参七胶囊的质量控制方法

The quality standard of Shenqi capsules

目的建立参七胶囊的质量标准。方法采用薄层色谱法鉴别参七胶囊中的丹参和三七;采用HPLC法测定丹参酮ⅡA和丹酚酸B的含量。结果丹参酮ⅡA色谱柱:安捷伦ZORBAX SB-C18(250 mm×4.6 mm,5μm),流动相:甲醇-水(体积比为82∶18),流速:1.0 m L·min-1,检测波长:270 nm,平均回收率:100.5%,RSD=1.7%(n=6)。丹酚酸B色谱柱:Kromsail C18(150 mm×4.6 mm,5μm),流动相:甲醇-乙腈-甲酸-水(体积比为49∶16∶2∶132),流速:1.0 m L·min-1,检测波长:286 nm,平均回收率:100.4%,RSD=1.3%(n=6)。结论本法可用于参七胶囊的质量控制。

Objective To establish the quality standard of Shenqi capsules. Methods The thin layer chromatography was used for qualitative identification of Salviae Miltiorrhizae Radix et Rhizoma and Panax Notoginseng Radix et Rhizoma. The contents of tanshinone 11 A and salvianolic acid B in the preparation were determined by HPLC. The HPLC separation was performed on Agilent C18 （250 mm × 4. 6 mm, 5 μm） and Kromasil C18 （200 × 4. 6 mm,5 μm）column respectively. The mobile phase of tanshinone Ⅱ A was methanolwater（ V： V=82： 18） ,at a flow rate of 1.0 mL.min-1. Detection wavelength was set at 270 nm. The mobile phase of salvianolic acid B was methanol-acetonitrile-formicacid-water（ V： V： V = 49： 16：2：132 ）, at a flow rate of 1.0 mL. min-1. Detection wavelength was at 286 nm. Results The spots of TLC were clear, with strong specificity. The linear range of tanshinone 11 A was 0. 001-0. 032 2 μg（ r =0. 999 8 ,n =6）. The average recovery was 100. 5% （RSD = 1.7% ,n =6） ,100. 4% （RSD = 1.34% ,n = 6） respectively. And there was a good liner relationship of salvianolic acid B within the range of 12. 5 -400. 0 mg.L-1 （r =0. 999 9, n = 6）. The average recovery was 100. 4 %, RSD = 1.3 % （ n = 6）. Condusions The method is simple, accurate and reproducible, and availed for quality control of Shenqi yangxue Mixture.