替代对照品法在中药多指标含量测定中的应用与技术要求探讨

本文分析和归纳了替代对照品法的国内外应用情况及研究中存在的问题,定量方面提出相对校正因子为物质百分吸光系数之比,并以此为基础分析了影响定量准确度的因素,认为波长和对照品为影响定量的关键因素;比较了相对保留时间法和对照提取物定性法等7种定性方法的优缺点;在方法实用性方面,提出色谱仪校正和色谱柱相似度评价等可能的研究方向;为该法的后续研究提供参考。

The application and problems of substitute reference substance method in China and abroad were reviewed and discussed in this paper.On quantitative aspect, we put forward that the relative correction factor is the ratio of percent absorption coefficient;on this basis, the factors were analyzed that influenced quantitative accuracy, regarding the wavelength and reference substance as key factors.On qualitative aspect, we compared the advantages and disadvantages of the method of the relative retention time, the qualitative method of reference extract and the other five qualitative methods.On practical aspect, several possible research directions such as HPLC instrument calibration and chromatographic column similarity evaluation were proposed, providing references for further study of this method.