CN1138483A - Fibre proteinogen compound and its prepn. method - Google Patents
Fibre proteinogen compound and its prepn. method Download PDFInfo
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- CN1138483A CN1138483A CN 95106859 CN95106859A CN1138483A CN 1138483 A CN1138483 A CN 1138483A CN 95106859 CN95106859 CN 95106859 CN 95106859 A CN95106859 A CN 95106859A CN 1138483 A CN1138483 A CN 1138483A
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- fibre proteinogen
- proteinogen compound
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Abstract
A fibrinogen compound is prepared from blood of mammal through aseptic blood collection, separation of blood plasma, extraction,s torage, package and radiation sterilization by Co60 and can be used to replace the fibrinogen from human blood and as the principal component of absorbable biologic anastaltic for operational or intravenous hemorrhage. Its advantages include wide resource of raw material, and avoiding the transmission of hematogenous diseases.
Description
The present invention relates to fibre proteinogen compound, particularly a kind of mammalian of utilizing is fibre proteinogen compound of raw material and preparation method thereof.
Fibre proteinogen compound is one of main component of the biological colloid styptic of absorbability, its mechanism of action is the final stage of imitateing blood coagulation, make Fibrinogen under the effect of thrombin and calcium ion, change the fibrin net into, under the effect of the XIII factor, become stable fibrin net again.Thereby bring into play its hemostasia effect.Common fibre proteinogen compound is by the human plasma preparation that compiles, its preparation method is to gather people's whole blood under aseptic technique, obtain blood plasma with centrifuging, the sedimentation method or Filtration, then utilize various chemical reagent such as Polyethylene Glycol, ether, ethanol, ammonium sulfate or glycine, concentration of fibre proteinogen complex by low-temperature precipitation and precipitation and from human plasma.Its whole process of preparation must be carried out under aseptic condition, otherwise is difficult to conventional method (as Filtration, heating, gas sterilization, chemical disinfection) the removal of microorganisms in the spissated fibre proteinogen compound.Adopt the fibre proteinogen compound of human blood preparation, its weak point is that the raw material sources feedback is weary, and the cost costliness easily causes the propagation of human blood borne disease (as hepatitis B, hepatitis C, AIDS etc.).Therefore conventional Fibrin Glue does not obtain the approval of U.S. FDA so far.Relevant employing mammalian blood prepares fibre proteinogen compound and preparation method thereof, no special event is not seen relevant basic medical and the clinical application research report of using the biological colloid styptic of absorbability of mammalian blood fibre proteinogen compound preparation yet on the document at present.
It is extensive, with low cost to the purpose of this invention is to provide a kind of raw material sources, fibre proteinogen compound that the mammalian that can avoid human blood borne disease to propagate is originated and preparation method thereof.
Technical solution of the present invention is: fibre proteinogen compound is the blood that adopts mammal (pig, cattle, sheep, Canis familiaris L., horse), under the aseptic technique of strictness or do not adopt aseptic technique, or the part process adopts, and aseptic technique is gathered, separation, extraction, storage and the packing of blood plasma are made, to this compound sterilization of Fibrinogen that derives from animal blood, be to adopt the co-60 radiation sterilization, this sterilization can implemented under the fibrin compound water solution state or under the freeze dried powder state, and its radiation dose is 50,000 to 2,400,000 rads.
Preparation method of the present invention is: the animal blood of gathering is imported one, and anticoagulant is housed is in the airtight sterile chamber received of 1: 9 3.8% citric acid, with blood centrifugal 30 minutes with 3000RPM, obtain blood plasma, utilize the cryoprecipitate method in sterile chamber, to produce spissated animal fibrinogen complex again, be dissolved in the normal saline, concentration is 20～200 mg/ml, 2 milliliters/bottle of packing, lyophilization, through cobalt 60 irradiations, radiation dose is respectively 5,10,20,40,60,80,100,120,140,160,200,220,2,400,000 rads, after above-mentioned irradiation, do aerobic and anaerobe bacterium inspection, find no bacterial growth through the fibre proteinogen compound of the above dosage irradiation of 100,000 rads.With this complex with after the 2 ml physiological salines dissolvings, add equivalent and contain 40 mM calcium chloride, 500 iu thrombin solutions, observe fibrin gel and form situation, the fibre proteinogen compound of handling through the following radiation dose of 1,600,000 rads formed translucent milky and coagulates colloid substance in 15 seconds, this gelling material can be to the oozing of blood and the effective hemostasia effect of the hemorrhage performance of veins of the art open country of performing the operation.
The present invention can be made into freeze dried powder or aqueous solution, also it can be adhered to other polymeric biomaterial, as gelatin foam, collagen film and poly tetrafluoroethylene etc.
