补中益气丸(浓缩丸)的质量标准研究

Study of quality standard of Buzhongyiqi pills

目的研究补中益气丸(浓缩丸)的质量标准。方法采用薄层色谱法对当归和甘草进行定性鉴别;采用双波长薄层扫描法测定黄芪甲苷的含量;采用古蔡氏法检查砷盐。结果建立了该制剂的定性和定量及限量检查方法;暂定黄芪甲苷的含量为≥0.008%;暂定重金属<20μg·mL-1,砷盐<2μg·mL-1。结论实验具有定性、定量和限量检查三重意义,为该制剂的质量控制和标准提升提供了科学依据。

Objective To study quality standard of Buzhongyiqi pills.Methods Glycyrrhiza and Angelica were identified by Thin Layer Chromatography (TLC) .AstragalosideⅣwas determined with Thin Layer Chromatography Scanning.Arsenic was examined by Gucai's method.Results The methods of identification,determination and examination of limitation in this preparation,were developed.Determination of Astragaloside Ⅳwas limited temporarily over 0.008%.Harmful elements both heavy metal and Arsenic were limited temporarily less 20 μg·mL^(-1) and 2 μg·mL^(-1),respectively.Conclusion The experiment with triple meanings including identification,determination and examination of limitation provided a new idea to control quality and improve the.standard of this preparation.