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
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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.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.
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