Comparison of Statistical Analysis of Biological Assays of Anticoagulation Activity of Leeches between European and Chinese Pharmacopeias / 中国药学杂志

ABSTRACT

OBJECTIVE: To compare two biological standardization calculation methods for evaluating the anticoagulation activity of different leeches in the same measure. METHODS: Heparin was used as the reference substance. The APTT values of W. pigra, H. nipponica and P. manillensis were used as the anticoagulant activity evaluation potency. The slope ratio model of European Pharmacopoeia 7.0 and the parallel reaction model of Ch.P 2015 were used to calculate the activity and the results were compared. RESULTS: The logarithm dose response curves of three kinds of leeches displayed linear relationship. Both of biological standardization statistical methods could be used for the calculation. The slope ratio model complete randomized design(0, 3, 3) of European Pharmacopoeia 7.0 was suitable to calculate the activity potency of different leeches, but the parallel reaction model of Chinese Pharmacopoeia 2015 was only suitable for P. manillensis. CONCLUSION: Taking the anticoagulation potency of heparin sodium as the reference, the slope ratio model complete randomized design(0, 3, 3) of European Pharmacopoeia 7.0 can be used as a standard method to evaluate the anticoagulation activity of different leeches.