Quality Standard Improvement for Compound Huanghuai Tablets / 中国药师

ABSTRACT

Objective:To improve the quality standard for compound Huanghuai tablets. Methods: The main components of the preparation including Flos Sophorae Immaturus, Radix Scutellariae Baicalensis, Radix Paeoniae Rubra, Radix et Rhizoma Rhei Palma-ti, Rhizoma Imperatae, Caulis Spatholobi, Semen Coicis and Spica Prunellae Vulgaris were identified by TLC qualitatively. The content of rutin in Flos Sophorae Immaturus was determined by HPLC. A DIKMA? Spursil C18 (250 mm × 4. 6 mm, 5 μm) column was used with methanol-0. 2% phosphoric acid solution (45:55) as the mobile phase. The flow rate was 1. 0 ml·min-1 , the detection wave-length was set at 350 nm, the column temperature was maintained at 25℃, and the injection volume was 20μl. Results:The spots in TLC were clear without any interference. The calibration curve was linear within the range of 0. 0116-0. 1859 mg · ml-1 ( r =0. 9999) for rutin. The average recovery was 98. 93% (RSD=1. 14%,n=6). Conclusion: The improved quality standard is sim-ple, specific and reproducible, which can be used for the quality control of compound Huanghuai tablets.