding Methods 0.000 claims description 3
- 235000013861 fat-free Nutrition 0.000 claims description 3
- 235000014593 oils and fats Nutrition 0.000 claims description 3
- 238000000746 purification Methods 0.000 claims description 3
- 238000003307 slaughter Methods 0.000 claims description 2
- 206010052428 Wound Diseases 0.000 abstract description 9
- 208000027418 Wounds and injury Diseases 0.000 abstract description 9
- 238000010521 absorption reaction Methods 0.000 abstract description 4
- 230000002439 hemostatic effect Effects 0.000 abstract description 4
- 230000000740 bleeding effect Effects 0.000 abstract description 3
- 239000008280 blood Substances 0.000 abstract description 3
- 210000004369 blood Anatomy 0.000 abstract description 3
- 238000011049 filling Methods 0.000 abstract description 2
- 238000007710 freezing Methods 0.000 abstract description 2
- 230000008014 freezing Effects 0.000 abstract description 2
- 102000035195 Peptidases Human genes 0.000 abstract 1
- 230000002349 favourable effect Effects 0.000 abstract 1
- 238000005187 foaming Methods 0.000 abstract 1
- 239000011148 porous material Substances 0.000 abstract 1
- 235000019833 protease Nutrition 0.000 abstract 1
- 238000007493 shaping process Methods 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 15
- 108010010803 Gelatin Proteins 0.000 description 10
- 229920000159 gelatin Polymers 0.000 description 10
- 239000008273 gelatin Substances 0.000 description 10
- 235000019322 gelatine Nutrition 0.000 description 10
- 235000011852 gelatine desserts Nutrition 0.000 description 10
- 230000023597 hemostasis Effects 0.000 description 5
- 239000000047 product Substances 0.000 description 4
- 238000010025 steaming Methods 0.000 description 4
- 241000282472 Canis lupus familiaris Species 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 3
- 239000012670 alkaline solution Substances 0.000 description 3
- 230000004071 biological effect Effects 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
- 238000006731 degradation reaction Methods 0.000 description 3
- 239000010985 leather Substances 0.000 description 3
- 108090000623 proteins and genes Proteins 0.000 description 3
- 229920000742 Cotton Polymers 0.000 description 2
- 208000023329 Gun shot wound Diseases 0.000 description 2
- 238000009835 boiling Methods 0.000 description 2
- 210000000988 bone and bone Anatomy 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 230000029087 digestion Effects 0.000 description 2
- 235000013373 food additive Nutrition 0.000 description 2
- 239000002778 food additive Substances 0.000 description 2
- 239000003292 glue Substances 0.000 description 2
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- 238000011160 research Methods 0.000 description 2
- 238000005507 spraying Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 241000628997 Flos Species 0.000 description 1
- 235000019082 Osmanthus Nutrition 0.000 description 1
- 241000333181 Osmanthus Species 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
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- 238000013019 agitation Methods 0.000 description 1
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- 238000007664 blowing Methods 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
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- 238000004140 cleaning Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000000249 desinfective effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 210000002249 digestive system Anatomy 0.000 description 1
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- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 210000001105 femoral artery Anatomy 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000002594 fluoroscopy Methods 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 238000009399 inbreeding Methods 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 235000013372 meat Nutrition 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 244000309715 mini pig Species 0.000 description 1
- 210000003928 nasal cavity Anatomy 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 230000035479 physiological effects, processes and functions Effects 0.000 description 1
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- 239000002699 waste material Substances 0.000 description 1
- 230000029663 wound healing Effects 0.000 description 1
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- Materials For Medical Uses (AREA)
Abstract
The present invention relates to a technology for producing biological expansive hemostatic sponge, which comprises the steps: 1) adding proteinase which accounts for 10 to 20% of the weight of collagen into 15 to 25% of collagen solution, and fermenting the solution at the temperature of 50 to 80DEGC for 0.5 to 2.5 hours to obtain fermented liquid A; 2) foaming the fermented liquid A to obtain foamed liquid B; 3) pouring the liquid B into a mould for freezing and shaping until the liquid B is frozen and dewatered to contain less than 10% of water so as to obtain biological sponge; and 4) compressing and punching the biological sponge to reduce the volume of the biological sponge to less than 1/10 of the original volume. The present invention also relates to biological expansive hemostatic sponge produced by the technology, which has favorable water absorption power and large expansion rate, wherein the water absorption power is greater than 80 times, and the expansion rate can be greater than 20 times. Thus, when used for filling and stopping bleeding of wounds of cavity channels and pore canals or operations, the biological expansive hemostatic sponge can rapidly absorb blood flowing out and expand to oppress the wounds to stop bleeding.
