盐酸苯海拉明乳膏的基质优选研究  

Study of optimization for the cream base of benzhydramine hydroehloride

作　　者：孙华燕[1] 徐风华[1] 李婕[1] 白林[2] 蔡乐[2] 

机构地区：[1]解放军总医院制剂室,北京100853 [2]解放军总医院药检室,北京100853

出　　处：《药学实践杂志》2016年第5期455-458,共4页Journal of Pharmaceutical Practice

基　　金：军队医疗机构制剂标准提高科研专项课题(13ZJZ05)

摘　　要：目的优选盐酸苯海拉明乳膏基质。方法以5种非离子型表面活性剂为乳化剂制备盐酸苯海拉明乳膏,观察5种乳膏的性状,完成稳定性初筛实验、加速实验、常温实验,初步评价5种乳膏基质优劣。结果 5种非离子型乳化剂均可初步制备盐酸苯海拉明乳膏。外观性状,即乳膏细腻度、光泽度、涂展性方面,处方E最佳,处方B和D接近,仅次于处方E,处方A最差;乳膏稳定性方面,在离心实验和低温实验中,各基质均无明显性状改变;高温实验中,处方E最稳定,处方A、B、D次之,处方C析水分层;室温放置,处方C 5d析水,处方A 1个月变为半流动状,处方B 2个月析水,处方D和E放置6个月均无性状和含量变化。结论处方D和E较稳定,具备临床应用价值。Objective To optimize the cream base of benzhydramine hydroehloride .Methods Five nonionic surfactants as an emulsifier were used to prepare benzhydramine hydroehloride creams .The five sorts of cream were evaluated from the ap-pearance ,preliminary stability ,accelerated test stability and room temperature stability .Results Benzhydramine hydroehloride cream could be prepared using five nonionic surfactants .On appearance of smoothness ,gloss and spread ,formula E was best but formula A was worst ,while formulas B and D were close and worse than formula E only .In the stability tests ,all of creams had no obvious change after the centrifugal experiment and the low temperature experiment .In the high temperature ex-periment ,the formula E was stable ,formulas A ,B and D showed a little appearance change ,and the formula C became layered bleeding .In room temperature ,the formula C became bleeding after five days ,which happened to the formula A after one month ,and formula B after two months .The formulas D and E had no obvious change until six months in room temperature . Conclusion The formulas D and E were stable ,which had clinical application value .

关 键 词：盐酸苯海拉明乳膏 基质处方 质量控制 

分 类 号：R944[医药卫生—药剂学]