神泰片质量标准研究Study on Quality Standards of Shentai Tablets
杨宝,刘佳,陈彬
YANG Bao,LIU Jia,CHEN Bin
摘要(Abstract)：
目的建立神泰片的质量标准。方法采用TLC法对神泰片中首乌藤、柴胡、钩藤进行定性鉴别;用HPLC法对制剂中首乌藤的活性成分2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷进行含量测定。色谱条件:色谱柱为Agilent ZORBAX(4.6mm×250 mm,5μm),流动相为乙腈-水(15∶85),流速为1.0 m L/min,检测波长为320 nm,柱温为30℃。结果薄层鉴别斑点清晰,阴性对照无干扰;2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷在19.22~96.10μg/m L范围内呈良好的线性关系,r=0.999 9,平均回收率为98.39%,RSD为2.06%(n=6)。结论该方法灵敏准确、专属性强,可用于神泰片的质量控制。
OBJECTIVE To establish a method for the quality control of Shentai tablets. METHODS The presence of Caulis Polygoni Multiflori,Radix Bupleuri and Ramuli Uncariae Cum Uncis was identified by TLC. The content of 2,3,5,4-tetrahydroxydiphenystibene-2-O-β-D-glucoside in Caulis Polygoni Multiflori was determined by HPLC. Instrument for Agilent 1100 highperformance liquid chromatograph was used with acetonitrile-water( 15 ∶85) as mobile phase,UV detection wavelength was at 320 nm,and the column temperature was 30 ℃. RESULTS TLC spots were clear,without interference of negative control. The liner range of2,3,5,4'-tetrahydroxydiphenystibene-2-O-β-D-glucoside was 19.22-96.10 μg / m L( r = 0.999 9). The average recovery rate( n = 6) was98.39%. CONCLUSION This method is simple,accurate and reliable.It can be used for the quality control of Shentai tablets.
关键词(KeyWords)：
神泰片;质量标准;薄层色谱法;高效液相色谱法;2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷
Shentai tablets;auality standards;TLC;HPLC;2,3,5,4'-tetrahydroxydiphenystibene-2-O-β-D-glucoside
基金项目(Foundation):
作者(Author):
杨宝,刘佳,陈彬
YANG Bao,LIU Jia,CHEN Bin
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