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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
引用本文:李茹冰,王晓会,李若冰,李超,陈行愉,韩丽萍,万华印. 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[J]. 广东药学院学报, 2011, 27(6): 559-562. DOI: 10.3969/j.issn.1006-8783.2011.06.002
作者姓名:李茹冰  王晓会  李若冰  李超  陈行愉  韩丽萍  万华印
作者单位: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
基金项目:国家"十二五"重大新药创制科技重大专项,科技部创新基金项目,广东省中国科学院全面战略合作项目,广州市专利技术产业化示范项目,广州市重大专项课题
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3h和慢冻法-30℃预冻5h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...

关 键 词:盐酸椒苯酮胺  助溶剂  聚乙二醇  真空冷冻干燥

Study on the effect of polyethylene glycol and vacuum freeze-drying on piperphentonamine hydrochloride preparation
LI Ru-bing,WANG Xiao-hui,LI Ruo-bing,LI Chao,CHEN Xing-yu,HAN Li-ping,WAN Hua-yin. Study on the effect of polyethylene glycol and vacuum freeze-drying on piperphentonamine hydrochloride preparation[J]. Academic Journal of Guangdong College of Pharmacy, 2011, 27(6): 559-562. DOI: 10.3969/j.issn.1006-8783.2011.06.002
Authors:LI Ru-bing  WANG Xiao-hui  LI Ruo-bing  LI Chao  CHEN Xing-yu  HAN Li-ping  WAN Hua-yin
Affiliation:1.Department of Pharmacy,Guangzhou General Hospital of Guangzhou Military Command Area,Guangzhou 510010,China;2.Forth Department of Ward,Guangzhou General Hospital of Guangzhou Military Command Area,Guangzhou 510010,China;3.Cardial Surgery of the People Hospital of Guangdong Province,Guangzhou 510010,China;4.Guangzhou Zongwei Biotechnology Limited Company,Guangzhou 510604,China)
Abstract:
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.
Keywords:piperphentonamine hydrochloride  polyethylene glycol  vacuum freeze-drying
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