双参胶囊的质量标准提高研究 点击下载
论文标题: 双参胶囊的质量标准提高研究
英文标题:
中文摘要: 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 C18(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2 μl。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 2~0.792 μg(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。
英文摘要: OBJECTIVE:To improve the quality standard of Shuangshen capsule. METHODS: TLC was conducted for the qualitative identification of Curcumnae radix and Rehmannia glutinosa in the preparation. HPLC was used for the content determination of salvianolic acid B in the preparation: the column was Diamonsil C18(2) with mobile phase of acetonitrile-0.1% H3PO4(22 ∶ 78,V/V) at a flow rate of 0.5 ml/min, detection wavelength was 286 nm, column temperature was 30 ℃, and the injection volume was 2 μl. RESULTS: The TLC spots of C. radix and R. glutinosa were clear and well separated; the linear range of salvianolic acid B was 0.079 2-0.792 μg(r=0.999 9); RSDs of precision,stability and reproducibility tests were lower than 1%; recovery was 100.71%-101.82%(RSD=0.50%,n=6). CONCLUSIONS:The established standard can be used for the quality control of Shuangshen capsule.
期刊: 2016年第27卷第12期
作者: 崔小敏,李芳,李凡,王卫锋
英文作者: CUI Xiaomin,LI Fang,LI Fan,WANG Weifeng
关键字: 双参胶囊;丹酚酸B;薄层色谱法;高效液相色谱法
KEYWORDS: Shuangshen capsule; Salvianolic acid B; TLC; HPLC
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