一测多评法测定元胡止痛胶囊中欧前胡素、异欧前胡素和延胡索乙素的含量

Content Determination of Imperatorin,Isoimperatorin and Tetrahydropalmatione in Yuanhu Zhitong Capsules by QAMS

目的:建立以一测多评法测定元胡止痛胶囊中欧前胡素、异欧前胡素、延胡索乙素含量的方法,并验证此方法在该制剂中应用的可行性和技术适应性。方法:以欧前胡素对照品为内参物,在一定线性范围内,采用高效液相色谱法建立其与异欧前胡素、延胡索乙素的相对校正因子,并用该校正因子进行异欧前胡素、延胡索乙素的含量计算,实现一测多评;同时采用外标法测定元胡止痛胶囊中这3种成分的含量,并比较2种方法测定结果。结果:8批药品中3种成分含量的2种方法测定结果无显著性差异(RSD<5%)。结论:一测多评法控制元胡止痛胶囊的质量快速、准确、可行,且成本低廉。

OBJECTIVE： To develop a QAMS method for simultaneous determination of imperatorin, isoimperatorin and tetra- hydropalrnatione, in Yuanhu zhitong capsules, and to validate its feasibility. METHODS： With imperatorin as internal reference standard, and relative correction factors （RCF） of isoimperatorin and tetrahydropalmatione to imperatorin were determined by HPLC within certain linear ranges. The contents of isoimperatorin and tetrahydropalmatione were calculated with RCF and QAMS. The contents of 3 components in Yuanhu zhitong capsules were determined by external standard method. The quantitative results were compared between 2 methods. RESULTS： There was no significant differences were found in the quantitative results of 3 com- ponents in 8 batches of Yuanhu zhitong capsules determined by the 2 methods （RSD〈 5 % ）. CONCLUSION： QAMS is rapid, accurate and feasible for quality control of Yuanhu zhitong capsule with low cost.