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目的:建立醋酸氯己定灭菌溶液细菌内毒素检查方法。方法:参照《中国药典》2010年版(二部)附录ⅪE细菌内毒素检查法进行试验及结果判定。结果:用稀释法难以消除醋酸氯己定灭菌溶液的干扰作用,采用氢氧化钠酸碱沉淀去除醋酸氯己定后可消除其干扰作用。结论:该法可用于含醋酸氯己定溶液的细菌内毒素检查以控制其细菌内毒素限度。
Objective: To establish a bacterial endotoxin test method of chlorhexidine acetate sterilization solution. Methods: According to “Chinese Pharmacopoeia” 2010 edition (2) Appendix ⅪE bacterial endotoxin test method to determine the results. Results: The dilution method is difficult to eliminate the interference effect of chlorhexidine acetate sterilization solution, the use of sodium hydroxide acid alkali precipitation to remove chlorhexidine acetate can eliminate the interference. Conclusion: This method can be used for bacterial endotoxin test in chlorhexidine acetate solution to control bacterial endotoxin limit.