地西泮-布洛芬栓制备及质量标准研究  

Preparation and quality control of diazepam- ibuprofen suppository

作　　者：李兰兰[1] 杨天鸣 虎亚光[1] 火统武[1] 陈晓惠[1] 张福琴[1] 

机构地区：[1]甘肃省妇幼保健院药剂科,兰州730050 [2]兰州军区药品仪器检验所,兰州730050

出　　处：《药物分析杂志》2013年第10期1783-1786,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:制备地西泮-布洛芬栓,并进行质量控制;建立地西泮及布洛芬含量测定的HPLC方法。方法:以混合脂肪酸甘油酯为基质制备地西泮-布洛芬栓,按照2010年版中国药典标准进行质量控制。地西泮及布洛芬含量测定色谱条件为:采用Shim-pack VP-ODS(150 mm×4.6 mm,5μm)色谱柱;流动相为乙腈-pH 2.5醋酸缓冲液(65∶35);流速1 mL·min-1;检测波长263 nm;柱温25℃。结果:栓剂的重量差异、融变时限均符合中国药典标准。结论:栓剂的制备方法简单易行,质量控制方法可靠。Objective： To prepare and control the quality of diazepam-ibuprofen suppository,and establish the HPLC method for the determination of diazepam and ibuprofen. Methods： The mixed fatty acid glyceride was used as the matrix of diazepam-buprofen suppository,according to the Chinese Pharmacopoeia 2010 standards for quality control.The chromatographic conditions of diazepam and ibuprofen for quantitative determination were as follows：the Shim-pack VP-ODS（150 mm×4.6 mm,5 μm）column was used in the chromatographic process;the mobile phase was acetonitrile-pH2.5 acetate buffer（65： 35）,the flow rate was 1 mL·min-1;the detective wavelength was 263 nm;the column temperature was 25℃. Results： Suppository weight differences,melting time were in line with the Chinese Pharmacopoeia standard. Conclusion： The preparation method is easy to operate,and the quality control method is reliable.

关 键 词：地西泮 布洛芬 栓剂制备 质量标准 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]