盐酸丁咯地尔氯化钠注射液的细菌内毒素检测  

The Bacterial Endotoxin Test of Buflomedil Hydrochloride Sodium Chloride Injection

作　　者：杜立峰[1] 

机构地区：[1]浙江省台州市第一人民医院,台州318020

出　　处：《中国药品标准》2005年第4期58-60,共3页Drug Standards of China

摘　　要：目的:建立盐酸丁咯地尔氯化钠注射液的细菌内毒素检测方法。方法:将3批样品用两个不同厂家生产的鲎试剂,按《中国药典》2000年版二部附录E方法进行干扰试验考察。结果:将盐酸丁咯地尔氯化钠注射液稀释至0.33mg/ml,对实验不造成干扰。结论:可建立盐酸丁咯地尔氯化钠注射液的细菌内毒素检测法。Objective.. To establish bacterial endotoxin test method of Buflomedil Hydrochloride Sodium Chloride Injection. Method：The interference test of 3 batches of Buflomedil Hydrochloride Sodium Chloride Injection with 2 kinds of limulus test agent was done according to the method in appendix of China Pharmacopoeia （Volume ⅡAppendix Ⅺ E,2000 edition）. Resuit：There is no interference between the sample and limulus test agent when the sample was diluted to 0.33mg/ml. Conclusion：The bacterial endotoxin test of Buflomedil Hydrochloride sodium chloride injection can be established to replace the detection of pyrogen.

关 键 词：盐酸丁咯地尔氯化钠注射液 细菌内毒素 鲎试剂 干扰试验 细菌内毒素检测法 氯化钠注射液 盐酸丁咯地尔 《中国药典》2000年版 不同厂家 

分 类 号：R927.1[医药卫生—药学] R927.2