门冬氨酸鸟氨酸注射液安全性检查法的研究  

Study on the Safety Test of Ornithine Aspartate Injection

作　　者：许雷鸣[1] 武谷 堵伟锋[1] 顾倩[2] 

机构地区：[1]安徽省食品药品检验所,合肥230051 [2]皖南医学院,安徽芜湖241000

出　　处：《中国现代应用药学》2014年第1期87-90,共4页Chinese Journal of Modern Applied Pharmacy

基　　金：安徽省食品药品监管系统科研项目(0004)

摘　　要：目的建立门冬氨酸鸟氨酸注射液的安全性检查方法。方法在原国家标准热原检查的基础上增设了异常毒性、过敏反应、降压物质3个安全性检查项目,确定了检查限值,并按照中国药典2010年版附录方法进行相关的检查验证。结果门冬氨酸鸟氨酸注射液的异常毒性检查限值为0.87 g·kg-1,过敏反应检查限值为0.83 g·kg-1,降压物质检查限值为0.15 g·kg-1。结论本研究为门冬氨酸鸟氨酸注射液质量标准的完善和提高提供了实验依据。Objective To establish the safety test methods for ornithine aspartate injection. Methods Abnormal toxicity test, allergic response test, and depressor substances test were added and their limit values were set separately on the basis of pyrogen test in present national standard. The correlative verification tests were carried out according to the methods indexed in the appendix of Ch.P 2010 Vol II. Results The limit value of abnormal toxicity test was 0.87g？kg-1, the limit value of allergic response test was 0.83g？kg-1 and the limit value of depressor substances test was 0.15g？kg-1. Conclusion This study provided experimental basis for the improved quality standard of ornithine aspartate injection.

关 键 词：门冬氨酸鸟氨酸注射液 异常毒性 过敏反应 降压物质 

分 类 号：R927.1[医药卫生—药学]