塞来昔布乳膏的制备及质量控制  

Preparation and Quality Control of Celecoxib Cream

作　　者：郑江萍[1] 王永惠[1] 李鹂[1] 

机构地区：[1]郧阳医学院附属太和医院药学部,湖北十堰442000

出　　处：《中国药业》2011年第2期48-49,共2页China Pharmaceuticals

摘　　要：目的制备塞来昔布乳膏并建立其质量控制方法。方法以油酸为透皮吸收促进剂,用二甲亚砜作溶剂,制备水包油型乳膏;用高效液相色谱法测定主药含量。结果制得的乳膏均匀细腻,易涂布;建立的色谱方法能排除辅料对塞来昔布的干扰,塞来昔布质量浓度在2.054～205.4μg/mL范围内与峰面积线性关系良好(Y=0.492 X-0.100 5,r=0.999 99),平均回收率为99.34%,RSD=0.37%(n=9)。结论塞来昔布乳膏制备方法简单,制得的乳膏符合要求;质量控制方法可靠。Objective To prepare Celecoxib Cream and to establish its quality control method.Methods With oleic acid as the skin penetration enhancer and dimethylsulfoxide as solution medium of celecoxib,the oil-in-water type cream was prepared.The main drug content was determined by HPLC.Results The prepared cream was uniform,smooth and fine,which was easily to be coated.The established chromatographic method was enabled to eliminate the interference of auxiliary material to celecoxib.The concentration of celecoxib showed the linearity in the range of 2.054～205.4 μg/mL（Y=0.492X-0.100 5,r=0.999 99）.The average recovery rate was 99.34%with RSD of 0.37%（n=9）.Conclusion The preparation technique is simple and the prepared cream meets the requirement with the reliable quality control method.

关 键 词：塞来昔布 乳膏剂 油酸 透皮吸收促进剂 质量控制 

分 类 号：R944.21[医药卫生—药剂学] R971.1[医药卫生—药学]