TRODAT-1冻干品稳定性探讨  

Evaluation on stability of TRODAT-1 kit

作　　者：王颂佩[1] 陈正平[1] 张同兴[1] 李晓敏[1] 傅榕赓[1] 徐希杰[1] 

机构地区：[1]江苏省原子医学研究所,江苏无锡214063

出　　处：《中国新药与临床杂志》2004年第7期430-432,共3页Chinese Journal of New Drugs and Clinical Remedies

基　　金：国家科技攻关资助项目 (2 0 0 1BA70 2B0 2 )

摘　　要：目的 :研究TRODAT 1冻干品的稳定性。方法 :经光照、高温、高湿、加速、室温留样、低温(- 18°C)条件放置 ,测定其标记率及pH值。结果 :在光照、高湿度下 ,标记率及 pH值均没有明显变化 ;(4 1.0±s1.0 )°C的高温下 ,标记率有明显降低 ;室温下 3mo内稳定 ;加速条件下 2mo内稳定。结论 :TRODAT 1冻干品对光、湿稳定 ,对热不稳定 ,应保存在冰箱冷冻室中 ,在此条件下 ,有效期至少 1a ,能满足常规临床要求。AIM: To study the stability of TRODAT-1 kit. METHODS: Labeling yield and pH of TRODAT-1 kit were examined,under the different conditions of light,high temperature,heavy humidity,accelerated speed test,room temperature and low temperature(-18 °C ). RESULTS: Labeling yield and pH were not changed obviously under light and heavy humidity,whereas there was a significant reduction in labeling yield under high temperature (41.0± s 1.0) °C . TRODAT-1 kit was stable,under room temperature in three months,accelerated speed test in two months,and low temperature(-18 °C )in one year. CONCLUSION: TRODAT-1 kit is stable to the light,humidity,but not stable to the heat. It should be stored in freezing compartment. Validity of TRODAT-1 kit should be one year at least to meet general clinical use.

关 键 词：放射性药物 多巴胺 载体蛋白质类 TRODAT-1冻干品 稳定性 标记率 

分 类 号：R981.9[医药卫生—药品] R927.11[医药卫生—药学]