Description
(1) technical field:
The present invention relates to a kind of being used to perform the operation time hemostasis, stopping up the good biological dilatancy sthptic sponge of bio-sponge, particularly physical expansion performance of effect such as wound with animal bone, skin or manufacturing of gelatin.
(2) background technology:
After being provided, a kind of operation need not take out, the surgical hemostasis sponge that can be absorbed by the body, the applicant has applied for that application number is 01133795.8, name is called " new technology of operation absorption styptic sponge " and application number is 03117311.x, and name is called the patent of invention of " bioresorbable styptic cotton and production technology thereof "." new technology of operation absorption styptic sponge " is to be raw material with the waste leather, utilize the pigment on the alkaline solution removal leather, and the leather hide fiber is expanded, comprehensive with acid solution then, and the high temperature steaming skin material, make it into gelatin-like, stir at last, dilute, filter rare gelatin solution, then rare gelatin is concentrated to desired concn, carries out physics and get blisters, with the gelatin solution after getting blisters with the high pressure cold air drying be shaped finished product." bioresorbable hemostasis silk floss and production technology " thereof then is that to select 3 months for use be raw material with interior thin skin piglets skin, also be to adopt alkaline solution to soak, the piglets skin is expanded, wash away alkali liquor with clear water then, use the temperature about 40 ℃ that the steaming and decocting of piglets skin is aqueous to transparent adhesive tape then, back dilute filtration, must dilute gelatin solution, at last the glue spraying is shaped and drying, blows with cold wind during spraying, make it to form cotton shape; Also can be with behind the gelatin solution physical blowing, lyophilization gets gelfoam.Because its coefficient of expansion of product that above-mentioned two patents are made is lower, so it fills wound and the performance of sucking blood all is restricted, and all adopts alkaline solution to soak animal skins in above-mentioned two kinds of technologies, and therefore, its biological property all has been subjected to destroying largely.
(3) summary of the invention:
It is good that the present invention will disclose a kind of expansion character, can absorb fully, and can clog the biological dilatancy sthptic sponge of wound hemostatic rapidly.
The present invention is that the collagen water is modulated into content is 15～25%, and preferably content is 20% collagen solution, adds protease and ferment in collagen solution, and the addition of protease is generally 10～20% of collagen weight, and is preferred 13～18%, and the best is 15%; Fermentation temperature is generally at 50～80 ℃, and preferred 60～70 ℃, the best is 65 ℃; Fermentation time was generally 0.5～3 hour, and preferred 1～2 hour, the best was 1.5 hours.Collagen solution after the fermentation is carried out physics get blisters, have best water absorbing capacity for making it, need control the density of getting blisters when getting blisters, the diameter that preferably makes bubble is to make the diameter of the bubble more than 90% between 0.1～0.2mm between 0.1～0.2mm at least; It is spongy that the glue that will send out bubble then good is poured in the mould freezing formation into, makes it the lyophilizing dehydration, to water content less than 10%, preferably less than 8%, then obtain bio-sponge; With bio-sponge punching press compression, obtain biological expanded tampon sponge at last, during punching press, generally making its volume-diminished is 1/10 of original volume, is preferably in below 1/20; During punching press, temperature is preferably 10～30 ℃, and the intensity of pressure is 4～5 tons/square metre.
