|
|||||
|
|
| 人免疫球蛋白白喉抗体国家标准品的协作标定 | |
| 引用本文： | 沈琦,卢莲玉,王威,金于兰,倪永碧. 人免疫球蛋白白喉抗体国家标准品的协作标定[J]. 中国生化药物杂志, 2007, 28(2): 122-123 |
| 作者姓名： | 沈琦 卢莲玉 王威 金于兰 倪永碧 |
| 作者单位： | 1. 中国药品生物制品检定所,北京,100050 2. 上海生物制品研究所,上海,200052 3. 成都蓉生药业有限公司,四川,成都,610063 |
| 基金项目： | 致谢：有关血液制品企业参加该批人免疫球蛋白白喉抗体国家标准品的协作标定,在此一并表示感谢. |
| 摘 要： | 目的协作标定人免疫球蛋白白喉抗体国家标准品。方法用世界卫生组织提供的白喉抗毒素国际标准品(批号:9897/762)为标准,采用被动血凝法标定我国人免疫球蛋白白喉抗体国家标准品,将待标品按标示量加水溶解后,置于4℃保存6个月和将冻干待标品分别置于4,25,37℃保存6个月,进行稳定性考查。结果人免疫球蛋白白喉抗体国家标准品的效价为0.4 HAU/支,稳定性好,其他项目符合国家标准品要求。结论该批冻干人免疫球蛋白白喉抗体国家标准品可取代上批国家标准品。 |
| 关 键 词： | 人免疫球蛋白白喉抗体国家标准品 被动血凝法 协作标定 |
| 文章编号： | 1005-1678（2007）02-0122-02 |
| 收稿时间： | 2006-04-30 |
| 修稿时间： | 2006-07-07 |
The calibration of the national standard for diphtheria antibody human immunoglobulin |
|
| SHEN Qi,LU Liang-yu,WANG Wei,JIN Yu-lan,NI Yong-bi. The calibration of the national standard for diphtheria antibody human immunoglobulin[J]. Chinese Journal of Biochemical Pharmaceutics, 2007, 28(2): 122-123 | |
| Authors: | SHEN Qi LU Liang-yu WANG Wei JIN Yu-lan NI Yong-bi |
| Affiliation: | 1. National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China; 2. Shanghai Biological Products Institute, Shanghai 200052, China ; 3. Chengdu Rongsheng Medical Co. , LTD. , Chengdu 610063, China |
| Abstract: | Purpose The aim is to calibrate the national standard for diphtheria antibody human immunoglobulin by the collaborative study to replace the previous national standard.MethodsThe potencies of the national standard for diphtheria antibody were assayed against the international standard for diphtheria antitoxin equine(lot:9897/762)by passive hemagglutination method.The reconstituted solutions of diphtheria antibody national standard were stored at 4℃ for 6 months and the freeze-dry national standard for diphtheria antibody was stored at 4,25,37℃ for 6 months for stability studies.ResultsThe potency of diphtheria antibody is 0.4 HAU/ampoule.The results of stability studies showed that the preparation was very stable.All the other items met the requirements for national standard of China.ConclusionThe national standard for diphtheria antibody human immunoglobulin can replace the previous national standard. |
| Keywords: | national standard for diphtheria antibody human immunoglobulin passive hemagglutination method collaborative study |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |