Preparation method of blood coagulation factor IX quality control product

Abstract

The invention relates to a preparation method of a clinical blood coagulation inspection preparation and particularly relates to a preparation method of a blood coagulation factor IX quality control product. The preparation method comprises the following steps: carrying out affinity chromatography on the mixed blood plasma of multiple persons by using an anti-human blood coagulation factor IX monoclonal antibody immunoaffinity chromatography column, removing a blood coagulation factor IX in the mixed blood plasma of multiple persons to obtain a blood plasma in shortage of the blood coagulation factor IX; mixing the mixed blood plasma of multiple persons with the blood plasma in shortage of the blood coagulation factor IX according to a certain proportion to prepare a blood coagulation factor IX quality control product with the content of the blood coagulation factor IX at different concentration levels, adding a freeze-drying protective additive, carrying out sub-packaging, and carrying out freeze drying so as to obtain the blood coagulation factor IX quality control product. According to the blood coagulation factor IX quality control product prepared by the preparation method, the uniformity, the stability and the stability of freeze-dried aquatic product subjected to re-melting are good, and the quality control product can replace an imported product to be used for quality control on detection of blood coagulation factor IX, so that the reduction of the detection cost is facilitated and the capability of detecting the blood coagulation factor IX in China can be promoted.

Description

technical field [0001] The invention relates to a preparation method of a clinical blood coagulation test preparation, in particular a preparation method of a blood coagulation factor IX quality control product. Background technique [0002] Determination of coagulation factor IX has important clinical significance. As the blood coagulation factor IX activity test project continues to expand to various fields in disease diagnosis and treatment, it is particularly important to use blood coagulation factor IX quality control products to conduct internal quality control and external quality assessment for blood coagulation factor IX activity detection. At present, there are many reagents and instruments for the detection of blood coagulation factor IX. Different reagents, detection instruments, and detection principles are different, resulting in great differences in the results. Regardless of the method used, internal quality control and external quality assessment are necess...

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Problems solved by technology

[0003] At present, the blood coagulation quality control substances used in clinical laboratories are usually multi-parameter blood coagulation quality control substances, and the abnormal values ​​of the blood coagulation quality control substances are also abnormal except for the abnormal level of coagulation factor IX. Accuracy, but also difficult to guarantee the effectiveness of coagulation factor IX internal quality control and external quality assessment

[0004] Domestic coagulation quality control products are almost monopolized by foreign reagent manufacturers. The products are expensive and have a single level, which cannot meet the needs of clinical testing with multiple activity levels.

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