In order to make biological expanded tampon sponge of the present invention have better biological activity, the raw material of its use is preferably biological collagen.Promptly adopting fragrant pig Corii Sus domestica is production raw material production biological collagen.Fragrant pig title is of long duration, and what word degree of the Ming Dynasty is shown in " Yidu topics to chat about " book is loaded with: " Songpan, Jianchang all goes out fragrant pig, and is little and fertile, and meat is quite fragrant." history of visible fragrant pig surplus China existing 500 year.Fragrant pig is more extensive in the area that China distributes, except that Songpan, Jianchang, in the Guizhou Province, what osmanthus two provinces all have support.As the fragrant pig in the Congjiang, the fragrant pig in ring river and the fragrant pig of Ba Ma be.These kinds all are build pig kinds seldom, be characterized in the petite short circle of the bodily form, the thin foot of bone is short, the property wild precocious, the crude feed tolerance material, grow at the mountain region in pollution-free source free choice feeding, this pig have immunity extremely strong, be rich in aminoacid, high protein, high calcium and phosphorus, lean, characteristics and The experimental results that heat energy is low show: miniature pig has great similarity at the aspects such as dissect physiology, cardiovascular system, digestive system, skeleton development, nutritional need, mineral metabolism and the mankind, and be easy to obtain, be easy to raise, so in biological study, cause very big attention.And as research human diseases laboratory animal be widely used in growth, the medical research.Fragrant pig contains the gene compatible with human body, has inbreeding, the characteristics that gene are stable, and its skin is thin, and hair is thick and sparse.
The present invention generally selected for use in 3 months monthly ages, was preferably 1.5 month monthly age with interior healthy anosis piglets, after cleaning is slaughtered, and peeling, carry out following operation:
1) with the Corii Sus domestica unhairing, the degrease layer must not have hair, fat free Corii Sus domestica, and this Corii Sus domestica general thickness is between 0.5～1.5 millimeter;
2) with the Corii Sus domestica sterilization, sterilization can be soaked in Corii Sus domestica in the malicious water with disinfection ability, as edible disinfecting liquid; Also can carry out disinfection sterilization processing or use microwave disinfection with ultraviolet;
3) the Corii Sus domestica water after will sterilizing, sterilizing cleans up;
4) with normal saline steaming and decocting Corii Sus domestica, for preventing to destroy the biological activity of collagen protein in the Corii Sus domestica, boiling temperature is 30～40 ℃, and pressure is 0.2～0.4MPa, and digestion time is 2～4 hours;
5) extract collagen, and carry out high temperature degradation; As with collagen in transient heating to 80～100 ℃, and kept 1～2 minute, can realize high temperature degradation;
6) filter purification;
7) separate the removal oils and fats;
8) lyophilizing dehydration, collagen is shaped, the cold wind dehydration, cold wind is from subzero 5～6 ℃, with the speed that once descended in per 10～30 minutes, progressively reduces to subzero 30～40 ℃, treats that water content is less than 10% in the collagen to get final product.
Since this biological expanded tampon sponge with collagen solution through the fermentation after, get blisters and make bio-sponge, after punching press, form again, therefore, this biological expanded tampon sponge and fabulous water absorbing force is arranged and great expansion rate, its water absorbing force can be greater than 80 times, and expansion rate can be greater than 28 times, therefore when using it for tract and duct wound or operation filling hemostasis, it can absorb effusive blood rapidly and expand the compressing wound hemostasis; For the biological expanded tampon sponge of using biological collagen to make,, therefore, be easy to be absorbed by the body owing to have fabulous intermiscibility with human body.
(4) specific embodiment:
Be several non-limiting examples of the present invention below.
Implement sharp one
1) be to add the protease that accounts for collagen weight 20% in 20% the collagen solution to content, and with above-mentioned solution place 70 ℃ of bottom fermentations 2 hours fermentation liquid A;
2) fermentation liquid A is got blisters, when getting blisters, control the density of getting blisters, the diameter that makes the bubble more than at least 90% gets expanding foam solution B between 0.1～0.2mm; (reaching the density of control foam through the physical agitation speed)
3) pour B into mold cold and be frozen into shape, make it lyophilizing and dewater to water content and be less than 10%, bio-sponge.
