摘要
目的:建立通脉丸的质量标准。方法:采用薄层色谱(TLC)法对制剂中丹参、当归、红花进行定性鉴别。采用高效液相色谱法测定制剂中阿魏酸的含量:色谱柱为Diamonsil C18,流动相为乙腈-0.1%磷酸(17∶83,V/V),流速为1 ml/min,检测波长为316nm,柱温为30℃,进样量为10μl。结果:丹参、当归、红花TLC图斑点清晰,分离度好。阿魏酸检测质量浓度线性范围为8~80μg/ml(r=0.999 8);精密度、稳定性、重复性试验的RSD〈2%;加样回收率为97.2%~99.6%(RSD=1.2%,n=6)。结论:该研究所建标准可用于通脉丸的质量控制。
OBJECTIVE:To establish the quality standard for Tongmai pill. METHODS:TLC was used for the qualitative identification of Salvia miltiorrhiza,Angelica sinensis and Carthamus tinctorius. HPLC was used for the content determination of ferulic acid. The column was Diamonsil C18 with mobile phase of acetonitrile-0.1% aqueous phosphoric acid(17∶83,V/V)at a flow rate of 1 ml/min,the detection wavelength was 316 nm,the column temperature was 30 ℃,and the injection volume was 10 μl..RESULTS:The TLC of S. miltiorrhiza,A. sinensis and C. tinctorius showed clear spots and good separation. The linear range of ferulic acid was 8-80 μg/ml(r=0.999 8);RSDs of precision,stability and reproducibility tests were lower than 2%;recovery was97.2%-99.6%(RSD=1.2%,n=6). CONCLUSIONS:The standard can be used for the quality control of Tongmai pill.
出处
《中国药房》
CAS
北大核心
2016年第6期821-823,共3页
China Pharmacy
基金
军队医疗机构制剂标准提高专项课题(No.14ZJZ03)