动态浊度法检测盐酸克林霉素注射液中细菌内毒素研究  

Measurement of endotoxin in clindamycin hydrochloride injection by the kineticturbidimetric technique

作　　者：苑庆华[1] 孙淑莲[1] 芮菁[1] 华晓东[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《药学实践杂志》2005年第5期306-308,共3页Journal of Pharmaceutical Practice

基　　金：天津市科委自然基金项目(003610811)

摘　　要：目的:对盐酸克林霉素注射液进行细菌内毒素定量检查试验,建立定量检测盐酸克林霉素注射液中细菌内毒素试验方法方法:采用《中国药典》2000年版附录检测细菌内毒素动态比浊法。结果:盐酸克林霉素注射液在稀释药液浓度为0.075mg/mL时检测可排除干扰因素的影响,内毒素回收率在50%-200%范围结论:用细菌内毒素动态比浊法定量检查盐酸克林霉素注射液中的内毒素是可行的。Objective：To Establish the kinetic-turbidimetric technique for practical quality control on endotoxin content in clindamycin hydrochloride injection Methods： The kinetic-turbidinletric technique and eliminated interfere factors approved by Chinese pharmacopoeia 2000 edition were used. Results： Endotoxin added to clindamycin hydroehloride injection was recovered in a quantitative manner showing neither inhibition nor enhancement in diluted solution concentration 0. 075 mg/ml, the endotoxin recovery was more than 50 percent and less than 200 percent. Conclusion： These results suggested that the kinetic-turbidimetric technique of LAL-test was suitable for the detection of endotoxin in clindamycin hydrochloride injection .

关 键 词：盐酸克林霉素注射液 动态比浊法 细菌内毒素 干扰试验 

分 类 号：R953[医药卫生—药学]