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参芍止带片的质量标准研究
引用本文:南敏伦,;赫玉芳,;赵昱玮,;赵全成.参芍止带片的质量标准研究[J].中国药房,2014(43):4085-4087.
作者姓名:南敏伦  ;赫玉芳  ;赵昱玮  ;赵全成
作者单位:[1]吉林省中医药科学院,长春130012; [2]吉林农业大学中药材学院,长春130118
基金项目:吉林省科技发展计划项目(No.20120944)
摘    要:目的:建立参芍止带片的质量标准。方法:采用薄层色谱(TLC)法对制剂中的苦参、延胡索、香附、关黄柏进行定性鉴别;采用高效液相色谱法测定赤芍中芍药苷的含量:色谱柱为Agilent C18(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(18∶82,V/V),检测波长为230 nm,柱温为25℃,流速为1.0 ml/min。结果:苦参、延胡索、香附、关黄柏的TLC斑点清晰,分离度好。芍药苷的进样量在0.130 60.652 8μg范围内与其峰面积积分值呈良好线性关系(r=0.999 8);精密度、重复性、稳定性试验的RSD均≤1.97%;平均加样回收率为99.66%,RSD=1.09%(n=6)。结论:所建标准可用于参芍止带片的质量控制。

关 键 词:参芍止带片  质量标准  薄层色谱法  高效液相色谱法  芍药苷

Study on Quality Standard for Shenshao Zhidai Tablets
Institution:NAN Min-lun, HE Yu-fang, ZHAO Yu-wei, ZHAO Quan-cheng (1.Jilin Province Academy of Chinese Medi- cal Sciences, Changchun 130012, China; 2.College of Chincse Medicinal Material, Jilin Agricultural University, Changchun 130118, China)
Abstract:OBJECTIVE: To establish the quality standard of Shenshao zhidai tablets. METHOD S:Sophora flavescens, Coryda- lis yanhusuo, Cyperus rotundus and Phellodendron amurense were identified by TLC qualitatively. The content of paeoniflorin was determined by HPLC. The separation was performed on Agilent-C18(250 mm×4.6 mm, 5 μm)column with mobile phase consisted of acetonitrile -0.1% phosphoric acid (18:82, V/V)at the flow rate of 1.0 ml/min. The detection wavelength was set at 230 nm, and the column temperature was 25℃. RESULTS: S. flavescens, C. yanhusuo, C. rotundus and P. amurense could be identified by TLC and separated well. The linear range of paeoniflorin were 0.130 6-0.652 8 μg(r=0.999 8). RSDs of precision, stability and reproducibili- ty tests were all lower than 1.97%. The average recovery was 99.66% (RSD=1.09% ,n=6). CONCLUSIONS: The established standard can be used for the quality control of Shenshao zhidai tablets.
Keywords:Shenshao zhidai tablets  Quality standard  TLC  HPLC  Paeoniflorin
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