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.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
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 )
