附子理中丸(浓缩丸)质量标准的建立

Study on Quality Standard for Fuzi Lizhong Pills(Concentrated Pills)

目的:建立附子理中丸(浓缩丸)质量控制方法。方法:采用薄层色谱法对方中干姜、甘草进行定性鉴别;采用高效液相色谱法测定样品中甘草苷含量。色谱柱为Agilent Zorbax-SB C_(18)(250 mm×4.6 mm,5μm),流动相:乙腈-0.5%醋酸溶液(20:80),柱温:35℃,流速:0.8 ml·min^(-1),检测波长:276 nm。结果:薄层定性鉴别的斑点清晰,分离效果良好;甘草苷对照品在0.016～0.477μg范围内线性关系良好(r=0.999 9),平均回收率为98.11%,RSD为1.12%(n=9)。结论:本法简便、可靠、准确,可用于该制剂的质量控制。

Objective： To establish the quality standard for Fuzi Lizhong pills （ coneentrated pills）. Method ： Zingiberis Rhizoma and Glyeytthizae Radix et Rhizoma were identified by TLC. The eontent of liquiritin in the coneentrated pills was determined by HPLC. An Agilent Zorbax-SB C18（250 mm ×4.6 mm,5 μm） column was eluted with the mobile phase eonsisted of acetonitrile-O. 5% acetic aeid （20： 80） at the column temperature of 35℃. The flow rate was 0.8 ml min-1 and the deteetion wavelength was 276 nm. Result： The spots in TLC were quite clear. The linear range of liquiritin was within O. 016-0. 477 μg（ r = 0. 999 9 ）, the average recovery of liquiritin was 98.11% with RSD of 1.12% （n = 9 ）. Conclusion： The established method is simple, reliable and accurate, and can be used as the quality control method of Fuzi Lizhong pills （ concentrated pills）.