元胡止痛系列制剂中5种有效成分定量测定的研究

Assay of five active constituents in Yuanhu Zhitong Series Preparations

目的研究建立元胡止痛系列制剂中(延胡索、白芷)有效成分定量测定的方法,分析各成分之间的关系,比较不同剂型间差异。方法采用HPLC法,固定相C18,乙腈-0.03 mol/L乙酸铵溶液(用冰醋酸调pH6.0)梯度洗脱的方法,测定去氢延胡索甲素、延胡索乙素、延胡索甲素3种生物碱类,欧前胡素、异欧前胡素两种香豆素类成分。通过对制剂中各成分含有量比值与药材中相应成分含有量比值之间的关系的比较,建立定量测定标准。结果建立的元胡止痛系列制剂中5种有效成分定量测定的方法表明不同剂型间各成分含有量差异明显,但欧前胡素和异欧前胡素比例相对稳定。结论对元胡止痛系列制剂质量监控应测定去氢延胡索甲素、延胡索乙素、延胡索甲素和欧前胡素。

AIM To empoly the assay of active constituents inYuanhu Zhitong Series Preparations（Corydalis Rhizoma,Angelicae dahuricae Radix）,and to compare and analyse the difference in active constituents among series preparations.METHODS HPLC was carried out on column C18.The acetonitrile-0.03 mol/L ammonium acetate（adjusted pH to 6.0 with glacial acetic acid） as gradient elution was used to determine three alkaloids（dehydrocorydaline,tetrahydropalmatine,corydaline） and two coumarins（imperatorin,isoimperatorin） contents.Through comparing the ratio of every constituents in preparation,the analytical method was established rationally.RESULTS The established determination method showed that five active constituents in Yuanhu Zhitong Series Preparation were different,but the content ratio of imperatorin and isoimperatorin was relatively stable.CONCLUSION The experiment reveals that the quantity control over Yuanhu Zhitong Series Preparations should include the assay of dehydrocorydaline,tetrahydropalmatine,corydaline and imperatorin.