妇血安薄膜衣片的质量标准

Quality Standard of Fuxue'an Film-coated Tablets

建立了妇血安薄膜衣片的质量控制标准。以薄层色谱法对其中的三七、女贞子、丹参、白术、仙鹤草和党参进行定性鉴别,以高效液相色谱法测定阿魏酸。采用Kromasil C18色谱柱,以甲醇-1%冰乙酸(33:67)为流动相,检测波长330 nm。阿魏酸在5～80 g/ml范围内线性关系良好,平均回收率为98.9%,RSD为1.12%。

The quality control standard of Fuxue＇an film-coated tablets were established. A TLC method was used for the identification of Panax notoginseng, Ligustrum lucidum, Salvia miltiorrhiza, Atractylodes macrocephala, Agrimonia pilosa and Codonopsis pilosula in Fuxue＇an film-coated tablets. An HPLC method was applied for the determination of ferulic acid. A Kromasil C18 column was used with the mobile phase of methanol-1% acetic acid （33 ： 67） at the detection wavelength of 330 nm. The calibration curve of ferulic acid was linear in the concentration range of 5 - 80 μg/ml. The average recovery was 98.9 %, with RSD of 1.12 %.