胆胰康泰散质量标准研究

Study on the Quality Control of Danyikangtai Powder

目的 建立胆胰康泰散的质量标准。方法 采用 TL C法对胆胰康泰散中的大黄、丹参进行定性鉴别 ;并采用 HPL C法对处方中的黄芩所含黄芩苷进行了含量测定。ODS分析色谱柱 (4 mm× 2 5 0 mm,7μm) ;流动相为甲醇 -四氢呋喃 - 0 .0 2 m ol/ L KH2 PO4(4∶ 1∶ 6 ) ;流速 :0 .8ml/ min;检测波长 :2 76 nm。结果 处方中大黄、丹参所含主要成分与其它成分分离良好。 HPL C法测定黄芩苷可达基线分离 ,进样量为 0 .0 8～ 0 .8m g· ml- 1时线性良好 ,回归方程 :Y=15 6 32 X- 2 36 6 ,r=0 .9996 ,5次测定平均加样回收率为 99.47 ,RSD为0 .71%。结论 该法操作简便 ,结果准确 ,重现性好 ,可作为该制剂的质量控制方法。

Objective To develop the quality control of Danyikangtai powder. Methods Rheum officinale Baill. and Salvia miltiorrhiza Bge.were identified by TLC,and baical in danyikangtai powder was separated and determined by HPLC with conditions as ODScolumn (4.6× 2 5 0 mm,7μm) ,the mobile phase consisted of methanol- tetrahydrofuran- 0 .0 2 mol·L-1potassium dihydrogen phosphate(4∶ 1∶ 6 ) , at a rate of0 .8ml·min-1.The detection wavelength at2 76 nm.Results The standard curves of baical was linear in the concentration range of0 .0 8～ 0 .8mg· ml-1.The average recovery was99.47% (n=5 , RSD=0 .71 % ) .Conclusion This method was sensitive,quick and accurate forthe quality control of this preparation.