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作 者:张晓红[1] 杨莉[2] 栾瀚森[2] 蔡国强[1]
机构地区:[1]上海现代制药股份有限公司,上海200040 [2]中国医药工业研究总院药物制剂国家工程研究中心,上海201203
出 处:《中国医药工业杂志》2013年第9期904-906,共3页Chinese Journal of Pharmaceuticals
基 金:符合GLP要求的新制剂与新释药系统技术平台建设(2012ZX09304004);注射用可生物降解药用辅料PLGA的产业化研究(2011ZX09401-403-1);新型缓控释药用辅料开发与应用的关键技术(2011ZX09501-001-03)
摘 要:将丙交酯-乙交酯共聚物(PLGA)溶于二氯甲烷中,用稀盐酸为萃取剂(即稀酸萃取法)或乙醇为沉淀剂(乙醇沉淀法)去除PLGA中残留的乙交酯和丙交酯单体。考察了两种方法的工艺参数对单体残留量的影响。结果表明,稀酸萃取法比乙醇沉淀法的去除效果好,但所用盐酸会破坏PLGA;沉淀法能有效避免PLGA的降解,且工艺简单。上述两法的去除效果均优于真空加热法。The poly (lactic-co-glycolic acid) (PLGA) was dissolved in dichloromethane, then the solution was treated by extraction method with diluted hydrochloric acid or precipitation method with ethanol as precipitation agent to remove the residual monomers in PLGA. The residual monomer contents of glycolide and lactide in PLGA treated by these methods were determined by GC. The results showed the effects of the two methods were both better than vacuum- heating, and the diluted acid extraction method was better than precipitation method, but PLGA would be degraded by the dilute hydrochloric acid. Therefore, the precipitation method was more suitable.
关 键 词:丙交酯-乙交酯共聚物 萃取 沉淀法 残留单体
分 类 号:TQ314.2[化学工程—高聚物工业]
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