活血止痛片质量控制方法研究

Studies on the Quality Control Method of Huoxuezhitong Tablets

目的 研究活血止痛片质量控制方法.方法 采用TLC对活血止痛片中当归、三七、乳香、冰片和土鳖虫进行定性鉴别;采用HPLC对活血止痛片中的阿魏酸进行含量测定,色谱柱为 Hypersil ODS2(4.6 mm×250 mm,5 μm),流动相为甲醇-1%乙酸水溶液(30∶70),检测波长为320 nm,流速为1.0 mL·min-1.结果 薄层色谱鉴别专属性强,阿魏酸进样量在0.01～0.14 μg范围内线性关系良好(r=0.999 9),平均加样回收率为98.60%(RSD=0.64%).结论 本方法操作简便,结果可靠,重现性好,可用于活血止痛片的质量控制.

OBJECTIVE To establish a quality control method for Huoxuezhitong tablets.METHODS Radix angelicae sinensis,Radix Notoginseng,Olibanum,Borneolum Syntheticum and Eupolyphaga Seu Steleophaga in Huoxuezhitong tablets were identified by TLC.Ferulic acid in Huoxuezhitong tablets was determined by HPLC.The separation was performed on Hypersil ODS2 column(4.6 mm×250 mm,5 μm),the mobile phase consisted of methanol-1% acetic acid(30∶70) with detection wave length at 320nm and flow rate at 1.0 mL·min-1.RESULTS TLC identification is a highly specific approach.The calibration curve of ferulic acid was linear within the range of 0.01～0.14μg(r=0.999 9),with average recovery at 98.60%(RSD=0.64%).CONCLUSION This methods is simple,reliable,reproducible,and suitable for the quality control of Huoxuezhitong Tablets.