甲钴铵注射液的安全性试验

Examinations of security of vancomin injection

目的探讨甲钴铵注射液的安全性。方法根据临床用药方案,进行家兔血管壁刺激试验、肌肉刺激试验、溶血试验和豚鼠过敏性试验,观察甲钴铵注射液对注射部位的影响及是否产生溶血和过敏反应。结果过敏反应阴性;溶血阴性但较高浓度时可致轻度红细胞凝集;血管壁及周围组织结构未见明显刺激性反应,与对照组比较无显著差异;肌肉组织有轻度刺激性反应。结论甲钴铵注射液的安全性试验结果提示其符合注射剂要求。

OBJECTIVE To investigate the security of vancomin injection. METHODS According to the clinical usage, the stimulation test of vessel wall and muscle in rabbit, hemolysis test in rabbits and sensitivity test in cavy were undertaken to investigate the influences of vancomin injection to the injection site and whether the hemoly- sis and hypersensitive reaction would happen. RESULTS The hypersensitive reaction was negative. The hemolysis was negative, but the higher density of the injection would cause slight red cell agglutination. There appeared no obvious stimulation reaction in vessel wall and the tissues around and the deviation was not significant compared with the control group. The muscle tissues had a slight stimulation reaction. CONCLUSION The results of the security tests of vancomin injection showed that it fited the request of injection.