摘要
通过查阅中、美、英、日四国药典中胰岛素效价测定方法的相关内容,对其历年来的胰岛素效价测定方法进行分析与对比,结果各国药典中胰岛素的效价测定方法还存在差异,胰岛素效价测定方法的发展方向与改进空间应参考国外药典,逐步取消生物测定法以HPLC法进行替代。
The related contents of insulin titer determination methods in ChP, USP, BP and JP were reviewed, and the insulin titer determination methods over these years were analyzed and compared. It was found that the insulin titer determination methods in these pharmacopoeias had some differences. The foreign pharmacopoeias should be referred to the development and improvement of insulin titer determination method in ChP. The bioassay method should be cancelled gradually and replaced with HPLC method.
作者
贾首前
王莉芳
冯润东
JIA Shouqian;WANG lifang;FENG Rundong(Shaanxi Institute for Food and Drug Control,Xi'an 710065,China)
出处
《中国药品标准》
CAS
2019年第6期465-468,共4页
Drug Standards of China
关键词
胰岛素
中国药典
美国药典
英国药典
日本药典
效价测定
insulin
Chinese Pharmacopoeia
United States Ph armacopoeia
British Pharmacopoeia
Japanese Pharmacopoeia
insulin titer determination
