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目的:优化和提高双参胶囊的质量标准。方法:采用薄层色谱(TLC)法对制剂中的郁金、熟地黄进行定性鉴别。采用高效液相色谱法测定制剂中丹酚酸B的含量:色谱柱为Diamonsil C_(18)(2),流动相为乙腈-0.1%磷酸(22∶78,V/V),流速为0.5 ml/min,检测波长为286 nm,柱温为30℃,进样量为2μl。结果:郁金、熟地黄的TLC图斑点清晰,分离度好;丹酚酸B检测进样量线性范围为0.079 2~0.792μg(r=0.999 9);精密度、稳定性、重复性试验的RSD<1%;加样回收率为100.71%~101.82%(RSD=0.50%,n=6)。结论:经优化和提高的标准可用于双参胶囊的质量控制。
Objective: To optimize and improve the quality standard of Shuangshen capsule. Methods: The TLC and TLC methods were used to qualitatively identify tulip and Rehmannia glutinosa. The content of salvianolic acid B in the preparation was determined by HPLC: Diamonsil C_ (18) (2), acetonitrile-0.1% phosphoric acid (22:78, V / V) / min, the detection wavelength was 286 nm, the column temperature was 30 ℃, and the injection volume was 2μl. Results: The TLC spots of Turmeric and Rehmannia glutinosa were clear and the resolution was good. The linear range of the sample of Salvianolic acid B was 0.079 2-0.792 μg (r = 0.999 9). The precision, stability and reproducibility RSD <1%. The average recovery was 100.71% ~ 101.82% (RSD = 0.50%, n = 6). Conclusion: The optimized and improved standard can be used for the quality control of Shuangshen capsule.