Tumor mark quality control product preparation method

Abstract

A preparation method of tumor labeled substance quality control belongs to the biological product technical field and comprises the following steps: after being added calcium chloride solution, the finished product human plasma is hatched for 1-3 hours in 36-38 DEG C and is centrifugalized at the speed of 3500-4500 r / m; after fiber protein in the plasma is eliminated, the plasma becomes quality control serum metrix; after being added tumor labeled substance quality control specimen in a certain scope of contents, the quality control serum metrix becomes the crude product of quality control product; after being added antiseptic and mixed uniformly, the quality control crude product is fractionally packed, dried in vacuum and low temperature and determined. The preparation method of tumor labeled substance quality control adopts the finished product human plasma which has adequate source and is easy to obtained as material; after the plasma is processed, the ingredients of organic substance in the plasma is totally identical with the ingredients of serum, which not only guarantees the quantity and the quality of quality control product but also has the advantages of less additive, less modulated substance, small vial to vial difference, a full set of quality control detecting projects, low production cost and long period of validity; furthermore, a lyophilizing reagent has sound stability after being reconstituted.

Description

technical field [0001] The invention belongs to the technical field of biological products, in particular to a method for preparing a tumor marker substance control product. Background technique [0002] In the detection of tumor markers, due to the complexity of their structures, most tumor markers currently lack international standards, which may cause inconsistencies in the detection results obtained by different detection methods or detection products from different manufacturers. In the quality management system of tumor marker detection, the use of quality control materials for indoor quality control and participation in quality evaluation between laboratories is to ensure the quality of laboratory test results, reduce errors, and make the results of different laboratories have better comparability. important measures. [0003] At present, the sources of matrix components in the preparation of immune quality control products mainly include animal serum and mixed norma...

AI Technical Summary

Problems solved by technology

[0003] At present, the sources of matrix components in the preparation of immune quality control products mainly include animal serum and mixed normal human serum, but the use of animal serum or mixed normal human serum mainly has the following defects: 1. Medical testing is mainly based on human serum for detection purposes , There is incomparability in using animal serum as a matrix, and there are unpredictable interference factors in theory, and unknown infectious pathogens may exist in animal blood; 2. One of the sources of mixed normal human serum is the remaining in the daily work of medical testing Specimens, since the serum volume of each remaining specimen is generally less than 2 ml, it is not suitable for commercial production requiring more than thousands of milliliters, and the detection of infectious pathogens for each specimen is also expensive; 3. Mixing normal human serum Another source is the volunteer supply. After the blood is collected, it will naturally coagulate and separate the serum, but it will waste the other main component in the blood - red blood cells. Compared with the preciousness of blood resources, it is also an unacceptable method.