|
|
|
| Study on Bacterial Endotoxin Test of Fasudil hydrochloride Injection |
| GUO Qian, DONG Xin-ming, LI Ying, CHEN Li |
| CSPC Ouyi Pharmaceutical Corporation Ltd.,Shijiazhuang 050000, China |
|
|
|
|
Abstract In order to ensure that test results meet quality standards,a method for testing bacterial endotoxin in fasudil hydrochloride injection using tachypleus amebocyte lysate(TAL)was established.The tests were conducted according to appendix Ⅺ E of Chp 2010. Results showed when the maximum concentration of fasudil hydrochloride injection was 0.5 mg/mL,there was non-interference using TAL which sensitivity was 0.25 EU/mL in the interference test. It was pointed out that the limit of bacterial endotoxin was 5.0 EU/mg and bacterial endotoxin test could be used for the detection of endotoxin in fasudil hydrochloride injection.
|
|
|
|
|
|
| [ 1 ] 高 晨,依立卢[ J ]. 中国新药杂志,2002,11( 5 ):404 - 405.[ 2 ] 国家药典委员会. 中华人民共和国药典(二部) [ S ]. 北京:中国医药科技出版社,2010:附录99 - 102.[ 3 ] 中国药品生物制品检定所. 中国药品检验操作规范 [ M ]. 北京:中国医药科技出版社,2010:310.[ 4 ] 张义伟. 细菌内毒素检查的几点体会[ J ]. 中国实用医药,2010,5(3):86. |
|
|
|