通脉丸的质量标准研究
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篇名: 通脉丸的质量标准研究
TITLE:
摘要: 目的:建立通脉丸的质量标准。方法:采用薄层色谱(TLC)法对制剂中丹参、当归、红花进行定性鉴别。采用高效液相色谱法测定制剂中阿魏酸的含量:色谱柱为Diamonsil C18,流动相为乙腈-0.1%磷酸(17 ∶ 83,V/V),流速为1 ml/min,检测波长为316 nm,柱温为30 ℃,进样量为10 μl。结果:丹参、当归、红花TLC图斑点清晰,分离度好。阿魏酸检测质量浓度线性范围为8~80 μg/ml(r=0.999 8);精密度、稳定性、重复性试验的RSD<2%;加样回收率为97.2%~99.6%(RSD=1.2%,n=6)。结论:该研究所建标准可用于通脉丸的质量控制。
ABSTRACT: OBJECTIVE:To establish the quality standard for Tongmai pill. METHODS: TLC was used for the qualitative identification of Salvia miltiorrhiza, Angelica sinensis and  Carthamus tinctorius. HPLC was used for the content determination of ferulic acid. The column was Diamonsil C18 with mobile phase of acetonitrile-0.1% aqueous phosphoric acid (17 ∶ 83,V/V) at a flow rate of 1 ml/min, the detection wavelength was 316 nm, the column temperature was 30 ℃,and the injection volume was 10 μl.. RESULTS: The TLC of S. miltiorrhiza, A. sinensis and  C. tinctorius showed clear spots and good separation. The linear range of ferulic acid was 8-80 μg/ml(r=0.999 8); RSDs of precision, stability and reproducibility tests were lower than 2%; recovery was 97.2%-99.6%(RSD=1.2%,n=6). CONCLUSIONS: The standard can be used for the quality control of Tongmai pill.
期刊: 2016年第27卷第6期
作者: 崔思娇,于士龙,薛强,杨光照,钟文雨,徐菁阳,牛佳,汪宇
AUTHORS: CUI Sijiao,YU Shilong,XUE Qiang,YANG Guangzhao,ZHONG Wenyu,XU Jingyang,NIU Jia,WANG Yu
关键字: 通脉丸;质量控制;薄层色谱法;高效液相色谱法
KEYWORDS: Tongmai pill; Quality standard; TLC; HPLC
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