不同质量标准中生物学活性测定四参数回归计算法的比较

Comparison of Calculation Method by Four-parameter Logistic Model for Biological Activity in Different Quality Standards

在同批供试品生物学活性测定时,选取标准品和供试品剂量反应曲线平行性好和平行性不好的试验数据各一套,用于比较不同质量标准中生物学活性测定数据处理的四参数回归计算法,以阐明各标准中算法的科学性和合理性。结果显示,当标准品和供试品的剂量反应曲线平行性较好时,以不同算法计算得到的供试品的生物学活性很接近;反之,结果差异较大,甚至根据部分质量标准的算法应判定为无效数据。该结果表明,对标准品和供试品的剂量反应曲线进行平行性判定是测定供试品生物学活性的前提,在平行性成立的条件下,再按等反应剂量比值的原则计算供试品的生物学活性,是更为科学合理的计算方法。

To clarify the scientificity and rationality of calculation methods by four-parameter logistic model for biological activity in different quality standards, two sets of data were chosen which fit good and bad for parallel doseresponse curves separately from the same batch of standard and test samples. The biological activity of test sample was calculated and compared by calculation methods using four-parameter logistic model from current version of Chinese Pharmacopoeia and the National Drug Registration Standards. When the dose-response curves of the standard and test samples showed good parallelism, the results calculated from different methods were similar. Otherwise, the results were quite different. Some result may be invalid according to some quality standard. It was shown that parallelism assessment between a pair of dose-response curves of reference standard and test sample was a prerequisite for the determination of biological activity. Only under the conditions of established parallelism, calculating biological activity of test sample according to ratio of equally effective doses was scientific and rational.