|
|||||
|
|
| 第二批人凝血酶国家标准品协作标定 | |
| 引用本文： | 沈琦,王青(竹舟),郝杰,盛凤仙,李玲,金于兰. 第二批人凝血酶国家标准品协作标定[J]. 中国生化药物杂志, 2004, 25(4): 233-234 |
| 作者姓名： | 沈琦 王青(竹舟) 郝杰 盛凤仙 李玲 金于兰 |
| 作者单位： | 1. 中国药品生物制品检定所,北京,100050 2. 上海新兴医药股份有限公司,上海,200135 3. 上海生物制品研究所,上海,200052 |
| 摘 要： | 目的协作标定第二批人凝血酶国家标准品。方法用世界卫生组织首批α 凝血酶国际标准品 (批号 :89/ 5 88)为标准 ,采用纤维蛋白原凝固法标定。并将标准品分别于 2 5℃、37℃、4 5℃保存 6个月 ,进行稳定性考查。结果第二批人凝血酶国家标准品的效价为 12 7IU/支 ,稳定性良好 ,其他项目符合国家标准品要求。结论已成功研制第二批人凝酶国家标准品 ,可以取代首批人凝血酶国家标准品。 |
| 关 键 词： | 人凝血酶 协作标定 标准品 |
| 文章编号： | 1005-1678(2004)04-0233-02 |
| 修稿时间： | 2003-05-26 |
The calibration of the 2nd national standard for human thrombin |
|
| SHEN Qi,WANG Qing-zhou,HAO Jie,SHENG Feng-xian,LI Ling,JIN Yu-lan. The calibration of the 2nd national standard for human thrombin[J]. Chinese Journal of Biochemical Pharmaceutics, 2004, 25(4): 233-234 | |
| Authors: | SHEN Qi WANG Qing-zhou HAO Jie SHENG Feng-xian LI Ling JIN Yu-lan |
| Affiliation: | SHEN Qi1,WANG Qing-zhou1,HAO Jie1,SHENG Feng-xian2,LI Ling2,JIN Yu-lan3 |
| Abstract: | PurposeTo calibrate the 2 nd national standard for human thrombin by the collaborative study.MethodsThe potencies of the national standard for human thrombin were assayed against 1 st International Standard for Alpha- thrombin (89/588)by fibrinogen clotting method. Ampoules of thrombin national standard were stored at 25℃、37℃、45℃ for 6 months for accelerated degradation studies.ResultsThe potency of thrombin is 127 IU/ampoule.The results of accelerated degradation studies showed that the preparation is very stable. All the other items met the requirements for national standard of China.ConclusionThe 2 nd national standard for human thrombin was established to replace the 1 st National Standard for human thrombin. |
| Keywords: | human thrombin collaborative study standard |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |