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

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(10 :30 :59 :1)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.

Improvement of Quality Standard for Shenyan Ⅱ Granules / 中国药师

Objective:To establish the quality standard for Shenyan Ⅱ granules. Methods:The characteristics of Folium Pyrrosiae were identified by microscopy. The three herbs in the preparation,rehmannia,madder and thistle were identified by TLC qualitatively. The content of ginsenoside in American ginseng was determined by HPLC. Chromatographic separation was carried out by using a WONDER CRACT ODS-2(150 mm × 46 mm,5 μm)column. The mobile phase consisted of acetonitrile-0. 1% phosphoric acid(28 ∶72)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 203 nm and 40 ℃,respectively. Results:The spots in TLC were clear without any interference. The linear range of ginsenoside was 38. 9- 194. 5 μg·ml -1(r = 0. 999 3). The average recovery was 98. 3% and RSD was 1. 9%(n = 6). Conclusion:The method is simple and highly specific with good repeatability,which can be used as the quality control method for Shenyan Ⅱ granules.