The present invention is the biological colloid styptic of a kind of absorbability, is a kind of biological hygienic material.Its mechanism of action is the final stage of imitateing blood coagulation, makes Fibrinogen change the fibrin net under the effect of thrombin and calcium ion, becomes stable fibrin net again under the effect of the XIII factor, thereby brings into play its hemostasia effect.The present invention can be widely used in general surgery clinically as a kind of local hemostatic, fields such as neurosurgery, cardiovascular and cerebrovascular vessel surgery, Urology Surgery, department of obstetrics and gynecology, plastic surgery, department of eye Department of B urn.To the oozing of blood of operation art open country and the hemorrhage enforcement of veins anastalsis effectively.The present invention not only raw material sources is extensive, and is cheap, also can avoid the propagation of various human blood borne diseases simultaneously effectively.
Below fibre proteinogen compound of deriving from Sanguis sus domestica and preparation method thereof is illustrated.
Embodiment one:
After the raw material pig made whole body and clean, 1: 1000 bromo geramine solution of reuse was implemented sterilization 10 minutes to the pig body surface.In cleanliness factor is 100,000 grades workshop, gather Sanguis sus domestica, Sanguis sus domestica is imported an airtight sterile chamber (anticoagulant: 1: 9 3.8% sodium citrate) through puncture.In above-mentioned workshop,, obtain blood plasma with Sanguis sus domestica centrifugal 30 minutes with 3000PRM.Utilize the cryoprecipitate method to produce spissated pig fibre proteinogen compound in sterile chamber, be dissolved in the normal saline, concentration is the 20-200 mg/ml, and preferred concentration is the 70-140 mg/ml.2 milliliters/bottle of packing; Lyophilization, cobalt 60 irradiations, radiation dose is respectively 5,10,20,40,60,80,100,120,140,160,200,220,2,400,000 rads.After above-mentioned irradiation, do aerobic and the inspection of anaerobe bacterium.When the fibre proteinogen compound of the above dosage irradiation of 100,000 rads finds no bacterial growth.This complex with after the 2 ml physiological salines dissolvings, is added equivalent and contains 40 mM calcium chloride, and 500 iu thrombin normal saline solutions are observed fibrin gel and are formed situation.The fibre proteinogen compound of handling through the following radiation dose of 1,600,000 rads formed translucent milky and coagulates colloid substance in 15 seconds.Should coagulate oozing of blood and the veins hemorrhage haemostatic effect with special place of colloid substance to rat, rabbit, Rhesus Macacus and human surgical wound surface.
Embodiment two:
Obtain fresh Sanguis sus domestica from the slaughterhouse.3.8% sodium citrate anticoagulant with 1: 9.With Sanguis sus domestica centrifugal 30 minutes, obtain blood plasma with 3000RPM.Utilize the cryoprecipitate method to produce spissated pig fibre proteinogen compound.Be dissolved in the normal saline, concentration is the 20-200 mg/ml, and preferred concentration is the 70-140 mg/ml, 2 milliliters/bottle of packing, lyophilization, cobalt 60 irradiations, radiation dose is respectively 5,10,20,40,60,80,100,120,140,160,200,220,2,400,000 rads.After above-mentioned irradiation, do aerobic and the inspection of anaerobe bacterium.Fibre proteinogen compound through the above dosage irradiation of 300,000 rads finds no bacterial growth.This complex with after the 2 ml physiological salines dissolvings, is added equivalent and contains 40 mM calcium chloride, and 500 iu thrombin normal saline solutions are observed fibrin gel and are formed situation.The fibre proteinogen compound of handling through the following radiation dose of 1,600,000 rads formed translucent milky and coagulates colloid substance in 15 seconds.Should coagulate oozing of blood and the veins hemorrhage haemostatic effect with special place of colloid substance to rat, rabbit, Rhesus Macacus and human surgical wound surface.
Claims (7)
1, a kind of fibre proteinogen compound is characterized in that: this complex is the blood that adopts mammal (pig, cattle, sheep, Canis familiaris L., horse), under the aseptic technique of strictness; Or part process employing aseptic technique, the part process does not adopt aseptic technique; Or whole process do not adopt separation, extraction, storage and the packing of aseptic technique collection, blood plasma to make, and wherein the sterilizing methods to the fibre proteinogen compound in this animal blood source is to adopt the co-60 radiation sterilization.This sterilization can implemented under the fibrin compound water solution state or under the freeze dried powder state.Its radiation dose is 50,000 to 2,400,000 rads.
2, fibre proteinogen compound according to claim 1 is characterized in that: adopting the best radiation dose of the fibre proteinogen compound radiation sterilization of strict aseptic technique preparation is 100,000 to 500,000 rads; To not adopting aseptic technique or part process to adopt the best radiation dose of the fibre proteinogen compound of aseptic technique preparation is 600,000 to 1,000,000 rads.
