Biological effects based quality control of a traditional Chinese medicine

The main objective of this paper is to establish a quality control method based on lipid-lowering and anti-oxidation effect of Jiang-Zhi-Ning (JZN). Biological effects based quality standard of its active components was investigated. Two kinds of cells: oxidized low-density lipoprotein (Ox-LDL) injured human umbilicalvein endothelial cell (HUVEC) and human hepatoma cell line Bel-7402 were employed to investigate the biological effects of the standard product of JZN and 5 batches of its test samples. Calculation of the biological effect ratio (BER) = effect of test products of JZN / effect of active constituents of JZNx100%. By evaluation of the effect indexes of lipid-lowering and antioxidant activities of JZN, and by the computation of the biological effect ratio, the biological effect of the active constituents of JZN was confirmed and 11 indexes were assessed as standard biological effect indexes. Moreover, the biological effect ratio of the active constituents of JZN in low, middle and high concentrations of five test samples all ranges from 80 to 120%; as such, they were all judged as eligible products. The standard biological effect of active constituents of JZN could be assessed as standard effect. This research also provided evidence for quality standard evaluation system of Chinese herbal compound.