牛黄化毒片的质量标准研究  

Study on quality tandard of Niuhuang Huadu tablets

作　　者：刘冰[1] 王佳[2] 苗淑杰[2] 

机构地区：[1]天津市药品检验所,天津300070 [2]天津同仁堂集团股份有限公司,天津300385

出　　处：《天津药学》2011年第4期5-8,共4页Tianjin Pharmacy

摘　　要：目的:建立牛黄化毒片的质量标准。方法:采用薄层色谱法对该制剂中的连翘、甘草和人工牛黄进行鉴别,采用高效液相色谱法测定制剂中欧前胡素的含量。色谱柱:Agilent zorbax SB-C18色谱柱(4.6 mm×250 mm,5μm);流动相:乙腈-水(52∶48);流速:1.0 ml/min;柱温30℃;检测波长为300 nm。结果:薄层色谱斑点清晰,重现性好;欧前胡素的平均加样回收率为98.77%,RSD为0.67%(n=6)。结论:该方法准确可靠,重复性好,为牛黄化毒片的质量控制和评价提供了依据。Objective： To establish the quality standard for Niuhuang Huadu Tablets.Methods： Weeping Forsythia,Radix et Rhizoma Glycyrrhizae and artificial bezoar were identified by TLC,and the content of imperatofin was determined by HPLC.The chromatographic separation was achieved on an Agilent ZORBAX SB-C18（4.6 mm×250 mm,5 μm） column with a mobile phase of acetonitrile-water（52∶48）,the UV detection wavelength was at 300 nm,the flow rate was 1.0 ml/min with column temperature at 30 ℃.Result： The TLC spots were clear and reproducible.The average recovery rate of imperatofin by HPLC was 98.77% and RSD was 0.67%（n=6）.Conclusion： The method is reliable and accurate with high reproducibility.It can be used for quality control of Niuhuang Huadu Tablets.

关 键 词：牛黄化毒片 质量标准 连翘 甘草 人工牛黄 薄层色谱法 欧前胡素 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]