摘要
目的通过细菌内毒素干扰预试验及干扰试验,建立异甘草酸镁注射液的细菌内毒素检查方法。方法采用凝胶法,参照《中国药典》2010年版附录对异甘草酸镁注射液进行细菌内毒素的方法学研究。结果经过30、40、50、60倍稀释,通过试验最终判定异甘草酸镁注射液在60倍稀释时对细菌内毒素无干扰作用,用灵敏度为0.125 EU/ml的鲎试剂进行试验,供试品不干扰细菌内毒素检查。结论建立的异甘草酸镁注射液的细菌内毒素检查法可行。
Objective To establish a method of bacterial endotoxin experiment for magnesium Isoglycyrrhizinate injection. Methods By gelation assay and referencing appendix of China Pharmacopoeia 2010 edition, the methodology for the bacterial endotox- ins test for magnesium Isoglycyrrhizinate injection was researched. Results It was diluted by 30 times, 40 times, 50 times and 60 times, and it had proved that the product did not interfere endotoxin if it was diluted by 60 times. It was feasibly done through 0. 125 EU/ml Tachypleus Amebocyte Lysate reagents for bacterial endotoxin test. Conclusion It can be used for the bacterial endotoxins test for magnesium Isoglycyrrhizinate injection.
出处
《宁夏医学杂志》
CAS
2012年第11期1101-1102,共2页
Ningxia Medical Journal
关键词
细菌内毒素检查法
异甘草酸镁注射液
干扰试验
Bacterial endotoxins
Magnesium isoglycyrrhizinate injection
Interference test
