冠脉宁片的制备与质量标准完善

目的：制备冠脉宁片,完善其质量标准。方法：采用薄层色谱法对鸡血藤进行定性鉴别。采用HPLC法对丹参中丹参素进行定量分析,色谱柱为Diamonsil C18柱（200mm×4.6mm,5μm）,流动相为甲醇-1%冰乙酸（10∶90）,流速1.0ml/min,检测波长280nm。结果：该制备工艺简便可行。鸡血藤的薄层色谱斑点清晰,专属性强。在10.71~96.39μg/ml范围内,丹参素浓度与色谱峰面积线性关系良好（r=0.999 9）,平均回收率为98.72%,RSD为0.82%（n=3）。结论：本研究所建立的定性定量方法简便、准确、重复性好,可作为冠脉宁片的质量控制方法。

Preparation of Guanmaining tablets and perfection of its quality control standards

Objective： To prepare Guanmaining tablets and to perfect its quality control standards. Methods.. Spatholobi caulis was qualitatively identified by thin-layer chromatography （TLC）, and the content of Danshensu in Salviae rniltiorrhiza Bge. was analyzed by HPLC. The chromatographic column was Diamonsil C18 （200 minx 4.6 ram, 5 tLm）, the mobile phase was methanol-l% glacial acetic acid （10 .＂ 90）, the flow rate was 1.0 ml/min, and the detection wavelength was 280 nm. Results： The preparation process was simple and practicable. The TLC identification of Spatholobi caulis was highly specific and the spots were clear. There was a good linearity between the concentrations and the peak area of Danshensu in the range of 10.71-96.39 gg/ml （r：0. 999 9）, and average recovery rate was 98.72% with the RSD 0.82% （n：3）. Conclusion： The qualitative and quantitative analysis methods were simple, accurate and reproducible, which could be used for the quality con- trol of Guanmaining tablets.