3, a kind of method for preparing claim 1, it is characterized in that: pouring the animal blood of gathering into one, anticoagulant is housed is in 1: 9 the container of 3.8% sodium citrate, with blood centrifugal 30 minutes with 3000RPM, obtain blood plasma, utilize the cryoprecipitate method to produce spissated animal fibrinogen complex again, be dissolved in the normal saline, concentration is 20～200 mg/ml, 2 milliliters/bottle of packing, lyophilization, through cobalt 60 irradiations, radiation dose is respectively 5,10,20,40,60,80,100,120,140,160,200,220,2,400,000 rads, after above-mentioned irradiation, do aerobic and the inspection of anaerobe bacterium.When the fibre proteinogen compound of the above dosage irradiation of 100,000 rads finds no bacterial growth, with this complex with after the 2 ml physiological salines dissolvings, add equivalent and contain 40 mM calcium chloride, 500 iu thrombin solutions, observe fibrin gel and form situation, the fibre proteinogen compound of handling through the following radiation dose of 1,600,000 rads formed translucent milky and coagulates colloid substance in 15 seconds.
4, the preparation method of fibre proteinogen compound according to claim 3 is characterized in that: utilize the cryoprecipitate method to produce spissated animal fibrin complex, the preferred concentration that is dissolved in the normal saline is 70～140 mg/ml.
5, fibre proteinogen compound according to claim 1 is characterized in that: this fibre proteinogen compound is a freeze dried powder.
6, fibre proteinogen compound according to claim 1 is characterized in that: this fibre proteinogen compound is an aqueous solution.
7, fibre proteinogen compound according to claim 1 is characterized in that: this complex can adhere to other polymeric biomaterial, as gelatin foam, collagen film and poly tetrafluoroethylene.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 95106859 CN1138483A (en) | 1995-06-22 | 1995-06-22 | Fibre proteinogen compound and its prepn. method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 95106859 CN1138483A (en) | 1995-06-22 | 1995-06-22 | Fibre proteinogen compound and its prepn. method |
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| Publication Number | Publication Date |
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| CN1138483A true CN1138483A (en) | 1996-12-25 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 95106859 Pending CN1138483A (en) | 1995-06-22 | 1995-06-22 | Fibre proteinogen compound and its prepn. method |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102286095A (en) * | 2011-07-06 | 2011-12-21 | 大田华灿生物科技有限公司 | Preparation method for fibrinogen |
| CN103163307A (en) * | 2013-03-20 | 2013-06-19 | 上海太阳生物技术有限公司 | Blood coagulation quality control product and preparing method thereof |
| CN103230589A (en) * | 2013-04-25 | 2013-08-07 | 上海神因生物科技有限公司 | Fibrinogen compound and application thereof |
| CN105664197A (en) * | 2008-04-24 | 2016-06-15 | 麦德托尼克公司 | Cold ionizing radiation sterilization |
| CN105854107A (en) * | 2015-01-22 | 2016-08-17 | 上海利康瑞生物工程有限公司 | Method for collecting plasma of live pig |
| CN108478864A (en) * | 2017-08-07 | 2018-09-04 | 上海交通大学医学院附属第九人民医院 | Composite fibrous scaffold |
| CN109620999A (en) * | 2019-01-12 | 2019-04-16 | 王若梅 | A kind of preparation method of compound hemostatic medical tissue glue |
| CN111518197A (en) * | 2020-03-30 | 2020-08-11 | 哈尔滨派斯菲科生物制药股份有限公司 | Production method of fibrinogen |
-
1995
- 1995-06-22 CN CN 95106859 patent/CN1138483A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105664197A (en) * | 2008-04-24 | 2016-06-15 | 麦德托尼克公司 | Cold ionizing radiation sterilization |
| CN102286095A (en) * | 2011-07-06 | 2011-12-21 | 大田华灿生物科技有限公司 | Preparation method for fibrinogen |
| CN103163307A (en) * | 2013-03-20 | 2013-06-19 | 上海太阳生物技术有限公司 | Blood coagulation quality control product and preparing method thereof |
| CN103163307B (en) * | 2013-03-20 | 2015-06-03 | 上海太阳生物技术有限公司 | Blood coagulation quality control product and preparing method thereof |
| CN103230589A (en) * | 2013-04-25 | 2013-08-07 | 上海神因生物科技有限公司 | Fibrinogen compound and application thereof |
| CN103230589B (en) * | 2013-04-25 | 2015-01-14 | 上海神因生物科技有限公司 | Fibrinogen compound and application thereof |
| CN105854107A (en) * | 2015-01-22 | 2016-08-17 | 上海利康瑞生物工程有限公司 | Method for collecting plasma of live pig |
| CN108478864A (en) * | 2017-08-07 | 2018-09-04 | 上海交通大学医学院附属第九人民医院 | Composite fibrous scaffold |
| CN109620999A (en) * | 2019-01-12 | 2019-04-16 | 王若梅 | A kind of preparation method of compound hemostatic medical tissue glue |
| CN111518197A (en) * | 2020-03-30 | 2020-08-11 | 哈尔滨派斯菲科生物制药股份有限公司 | Production method of fibrinogen |
| CN111518197B (en) * | 2020-03-30 | 2024-01-05 | 哈尔滨派斯菲科生物制药有限公司 | Production method of fibrinogen |
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