| 注射用辅酶A细菌内毒素检查方法的探讨 |
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| 引用本文： | 李文萍,田德娟,李文红,张玉芳,宋海怡. 注射用辅酶A细菌内毒素检查方法的探讨[J]. 齐鲁药事, 2009, 28(8): 473-474 |
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| 作者姓名： | 李文萍 田德娟 李文红 张玉芳 宋海怡 |
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| 作者单位： | 青岛海尔药业有限公司,山东,青岛,266013 |
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| 摘 要： | 目的建立注射用辅酶A细菌内毒素检查方法。方法遵照《中国药典》2005年版附录XIE细菌内毒素检查法检查。结果注射用辅酶A在0.67单位.mL-1浓度下无干扰作用,可进行细菌内毒素检查。结论凝胶法检查注射用辅酶A中细菌内毒素的方法是:取本品依法检查,每单位中含内毒素量应小于0.75EU。
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| 关 键 词： | 注射用辅酶A 细菌内毒素 鲎试剂 |
The discussion of coenzyme A for injection bacterial endotoxin method |
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| LI Wen-ping,TIAN De-juan,LI Wen-hong,ZHANG Yu-fang,SONG Hai-yi. The discussion of coenzyme A for injection bacterial endotoxin method[J]. qilu pharmaceutical affairs, 2009, 28(8): 473-474 |
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| Authors: | LI Wen-ping TIAN De-juan LI Wen-hong ZHANG Yu-fang SONG Hai-yi |
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| Affiliation: | Qingdao Haier Pharmaceutical Co.;Ltd.;Qingdao 266013 |
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| Abstract: | OBJECTIVE To develop a bacterial endotoxin test method of coenzyme A for injection. METHODS In ac- cordance with the Chinese Pharmacopoeia 2005 edition Appendix XIE bacterial endotoxin test to check. RESULTS Coenzyme A for injection with 0. 67units ·mL-1 has non-interference,may carry on the bacteritμm endotoxin test. CONCLUSION The bac- terial endotoxin test method of coenzyme A for injection using gel method was as follow：check the goods in accordance with the method ,the content of endotoxin in each unit should be smaller than 0.75EU. |
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| Keywords: | Coenzyme A for injection bacterial endotoxin Tachypleus Amebocyte Lysate |
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