一测多评法测定中成药中洋川芎内酯A和藁本内酯

Determination of senkyunolide A and ligustilide in Chinese tranditional patent medicines by QAMS

目的以丁苯酞为内标一测多评法测定都梁滴丸、白带丸、血府逐瘀胶囊中洋川芎内酯A和藁本内酯。方法待测药物以甲醇提取,HPLC分析采用的色谱柱为Agilent Eclipse XDB-C18(4.6 mm×150 mm,5μm),流动相为甲醇-水(52∶48)。测定洋川芎内酯A和藁本内酯的相对校正因子,考察其校正因子的重现性,并与外标法进行比较。结果都梁滴丸和血府逐瘀胶囊能同时检测出洋川芎内酯A和藁本内酯,而白带丸仅检测出藁本内酯。在Agilent Eclipse XDB-C18、Phenomenex Luna C18和Agilent Zorbax SB-C18色谱柱上测定的相对校正因子重现性好,与外标法实测值无显著差异。结论本法可用于川芎、当归的质量控制,解决了洋川芎内酯A和藁本内酯对照品不稳定的难题。

AIM To take butylphalide as the internal reference standard to establish an HPLC method for simultaneously determining senkyunolide A and ligustilide in Duliang Dropping Pills,Baidai Pills and Xuefu Zhuyu Capsules using quantitative analysis of multi-components by single marker（QAMS）. METHODS The analyses of methanolic extracts of above pills and capsules were performed on Agilent Eclipse XDB- C18（4. 6 mm × 150 mm,5 μm） column with methanol-water（52 ∶ 48） as mobile phase,the relative correction factors of ligustilide and senkyunolide A were measured and their reproducibility examined under different conditions,and the comparison was made with external standard method. RESULTS The contents of senkyunolide A and ligustilide in Duliang Dropping Pills and Xuefu Zhuyu Capsules were found,only ligustilide in Baidai Pills was detected. The relative correction factors presented good reproducibility on Agilent Eclipse XDB-C18,Phenomenex Luna C18 and Agilent Zorbax SB-C18 columns. There was no significant difference between QAMS and external standard method.CONCLUSION The adopted QAMS can be applied to the quality control of Chuanxiong Rhzoma and Angelicae sinensis Radix in aid of solving the instability of senkyunolide A and ligustilide.