4) utilize rustless steel model stamping machine with bio-sponge punching press compression molding, the bio-sponge that the plane punching press is 0.5 square metre, stamping press are 5 tons, the bio-sponge that 20cm is thick strikes out 0.5cm, after the punching press in 2 seconds, its volume-diminished is original 1/40, biological dilatancy sthptic sponge.
5) check warehouse-in.
Its water absorbing force is 80 times after testing, and expansion rate is 28 times.
Other index employing China will use the detection method of dressing gelatin standard code in 1987 to 2000 editions pharmacopeia of food additive gelatin issue GB783-86 standard and China.
Implementation column two
1) select health, virus-free for use, 3 months with fragrant pig in interior age, cleans, slaughters, peeling;
2) unhairing, degrease layer must not have hair, fat-free Corii Sus domestica;
3) with Corii Sus domestica sterilization, sterilization;
4) the Corii Sus domestica water after will sterilizing, sterilizing cleans up;
5) with normal saline steaming and decocting Corii Sus domestica, boiling temperature is 30～40 ℃; Pressure is 0.2～0.4MPa; Digestion time is 2～4 hours;
6) extract collagen, and carry out high temperature degradation;
7) filter purification;
8) separate the removal oils and fats;
9) it being adjusted into content is 15% collagen solution, to wherein adding the protease that accounts for collagen weight 15%, and with above-mentioned solution place 80 ℃ of bottom fermentations 1.5 hours fermentation liquid A;
10) fermentation liquid A is got blisters expanding foam solution B;
11) pour B into mold cold and be frozen into shape, make it lyophilizing and dewater to water content and be less than 8%, bio-sponge;
Do zoopery with products obtained therefrom, 2 centimetres of long incision are cut at the back leg tremulous pulse place of Canis familiaris L., dark 1 centimetre, femoral artery is cut off 50%, with long 2 centimetres, wide 2 centimetres the said goods plug is tightened with binder in the wound, stops in 1 minute and bleeding, after 24 hours, Canis familiaris L. can walk freely fully, after 10 days, the wound of Canis familiaris L. heals fully, according to shadow, the blood vessel reparation is normal, does not have any thrombosis phenomenon by x-ray fluoroscopy.
12) utilize the punching press prototype with bio-sponge punching press compression molding, the bio-sponge that the plane punching press is 0.5 square metre, stamping press are 5 tons, the bio-sponge that 100mm is thick struck out 5mm, after the punching press in 2 seconds, its volume-diminished is original 1/20, biological dilatancy sthptic sponge.
5) check warehouse-in.
Its water absorbing force is 80 times after testing, and expansion rate is 20 times.
Other index employing China will use the detection method of dressing gelatin standard code in 1987 to 2000 editions pharmacopeia of food additive gelatin issue GB783-86 standard and China.
Do clinical trial 30 examples with the said goods, gunshot wound 12 examples wherein, surgery of nasal cavity 18 examples, clog this product after, stopped in 30 seconds to 60 seconds and to bleed, after 8 to 10 days, the gunshot wound wound healing is absorbed fully.
Claims (10)
1, the bio-sponge production technology comprises the steps:
1) be to add the protease that accounts for collagen weight 10～20% in 15～25% the collagen solution to content, and with above-mentioned solution place 50～80 ℃ of bottom fermentations 0.5～2.5 hour fermentation liquid A;
2) fermentation liquid A is got blisters expanding foam solution B;
3) pour B into mold cold and be frozen into shape, make it lyophilizing and dewater to water content and be less than 10%, bio-sponge.
2, bio-sponge production technology according to claim 1 is characterized in that: when getting blisters, control the density of getting blisters, the diameter that makes the bubble more than at least 90% is between 0.1～0.2mm.
3, bio-sponge production technology according to claim 1 is characterized in that: fermentation temperature is 60～70 ℃.
4, bio-sponge production technology according to claim 1 is characterized in that: fermentation time is 1～2 hour.
