Preparation method of freeze-dried plasma

A plasma and freeze-drying technology, applied in the field of freeze-dried plasma preparation, can solve problems such as plasma protein activity description

Active Publication Date: 2021-08-13
ACADEMY OF MILITARY MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the plasma freeze-drying procedure disclosed in Chinese patent 02103960.7, low-temperature spin-freezing is also carried out before freeze-drying, and the total time is as long as 100-120 hours, and the activity of plasma protein in the prepared freeze-dried plasma is not described

Method used

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  • Preparation method of freeze-dried plasma
  • Preparation method of freeze-dried plasma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Preparation of fresh frozen plasma: collect whole blood from blood donors by venipuncture, and store the collected blood samples at a temperature of 2-8°C as soon as possible. Store in a refrigerator below -18°C.

[0043] Thaw the fresh frozen plasma in a water bath at 37°C. After thawing, divide the plasma into 200ml freeze-dried vials, 100mL of plasma per vial.

[0044] The plasma was put into a freeze dryer, cooled to -45°C at a rate of 1°C / min, maintained for 18 hours, and then evacuated to 0.100mbar.

[0045] The temperature was raised to -30°C within 3h and maintained at this temperature for 12h.

[0046] After that, the temperature was slowly increased by 5°C every 4 hours until -15°C.

[0047] The temperature was raised to -10°C within 2h and maintained at this temperature for 16h.

[0048] The temperature was raised to -5°C within 2h and maintained at this temperature for 16h.

[0049] The temperature was raised to 0°C within 2h and maintained at this tempe...

Embodiment 2

[0066] Apheresis of fresh frozen plasma: Use a blood apheresis machine to automatically separate the plasma from the whole blood under fully enclosed conditions, and quickly put it into a quick freezer to freeze into a solid within 6 hours, and then put it in a low-temperature refrigerator below -18°C Save within.

[0067]Thaw the fresh frozen plasma in a water bath at 37°C. After thawing, divide the plasma into 200ml freeze-dried vials, 100mL of plasma per vial.

[0068] The plasma was put into a freeze dryer, cooled to -45°C at a rate of 1°C / min, maintained for 20 hours, and then vacuumed to 0.100mbar.

[0069] The temperature was raised to -30°C within 3h and maintained at this temperature for 14h.

[0070] After that, the temperature was slowly increased by 5°C every 4 hours until -15°C.

[0071] The temperature was raised to -10°C within 2h and maintained at this temperature for 18h.

[0072] The temperature was raised to -5°C within 2h and maintained at this temperatu...

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Abstract

The invention discloses a preparation method of freeze-dried plasma. According to the method, a protective agent is not added, spin freezing is not carried out before freeze-drying, the recovery rate of the blood coagulation factor VIII and von Willebrand factor (vWF) can reach 70% or above, the recovery rate of other plasma proteins can reach 80% or above, and the method has important application value.

Description

technical field [0001] The invention belongs to the field of blood products and relates to a preparation method of freeze-dried plasma. Background technique [0002] In view of a series of problems in the preservation (-20°C) and transportation (cold chain) of fresh frozen plasma, which cannot meet the needs of emergency rescue in special environments and remote areas, freeze-dried plasma has become an ideal choice for fresh frozen plasma in the resuscitation and treatment of traumatic shock. substitute. [0003] Compared with fresh frozen plasma, the basic components of freeze-dried plasma are the same (including albumin, immunoglobulin, fibrinogen and most coagulation factors). Although the biological activity of some coagulation factors has been reduced, it still has the ability to maintain patient The main functions of colloid osmotic pressure in the body, increasing circulating blood volume and supplementing plasma protein. Freeze-dried plasma can be stored below 10°C...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/16
CPCA61K35/16
Inventor 马玉媛章金刚赵雄王强贾俊婷陈敬韬张欢杨姝王蕊
Owner ACADEMY OF MILITARY MEDICAL SCI
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