CN1454667A - Convenient fibrin blocking agent - Google Patents

Convenient fibrin blocking agent Download PDF

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Publication number
CN1454667A
CN1454667A CN 03111628 CN03111628A CN1454667A CN 1454667 A CN1454667 A CN 1454667A CN 03111628 CN03111628 CN 03111628 CN 03111628 A CN03111628 A CN 03111628A CN 1454667 A CN1454667 A CN 1454667A
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CN
China
Prior art keywords
fibrin
fibrinogen
buffer
factor
thrombin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN 03111628
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Chinese (zh)
Inventor
徐振彪
宋林霞
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CN 03111628 priority Critical patent/CN1454667A/en
Publication of CN1454667A publication Critical patent/CN1454667A/en
Pending legal-status Critical Current

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Abstract

The invention provides a convenient sealing agent for fibrin. It is made up of fibrin source 60-100 mg/ml, factor XIII (FXIII) 30-60 U/ml, thrombin 200-600 IU/ml and the buffer, the PH value is 6-8. the invention has rheology character, and strong adhesive ability, imitates the final period of physical cruor mechanism. It exerts functions of biological hemostasis, promotes the concrescence of wound, prevents organism conglutination, conglutinates viscera gap, seals lacuna organism in order to decrease the exudation, medicine releasing carrier slowly. It applies to all the modern surgical.

Description

Fibrin sealant easy to use
(1), affiliated field
What the present invention relates to is a kind of medical preparation, specifically a kind of medical preparation that is used for surgical hemostasis, promotion wound healing etc.
(2), background technology
The healing of wound and hemorrhagely be not only the problem that modern surgery operation faces if handle untimelyly or improper simultaneously, also can bring life danger to the patient.Through years of researches, scientist has developed " human body glue ", and its Main Ingredients and Appearance is Fibrinogen and thrombin etc.Though its title is varied, needing only Main Ingredients and Appearance and action principle basic identical is exactly with a kind of product.Below with fibrin sealant (Fibrin sealant, FS) expression.This product simulation the human body self coagulation process final stage and work, simultaneously its composition is the protein of pure natural, so reduced the toxicity, side effect in the use to greatest extent.Can on a lot of magazines, newpapers and periodicals, medium, see or find about the advantage that the composition of this product and operation instruction, this product are compared with other similar products, also known simultaneously by the scientific and technical personnel in this area.But the use of FS is very loaded down with trivial details, and operation is trouble (seeing product and the operation instruction of FS) quite.So not only make troubles, and incur loss through delay rescue time sometimes to use.Particularly the redissolution of one of component of product fibrinogen concentrate is very difficult, and its dissolution time often is unfavorable for doctor's operation technique generally at 30-60 minute.
(3), summary of the invention
Do not need dissolving when the object of the present invention is to provide a kind of use or can dissolve fibrin sealant easy to use fast.
The object of the present invention is achieved like this: it is by Fibrinogen 60-100mg/ml, factor XI, plasma thromboplastin antecedent II (FXIII) 30-60U/ml, and the buffer of thrombin 200-600IU/ml and surplus is formed, and its pH value is at 6-8.Buffer wherein is phosphate buffer and Tris-Hcl buffer.Its dosage form can be at-20 ℃ cryogen after the solution packing; Also can be to be ground into the microgranule lyophilized powder of particle diameter between the 50-500 micron after the lyophilizing.
Product of the present invention has very strong rheological properties (as viscosity, elasticity), and very strong adhesive capacity arranged, imitate the final stage of human body clotting mechanism fully, the biological hemostasis of performance, promote wound healing, prevent the tissue adhesion, bonding internal organs breach, sealing defective tissue with minimizing ooze out, function such as slow releasing carrier of medication, be applicable in all modern surgery operations.Great advantage of the present invention is to dissolve rapidly, simplifies procedures, and increases work efficiency, thereby for shortening operative process, wins the quality time for rescuing the wounded simultaneously.If cryogen only need take out frozen product during use, be put under 37 ℃ of conditions and dissolve, the complete dissolution time of 2.5ml specification product was at 3-8 minute, and is simple to operation.If its solidifiable protein component dissolution time of microgranule lyophilized powder only needs 3-5 minute.Thereby, win the quality time for rescuing the wounded simultaneously for shortening operative process.
(4), specific embodiments
For example the present invention is done in more detail below and describes:
Embodiment one
The solidifiable protein concentrate mainly refers to Fibrinogen, factor XI, plasma thromboplastin antecedent II (FXIII) etc. among the present invention, can activate to solidify under corresponding thrombin catalysis in blood.Solidifiable protein concentrate in the invention can derive from human blood also can derive from any mammalian such as pig, cattle etc.The proteic separation of solidifiable can adopt any for the known method of those skilled in the art as freezing precipitation, ethanol precipitation, chromatography, any known sophisticated method that solidifiable albumen in the blood is separated purification of saltouing or the like.Press Fibrinogen 60-100mg/ml, factor XI, plasma thromboplastin antecedent II 30-60U/ml, the ratio of thrombin 200-600IU/ml is got raw material ready.Fibrinogen wherein and factor XI, plasma thromboplastin antecedent II are called the solidifiable protein concentrate again in a kind of component, concentration should reach 80-150mg/ml.Fibrinogen and factor XI, plasma thromboplastin antecedent II are mixed into the solidifiable protein concentrate, with solidifiable protein concentrate and prothrombin complex, respectively with phosphate buffer and the dissolving of Tris-Hcl buffer, adjust pH to 6-8, filtration sterilization then, ultrafiltration and concentration, sterile filling then.After all indexs detections are qualified, be put under-20 ℃ of conditions frozen.This product stock, traffic requirements are under-10 to-20 ℃ of conditions.
Embodiment two,
Press Fibrinogen 80mg/ml, factor XI, plasma thromboplastin antecedent II 50U/ml, the ratio of thrombin 400IU/ml is got raw material ready.Fibrinogen wherein and factor XI, plasma thromboplastin antecedent II are called the solidifiable protein concentrate again in a kind of component, concentration should reach 80-150mg/ml.Fibrinogen and factor XI, plasma thromboplastin antecedent II are mixed into the solidifiable protein concentrate, with solidifiable protein concentrate and prothrombin complex, respectively with phosphate buffer and the dissolving of Tris-Hcl buffer, adjust pH to 6-8, filtration sterilization then, ultrafiltration and concentration, sterile filling then.
Embodiment three,
Press Fibrinogen 60-100mg/ml, factor XI, plasma thromboplastin antecedent II 30-60U/ml, the ratio of thrombin 200-600IU/ml is got raw material ready.Fibrinogen wherein and factor XI, plasma thromboplastin antecedent II are called the solidifiable protein concentrate again in a kind of component, concentration should reach 80-150mg/ml.Fibrinogen and factor XI, plasma thromboplastin antecedent II are mixed into the solidifiable protein concentrate, with solidifiable protein concentrate and prothrombin complex, respectively with phosphate buffer and the dissolving of Tris-Hcl buffer, adjust pH to 6-8, filtration sterilization then, ultrafiltration and concentration, adopt and any can freeze dried methods be lyophilized into bulk, then the lyophilizing piece is blended into fine-powder shape granule with any method that can blend, and sieve and make the ground product particle diameter between the 50-500 micron, carry out the cillin bottle packing then.
Embodiment four
Press Fibrinogen 70mg/ml, factor XI, plasma thromboplastin antecedent II 50U/ml, the ratio of thrombin 300IU/ml is got raw material ready.Fibrinogen wherein and factor XI, plasma thromboplastin antecedent II are called the solidifiable protein concentrate again in a kind of component, concentration should reach 80-150mg/ml.Fibrinogen and factor XI, plasma thromboplastin antecedent II are mixed into the solidifiable protein concentrate, with solidifiable protein concentrate and prothrombin complex, respectively with phosphate buffer and the dissolving of Tris-Hcl buffer, adjust pH to 6-8, filtration sterilization then, ultrafiltration and concentration, adopt and any can freeze dried methods be lyophilized into bulk, then the lyophilizing piece is blended into fine-powder shape granule with any method that can blend, and sieve and make the ground product particle diameter between the 50-500 micron, carry out the cillin bottle packing then.

