中国药房2017，Vol.28Issue(31)：4398-4400,3.DOI:10.6039/j.issn.1001-0408.2017.31.20
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
Abnormal Toxicity Test and Study on the in vitro Hemolytic Reaction of Gluconate Enoxacin Injection
翁鹭娜 1宋婧 2洪颖 1张盈3
作者信息
- 1. 厦门市食品药品质量检验研究院,福建厦门 361012
- 2. 厦门大学实验动物中心,福建厦门 361005
- 3. 福建省食品药品质量检验研究院,福州 350001
- 折叠
摘要
Abstract
OBJECTIVE:To conduct the abnormal toxicity test and study on the in vitro hemolytic reaction of Gluconate enoxa-cin injection,and provide reference for its safe use. METHODS:According to"Test for Abnormal Toxicity"in Chinese Pharmaco-poeia(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 con-centration(0.2 g/100 mL)met requirements. CONCLUSIONS:In order to reduce the clinical ADR and feasibility of ensuring quali-ty standard,the abnormal toxicity limit of Gluconate enoxacin injection should be set as 28.4 mg/kg.关键词
葡萄糖依诺沙星注射液/异常毒性/溶血反应/体外Key words
Gluconate enoxacin injection/Abnormal toxicity/Hemolysis reaction/in vitro分类
医药卫生引用本文复制引用
翁鹭娜,宋婧,洪颖,张盈..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[J].中国药房,2017,28(31):4398-4400,3.
