肾康注射液细菌内毒素检查法的建立OACSTPCD
Establishment of Bacterial Endotoxin Test of Shenkang Injection
目的 建立肾康注射液的细菌内毒素检查法.方法按2010年版<中国药典(二部)>附录Ⅱ细菌内毒素检查法,用不同厂家的鲎试剂对3批肾康注射液分别进行干扰试验和细菌内毒素检查.结果肾康注射液稀释6倍时对细菌内毒素检查无干扰,细菌内毒素限值为4EU/mL.按照拟订标准,3批样品的细菌内毒素检查均符合规定.结论所建立的细菌内毒素检查法可用于肾康注射液的细菌内毒素检查.
Objective To establish the bacterial endotoxin test of Shenkang injection. Methods Based on Chinese Pharmacopeia (edition 2010, Vol Ⅱ), the interference test and bacterial endotoxin test were conducted on 3 batches of Shenkang injection samples using tachypleus amebocyte lysate from different companies. Results 6- fold dilution of Shenkang Injection had no interference to the bacterial endotoxin test. The limit value of the bacterial endotoxin was L=4 EU/mL…查看全部>>
吴寒寅;孟德胜
中国人民解放军第三军医大学第三附属医院野战外科研究所药剂科,重庆,400042中国人民解放军第三军医大学第三附属医院野战外科研究所药剂科,重庆,400042
医药卫生
肾康注射液细菌内毒素检查法干扰试验
《中国药业》 2011 (8)
38-39,2
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