文献类型：期刊文献

中文题名：氟比洛芬酯脂微球注射液的研制

英文题名：Preparation of Flurbiprofen Axetil Lipid Microspheres Injection

作者：屠祎惺[1];姚芳[2];方源[1];付爱玲[3];高峰[1,2,4]

机构：[1]华东理工大学,上海市功能性材料化学重点实验室,上海200237;[2]华东理工大学,上海市新药设计重点实验室,上海200237;[3]上海景峰制药股份有限公司,上海201908;[4]华东理工大学药学院药剂教研组,上海200237

年份：2014

卷号：45

期号：9

起止页码：849

中文期刊名：中国医药工业杂志

外文期刊名：Chinese Journal of Pharmaceuticals

收录：CSTPCD;;北大核心:【北大核心2011】；CSCD:【CSCD2013_2014】；

基金：上海市科学技术委员会项目资助(11DZ2260600和10DZ2220500)

语种：中文

中文关键词：脂微球;注射液;制备工艺;氟比洛芬酯

外文关键词：lipid microsphere; injection; preparation technology; flurbiprofen axetil

摘要：以两步乳匀法制备氟比洛芬酯(1)脂微球注射液。采用单因素法结合正交试验优化得到的制备工艺为:乳化温度65℃,20 000 r/min高速剪切8 min,1 000 bar高压均质6次,再调节pH值至8.5,灌装熔封于5 ml安瓿,115℃高压灭菌30 min。优化制品灭菌后的脂微球粒径约200 nm,ζ电位为-36 mV,包封率为99.3%,pH值约7.0。
Flurbiprofen axetil lipid microspheres for injection were obtained by two-step emulsifying method. The final preparation technology optimized by single factor test and orthogonal design was as follows： the lipid microspheres were obtained by emulsion at 65 ~C with a high-speed shear rate of 20 000 r/min for 8 min, followed by high pressure homogenization at 1 000 bar for six times, then the pH value was adjusted to 8.5. The product was sealed into a 5 ml ampoule and sterilized at 115 ℃ for 30 min. The particle size,ζ potential, entrapment efficiency and pH value of the product after sterilization were 200 nm, -36 mV, 99.3 % and 7.0, respectively.