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.