Composite quality control product of liver function, and preparation method and application thereof

[0029] In the preparation process of composite quality control products, adding salting-out drug purification steps has a great influence on the enzyme activity and concentration in the finished product. Different proteins require different salt concentrations during salting out and purification. Therefore, this embodiment mainly focuses on the properties of the three target enzymes, and optimizes step S5 in the preparation method so that other proteins and impurities can be precipitated out, thereby obtaining a relatively high concentration of protein. High concentration of active enzyme liquid.

[0030] The preparation method of each solution in the present embodiment is as follows:

[0031] (1) Extraction solution: Prepare 50mmol / L Tris (trishydroxymethylaminomethane) buffer solution, then add potassium chloride to the buffer solution to a concentration of 5mmol / L, add EDTA to a concentration of 6mmol / L, and then add Sodium nitride to a concentration of 2 g / L, adjust the p...

[0046] In order to improve the stability of the composite quality control product, on the basis of the preparation method described in Example 1, the liver function composite quality control product obtained in Example 1 Group 4 was diluted with a protective agent, and then freeze-dried The process obtains the freeze-dried powder of the compound quality control product to significantly improve the stability of the reagent.

[0047] The formula of the protective agent is as follows: prepare 50mmol / L Tris buffer solution, add sodium chloride to a concentration of 0.5mmol / L, mannitol to a concentration of 8g / L, dextran to a concentration of 6g / L, bovine serum white Protein to a concentration of 10g / L, EDTA to a concentration of 0.5mmol / L and sodium azide to a concentration of 0.5g / L, adjust the pH to 7.4, and constant volume to obtain the protective agent.

[0048] After diluting the liver function compound quality control product obtained in Example 1 Group 4 20 times with the a...

[0050] The difference between this embodiment and Example 2 is that the formula of the protective agent is: 20mmol / L Tris buffer solution, 0.05mmol / L sodium chloride, 4g / L mannitol, 3g / L dextran, 8g / L L bovine serum albumin, 0.03mmol / L EDTA and 0.1g / L sodium azide.