摘要
《中国药典》是国内最高水平的药品质量标准,在《中国药典》2010年版开始实施之际,解读2010版《中国药典》质量标准的变化,分析药品质量标准的变化趋势,不仅有利于新版药典的执行,且有利于明确未来药品质量标准增修订的方向。作者从10个方面对《中国药典》2010年版在化学/抗生素质控项目、质控方法和质控限度的变化进行了解读,并对今后化学/抗生素药品质量标准的增修订阐述了自己的观点。
The Chinese Pharmacopoeia is the highest level of pharmaceutical quality standards. For the Chinese Pharma- copoeia 2010 beginning to practice,to interpret the change of quality standards in the Chinese Pharmacopoeia 2010 and analyze change tendency of pharmaceutical quality standards, can not only conducive to carry out the new pharmacopoeia, but also conducive to define the revised direction of future pharmaceutical quality standards. This article interpreted the changes of quality control item, quality control methods, quality control limits of chemical/antibiotic drugs in the Chinese Pharmacopoeia from 10 aspects, and expounded own viewpoints for the revision of pharmaceutical quality standards of chemical/antibiotic drugs.
出处
《齐鲁药事》
2011年第1期33-37,共5页
qilu pharmaceutical affairs
关键词
药典
药品标准
化学/抗生素药品
标准修订
Pharmacopoeia
Drug standard
Chemical/antibiotic drugs
Standard revision
