蒋宫平,骆翔,程晓波,佘振南,宋艳志,邓意辉
JIANG Gong-ping,LUO Xiang,CHENG Xiao-bo,SHE Zhen-nan,SONG Yan-zhi,DENG Yi-hui*(School of Pharmacy

• 1:沈阳药科大学药学院

摘要(Abstract)：

目的确定挤出法制备乳剂的最优工艺。方法经挤出仪制备乳剂,采用正交设计法,以乳剂的平均粒径、变异系数为评价指标,考察了乳剂挤出工艺中滤膜孔径、挤出次数、温度及压力对制剂的影响,及最优工艺制得乳剂的离心稳定性、灭菌稳定性和冻融稳定性。结果采用优化挤出工艺制得乳剂的平均粒径为(116.7±2.2)nm,变异系数为(0.453±3.400),且离心稳定性、灭菌稳定性和冻融稳定性良好。结论挤出法可以制备粒径小、粒度分布均匀、稳定性良好的乳剂,该方法在热不稳定性药物乳剂的制备中具有很大的应用前景。
Objective To optimize the process of emulsion using extrusion method.Methods The emulsion was prepared by extruder.In the orthogonal design,mean diameter and coeff.of var′n were selected as evaluation variables,membrane pore,cycle times,temperature and pressure were employed as independent variables.The optimal process was predicted by orthogonal design,and then the sterilization stability,frozen stability and centrifugation stability of emulsion were predicted by the optimal process.Results The mean diameter and coeff.of var′n of the optimal preparation were(116.7±2.2) nm and(0.453±3.400),respectively,and the stability of sterilization,frozen and centrifugation were fine.Conclusions Extrusion is a suitable method for preparing emulsion with small particle size,uniform distribution and good stability;this method has a great prospect in preparing thermally unstable substance emulsion.

关键词(KeyWords)： 乳剂;挤出;正交设计;平均粒径;变异系数;灭菌稳定性;冻融稳定性
emulsion;extrusion;orthogonal design;mean diameter;coeff.of var′n;sterilization stability;frozen stability

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 蒋宫平,骆翔,程晓波,佘振南,宋艳志,邓意辉
JIANG Gong-ping,LUO Xiang,CHENG Xiao-bo,SHE Zhen-nan,SONG Yan-zhi,DENG Yi-hui*(School of Pharmacy

DOI: 10.14066/j.cnki.cn21-1349/r.2013.08.002

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