芪参益智胶囊质量标准研究

目的建立芪参益智胶囊的质量标准。方法采用薄层色谱法对芪参益智胶囊中党参、枸杞子、陈皮等进行定性鉴别；采用高效液相色谱法测定黄芪甲苷的含量。色谱柱：Agilent Hypersil ODS十八烷基键合硅胶柱（4．5mm×250mm，5μm）；流动相：乙腈-水（32：68）；流速：1．0ml／min；漂移管温度：45℃；气体流速：1．5L/min。结果定性鉴别薄层色谱斑点清晰，阴性无干扰；黄芪甲苷在0．506—4．554μg范围内呈良好线性关系；平均回收率为103．05％，RSD为1．43％（n=6）。结论该方法简便、准确、可靠，可作为芪参益智胶囊的质量控制方法。

Studies on the quality standard of qishenyizhi capsule

Objective To establish the quality standard of qishenyizhi capsule. Methods TLC were used to distinguish Dangshen,Pugongying,Zhizi and Chishao. HPLC were used for the deterimination of Berber- ine. The column was PHENOMENEX ODS C18 （4. 6 mm × 250 mm,5 μm） ;the acetonitrile-water （35：65 ）as mobile phase, the flow ratewas 1.0 ml/min, the temperature of drift the was 45 ℃ and tube flow rate of gas was 1.5 L/min. Results The thin-layer chromatography spots were clear and the negative samples and had no interferences;and Astragaloside Ivshowed good linearity in the range of 0. 506-4. 554 μg, and the average recovery was 103.05% with RSD 1.43 % （ n = 6）. Conclusion This method is simple, accurate, reliable and can be used as a quality control method for qishenyizhi Capsule.