论文部分内容阅读
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 search for the calculation methods of different leech bioassays, and to achieve the purpose of measuring the activity of different leeches with a uniform standard. Methods The heparin sodium was used as the standard. The results of the partial thromboplastin time assay of Hirudo nipponensis, Hirudo nipponense and Leuconostus nipponense were respectively fitted with the “European Pharmacopoeia” 7.0 slope model and the Chinese Pharmacopoeia 2015 volume response Parallel line model for comparative calculation. Results The results showed that there was a linear relationship between the response curves of three species of leeches and the two bioassay methods. The complete randomization of the “European Pharmacopoeia” slope model (0, 3, 3) is suitable for the bioassay of these three leeches, but the “Chinese Pharmacopoeia” volume response parallel line 3, 3 method is only suitable for bioassay . Conclusion The heparin sodium anticoagulant titer as a standard, using the “European Pharmacopoeia” slope model completely randomized (0,3,3) method, to achieve a unified standard measure of different varieties of leeches activity.