复聪合剂质量标准研究

STUDIES ON QUALILY STANDARD OF FUCONG MIXTRUE

目的建立复聪合剂的质量控制方法。方法用薄层色谱法对其中黄芪、丹参进行了定性鉴别;用高效液相色谱法对黄芪中有效成分黄芪甲苷进行了含量测定。结果本品定性鉴别色谱特征明显易于区别;本品中黄芪甲苷含量测定线性范围为1.8～9.0μg,平均回收率97.63%,RSD为1.2%。结论建立了该制剂的质量标准,其鉴别与含量测定方法简便、可靠、实用。

Objective Establish a method for the quality control of Fueong mixture. Methods Radix Astragali, Radix Salviac mitiorrhizae were identified by TLC. A method of HPLC-ELSD to determine astragaloside IV, the main effective component from Radix Astragab in the mixture, was developed. Results The studies on the quality control showed that the characteristics for identification by TLC were distinct. The quantification method had the linear range of 1.8～9.0 μg. The average recovery was 97.63% and its RSD was 1.2%. Conclusion The quality standard of the mixture was provided. The methods for identification and quantification were simple, reproducible and realizable.