| 盐酸多巴酚丁胺注射液细菌内毒素检查法的建立 |
| |
| 引用本文： | 李逢春,李震.盐酸多巴酚丁胺注射液细菌内毒素检查法的建立[J].中国药房,2012(1):77-78. |
| |
| 作者姓名： | 李逢春 李震 |
| |
| 作者单位： | [1]河南省食品药品检验所,郑州450003 [2]河南南阳市中心医院,河南南阳473000 |
| |
| 摘 要： | 目的:研究盐酸多巴酚丁胺注射液细菌内毒素检查法的可行性。方法:采用鲎试剂法根据《中国药典》2005年版(二部)附录细菌内毒素检查法进行样品预干扰试验和正式干扰试验,确定样品的试验浓度及内毒素限值。结果:将样品浓度稀释到0.8mg·mL-1时,不干扰细菌内毒素试验,其细菌内毒素限值定为1.2EU·mg-1。结论:采用鲎试剂法检查盐酸多巴酚丁胺注射液中的细菌内毒素是可行的。
|
| 关 键 词： | 盐酸多巴酚丁胺注射液 细菌内毒素 鲎试剂 干扰试验 |
Study on Determination of Bacterial Endotoxin of Dobutamine Hydrochloride Injection |
| |
| LI Feng-chunHenan Province Institute for Food and Drug Control,Zhengzhou,China LI Zhen.Study on Determination of Bacterial Endotoxin of Dobutamine Hydrochloride Injection[J].China Pharmacy,2012(1):77-78. |
| |
| Authors: | LI Feng-chunHenan Province Institute for Food and Drug Control Zhengzhou China LI Zhen |
| |
| Institution: | LI Feng-chun(Henan Province Institute for Food and Drug Control, Zhengzhou 450003,China) LI Zhen(Nanyang Central Hospital of Henan Province, Henan Nanyang 473000, China) |
| |
| Abstract: | OBJECTIVE： To study the feasibility of bacterial endotoxin determination of Dobutamine hydrochloride injection. METHODS： Using TAL, the interference pretest and interference test of test sample were conducted according to bacterial endotoxin determination stated in appendix Ⅱ of Chinese Pharmacopiea （2005 edition）. The concentration of samples and bacterial endotoxin limit were determined. RESULTS： Samples were diluted to 0.8 mg. mL-1, which did not interfere with bacteria endotoxin test. The limitation of bacteria endotoxin was 1.2 EU. mg-1. CONCLUSION： It is feasible to detect the bacterial endotoxin of Dobuta- mine hydrochloride injection by the method of TAL. |
| |
| Keywords: | Dobutamine hydrochloride injection Bacterial endotoxin TAL Interference test |
| 本文献已被 CNKI 维普 等数据库收录！ |
