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| 注射用甲硫氨酸维生素B1的细菌内毒素检查 | |
| 引用本文： | 张 璟,王 芳,王金燕,李晓红.注射用甲硫氨酸维生素B1的细菌内毒素检查[J].河北科技大学学报,2007,28(4):298-301. |
| 作者姓名： | 张 璟 王 芳 王金燕 李晓红 |
| 作者单位： | 1. 河北科技大学实业开发总公司,河北石家庄,050018 2. 华北制药集团制剂有限公司,河北石家庄,050011 3. 华北制药股份有限公司115车间,河北石家庄,050015 |
| 摘 要： | 为考察注射用甲硫氨酸维生素B1的细菌内毒素检查法的可行性，采用《中华人民共和国药典》（2005年版）细菌内毒素检查法。结果得知，注射用甲硫氨酸维生素B1质量浓度为0．25mg／mL的稀释液可用灵敏度为0．25EU／mL的鲎试剂进行细菌内毒素检查，实验中3个批号的注射用甲硫氨酸维生素B1经检查均符合规定。 |
| 关 键 词： | 注射用甲硫氨酸维生素B1 细菌内毒素检查法 鲎试剂(TAL) |
| 文章编号： | 1008-1542（2007）04-0298-04 |
| 收稿时间： | 2007-05-18 |
| 修稿时间： | 2007-07-16 |
Bacterial endotoxins test of methiouine and vitamin B1for injection |
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| ZHANG Jing,WANG Fang,WANG Jin-yan and LI Xiao-hong.Bacterial endotoxins test of methiouine and vitamin B1for injection[J].Journal of Hebei University of Science and Technology,2007,28(4):298-301. | |
| Authors: | ZHANG Jing WANG Fang WANG Jin-yan and LI Xiao-hong |
| Institution: | ZHANG Jing, WANG Fang, WANG Jin-yan, LI Xiao-hong(1. Industrial Company , Hebei University of Science and Technology,Shiiiazhuang Hebei 050018,China;2. Formulation Company Limited, North China Pharmaceutical Group,Shijiazhuang Hebei 050011,Chinas3. Workshop No. 115, North China Pharmaceutical Coporation Limited, Shijiazhuang Hebei 050015 ,China) |
| Abstract: | To inspect on the feasibility of bacterial endotoxins test(BET) of methiouine and vitamin B1 for injection,the BET of China pharmacopoeia version 2005 is applied.Methiouine and vitamin B1 for injection with the sentivity of 0.25 mg/mL could be tested by tachypleus amebocyte lysate(TAL) with the sentivity of 0.25 EU·mL-1.Three batches of methiouine and vitamin B1 for injection met the requirements through testing. |
| Keywords: | methiouine and vitamin B1 for injection bacterial endotoxins test(BET) taciypleus amebocyte lysate(TAL) |
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