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Preparation method of long-term preservable plasma matrix universally used in quality control products

A quality control product and plasma technology, applied in the field of biological detection, can solve problems such as poor resolubility, affecting product properties, and product structure damage

Inactive Publication Date: 2017-12-15
SHANGHAI VASCUTECH DIAGNOSIS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For pre-freezing, slow freezing or quick freezing can be used. The advantage of slow freezing is that the freeze-dried block of the obtained product is relatively loose and has good resolubility. The disadvantage is that the structure of the product is easily damaged, which in turn affects the properties of the product.
The advantage of quick freezing is that it can better maintain the properties of the freeze-dried product. The disadvantage is that the freeze-dried block after freeze-drying has a relatively dense structure and poor resolubility

Method used

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  • Preparation method of long-term preservable plasma matrix universally used in quality control products
  • Preparation method of long-term preservable plasma matrix universally used in quality control products
  • Preparation method of long-term preservable plasma matrix universally used in quality control products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Preparation of Universal Plasma Matrix

[0043] Plasma acquisition: Use CTAD blood collection tubes, venipuncture to collect venous blood and mix it with citrate anticoagulant solution (0.11mol / L) at a volume ratio of 9:1, centrifuge at 18°C ​​for 15 minutes with at least 2500g centrifugal force within 1 hour, and separate get plasma. The subjects of blood collection were healthy normal people.

[0044] Add lyoprotectant to plasma: glycine 20g / L, mannitol 50g / L and potassium chloride 10g / L. Packed into 1ml / bottle.

[0045] The freeze-drying process provided by the invention adopts the SmartLyo 2 freeze-dryer of GEA Company. The specific process is:

[0046] A) Freeze the plasma to -45°C to obtain pre-frozen plasma and keep it for 1 hour; B) Under vacuum conditions, heat the pre-frozen plasma obtained in step A) for 3 hours at a temperature of -30°C; C) Under vacuum conditions, heat the heated plasma in step B) at a temperature of -30°C for 10 hours; D) under vacuum...

Embodiment 2

[0052] PT, APTT and FIB performance evaluation of quality control plasma.

[0053] After reconstitution of the freeze-dried product prepared according to Example 1, test PT, APTT and FIB (PT, APTT, FIB assay kit, purchased from Shanghai Sun Biotechnology Co., Ltd.) Uniformity of dry product. For the results, please refer to the attached table 2. It can be seen from the results that the PT, APTT and FIB of the freeze-dried product of the present invention are all within the qualified range, and the uniformity is good, which can meet the requirements of clinical quality control.

Embodiment 3

[0055] Antithrombin III performance evaluation of quality control plasma.

[0056] After reconstitution of the freeze-dried product prepared according to Example 1, test antithrombin III (ATⅢ assay kit, purchased from Shanghai Sun Biotechnology Co., Ltd.), detect 20 times, and observe whether the test result is qualified and the uniformity of the freeze-dried product For the results, please refer to the attached table 3. It can be seen from the results that the antithrombin III of the freeze-dried product of the present invention is within the range of normal test results, and has good uniformity, which can meet the requirements of clinical quality control.

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Abstract

The invention discloses a preparation method of long-term preservable plasma matrix universally used in quality control products. The universally used plasma matrix includes, but is not limited to, plasma which can be used for preparing blood coagulation quality control products, anticoagulant quality control products, and antithrombase quality control products. The invention also relates to a lyoprotectant and a lyophilization process of the universally used plasma. The lyoprotectant is prepared by mixing polyols, amino acids and inorganic salts according to certain proportions.

Description

technical field [0001] The invention belongs to the technical field of biological detection. More specifically, the present invention relates to a method for preparing a universal quality control product plasma matrix. Background technique [0002] Cardiovascular and cerebrovascular diseases are major diseases that endanger public health in modern society, ranking first among various causes of death. Cardiovascular and cerebrovascular diseases have the characteristics of high morbidity, high disability rate, high mortality rate, high recurrence rate and many complications. According to statistics, there are more than 270 million patients with cardiovascular and cerebrovascular diseases in China, and nearly 3 million people die of cardiovascular and cerebrovascular diseases every year, accounting for more than 30% of the total annual death causes in the country. Therefore, prevention of cardiovascular and cerebrovascular diseases is particularly critical. [0003] The core...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01N1/02
CPCA01N1/0221A01N1/0284
Inventor 乜永艳赵铁铭王哲
Owner SHANGHAI VASCUTECH DIAGNOSIS CO LTD
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