Improvement of Quality Standard for Zengguang Tablets / 中国药师

ABSTRACT

Objective: To improve the quality standard for Zengguang tablets.Methods: Instead of the microscopic identification, Acorus tatarinowii rhizoma,Lycii Fructus and Polygalae radix were indentified by TLC.The content of schisandrin in Schisandrae Chinensis Fructus was determined by HPLC.The HPLC system consisted of a Hypersil BDS C18(250 mm×4.6 mm,5 μm)column, methanol-water (1∶1) was used as the mobile phase at a flow rate of 1.0 ml·min-1, and the detection wavelength was at 250 nm.The column temperature was 35℃ and the sample size was 10 μl.Results: The microscopic images were with strong specificity.The developed TLC spots were quite clear, and the method of TLC was simple with strong specificity and good reproducibility.The linear range of schisandrin was 21.17-423.40 ng(r=0.999 9).The average recovery was 99.7% and the RSD was 1.4%(n=6).Conclusion: The method for the quality control of Zengguang tablets is comprehensive and perfect.