Improvement of the Quality Standard for Shule Capsules / 中国药师

ABSTRACT

Objective:To establish the quality standard for Shule capsules. Methods: The microscopic characteristic identifica-tion of Figwort and Radix bupleuri was performed under a microscope. The qualitative identification of fritillary, andrographispaniculata and polygonumbistorta was studied by TLC. The content of salvianolic acid B in Salvia miltiorrhiza was determined by HPLC. The chro-matographic separation was carried out by using a phenomenex synergi 4 hydro-RP 80A (250 mm × 4. 6 mm) column. The mobile phase consisted of acetonitrile-methanol-formic acid-water(1030591)with gradient elution at a flow rate of 1. 0 ml·min-1, and the injection volume was 10 μl . The detection wavelength and the column temperature was 286 nm and 20 ℃, respectively. Results:The microscopic characteristics were obvious. The spots in TLC were clear without any interference. The linear range was 10. 001-100. 007 μg·ml-1(r=1. 0000). The average recovery was 99. 3% with RSD of 1. 8% (n=6). Conclusion:The method is simple with high specificity and good repeatability, which can be used as the quality control method for Shule capsules.