| 三磷酸胞苷二钠注射液细菌内毒素检查法的研究 |
| |
| 引用本文： | 乔红群,何学军,陈国广. 三磷酸胞苷二钠注射液细菌内毒素检查法的研究[J]. 南京工业大学学报(自然科学版), 2006, 28(2): 53-55 |
| |
| 作者姓名： | 乔红群 何学军 陈国广 |
| |
| 作者单位： | 1. 南京凯腾科技有限公司,江苏南京,210009
2. 南京工业大学,制药与生命科学学院,江苏南京,210009 |
| |
| 摘 要： | 考察三磷酸胞苷二钠注射液细菌内毒素检查方法。按《中国药典》2000年版二部，制定本品细菌内毒素限值，并研究三磷酸胞苷二钠注射液对细菌内毒素检查试验的干扰情况，以确定本品是否适用细菌内毒素检查法。本品可采用细菌内毒素检查法，并建立了本品细菌内毒素检查法质量标准。
|
| 关 键 词： | 三磷酸胞苷二钠注射液 细菌内毒素检查法 干扰试验 |
| 文章编号： | 1671-7643（2006）02-0053-03 |
| 收稿时间： | 2005-06-30 |
| 修稿时间： | 2005-06-30 |
Establishment of the quality standard for bacterial endotoxins test of cytidine disodium triphosphate injection |
| |
| QIAO Hong-qun,HE Xue-jun,CHEN Guo-guang. Establishment of the quality standard for bacterial endotoxins test of cytidine disodium triphosphate injection[J]. Journal of Nanjing University of Technology, 2006, 28(2): 53-55 |
| |
| Authors: | QIAO Hong-qun HE Xue-jun CHEN Guo-guang |
| |
| Affiliation: | 1. Nanjing Coretech Technology Co. LT, Nanjing 210009, China; 2. College of Life Science and Pharmaceutical Engineering, Nanjing University of Technology, Nanjing 210009, China |
| |
| Abstract: | To establish the quality standard for the bacterial endotoxins test of cytidine disodium triphosphate injection to replace the test for pyrogens, the limit of bacterial endotoxins in this product was defined according to CP2000. The interference to bacterial endotoxins test by the injection was also carried out to confirm whether this product is suitable for this test. The bacterial endoxins limit of cytidine disodium triphosphate injection is 7.5 EU/mg. This product is suitable for bacterial endotoxins test and its standard was established. |
| |
| Keywords: | cytidine disodium triphosphate injection bacterial endotoxins test interfere factors. |
| 本文献已被 维普 万方数据 等数据库收录！ |
