克林霉素磷酸酯注射液细菌内毒素检查限值的研究  

Study on Bacterial Endotoxins Detection Limit of Clindamycin Phosphate Injection

作　　者：刘雪莉[1] 张敏[1] 袁坤[2] 

机构地区：[1]河北省药品检验所,石家庄050011 [2]石家庄市中医院,石家庄050051

出　　处：《中国药房》2012年第5期443-444,共2页China Pharmacy

摘　　要：目的:提高克林霉素磷酸酯注射液细菌内毒素检查限值,与临床实际用法用量及"化学药品注射剂安全性检查法应用指导原则"要求相符合,并与国际标准接轨。方法:按2010年版《中国药典》(二部)细菌内毒素检查法,用不同厂家鲎试剂对25个厂家生产的25批克林霉素磷酸酯注射液进行干扰试验和细菌内毒素检查。结果:样品浓度稀释到1.2mg.mL-1对所用细菌内毒素检查法无干扰作用,细菌内毒素的限值提高为"每1mg克林霉素中小于0.1EU",按此标准检查,25批样品细菌内毒素均符合规定。结论:建议克林霉素磷酸酯注射液细菌内毒素检查限值由2010年版《中国药典》规定的"每1mg克林霉素中小于0.6EU"提高至"每1mg克林霉素中小于0.1EU",可保证用药安全,且与2000年版《日本抗生物质医药品基准解说》对本品细菌内毒素检查限值要求一致。OBJECTIVE ： To improve the bacterial endotoxin detection limit of Clindamycin phosphate injection which matched the clinical usage and dosage and ＂Guidance for Security Test of Chemicals for Injection＂ and international level. METHODS： The interference test and bacterial endotoxin test of 25 batches of Clindamycin phosphate injection from 25 manufacturers were carried out in accordance with the bacterial endotoxin test approved by Vol. U of Chinese Pharmacopeia （2010 edition）. RESULTS ： No in- terference was found in the bacterial endotoxin test after Clindamycin phosphate injection was diluted to 1.2 mg.mL-~. The limit val- ue of bacterial endotoxin could be ＂below 0.1 EU of endotoxin in clindamycin per mg＂. The results of the bacterial endotoxin test of the 25 batches of samples were all accorded with the standard. CONCLUSION： The endotoxin test limit of Clindamycin phosphate injection could be improved from ＂it contains less than 0.6 EU of endotoxin in clindamycin per mg＂ to ＂it contains less than 0.1 EU of endotoxin in clindamycin per mg＂ which can ensure the clinical safety and consist with the Japanese Standards of Antibiotics （2000 edition）.

关 键 词：克林霉素磷酸酯注射液 细菌内毒素 限值 提高 鲎试剂 

分 类 号：R927.12[医药卫生—药学] R978.15