小儿用布洛芬中空栓剂的制备及其质量评价  

Preparation and Quality Evaluation of Ibuprofen Hollow Type Suppositories for Pediatric Usage

作　　者：陈鹏浩[1] 乔瑾[1] 王晨曦[1] 隋小宇[1] 姜帆[1] 

机构地区：[1]齐齐哈尔医学院药学院,黑龙江齐齐哈尔161006

出　　处：《中国医药工业杂志》2016年第10期1280-1283,共4页Chinese Journal of Pharmaceuticals

基　　金：黑龙江省大学生创新创业训练计划项目(201411230023)

摘　　要：以熔点、融变时间、外观与硬度为指标,考察了聚乙二醇(PEG)的种类(PEG 400、PEG 600和PEG 1000)和组成比例对空白栓剂基质的影响。结果表明,以PEG 400和PEG 1000(25∶75)为混合基质的空白栓剂熔点和融变时间为30.3℃和19.3 min,外观呈均匀白色,硬度适宜。在此基础上,采用直接加入原料药粉末的方式,制备了空腔直径3 mm、距栓尾深度为1.8或2.3 cm的载布洛芬50 mg的两种小儿用中空栓。结果所得载药中空栓外观和硬度与空白栓剂相似,融变时间为18.4 min。以市售小儿布洛芬栓为对照,考察自制中空栓的体外溶出情况。结果显示,两种中空栓在20 min内均达到溶出平衡,溶出率大于90%;而市售品70 min时溶出率为79%,提示中空栓能达到快速释药的目的。The effects of polyethylene glycol （PEG） types （PEG 400, PEG 600 and PEG 1000） and composition ratios on melting point, melting time, appearance and hardness of matrix of blank suppositories were investigated. The results showed that the melting point and melting time of the blank suppositories with PEG 400 and PEG 1000 in a weight ratio of 25∶75 as matrix were 30.3 ℃ and 19.3 min. The blank suppositories also had uniformly white appearances and appropriate hardness. Thus, the ibuprofen hollow type suppositories for pediatric usage were prepared based on above blank suppositories. Two kinds of self-made drug-loaded hollow type suppositories with the cavity diameter of 3 mm and depth of 1.8 or 2.3 cm were prepared by adding the powder of ibuprofen directly. The appearance and hardness of two products were similar to the blank suppositories, and the melting time decreased to 18.4 min. The dissolution profiles of two products were investigated with the commercial ibuprofen suppositories for pediatric usage as the control. The results showed that the dissolution of both self-made hollow type suppositories reached equilibrium within 20 min, and the dissolution amount were above 90%, while the dissolution of the commercial product at 70 min was 79%. It indicated that the hollow type suppositories could achieve the aim of quick release.

关 键 词：布洛芬 中空栓剂 聚乙二醇 融变时间 体外溶出 儿科用药 

分 类 号：R944.23[医药卫生—药剂学]