HPLC法同时测定补气活血颗粒中的两种指标性成分

Simultaneous Determination of Two Index Compounds in BuQi HuoXue Granules

目的 建立同时测定补气活血颗粒中两种指标性成分(白术内酯Ⅰ、党参炔苷)的含量,建立基于上述两种成分的制剂质量评价方法。方法 采用HPLC法,使用Dikma C18色谱柱(4.6×250mm,5μm),甲醇-0.2%甲酸为流动相,梯度洗脱,流速1.0mL·min^-1,检测波长254nm,柱温30℃,进样量10μL,共测定10批补气活血颗粒中白术内酯Ⅰ和党参炔苷的含量。结果 10批颗粒中,白术内酯Ⅰ的平均含量为0.520mg·g^-1,RSD为21.37%,党参炔苷的含量为1.100mg·g^-1,RSD为13.28%。结论 本文所用方法快速、准确、可靠,能够为建立补气活血颗粒的多指标质量评价方法奠定基础。

OBJECTIVE To establish a simultaneous determination method for two index compounds (atractylenolideⅠ and lobetyolin) in BuQi HuoXue Granules and the quality evaluation method based on those compounds. METHODSHPLC determination used Dikma C 18 column (4.6×250mm,5μm),a mobile phase containing methanol and 0.2% formic acid,the elution mode was gradient,the flow rate was 1.0mL·min^-1 ,detection wavelength was 254nm,column temperature was 30℃,injection volume was 10μL,and 10 batches of the granule was analyzed to obtain their own contents of atractylenolide Ⅰ and lobetyolin.RESULTS In 10 batches of the granules,mean content of atractyleno lide Ⅰ was 0.520mg·g^-1 ,RSD was 21.37%;that of lobetyolin was 1.100mg·g^-1 ,and RSD was 13.28%. CONCLUSION The method used was fast,accurate and reliable,which was capable of establishing multi indexes quality evaluation method for BuQi HuoXue Granules.