葡萄糖依诺沙星注射液的异常毒性检查与体外溶血反应研究
x

请在关注微信后,向客服人员索取文件

篇名: 葡萄糖依诺沙星注射液的异常毒性检查与体外溶血反应研究
TITLE:
摘要: 目的:对葡萄糖依诺沙星注射液进行异常毒性检查和体外溶血反应研究,为其安全用药提供参考。方法:根据2015年版《中国药典》(二部)附录中“异常毒性检查法”,使用小鼠进行葡萄糖依诺沙星注射液半数致死量(LD50)的测定和异常毒性限值的设定。根据2015年版《中国药典》(二部)附录中“溶血与凝聚检查法”,使用兔血进行体外溶血和凝聚反应的研究。结果:测得葡萄糖依诺沙星注射液对小鼠的LD50为248.9 mg/kg,其异常毒性检查项设定的限值为28.4 mg/kg,按此限值检查结果均符合相关规定。以临床最大剂量(0.2 g/100 mL)进行溶血与凝聚反应的检查结果均符合规定。结论:为减少临床不良反应和确保质量标准的可行性,葡萄糖依诺沙星注射液的异常毒性检查限值应设定为28.4 mg/kg。
ABSTRACT: OBJECTIVE: To conduct the abnormal toxicity test and study on the in vitro hemolytic reaction of Gluconate enoxacin injection, and provide reference for its safe use. METHODS: According to “Test for Abnormal Toxicity” in Chinese Pharmacopoeia (2015 edition, Vol.Ⅱ), half lethal dose (LD50) of Gluconate enoxacin injection and setting of abnormal toxicity limit were carried out in mice. According to “Test for Haemolysis and Agglomeration” in Chinese Pharmacopoeia (2015 edition, Vol.Ⅱ), study for the in vitro hemolytic and agglomeration reaction was carried out in rabbits. RESULTS: The LD50 of Gluconate enoxacin injection for mice was 248.9 mg/kg; the setting limit of abnormal toxicity test was 28.4 mg/kg, and the results derived from the test using this limit met requirements. The haemolysis and agglomeration results derived from the test using clinical maximum concentration (0.2 g/100 mL) met requirements. CONCLUSIONS: In order to reduce the clinical ADR and feasibility of ensuring quality standard, the abnormal toxicity limit of Gluconate enoxacin injection should be set as 28.4 mg/kg.
期刊: 2017年第28卷第31期
作者: 翁鹭娜,宋婧,洪颖,张盈
AUTHORS: WENG Luna,SONG Jing,HONG Ying,ZHANG Ying
关键字: 葡萄糖依诺沙星注射液;异常毒性;溶血反应;体外
KEYWORDS: Gluconate enoxacin injection; Abnormal toxicity; Hemolysis reaction; in vitro
阅读数: 241 次
本月下载数: 2 次

* 注:未经本站明确许可,任何网站不得非法盗链资源下载连接及抄袭本站原创内容资源!在此感谢您的支持与合作!