冠脉康片的质量标准研究

Study on Quality Standard of Guanmaikang Tablets

目的建立冠脉康片的质量标准。方法用薄层色谱法鉴别药材三七、佛手;用高效液相色谱法测定芍药苷的含量,色谱柱为Agilent Hypersill C18柱(250mm×4.0mm,5μm),流动相为乙腈-水(13∶87),检测波长为230nm。结果薄层色谱检出了三七、佛手的特征斑点;芍药苷进样量线性范围是0.20～2.4μg(r=0.9999),平均加样回收率为98.2%,RSD=2.46%(n=6)。结论所用方法稳定、可靠,可作为该药的质量控制方法。

Objective To establish a quality control for Guanmaikang Tablets. Methods TLC was applied to identify Radix Nologinseng and Citrus Medica in this prescription, and HPLC was taken for the determination of peoniflorin in Guanmaikang Tablets. An Agilent Hypersill C18 column was used, with acetonitril- water （13：87） as the mobile phase. The detection wavelength was 230 nm. Results The characteristic maculae of Radix Nologinseng and Citrus Medica were detected by TLC. The linear range of peoniflorin was 0. 20- 2.4 μg （r = 0. 999 9）, and the average recovery rate was 98.2%, RSD = 2.46% （n = 6）. Conclusion The method is simple, sensitive, accurate and reproducible. It can be used for the quality control of this medicine.