目的 探寻适合不同水蛭生物检定的计算方法,达到以统一标准衡量不同水蛭活性的目的。方法 以肝素钠为标准品,将宽体金线蛭、日本医蛭及菲牛蛭的活化部分凝血酶时间值检定结果,分别采用《欧洲药典》7.0斜率模型及《中国药典》2015年版量反应平行线模型进行比较计算。结果 3种水蛭的对数量反应曲线均能呈直线关系,能满足两种生物检定计算法的要求。《欧洲药典》斜率模型完全随机化(0,3,3)法适合此3种水蛭的生物检定计算,但《中国药典》量反应平行线3,3法仅适合于菲牛蛭的生物检定计算。结论 以肝素钠抗凝效价为标准,采用《欧洲药典》斜率模型完全随机化(0,3,3)法,可达到统一标准衡量不同品种水蛭活性的目的。

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.