Quality Standard for Sinapis Semen(stir-baked) Formula Granule / 中国药师

ABSTRACT

Objective:To establish the quality standard for Sinapis Semen( stir-baked) formula granule. Methods:TLC was used to identify Sinapis Semen; an HPLC method was applied in the content determination of Sinapine thiocyanate in Sinapis Semen ( stir-baked) formula granule with Hibar Purospher STAR C18 (250 mm × 4. 6 mm,5 μm ) column and with the mobile phase consisting of acetonitrile-0. 08 mol·L-1 potassium dihydrogen phosphate (10 ∶90) at the flow rate of 1. 0 ml·min-1 ,the column temperature was 35℃ and the detection wavelength was set at 326 nm. Results:The characteristic spots of Sinapis Semen( stir-baked) formula granule were clearly detected by the established TLC chromatography. Sinapine thiocyanate had a good linear relationship within the concentra-tion range of 0. 012 2-3. 912 3μg(r=0. 999 9). The average recovery was 100. 4% (RSD=0. 6%, n=6). The water content, dis-solution and particle size of Sinapis Semen formula granule all met the related requirements. Conclusion:The methods are simple and accurate with good reproducibility,which can be used to control the quality of Sinapis Semen( stir-baked) formula granule.