国产口服苯唑西林钠的质量评价与影响因素分析  

Quality evaluation and influencing factors analysis of domestic oral oxacillin sodium

作　　者：张斗胜[1] 王晨[1] 王立新[1] 崇小萌[1] 姚尚辰[1] 许明哲[1] ZHANG Dousheng;WANG Chen;WANG Lixin;CHONG Xiaomeng;YAO Shangchen;XU Mingzhe(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《药学研究》2019年第1期26-29,共4页Journal of Pharmaceutical Research

摘　　要：目的评价国产口服苯唑西林钠(片、胶囊)的质量现状,分析影响本品的质量因素。方法对2016年国抽样品,采用法定检验结合探索性研究开展实验,统计分析数据。结果抽样12批次样品法定检验均符合规定,通过探索性研究结合统计分析发现原辅料质量、工艺水平对产品的水分、有关物质、溶出度等关键质控项有密切影响,是影响本品的关键工艺参数。结论现行《中国药典》2015年版满足本品质控需要,胶囊质量好于糖衣片,建议企业应重视原辅料质量,优化生产工艺,加强过程控制,提高产品质量。Objective To evaluate the quality status of domestic oral oxacillin sodium(tablets and capsules)and analyze the influencing factors of the quality of the product.Methods For the sample in 2016,the experiment was carried out by means of statutory inspection combined with exploratory research,and the statistical data were analyzed.Results Statutory tests showed 12 batches of samples were all qualified.The exploratory research combined with the statistical analysis found that the quality of raw materials,production process level were closely effected the product of key quality factors,such as moisture,related substances,dissolution,were the the key process parameters of the product.Conclusion At present,the Chinese Pharmacopoeia 2015 edition meets the quality control requirement of this product.The quality of capsules is better than that of sugarcoated tablets.It is suggested that enterprises should attach importance to the quality of raw materials,optimize the production process,enhance process control and improve product quality.

关 键 词：苯唑西林钠 口服制剂 质量评价 因素分析 

分 类 号：R917[医药卫生—药物分析学]