Study on Improvement of Quality Standard of Kebai Mixture

OBJECTIVE To improve and upgrate the quality standard for Kebai Mixture. METHODS The content of astragaloside was taken as index components for TLC identification. HPLC method was adopted to determinate the contens of psoralen and isopsorate. Ten batches of Kebai Mixture samples were taken for qualitative and quantitative analysis, and then to propose the draft of quality standards for Kebai Mixture. RESULTS The TLC spots were clear and the degree of separation was good. Psoralen and isopsorate showed good linear range in 1.41~45.20 μg·mL^-1(r=1.000 0), 1.30~41.40 μg·mL^-1(r=1.000 0), the average recovery of psoralen and isopsorate were 98.1% and 98.3%, respectivey. RSDs were 0.6% and 0.6%(n=6). CONCLUSION The total quantity control of psoralen and isopsorate can be suggested containing no less than 38.0 μg·mL^-1 in Kebai Mixture. It can provide the quality assurance for clinical application after the quality standard system established.