^89SrCl2注射液的质量控制  

Quality Control of 89SrCl2 Injection

作　　者：秦为民 陈彧 刘军 杨小超 罗玉华 黎玉萍 余维珍 陈红 赵万洪 徐其英 

机构地区：[1]成都中核高通同位素股份有限公司，四川成都610005

出　　处：《同位素》2003年第3期194-196,共3页Journal of Isotopes

摘　　要：对本公司研制的^89SrCl2注射液的质量进行了分析，结果表明：^88Sr通过中子辐照反应^88Sr(n，γ)^89Sr及相关无菌工艺制得的^89SrCl2注射液的放射性核纯度不低于99．0％，放射性浓度不低于37GBq／L，pH为4．0～7．5，含铝量≤2mg／L，含锶量≤12．5g／L，细菌内毒素含量小于15EU／mL,无菌检验结果均无细菌生长。根据试生产^89SrCl2注射液的质量情况，制定了内控质量标准。89SrCl2 injection are prepared with neutron radiation reaction of 88Sr(n,γ)89Sr and asepsis technics, which radionuclide purity is not less than 99. 0%,radioconcentration is not less than 37 GBq/L, pH is in the range of 4. 0-7.5, aluminium content is not more than 2 mg/L and strontium content is not more than 12. 5 g/L,bacteria endotoxin content is less than 15 EU/mL and all the results of asepsis test are no growing up of bacteria. In corporation, the internal control standard of 89 SrCl2 injection is esta...

关 键 词：^89SrCl2注射液 质量控制 骨肿瘤治疗 半衰期 锶 放射性活度 

分 类 号：R979.1[医药卫生—药品] R815[医药卫生—药学]