摘要
目的考察眼用平衡盐溶液对细菌内毒素检查试验的干扰情况,并建立其细菌内毒素检查的方法。方法参照《中国药典》2010年版二部附录ⅪE进行试验。结果眼用平衡盐溶液对细菌内毒素检查无干扰作用,其内毒素限值为0.5 Eu·mL-1。结论建立了眼用平衡盐溶液的细菌内毒素检查的标准。
Objective To inspect the interference of ophthalmic balanced salt solution on bacterial endotoxins test and esta- bish the bacterial endotoxins test method for this specimen. Methods The test was carried out according to the appendix XI E of Chinese Pharmacopoeia（ Edition Ⅱ ）. Results Ophthalmic balanced salt solution had non - interference on bacterial endotoxins test and the valate limit of endotoxin was 0.5 EU · mL - 1. Conclusion The standard of bacterial endotoxins test method for oph- thalmic balanced salt solution was established.
出处
《齐鲁药事》
2012年第8期454-455,共2页
qilu pharmaceutical affairs
关键词
眼用平衡盐溶液
鲎试剂
细菌内毒素
Ophthalmic balanced salt solution
TAL
Bacterial endotoxin
