四国药典胰酶标准浅析  

Analysis on the pancreatin standards of four countries' pharmacopoeia

作　　者：黄素娟[1,2] 刘莉莎[1] 范慧红[1] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]中国药科大学,江苏南京211100

出　　处：《中国生化药物杂志》2016年第10期5-8,共4页Chinese Journal of Biochemical Pharmaceutics

基　　金：中国食品药品检定研究院2015年中青年发展研究基金(2015A02)

摘　　要：本文阐述了中国药典、美国药典、英国药典、日本药局方中胰酶标准的历史沿革,并对现行版四国药典胰酶标准进行比较和讨论,发现各国药典胰酶标准各有异同,其中活力限度要求差异较大,应予以重视,就效价测定方法而言,美国药典、英国药典的方法更为合理。The history about pancreatin standards in different pharmacopeia,i. e. the Chinese Pharmacopoeia（ Ch P）,the United States Pharmacopoeia（ USP）,the British Pharmacopoeia（ BP）,and the Japanese Pharmacopoeia（ JP） were clarified in this paper. As well as the latest edition of pancreatin standards in different pharmacopeia were compared and discussed. There are many similarities and differences of the pancreatin standards between Ch P and the three other pharmacopoeias. We should attach importance to the significant difference of the potency limitation in four countries＇ pharmacopoeia. Otherwise,the potency test method of pancreatin in USP and BP is more reasonable.

关 键 词：胰酶 中国药典 美国药典 英国药典 日本药局方 效价测定 

分 类 号：R921[医药卫生—药学]