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Establishment and validation of quantitative analysis of multi-components by a single marker for quality control of polygoni multiflori radix

机译:建立和验证何首乌质量控制的多组分定量分析方法

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Quality control of Traditional Chinese Medicine (TCM) is one of the biggest challenges facing its clinical practice. The quality of Polygoni Multiflori Radix (PM) is mainly attributed to the content of stilbenes and anthraquinones. Herein, a sensitive, precise, and specific high-performance liquid chromatography (HPLC) method is established for the quantification of the six major components in PM, which include cis-2,3,5,4a€2-tetrahydroxystilbene-2-O-?2-D-glucoside (cis-TSG), trans-2,3,5,4a€2-tetrahydroxystilbene-2-O-?2-D-glucoside (trans-TSG), emodin-8-O-?2-D-glucoside, physcion-8-O-?2-D-glucoside, emodin and physcion. Based on this, using trans-TSG as the internal reference, quantitative analysis of multi-components by a single marker (QAMS) was carried out, and relative correction factors (RCFs) were calculated to determine the contents of the other five components. Tested by a robustness experiment under certain changeable conditions, the RCFs proved to be stable with RSDs below 5.0%. Moreover, on comparing the contents of the target components determined by an external standard method (EMS) and QAMS, there were no significant differences observed between the two methods with absolute relative errors of 5%. The abovementioned results indicate that QAMS possesses high convenience, accuracy, and feasibility and can be successfully applied to PM and its preparations for multi-component quality control.
机译:中药(TCM)的质量控制是其临床实践面临的最大挑战之一。何首乌(PM)的质量主要归因于对苯二酚和蒽醌的含量。本文建立了灵敏,精确和特异的高效液相色谱(HPLC)方法来定量分析PM中的六种主要成分,其中包括顺式2,3,5,4a€2-四羟基-2--2-O -α2-D-葡糖苷(顺式-TSG),反式-2,3,5,4a€2-四羟基sti-2-O-β2-D-葡糖苷(反式-TSG),大黄素-8-O-? 2-D-葡萄糖苷,physcion-8-O-β2-D-葡萄糖苷,大黄素和physcion。在此基础上,以反式TSG为内参,用单一标记物(QAMS)进行多组分的定量分析,并计算相对校正因子(RCF)以确定其他五个组分的含量。通过在某些可变条件下进行的鲁棒性实验测试,证明RCF在RSD低于5.0%时是稳定的。此外,在比较通过外标方法(EMS)和QAMS测定的目标组分的含量时,两种方法之间的绝对相对误差均小于5%,没有发现显着差异。上述结果表明,QAMS具有很高的便利性,准确性和可行性,可以成功地应用于PM及其制备的多组分质量控制。

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