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Lyophilized stabilizer composition of human plasma protein C and use of composition

A technology of human plasma protein and freeze-drying stabilizer, which is applied in the field of plasma products, can solve the problems of damage to the target protein activity, protein structure denaturation, protein C activity reduction, etc., and achieves small loss of activity, high recovery rate, and improved appearance and molding. Effect

Active Publication Date: 2014-07-02
BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In human plasma protein C concentrate products, protein C has high purity and relatively small protein content. During the freezing process of the product, ice crystals are continuously produced in the solution, which makes the salt ion concentration of the product increase rapidly, and causes the internal pH of the product to change. Damage the activity of the target protein; during the drying process, factors such as the product solution transitioning to the glass state or being in the glass state, and the removal of protein-bound water are also likely to cause changes in the protein structure and denature, resulting in a decrease in the activity of protein C

Method used

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  • Lyophilized stabilizer composition of human plasma protein C and use of composition
  • Lyophilized stabilizer composition of human plasma protein C and use of composition
  • Lyophilized stabilizer composition of human plasma protein C and use of composition

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Embodiment 1

[0053] Embodiment 1 Preparation of human plasma protein C preparation of the present invention

[0054] 1. Preparation method

[0055] Ⅰ. Preparation of Human Protein C Concentrate

[0056] (1) Preparation of human cryoprecipitate plasma

[0057] About 1000L of human fresh frozen plasma that meets the requirements of the Pharmacopoeia (weight is about 1000kg), after disinfecting the plasma bag with alcohol, melt the plasma with water for injection at 0-5°C. The cryoprecipitated plasma was removed by centrifugation for later use.

[0058] (2) Gel adsorption and purification

[0059] ①DEAE Sephadex A50 adsorption: fully swell 2kg of DEAE Sephadex A50 gel dry powder, balance with balance solution (0.015M sodium citrate, 0.08M sodium chloride, pH7.3) for 5 times, 60L each time, and then add step (1 ) and the cryoprecipitated plasma was stirred and adsorbed at 2-8°C for 30 minutes, the supernatant was put into the plasma tank, and the gel was collected.

[0060] ② Washing: was...

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Abstract

The invention discloses a lyophilized stabilizer composition of human plasma protein C. The composition is a combination of any one or more than two of lactose, mannitol, mycose, histidine, arginine, tyrosine, aspartic acid and salts thereof. By adopting the stabilizer disclosed by the invention, the protein C can be effectively protected, and the prepared protein C preparation is good in molded appearance, small in activity loss of protein C and high in recovery rate, and has a good clinical application prospect.

Description

technical field [0001] The invention relates to the field of plasma products, in particular to a freeze-dried stabilizer composition of human plasma protein C and its application. Background technique [0002] Human plasma protein C, also known as protein C (protein C, PC), is a glycoprotein with a molecular weight of about 62kD, and its content in plasma is about 2-6mg / L. PC is a vitamin K-dependent plasma protein, which has similar physical and chemical properties to other vitamin K-dependent proteins (such as coagulation factors II, VII, IX, and X). It increases plasminogen activator by inactivating coagulation factors Va and VIIIa , so as to maintain the dynamic balance of blood coagulation and fibrinolysis system. The PC system composed of PC and its cofactors and inhibitors has been recognized as an important regulatory system of the body's anticoagulant mechanism and plays an important role in antithrombotic diseases. Currently, protein C is mainly isolated and puri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/17A61K47/22A61K47/26A61K47/18A61P7/02
Inventor 王宗奎王玉梅杜晞邓靖袁靖李长清陈云华刘欣晏杨刚
Owner BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI
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