Study on the Quality Standard of Mongolian Medicine Preparation Siridengchong-27 Pills
Objective To establish the quality standard of Siridengchong-27 Pills.Methods Gardeniae Fructus and Bovis Calculus Artifactus in the preparation were qualitatively identified,and the limit test for aconitine was performed by the thin-layer chromatography(TLC)method.The moisture content and dissolution time of the preparation were determined based on the general rules of the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ).The costunolide content in the preparation was determined by the high-performance liquid chromatography(HPLC)method.Results The TLC chromatograms of Gardeniae Fructus and Bovis Calculus Artifactus showed clear spots,good separation,and there was no interference from the negative reference.The TLC spots of aconitine were smaller than those of the reference,or there was no spot for aconitine.The moisture content and dissolution time both met the regulations(<9.0%,completely dissolved within 60 min).The linear range of costunolide was in the range of 9.91-99.10 µg/mL(r=0.999 9,n=5);the RSDs of precision,stability and repeatability tests were all lower than 2.0%;the average recovery rate was 95.83%with an RSD of 1.00%(n=9).Conclusion The newly-established identification,test and content determination methods is scientific and accurate,which can be used for the quality evaluation and control of Siridengchong-27 Pills.
quality standardSiridengchong-27 PillsTLCHPLClimit test
万方数据
维普
