Establishment of Quality Control Methods for Xinmeng Anshen Granule / 中国药师

ABSTRACT

Objective:To establish the quality control methods for Xinmeng Anshen granule. Methods:TLC was used to identify Salviae Miltiorrhizae Radix Et Rhizoma,Mori Fructus, Ziziphi Spinosae Semen( fried) ,Arachis Hypogaea L. and Schisandrae Chinensis Fructus in the granules. HPLC was used to determine the content of protocatechuic aldehyde in Salviae Miltiorrhizae Radix Et Rhizoma and spinosin in Ziziphi Spinosae Semen. Results:The TLC spots were clear and well-separated without any interference from the nega-tive sample. The calibration curves were linear within the range of 3.972-198.600 μg·ml-1(r=0.999 9) for protocatechuic alde-hyde and 7. 070-226. 240 μg·ml-1(r=0. 999 9) for spinosin. The average recovery was 98. 46% (RSD=1. 18%, n=9) for proto-catechuic aldehyde and 98. 20% (RSD=0. 90%, n=9) for spinosin. Conclusion:The established quality control methods are accu-rate, simple, repeatable and specific. It can be well used for the quality control of Xinmeng Anshen granule.