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目的:建立九味肝泰胶囊质量标准。方法:采用TLC法对五味子进行鉴别;并用HPLC法测定五味子中五味子醇甲的含量,色谱柱为Agilent ZORBAX SB-C18(250 mm×4.6 mm,5μm),流动相为甲醇-水(55∶45),柱温35℃,流速为0.8 ml·min-1,检测波长为250 nm。结果:TLC色谱斑点清晰;五味子醇甲对照品在82.54～3 896.48 ng范围内线性关系良好(r=0.999 9),平均回收率99.32%(RSD为1.05%)。结论:本法简便、可靠、准确,可用于该制剂的质量控制。
Objective: To establish the quality standard of Jiuwei Gantai capsule. Methods: The schisandra chinensis was identified by TLC method. The content of Schisandra chinense A was determined by HPLC. The mobile phase consisted of Agilent ZORBAX SB-C18 (250 mm × 4.6 mm, 5 μm) and methanol-water (55:45 ). The column temperature was 35 ℃, the flow rate was 0.8 ml · min-1 and the detection wavelength was 250 nm. Results: TLC chromatograms were clear. The reference standard of schisandrin was linear in the range of 82.54 ~ 3896.48 ng (r = 0.999 9) with an average recovery of 99.32% (RSD 1.05%). Conclusion: This method is simple, reliable and accurate and can be used for the quality control of the preparation.