摘要
药用辅料是药品重要的组成部分,药用辅料的质量直接关系到整个药品的安全性、有效性,《中国药典》标准是药用辅料质量控制的核心,2015年版《中国药典》与2010年版《中国药典》最大的变化之一就是药用辅料标准与通则合并成为单独第四册,新版药典收载的药用辅料品种将成倍增加,新技术、新方法得到了广泛应用,注射级药用辅料的标准日趋严格,功能性指标的设立令人耳目一新。本文将通过2015年版《中国药典》药用辅料标准的变化解读未来我国药用辅料行业的趋势,以及这些趋势对我国整个药品行业的影响。
Pharmaceutical excipients are important ingredients of drugs, and the quality of it directly related to the safety of drug. Compared to the 2010 edition, one of the most significant improvement of the 2015 edition of Chinese pharmacopoeia is the monographs of pharmaceutical exeipients will be available in an individual book （ Chinese Pharmacopoeia Book IV）. And also, some new features will be found in the new edition：the doubled varieties of chronicled pharmaceutical excipients, the application of new techniques, the strict standards of the excipients for injection, the establishment of functionality-related characteristics. This article will interpret the developing trend of the standards of pharmaceutical excipients and the effect of the trend on the entire pharmaceutical industry in the future via the improvement of Chinese Pharmacopoeia.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2015年第15期1353-1358,共6页
Chinese Pharmaceutical Journal
关键词
2015年版中国药典
药用辅料
药品安全性
注射用药用辅料
2015 edition of Chinese pharmacopoeia
pharmaceutical excipient
drug safety
excipients for injection
