人参中人参皂苷HPLC定量方法的测量不确定度的评定

目的　探讨人参中人参皂苷R_g1,R_e和R_b1的HPLC定量分析方法的测量不确定度的评定方法。方法　通过分析测量过程，确定并简化不确定度来源；利用HPLC法测定人参中人参皂苷R_g1, R_e和R_b1的方法验证数据及经验数据，通过统计学方法，量化不确定度分量；计算合成不确定度和扩展不确定度。结果　用HPLC法测定人参中人参皂苷R_g1, R_e和R_b1的扩展不确定度分别为 0 .12c, 0. 14c和 0. 13c。结论　测量不确定度可用于人参中人参皂苷的标准限量的制定；测量不确定度的评定方法的确立对于中药质量标准的研究具有重要意义。

Aim To set out the procedure for estimation of measurement uncertainty for the determination of ginsenosides R_g1, R_e and R_b1 in Radix ginseng by HPLC. Methods To facilitate the identification and analysis of the uncertainty sources arising from the procedure of analysis, a cause and effect diagram was constructed and simplified. Each uncertainty component, whether associated with individual sources or with the combined effects of several sources, was evaluated with respect to the significance of its contribution to the overall measurement uncertainty and was expressed as standard uncertainty. All the standard uncertainties were then combined according to the appropriate rules to give a combined standard uncertainty and an expanded standard uncertainty. Results The expanded standard uncertainties for the HPLC determination of ginsenoside R_g1, R_e and R_b1 are 0.12c,0.14c and 0.13c, respectively. Conclusion Measurement uncertainty is applicable to set the limit of the ginsenosides in Radix ginseng. The establishment of the methodology for the evaluation of measurement uncertainty is important to the studies of Chinese materia medica standards.