Objective To establish the quality standard of Zhusha Anshen Tablets.Methods Referring to the Pharmaceutical Standard of Ministry of Public Health of the People's Republic of China-Chinese Patent Drug,10 batches of samples were identified for their characteristics.Microscopic identification method was used for sample powder.Thin-layer chromatography(TLC)method was used for the qualitative identification of Coptidis Rhizoma in the sample.Titration method was used to determine the content of mercury sulfide.High-performance liquid chromatography(HPLC)fingerprint was established for 10 batches of samples,and the common peak was determined with berberine hydrochloride as the reference peak.The similarity was evaluated by the Similarity Evaluation System of Traditional Chinese Medicine Chromatographic Fingerprint(2004A version).The content of berberine hydrochloride in the sample was determined by the HPLC method,the chromatographic column was Welch ultimate XB-C18 column(250 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.05 mol/L potassium dihydrogen phosphate solution(1∶1,V/V,containing 4 mg of sodium dodecyl sulfate per 1 mL of mixed solution)-acetonitrile(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 345 nm,the column temperature was 30℃,and the injection volume was 10 μL.Results All 10 batches of samples were reddish brown in color,with a slight aroma and a bitter taste.The fiber of sample powder was bundled in bright yellow,with thick walls and obvious pores.The irregular small particles of sample powder were dark reddish brown,glossy,with black edges.The thin-walled cells around the fiber bundle contained calcium oxalate crystals,forming crystalline fibers.The TLC characteristic spots were clear,with good separation,and the negative control had no interference.The average content of mercury sulfide was 22.78% .Nine common peaks were identified,with a similarity of≥0.898.The linear range of berberine hydrochloride was 0.008 59-0.859 mg/mL(r=1.000,n=6).The average recovery of mercury sulfide was 99.96% with an RSD of 1.29(n=6).Conclusion The established method is stable and accurate,with good specificity and repeatability,which can be used for quality control of Zhusha Anshen Tablets.
Zhusha Anshen Tabletsmorphological identificationmicroscopic identificationTLCHPLCtitration methodquality standard
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