一测多评法同时测定蒙药扎冲十三味丸中4种成分的含量

目的 建立蒙药扎冲十三味丸中4种成分(丁香酚、木香烃内酯、去氢木香内酯、去氢二异丁香酚)的一测多评方法(QAMS),验证该方法在蒙药扎冲十三味丸质量分析中的可行性与科学性。方法 采用高效液相色谱法(HPLC),以丁香酚为内参物,建立木香烃内酯、去氢木香内酯、去氢二异丁香酚的相对校正因子,利用相对校正因子计算蒙药扎冲十三味丸中该3种成分的含量,同时采用外标法(ESM)计算各成分的含量,并比较2种方法之间的差异。结果 木香烃内酯、去氢木香内酯、去氢二异丁香酚的相对校正因子(f_S/ii)分别为 0.560 7、0.924 8、0.363 8。一测多评法与外标法测得的3个批次蒙药扎冲十三味丸样品中木香烃内酯、去氢木香内酯、去氢二异丁香酚含量的相对标准偏差(RSD)值均小于5.0%,没有显著差异。结论 以丁香酚为内参物建立的相对校正因子准确、易行,一测多评法可用于蒙药扎冲十三味丸中多指标成分的质量评价。

Simultaneous Determination of Four Components in Zhachong shisanwei Pills by QAMS

OBJECTIVE To establish a quantitative analysis of multi-components by single marker(QAMS) method for four components(eugenol, costunolide, dehydrocostuslactone and dehydrodiisoeugenol) in Zhachong shisanwei pills, and verify the feasibiliy and scientificity of the method in the quality analysis of Zhachong shisanwei pills. METHODS The relative correction factors of costunolide, dehydrocostanolide and dehydrodiisoeugenol were established by HPLC with eugenol as the internal reference substance. The contents of the three components in Zhachong shisanwei pills were calculated by using the relative correction factor, and the contents of each component were calculated by external standard method(ESM), and the differences between the two methods were compared. RESULTS The relative correction factors(f_S/i) of costunolide, dehydrocostuslactone and dehydrodiisoeugenol were 0.560 7, 0.924 8 and 0.363 8, respectively. The relative standard deviation(RSD) values of three batches of Mongolian medicine Zhachong shisanwei pills determined by the QAMS method and external standard method were all less than 5.0%, and there was no significant difference. CONCLUSION The relative correction factor established with eugenol as the internal reference material is accurate and easy to operate. The method of QAMS can be used for the quality evaluation of multi-index components in Mongolian medicine Zhachong shisanwei pills.