动态浊度法检测盐酸克林霉素注射液中细菌内毒素研究
投稿时间:2004-12-05    点此下载全文
引用本文:苑庆华,孙淑莲,芮菁,华晓东.动态浊度法检测盐酸克林霉素注射液中细菌内毒素研究[J].药学实践杂志,2005,(5):306~308
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作者单位
苑庆华 天津市药品检验所, 天津, 300070 
孙淑莲 天津市药品检验所, 天津, 300070 
芮菁 天津市药品检验所, 天津, 300070 
华晓东 天津市药品检验所, 天津, 300070 
基金项目:天津市科委自然基金项目(003610811)
中文摘要: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.
中文关键词:盐酸克林霉素注射液  动态比浊法  细菌内毒素  干扰试验
 
Measurement of endotoxin in clindamycin hydrochloride injection by the kineticturbidimetric technique
Abstract:Objective To Establish the kinetre-turbidimetrie techmque for practical quahly control on endotoxin content in elmda invcin hydrochloride mjection Methods The kmetie-turbidimetrie techmque and ehminated interfere factors approved by Chinese pharmacopoeia 2000 edition were used. Results Endotoxin added to clindamyem hydrochloride mjection 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 kinetre-turbidimetrie technique of LAL-test was suitable for the detection of eudoloxin in elindamycin hydrochloride mjection.
keywords:clindamyem hydrochloride mjection  kinetre turbidimetric techmque  baeterial endotoxin
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