中英两国药典关于右旋糖酐铁注射液铁吸收度的考察方法比较  

Iron Absorption Detection Method for Iron Dextran Injection Comparisons Between Chinese Pharmacopoeia and British Pharmocopoeia

作　　者：陈东英 

机构地区：[1]中国科学院上海药物研究所

出　　处：《中国药品标准》2004年第4期63-64,共2页Drug Standards of China

摘　　要：目的:比较中英两国药典中关于右旋糖酐铁注射液铁吸收度的考察方法,讨论两国药典差别,以期使该检查方法合理化和易操作化,有利于控制右旋糖酐铁注射液的质量。方法:分别从空白试验用兔的选择,注射部位直观判断,肌肉样品采集和测试空白选择等方面,比较两国药典的差别。结果:按中国药典标准检验右旋糖酐铁的铁吸收度,操作性较差,较难对产品进行有效的质量控制;按英国药典的检验标准,实际操作基本可行,可以有效控制产品的质量。结论:建议参照英国药典,在下版中国药典中提高该项检查的标准。Objective: Iron absorption detection methods for Iron Dextran Injection were compared between Chinese Pharmacopoeia and British Pharmacopoeia. The differences were discussed in order to rationalize its test operation and to have good quality control for the injection. Methods:Several aspects were compared,including the test rabbits selection,injection site examination, sample collection and assay blank choice. Results:The detection method for iron absorption described in Chinese Pharmacopoeia is quite difficult in carrying out test and cannot control the injection quality. The method described in British Pharmacopoeia, however, is relatively effective for the test and for the evaluation. Conclusions: It is suggested that the iron absorption detection standards in the next edition of Chinese Pharmacopoeia should be further improved according to that in British Pharmacopoeia.

关 键 词：英国药典 注射液 右旋糖酐铁 铁吸收 中国药典 检查方法 注射部位 产品 合理化 质量 

分 类 号：R921.2[医药卫生—药学] R927