一测多评法在肝能滴丸质量控制中的应用研究

目的建立一测多评法同时测定肝能滴丸及其原料药中8种成分(去氢双松柏醇、波棱醇I、波棱内酯A、波棱甲素、波棱素、herpetetrone、波棱酮、波棱乙素)的含量。方法采用HPLC法,以波棱甲素为内参物,建立波棱甲素与其他7种指标成分的相对校正因子(f_(k/m)),并计算各待测成分的量。同时采用外标法测定5批肝能滴丸及原料药中这8种成分的含量,比较一测多评法所得的计算值与实测值之间的差异,以验证建立的一测多评法的准确性与可行性。结果在一定线性范围内,波棱甲素与去氢双松柏醇、波棱醇I、波棱内酯A、波棱素、herpetetrone、波棱酮、波棱乙素的f_(k/m)分别为0.908、0.728、0.516、0.720、0.461、0.623、0.410,在不同情况下重现性良好;5批肝能滴丸及原料药的计算值与实测值无显著性差异。结论以波棱甲素为内参物,同时测定肝能滴丸及原料药中8种成分含量的一测多评方法可靠,结果准确,可用于肝能滴丸的质量控制。

Quality control for Ganneng Dripping Pills based on quantitative analysis on multi-components with single marker

Objective To establish a quantitative analysis of multi-components by single mark (QAMS) for determining the content of eight components in Ganneng Dripping Pills (GDP) and its active pharmaceutical ingredients (APIs), including dehydrodiconiferyl alcohol, herpetotriol I, herpetolide A, herpetrione, herpetin, herpetetrone, herpetone, and herpetenone. Methods Based on HPLC method, the relative correction factors (f_k/m) were established with the herpetrione as the internal reference, and the content of other seven components was calculated. Moreover, the content of eight components in five batches of GDP and its APIs were determined by the external standard method (EMS), and the difference between the calculated value and the measured value were compared to verify the accuracy and feasibility of QAMS. Results The f_k/m value of dehydrodiconiferyl alcohol, herpetotriol I, herpetolide A, herpetin, herpetetrone, herpetone, and herpetenone with reference to herpetrione were 0.908, 0.728, 0.516, 0.720, 0.461, 0.623, and 0.410, respectively; And it had good reproducibility under different conditions. There were no significantly differences in the content of eight components between EMS and QAMS. Conclusion Using GAPDH as an internal standard, the QAMS for determining the contents of eight components in GDP and raw material medicine was reliable and accurate and could be applied to control the quality of GDP.