心脑宁胶囊的质量控制

目的:建立并完善心脑宁胶囊的质量标准. 方法:用薄层色谱法定性鉴别薤白和小叶黄杨;采用高效液相色谱法测定心脑宁胶囊中丹酚酸B的含量,色谱柱:Thermo C18(150mm×4.6mm,5μm),流动相:甲醇-乙腈-1.7%甲酸溶液(20:10:70),检测波长:286nm,流速:1.0mL·min-1,柱温:30℃. 结果:薄层色谱斑点清晰,分离度好,阴性无干扰;丹酚酸B的线性范围分别为11.2954~112.954μg·mL-1(r=0.9999),平均加样回收率(n=6)分别为99.66%,RSD分别为2.19%.结论:定性定量分析方法快速、准确、专属性强,本法更好地控制心脑宁胶囊的质量.

Quality Control of Kaihoujian Spray

Objective: To establish quality standard of Xinnaoning Capsule. Methods: Xiebai and Xiaoyehuangyang in preparation were identified by Thin layer chromatography (TLC).The conent of Salvianolic acid B was determined by High efficiency liquid chromatography (HPLC). Thermo C18 Column (250mm ×4.6mm,5μm)was used as chromatographic column, methanol-acetonitrile-isopropanol-1.7% formic acid solution (20:10:70)as mobile phase, at detection wavelength of 286nm,flow rate at 1.0mL·min-1, and column temperatures at 30℃. Results: The TLC spots were clear and well-separated. Linear ranges of Salvianolic acid B was 11.2954 ~112.954μg·mL-1(r=0.9999), average recovery rates(n=6) was 99.66%, and RSD values was 2.19%.Conclusion:The qualitative analysis and quantitative analysis method of Kaihoujian Spray was simple, accurate, reproducible and could be used as quality standard of Xinnaoning Capsule.