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目的建立软脉灵颗粒的质量标准。方法用薄层色谱法对方中制何首乌、白芍、黄芪和淫羊藿进行定性鉴别,用高效液相色谱法测定制剂中丹酚酸B和芍药苷的含量。结果薄层色谱斑点清晰,专属性强;丹酚酸B进样量在9.442~47.210μg mL-1范围内与峰面积呈良好线性关系,平均加样回收率为99.68%,RSD%=1.08;芍药苷进样量在10.653~53.265μg.mL-1范围内与峰面积呈良好线性关系,平均加样回收率为99.61%,RSD%=0.69。结论本研究方法操作简便,结果可靠,重复性好,可用于软脉灵颗粒的质量控制。
Objective To establish the quality standard of Ruanmailing granules. Methods The contents of salvianolic acid B and paeoniflorin in the preparations were determined by TLC. The contents of salvianolic acid B and paeoniflorin in the preparations were determined by high performance liquid chromatography (HPLC). Results The TLC spots were clear and specific. The linear range was 9.42 ~ 47.210 μg mL-1 for salvianolic acid B. The average recovery was 99.68% and RSD% was 1.08. Paeoniflorin in the range of 10.653 ~ 53.265μg.mL-1 peak area showed a good linear relationship, the average recovery was 99.61%, RSD% = 0.69. Conclusion The method is simple, reliable, reproducible and can be used for the quality control of Ruanmailing granules.