杞菊地黄丸(浓缩丸)质量标准的研究

Study of quality standard of qi ju di huang pill

目的 研究杞菊地黄丸 (浓缩丸 )的质量标准。方法 采用薄层层析法 (TLC)对枸杞子和牡丹皮进行定性鉴别 ;采用薄层扫描法 (TLCS)测定熊果酸的含量 ;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 ;暂定熊果酸的含量为≥ 0 0 1 0 % ;暂定重金属 <2 0 ppm ,砷盐 <2 ppm。结论 该实验具有定性、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 Qi ju di huang pill .Methods Thin Layer Chromatography (TLC) was used to identify Fructus Lycii and Cortex Moutan.Ursolicacide was determined with Thin Layer Chromatography Scanning(TLCS) .Arsenic was examined by Gucai’s method.Results The methods about idetification,determing and examination of limitation in this preparation, were developed.Determination about Ursolicacide was limited temporarily over 0.010%.Harmful elements both heavy metal and Arsenic were limited temporarily less 20 ppm and 2 ppm,respectively.Conclusion The experiment with triple meanings including identification ,determing and examination of limitation provided a new idea to control quality and improve standard of this preparation.