5, bio-sponge production technology according to claim 1 is characterized in that: being to use biological collagen is raw material, and the production technology of biological collagen is:
1) select health for use, 3 months with fragrant pig in interior age, cleans, slaughters, peeling;
2) unhairing, degrease layer must not have hair, fat-free Corii Sus domestica;
3) with Corii Sus domestica sterilization, sterilization;
4) the Corii Sus domestica water after will sterilizing, sterilizing cleans up;
5) boil Corii Sus domestica with normal saline, its temperature is 30～40 ℃; Pressure is 0.2～0.4MPa; Boiled 2～4 hours;
6) extract collagen, and under 80～100 ℃ of temperature, degrade;
7) filter purification;
8) separate the removal oils and fats;
9) lyophilizing dehydration, collagen is shaped.
6, biological dilatancy sthptic sponge production technology is the bio-sponge punching press compression molding that any one described bio-sponge production technology in the claim 1～5 is made.
7, biological dilatancy sthptic sponge production technology according to claim 6 is characterized in that: after the punching press, it is original below 1/10 making its volume-diminished.
8, biological dilatancy sthptic sponge production technology according to claim 7 is characterized in that: after the punching press, it is original below 1/20 making its volume-diminished.
9, the biological dilatancy sthptic sponge that any one described explained hereafter goes out in the claim 6～8.
10, biological dilatancy sthptic sponge according to claim 9, it is characterized in that: its water absorbing force is greater than 80 times, and expansion rate is greater than 20 times.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031355765A CN100444901C (en) | 2003-08-07 | 2003-08-07 | Biologically expansive hemorrhage arresting sponge and its production process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031355765A CN100444901C (en) | 2003-08-07 | 2003-08-07 | Biologically expansive hemorrhage arresting sponge and its production process |
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| Publication Number | Publication Date |
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| CN1486748A CN1486748A (en) | 2004-04-07 |
| CN100444901C true CN100444901C (en) | 2008-12-24 |
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| CNB031355765A Expired - Fee Related CN100444901C (en) | 2003-08-07 | 2003-08-07 | Biologically expansive hemorrhage arresting sponge and its production process |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101422633A (en) * | 2008-11-25 | 2009-05-06 | 陈启忠 | Preparation method of no-skin wound skin-grafting slice |
| CN102357259A (en) | 2011-07-28 | 2012-02-22 | 王珊珊 | Bioprotein sponge and preparation method thereof |
| CN103394113B (en) * | 2013-06-28 | 2015-03-25 | 钟春燕 | Adhesive bandage |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4140537A (en) * | 1975-10-22 | 1979-02-20 | Collagen Corporation | Aqueous collagen composition |
| US4789401A (en) * | 1985-06-25 | 1988-12-06 | Merz+Co. Gmbh & Co. | Soluble collagen sponge |
| CN1210019A (en) * | 1998-09-10 | 1999-03-10 | 战丽芬 | Medical collagen sponge and manufacture thereof |
| CN1385143A (en) * | 2001-12-27 | 2002-12-18 | 唐宝辉 | Process for producing absorption styptic sponge used in operation |
| CN1416907A (en) * | 2001-11-09 | 2003-05-14 | 武继民 | Medical collagen sponge and its prepn |
-
2003
- 2003-08-07 CN CNB031355765A patent/CN100444901C/en not_active Expired - Fee Related
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4140537A (en) * | 1975-10-22 | 1979-02-20 | Collagen Corporation | Aqueous collagen composition |
| US4789401A (en) * | 1985-06-25 | 1988-12-06 | Merz+Co. Gmbh & Co. | Soluble collagen sponge |
| CN1210019A (en) * | 1998-09-10 | 1999-03-10 | 战丽芬 | Medical collagen sponge and manufacture thereof |
| CN1416907A (en) * | 2001-11-09 | 2003-05-14 | 武继民 | Medical collagen sponge and its prepn |
| CN1385143A (en) * | 2001-12-27 | 2002-12-18 | 唐宝辉 | Process for producing absorption styptic sponge used in operation |
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