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胆康片质量标准改进研究

Quality Standard Study for Dankang Tablets

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【作者】 王秀芹杨孝江顾利红

【Author】 WANG Xiu-qin1,YANG Xiao-jiang2,GU Li-hong1(1.Guangzhou Institute for Drug Control,Guangzhou,Guangdong 510160,China; 2.Shenzhen Kangzhe Pharmaceutical Company Ltd,Shenzhen,Guangdong 518057,China)

【机构】 广州市药品检验所深圳市康哲药业有限公司

【摘要】 目的研究修订胆康片的质量标准。方法 采用薄层色谱法对制剂中薄荷油、人工牛黄进行定性鉴别,采用高效液相色谱法测定栀子中栀子苷的含量。结果薄层色谱法鉴别专属性强,方法可行;栀子苷在0.069 66~1.393 20μg范围内与其峰面积线性关系良好(r=0.999 9),平均回收率为101.7%,RSD为0.9%(n=6)。结论所用方法简便、准确,完善了胆康片的质量标准。

【Abstract】 Objective To study and improve the quality standard of Dankang tablets.Methods The qualitative identification of Peppermint oil,Artificial Bezoar was carried out by TLC,and the content of gardenoside was determined by high-performance liquid chromatography(HPLC).Results The TLC identification was specific.The linear range of gardenoside was 0.069 66~1.393 20 μg(r=0.999 9) with an average recovery of 101.7%(RSD=0.9%,n=6).Conclusion These methods are simple,accurate,and can improve the quality control ofDankang tablets.

【关键词】 胆康片薄层色谱法高效液相色谱法质量标准
【Key words】 Dankang tabletsTLCHPLCquality standard
  • 【分类号】R286
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