Study on Quality Standard for Isatidis Folium Dispensing Granules / 中国药师

ABSTRACT

Objective:To establish the quality standard for Isatidis folium dispensing granules. Methods:Indigo and indirubin in the granules were identified by TLC. The extract content was determined by a hot dipping method for the determination of alcohol-solu-ble extract. The content of indirubin was determined by HPLC. Results:The spots in TLC were clear and well-separated. The extrac-tion limit no less than 12. 0% was preliminarily drawn up. Indirubin showed a good linear relationship within the range of 0. 50-8. 04μg·ml-1(r=0. 999 9) with the average recovery of 99. 41%(RSD=1. 21%, n=9). The content limit no less than 50. 0 μg per pack was preliminarily drawn up for indirubin. Conclusion: The method is easy-operated and accurate with good specificity for the quality control of Isatidis folium dispensing granules.