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.
出处
《中国药品标准》
CAS
2005年第4期58-60,共3页
Drug Standards of China
