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目的:建立甘草浸膏胶囊中两种有效成分质量控制标准。方法:采用TLC法对方中甘草进行鉴别;测定样品中甘草苷和甘草酸铵的含量。色谱条件:色谱柱为Inertsil C_(18)柱(150 mm×4.6 mm,5μm);流动相:乙腈(A)-0.2%磷酸(B)(0~8min:20%A~20%A;8~34 min:20%A~50%A;34~35 min:50%A~100%A;35~40 min:100%A~20%A);流速为1.0 ml·min~(-1);检测波长:237 nm;柱温:25℃。结果:薄层定性鉴别的斑点清晰,分离效果良好;甘草苷在0.002 0~0.100 0 mg·ml~(-1)浓度范围内线性关系良好(r=0.999 5),平均加样回收率为100.29%,RSD为2.94%(n=6);甘草酸铵在0.002 0~0.100 0 mg·ml~(-1)浓度范围内线性关系良好(r=0.999 8),平均加样回收率为101.46%,RSD为2.33%(n=6)。结论:所建立方法快速简便,重复性好,专属性强,可作为该制剂的质量控制方法。
Objective: To establish quality control standards of two active ingredients in licorice extract capsules. Methods: The TLC was used to identify the other licorice; the content of glycyrrhizin and ammonium glycyrrhizinate was determined. Chromatographic conditions: the column was Inertsil C 18 column (150 mm × 4.6 mm, 5 μm); the mobile phase consisted of acetonitrile (A) -0.2% phosphoric acid (B) (0-8 min: 20% A~20% A; ~ 34 min: 20% A~50% A; 34~35 min: 50% A~100% A; 35~40 min: 100% A~20% A); the flow rate was 1.0 ml · min -1 ; Detection wavelength: 237 nm; column temperature: 25 ℃. Results: The spots identified by TLC were clear and the separation effect was good. The calibration curve of glycyrrhizin was linear (r = 0.999 5) in the range of 0.002 0 ~ 0.100 0 mg · ml ~ (-1) and the average recovery was 100.29 %, And the RSD was 2.94% (n = 6). The linearity of ammonium glycyrrhizinate was good (r = 0.999 8) in the range of 0.002 0-0.100 0 mg · ml -1 with the average recovery of 101.46% , RSD was 2.33% (n = 6). Conclusion: The established method is rapid, simple, reproducible and specific, and can be used as a quality control method for this preparation.