摘要
为制备稳定的利福昔明悬乳剂,采用单因素试验法初步筛选了悬乳剂油相、乳化剂、辅助乳化剂的种类及悬乳剂配方。采用正交试验设计,对初定配方和生产工艺进行了优化,最终筛选的悬乳剂配方为:利福昔明1.08 g,油相20 m L,乳化剂7 m L,辅助乳化剂2 m L,水25 m L;生产工艺为:室温条件下以800 r/min搅拌速度乳化7 min;制备的悬乳剂黏度为424.58 m Pa·s,颗粒粒径大小均匀,呈正态分布,平均粒径为386 nm,稳定性好,室温久置不分层。试验结果表明,研制的2%利福昔明悬乳剂性状良好,符合相关质量要求。
In order to prepare a kind of stable rifaximin suspo-emulsions,the species of oil phase,emulsifier,coemulsifier,and the primary formulation of suspo-emulsions were screened by the univariate analysis.Then the preparation technology and the primary formulation were optimized by means of orthogonal test.The optimal formulation of suspo-emulsions was composed of rifaximin of 1.08 g,oil phase of 20 mL,emulsifier of 7 mL,coemulsifier of 2 mL and water of 25 mL.The optimum technology conditions were obtained：emulsifying time was 7 min,and stirring rate was 800 r/min.The viscosity of suspo-emulsions was 424.58 mPa·s,and the particle size was uniform and normally distributed,with an average size of 386 nm.The stability of suspo-emulsions was good and it could be stored for long time at room temperature without sedimentation or segregation.The experimental results indicated that the2% rifaximin suspo-emulsions was of good qualify and in conformity with the relevant standards.
作者
朱庆贺
王爽
陈羲
王观悦
丑晓丹
史同瑞
ZHU Qing-he WANG Shuang CHEN Xi WANG Guan-yue CHOU Xiao-dan SHI Tong-rui(Heilong~iang lnstitute of Veterinary Science, Qiqihar 161005, China Dongfang A olong Pharmaceutical Co.ltd, Foshan 528500, China)
出处
《中国兽医科学》
CAS
CSCD
北大核心
2017年第7期932-938,共7页
Chinese Veterinary Science
基金
黑龙江省应用技术研究与开发项目(czznkt2016-2)
关键词
利福昔明
悬乳剂
研制
稳定性
Rifaximin
suspo-emulsions
preparation
stability
