前列地尔微乳处方及制备工艺的优化.pdf

JournalofPharmaceuticals ·586· 中国医药工业杂志Chinese 2015，46(6) 前列地尔微乳处方及制备工艺的优化 刘洁，杨亚妮，何军丰，卞玮，李晓燕 (中国医药工业研究总院药物制剂国家工程研究中心，上海200437) 摘要：结合预试验结果，首先确定前列地尔微乳的处方组成，再通过星点设计一效应面法和绘制电导率一含水量曲线，确 定了前列地尔微乳处方中各组分的优化用量；最后以粒径和药物含量为指标，优化了微乳制备时的搅拌速度、时间和温 HS158％、蛋黄卵磷脂2％、中链甘油三酸酯4％、甘油 度等工艺参数。结果表明，前列地尔微乳优化处方为：Solutol r／min、30℃和0．5h。照上述优化处方制备的3批前列地尔微 6％和水80％；制备时搅拌的速度、温度和时间分别为300 乳粒径均约23～25nnl，且离心稳定性好。 关键词：前列地尔；微乳；星点设计一效应面法：电导率．含水量曲线 中图分类号：R944．9文献标志码：A 文章编号：1001—8255(2015)06．0586—06 DOh 10．16522／j．cnki．cjph．2015．06．010 of Microemulsions Preparation Optimization ofAlprostadil LIU Yani，HEJun+，BIAN Jie，YANG Wei，LIXiaoyan (NationalPharmaceuticalandResearchCenter,ChinaStateInstitute 200437) Engineering ofPharmaceuticalIndustry,Shanghai ABSTRAC7I’：Basedontheresultof of microemulsionsweredecided．The pre—test．thecompositionsalprostadil amountsofthese were central surface and by methodologydrawing compositionsoptimized compositedesign-response the of content．The as and time，were profilesconductivity—waterprocessparameters，suchstirringspeed，temperature with sizeand contentasindexes．Theresultsshowedthatthe microemulsionswere optimizedparticle drug optimal of8％SolutolHS1 chain and were 5，2％lecithin，4％mediu