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目的:建立安神静心胶囊的质量控制方法。方法:用TLC法对丹参、石菖蒲、五味子进行定性鉴别;HPLC法测定安神静心胶囊中五味子醇甲的含量,采用Diamonsil C_(18)柱;以甲醇-水(62:38)为流动相;流速为1.0ml·min~(-1);柱温:35℃;检测波长为254nm。结果:TLC法检出了丹参、石菖蒲、五味子特征斑点,五味子醇甲进样量在0.05～10.43μg范围内线性关系良好,r=1.0000,平均加样回收率为100.3%,RSD为1.5%(n=9)。结论:所建立的方法简便、稳定、准确、重复性好,可作为本品的质量控制方法。
Objective: To establish the quality control method of Anshen Jingxin Capsule. Methods: Salvia miltiorrhiza, Schisandra chinensis and Schisandra chinensis were identified qualitatively by TLC. Diamonsil C 18 column was used to determine the content of schisandrin in Anshen Jingxin Capsules by HPLC. The mobile phase was methanol - water (62:38) The flow rate was 1.0 ml · min -1. The column temperature was 35 ℃. The detection wavelength was 254 nm. Results: Salvia miltiorrhiza, Acorus calamus and Schisandra chinensis were detected by TLC method. The calibration curve of schisandrin was linear in the range of 0.05 ~ 10.43μg with r = 1.0000, the average recovery was 100.3% and the RSD was 1.5% (n = 9). Conclusion: The established method is simple, stable, accurate, reproducible, and can be used as the quality control method of this product.