Abnormal Toxicity Test and Study on the in vitro Hemolytic Reaction of Gluconate Enoxacin Injection
10.6039/j.issn.1001-0408.2017.31.20
- VernacularTitle: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
- Author:
Luna WENG
1
;
Jing SONG
;
Ying HONG
;
Ying ZHANG
Author Information
1. 厦门市食品药品质量检验研究院
- Keywords:
Gluconate enoxacin injection;
Abnormal toxicity;
Hemolysis reaction;
in vitro
- From:
China Pharmacy
2017;28(31):4398-4400
- CountryChina
- Language:Chinese
-
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.
