冻干工艺及助溶剂聚乙二醇对盐酸椒苯酮胺冻干制剂的影响  

Study on the effect of polyethylene glycol and vacuum freeze-drying on piperphentonamine hydrochloride preparation

作　　者：李茹冰[1] 王晓会[2] 李若冰[3] 李超[1] 陈行愉[1] 韩丽萍[1] 万华印 

机构地区：[1]广州军区广州总医院药剂科,广东广州510010 [2]广州军区广州总医院干部病房四科,广东广州510010 [3]广东省人民医院心外科,广东广州510010 [4]广州市众为生物技术有限公司,广东广州510604

出　　处：《广东药学院学报》2011年第6期559-562,共4页Academic Journal of Guangdong College of Pharmacy

基　　金：国家"十二五"重大新药创制科技重大专项(2011ZX091011-003);科技部创新基金项目(10C26214412687);广东省中国科学院全面战略合作项目(2009B091300065);广州市专利技术产业化示范项目(200903);广州市重大专项课题(2008A1-E4161)

摘　　要：目的建立适合盐酸椒苯酮胺的冻干工艺,并考察助溶剂聚乙二醇对盐酸椒苯酮胺制剂性状的影响。方法采用真空冷冻干燥速冻法-30℃预冻3 h和慢冻法-30℃预冻5 h制备盐酸椒苯酮胺冻干制剂,考察其性状,并观察加入不同相对分子质量的聚乙二醇后,冻干样品及其复溶后溶液的外观性状、颜色、澄清度和pH值。结果 2种冻干工艺获得的样品,其外观、溶解性及澄清度无明显差别,水分均<5%。加聚乙二醇冻干后的样品性状好,加水后易溶、澄清、无附着现象,但放置一段时间后颜色变黄,复溶后的溶液稍放一段时间后也变黄。结论 2种冻干工艺均可用于生产盐酸椒苯酮胺冻干制剂,优选慢冻法,聚乙二醇不适宜作为盐酸椒苯酮胺的助溶剂。Objective To establish a freeze-drying process and investigate the effect of polyethylene glycol（PEG） on Piperphentonamine（PPTA） hydrochloride.Methods The characteristics of PPTA were examined when the vacuum freeze-drying method was performed by pre-freezing temperature at-30 ℃ for 3 h or-30 ℃ for 5 h.The characteristics,clarity and color of PPTA preparations were surveyed after adding different relative molecular weights of PEG.Results The two freeze-drying process made no significant difference for PPTA.The products show qualified shape,content,clarity,color and pH value with polyethylene glycol as cosolvent,but the solutions turn yellow after a period of time.Conclusions Both the two freeze-drying process for PPTA are feasible,in which the slow pre-freezing method is preferred.PEG isn′t suitable as the cosolvent of Piperphentonamine Hydrochloride.

关 键 词：盐酸椒苯酮胺 助溶剂 聚乙二醇 真空冷冻干燥 

分 类 号：TQ463[化学工程—制药化工]