| 盐酸异丙嗪注射液细菌内毒素检验 |
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| 引用本文： | 吴鑫,吴向群,周志良,朱碧君. 盐酸异丙嗪注射液细菌内毒素检验[J]. 齐鲁药事, 2012, 31(5): 277-278,282 |
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| 作者姓名： | 吴鑫 吴向群 周志良 朱碧君 |
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| 作者单位： | 江西省食品药品检验所,江西,南昌,330029 |
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| 摘 要： | 目的建立快速的盐酸异丙嗪注射液中细菌内毒素检查方法。方法按《中国药典》2010年版(二部)附录细菌内毒素检查法,采用2个厂家的鲎试剂对国内9个生产厂家的盐酸异丙嗪注射液进行干扰试验的研究。结果盐酸异丙嗪注射液在1.0 mg.mL-1浓度时对细菌内毒素检查无干扰。结论本法简便、快速、灵敏,可以用作盐酸异丙嗪注射液的细菌内毒素限度检查。
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| 关 键 词： | 盐酸异丙嗪注射液 细菌内毒素 干扰试验 |
Bacterial endotoxin test of Promethazine Hydrochloride Injection |
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| WU Xin , WU Xiang-qun , ZHOU Zhi-liang , ZHU Bi-jun. Bacterial endotoxin test of Promethazine Hydrochloride Injection[J]. qilu pharmaceutical affairs, 2012, 31(5): 277-278,282 |
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| Authors: | WU Xin WU Xiang-qun ZHOU Zhi-liang ZHU Bi-jun |
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| Affiliation: | (Jiangxi Institute for Food and Drug Control,Nanchang 330029,China) |
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| Abstract: | Objective To establish a rapid method for bacterial endotoxin test of Promethazine Hydrochloride Injection.Methods Interference tests of Promethazine Hydrochloride Injections which producted by 9 domestic manufacturers were performed with TAL from 2 manufacturers according to bacterial endotoxin test method in Appendix of Chinese Pharmacopoeia(2010 Edition).Results No interference was found when Promethazine Hydrochloride Injection with concentration of 1.0 mg·mL-1.Conclution The method was simple,rapid,sensitive,and it can be used for the bacterial endotoxin limit test of Promethazine Hydrochloride Injection. |
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| Keywords: | Promethazine Hydrochloride Injection Bacterial endotoxin Interference test |
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