Quality Standard for Xilei San / 中国药师

ABSTRACT

Objective:To research the quality standard for Xilei San. Methods:Imdigo naturalis and calculus bovis were identi-fied by TLC and their contents were determined by HPLC, and Borneolum syntheticum was determined by GC. Results: Indirubin showed good linearity over the concentration range of 0. 043-4. 255 0 μg(r=0. 999 2) with the average recovery of 97. 9%(RSD=1.5%,n=6). Bilirubin showed good linearity over the concentration range of 9.968 ×10 -4-9.968 ×10 -2 μg(r=0.999 9) with the average recovery of 95.3%(RSD =0.55%, n =6). Borneolum syntheticum showed good linearity over the concentration range of 0. 010 3-0. 826 6 mg(r=0. 999 8) with the average recovery of 94. 9%(RSD=3. 2%,n=6). Conclusion: The method is accurate with good reproducibility,which can be used as the quality control for Xilei San.