一测多评法在四神丸中9种成分含量的测定及质量评价中的应用

The application of one test and multiple evaluation method in the content determination and quality evaluation of 9 components in Sishen pills

在高效液相色谱法(HPLC)基础上,采用一测多评法(QAMS)测定复方四神丸中分别来源于君、臣、佐药中的9种代表性有效成分的含量,并将方法应用于8个不同厂家的复方四神丸进行质量评价.采用HPLC法以水(A)-甲醇(B)为流动相进行梯度洗脱;采用多点校正法以补骨脂素为内参物建立9种有效成分的相对校正因子;计算8个厂家四神丸中9种有效成分的含量,通过评估有效成分的含量进而评估8个厂家的四神丸质量.结果表明:9种成分测定结果与外标法(ESM)测定结果的含量差异百分比均不超过3%.结论:一测多评法高效准确,能有效地测定四神丸中9种有效成分的含量,可以快速地对复方四神丸整体的质量进行评价.

On the basis of High Performance Liquid Chromatography(HPLC),the contents of 9 representative active components from Jun,Chen and adjuvants in compound Sishen pills were determined by Quantitative Analysis of Ulticomponents by Singlemarker(QAMS).The method was applied to evaluate the quality of compound Sishen pills from 8 different manufacturers.Gradient elution was performed using Water(A)-Methanol(B)as mobile phase by HPLC method;with psoralen as internal reference,multi-point correction method was used to establish the relative correction factors of 9 effective components.The quality of Sishen pills from 8 manufacturers was evaluated by calculating the content of 9 active ingredients in these pills.The results showed that the percentage difference between the results of ESM and those of 9 components was no more than 3%.Conclusion:The method of QAMS is efficient and accurate.It can effectively measure the contents of 9 effective components in Sishen pills and quickly evaluate the overall quality of compound Sishen pills.