Claims (4)

1, a kind of fibrin sealant easy to use is characterized in that: it is by Fibrinogen 60-100mg/ml, factor XI, plasma thromboplastin antecedent II 30-60U/ml, and the buffer of thrombin 200-600IU/ml and surplus is formed, and its pH value is at 6-8.
2, fibrin sealant easy to use according to claim 1 is characterized in that: described buffer is phosphate buffer and Tris-Hcl buffer.
3, fibrin sealant easy to use according to claim 1 and 2 is characterized in that: its dosage form is at-20 ℃ cryogen after the solution packing.
4, fibrin sealant easy to use according to claim 1 and 2 is characterized in that: its dosage form is to be ground into the microgranule lyophilized powder of particle diameter between the 50-500 micron after the lyophilizing.
CN 03111628 2003-05-07 2003-05-07 Convenient fibrin blocking agent Pending CN1454667A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 03111628 CN1454667A (en) 2003-05-07 2003-05-07 Convenient fibrin blocking agent

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN 03111628 CN1454667A (en) 2003-05-07 2003-05-07 Convenient fibrin blocking agent

Publications (1)

Publication Number Publication Date
CN1454667A true CN1454667A (en) 2003-11-12

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN 03111628 Pending CN1454667A (en) 2003-05-07 2003-05-07 Convenient fibrin blocking agent

Country Status (1)

Country Link
CN (1) CN1454667A (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102448442A (en) * 2009-05-28 2012-05-09 普罗菲布瑞克斯公司 Treatment of tissue adhesion
CN102448443A (en) * 2009-05-28 2012-05-09 普罗菲布瑞克斯公司 Dry powder fibrin sealant
CN105007841A (en) * 2012-12-31 2015-10-28 乔治·D.·福卢什 Lyophilized fibrin sealant for high volume hemorrhage
WO2017117996A1 (en) * 2016-01-08 2017-07-13 广州市众为生物技术有限公司 Biological product for surgical hemostasis and use method thereof
US20220096708A1 (en) * 2016-08-15 2022-03-31 Guangzhou Bioseal Biotech Co. Ltd. Hemostatic compositions and methods of making thereof

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102448442A (en) * 2009-05-28 2012-05-09 普罗菲布瑞克斯公司 Treatment of tissue adhesion
CN102448443A (en) * 2009-05-28 2012-05-09 普罗菲布瑞克斯公司 Dry powder fibrin sealant
US9089584B2 (en) 2009-05-28 2015-07-28 Profibrix B.V. Treatment of tissue adhesion
US9119897B2 (en) 2009-05-28 2015-09-01 Profibrix B.V. Dry powder fibrin sealant
CN105007841A (en) * 2012-12-31 2015-10-28 乔治·D.·福卢什 Lyophilized fibrin sealant for high volume hemorrhage
WO2017117996A1 (en) * 2016-01-08 2017-07-13 广州市众为生物技术有限公司 Biological product for surgical hemostasis and use method thereof
US20220096708A1 (en) * 2016-08-15 2022-03-31 Guangzhou Bioseal Biotech Co. Ltd. Hemostatic compositions and methods of making thereof

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