中药材定量分析中测量不确定度的评定方法及其影响因素的研究

目的：探讨中药材定量分析中测量不确定度的评定方法及其影响因素，为中药材分析方法的研究及中药质量标准的制定提供理论依据。方法：利用中药材多指标成分定量测定的方法验证数据和样品代表性实验数据，通过不确定度来源分析，运用现代误差理论，探讨了中药材多指标成分高效液相色谱定量方法的测量不确定度的评定方法。结果：将该方法应用于人参、三七和丹参3种中药材指标成分定量分析的测量不确定度的评定，并分析了影响测量不确定度的因素。中药材的样品均匀性是影响中药材多指标成分分析的测量不确定度的主要因素。结论：以方法验证数据和样品代表性实验数据来评定中药定量分析中的测量不确定度，方法简便，其评定结果对于中药材分析方法的建立及中药质量标准的制定具有重要意义。

Objective: To study the evaluating method and the affecting factors of measurement uncertainty for the determination of marker compounds in Chinese Materia Medica. Methods: The procedure for estimation of measurement uncertainty for the determination of the marker compounds in Chinese Materia Medica by using HPLC was established by using the validation data of assay for the marker compounds and experimental data of sample representation studies. The method of evaluation was achieved by analysis of the uncertainty sources arising from the procedure of analysis and by calculation of standard uncertainty according to the equations of statistics. Results: The measurement uncertainties of marker compounds in three Chinese Materia Medica, i.e., Radix Ginseng, Radix Notoginseng and Radix Salviae Miltiorrhizae were evaluated according the established method. The factors affecting on the measurement uncertainties of these three kinds of herbal medicines were analyzed. The homogeneity of sample was the primary factor for the measurement uncertainty of Chinese Materia Medica. Conclusion: The establishment of the methodology for the evaluation of measurement uncertainty is important to the studies of the assay methods and the quality standards for Chinese Materia Medica.