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肾石通片质量标准的研究

Quality Standard for Shenshitong Tablets
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摘要 目的研究肾石通片的质量标准。方法增加薄层法鉴别木香、金钱草及RP-HPLC法测定丹参中丹酚酸B的含量。含量采用Waters C18色谱柱;流动相:甲醇-乙腈-甲酸-水(30∶10∶1∶59);流速:1mL·min-1;检测波长:286nm。结果鉴别试验:阴性对照均无干扰;含量测定:丹酚酸B在0.017~2.25μg范围内呈良好的线性关系(r=0.9999),平均加样回收率为98.9%(n=6)。结论所建立方法简单、可靠,可用于肾石通片的质量控制。 Objective To establish a method for the quality control of Shenshitong Tablets. Methods The TLC methods were employed for Radix Aucklandiae and Herba Lysimachiae. RP-HPLC method was established for the determination of salvianolic acid B performed on Waters C18 analytical column with methanol-acetonitrile-formic acid-water (30 : 10 : 1 : 59) as the mobile phase at the flow rate of 1 mL- min^-1. The detection wavelength was set at 286nm. Results Identification test: there was no interference from negative control; content determination: a good linear relationship (r= 0. 9999) was observed in the range of 0. 017-2.25 μg for salvianolic acid B, and the average recovery (n=6) was 98. 9%. Conclusion The method is convenient, reliable and suitable for quality control of shengshitong Tablets.
作者 李虹 郭凤翔
出处 《中国药事》 CAS 2012年第6期556-559,共4页 Chinese Pharmaceutical Affairs
基金 国家药品标准提高行动计划(编号[2005]167)
关键词 去氢木香内酯 山柰素 槲皮素 金钱草 丹酚酸B 肾石通片 高效液相色谱法 dehydrocostuslactone kaempferol quercetin Herba Lysimachiae salvianolic acid B Shengshitong Tablets HPLC
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