Study on Improvement of Quality Standards of Shiwei Yipi Granules / 中国药房

ABSTRACT

OBJECTIVE：To prov ide reference for the improvement of quality standards of Shiwei yipi granules. METHODS ： According to the general rules of 2015 edition of Chinese Pharmacopeia （part Ⅳ），microscopic identification was used to identify Massa Medicata Fermentata and Galli Gigerii Endothelium Corneum ；TLC method was used to qualitatively identify Crataegi Fructus and Semen Raphani ；the content of sinapine thiocyanate in Semen Raphani was determined by HPLC. RESULTS ：The microscopic characteristics were obvious for Massa Medicata Fermentata （palisade cells of testa and stone cells of testa ）and Galli Gigerii Endothelium Corneum （irregular fragments ）. The same fluorescent spots of Crataegi Fructus and Semen Raphani were displayed at the same position of ursolic acid ，sinapine thiocyanate control and Semen Raphani reference substance. The linear range of sinapine thiocyanate was 23.27-9 574.42 ng （r＝1.000 0）. The LOD and LOQ were of 0.50 μ g/mL and 1.68 μ g/mL， respectively. RSDs of precision ，repeatability，intermediate precision and stability tests （24 h）were all less than 1.5％. The average recoveries were 99.40％-100.89％（RSDs were 0.18％-0.49％，n＝3）. The contents of sinapine thiocyanate in 3 batches of Shiwei yipi granules were 0.086 4-0.220 6 mg/g，the average was 0.168 4 mg/g. CONCLUSIONS ：The identification method of Massa Medicata Fermentata ，Galli Gigerii Endothelium Corneum ，Crataegi Fructus and Semen Raphani in Shiwei yipi granules as well as the method for content determination of sinapine thiocyanate in Semen Raphani are established successfully. The content of Semen Raphani in the Shiwei yipi granules is no less than 0.16 mg/g calculated by sinapine thiocyanate （C16H24NO·5 SCN）.