OBJECTIVE: To establish the quality standard for Gentiana scabra dispensing granule. METHODS: TLC was adopted to identify G. scabra in the preparation; HPLC was adopted to determine the content of gentiopicroside in the preparation: the column was Dionex C18 with mobile phase of methanol - water (25 ∶ 75,V/V) at a flow rate of 1.0 ml/min, the detection wavelength was 270 nm, column temperature was 30 ℃, the injection volume was 10 μl. RESULTS: TLC showed clear spots and good separation. The linear range of gentiopicroside injection volume was 0.302 6-3.026 μg (r=0.999 9); RSDs of precision, stability and reproducibility tests were lower than 2%; recovery was 98.27%-99.56% (RSD=0.68%,n=6). CONCLUSIONS: The established standard can be used for the quality control of Gentiana scabra dispensing granule.
关键词
龙胆配方颗粒薄层色谱法高效液相色谱法质量标准
Keywords
Gentiana scabraDispensing granuleTLCHPLCQuality standard