中国药典中口服药用塑料瓶及组件质量标准制定的建议  

Suggestions on drafting standards for plastic bottles and components for oral dosage forms in Chinese pharmacopoeia

作　　者：陆维怡 吕杨格格 LU Weiyi;LYU Yanggege(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201203

出　　处：《上海医药》2022年第13期67-69,73,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：目前我国口服药用塑料瓶及组件质量标准在一定时期内对产品质量控制起到了积极作用,随着包材管理模式的变化和行业发展,也反映出一定的局限。为更好保证药品质量,助力企业创新发展,对口服药用塑料瓶及组件质量标准发展方向进行探讨。建议在中国药典药包材标准体系的建设中,借鉴各国药典的长处,结合我国现状和发展需求,形成有自身特色的口服药用塑料瓶及组件标准。At present,the quality standards for oral medicinal plastic bottles and components in China have played a positive role in product quality control within a certain period,however it also reflects certain limitations with the changes in the packaging management and industry development.The development direction of our standard is discussed in order to better ensure the quality of medicines and help enterprises to innovate and develop.It is suggested that in the process of formulating the standard system of pharmaceutical packaging in Chinese pharmacopoeia,the advantages of pharmacopoeia of various countries should be used for reference and the current situation and development needs of our country should be also considered so as to form a standard for plastic bottles and components for oral dosage forms with its own characteristics.

关 键 词：口服药用塑料瓶 包装系统 质量标准 

分 类 号：R951[医药卫生—药学]