大黄微粉胶囊质量标准研究

Reasarch on Quality Standard of Chinese Rhubarb Micro-powder Capsules

目的建立大黄微粉胶囊的质量标准。方法采用薄层色谱鉴别法对方中的大黄进行定性鉴别；采用改进后的高效液相色谱法测定方中大黄素、大黄酚的含量。结果薄层色谱清晰，重现性好；大黄素在0．026～0．518μg呈良好的线性关系（r=1．0000），平均回收率101．23％（RSD2．15％，n=5）；大黄酚在0．089～1．786μg呈良好的线性关系（r=1．0000），平均回收率98．25％（RSD4．40％，n=5）。结论该方法能准确、快速地进行定性、定量检测，可用于黄微粉胶囊质量标准控制。改进后的液相方法检测效率高，检测成本低．环境污染轻。

OBJECTIVE To establish a quality control system for Chinese Rhubarb Micro-powder （CRM） cap- sules by identification and content determination. METHODS The capsule for CRM was identified by TLC with Chinese rhubarb as indexes. The content of emodin and chrysophanol in the capsule for CRM was determined by im- proved HPLC. RFSULTS The studies on the quality control showed that the characteristic of identification by TLC was distinct, accurate and reproducible. The methodological study showed that a good linear correlation existed in the range of 0. 026 ~0. 518μg （r = 1. 0000） of emodin,and 0. 089 ～ 1. 786μg （r = 1. 0000） of chrysophanol respective- ly. The average recovery of emodin was 101.23% with RSD of 2. 15% （ n = 5 ） and that of chrysophanol was 98.25% with RSD of 4. 40% （ n = 5）. CONCLUSION The methods are accurate and quick in qualitative identification an quantitative assay of this preparation, which can be used for the quality control of Chinese Rhubarb Micro-powder capsules. This improved method of HPLC is high efficient of determination with low cost and light environmental pol- lution.