复方元胡片质量标准研究

摘要

Objective To establish the quality standard for compound Yuanhu tablet. Methods Rhizoma cy-peri and Corydalis Rhizoma in the tablet were identified by TLC. The content of tetrahydropalmatine was determined by HPLC. A C18 (4. 6 mm × 250 mm,5 μm) was used with the mobile phase consisting of acetonitrile-0. 1% phosphoric acid (adjusting pH to 6. 0 with triethylamin) (40∶60) at the column temperature of 30 ℃. The flow rate was 1. 0 mL/min and the detection wavelength was 280 nm. Results The method of TLC had good resolution with clear spots and had interference from negative control. The good linearity was obtained within the range of 192~912 ng ( y=1. 108 9 x-20. 546,r=0. 999 6) for tetrahydropalmatine and the average recovery was 100. 82% (RSD=1. 27%,n=6). Con-clusion The established method is simple,accurate and sensitive,and can be applied in the quality control of com-pound Yuanhu tablet.%目的：建立复方元胡片的质量标准。方法采用薄层色谱法定性鉴别处方中的香附、延胡索,采用HPLC法测定延胡索乙素的含量。色谱柱为C18(4.6 mm×250 mm,5μm),乙腈-0.1%磷酸溶液(三乙胺调pH值至6．0)(40∶60)作为流动相,柱温为30℃,流速为1．0 mL/min,检测波长为280 nm。结果该质量标准薄层色谱法斑点清晰,分离度好,阴性对照无干扰；延胡索乙素在192~912 ng范围内呈良好的线性关系,回归方程：y=1．1089 x-20．546,r=0．9996,平均回收率为100．82%,RSD为1．27%(n=6)。结论本方法可有效控制复方元胡片的质量。