摘要
目的:根据国家药典委员会的要求,制订驱虫斑鸠菊注射液的安全性检查项目。方法:设置了异常毒性、热原、过敏反应、溶血与凝聚、无菌等五个检查项目,确定了检查限值,并参照《中国药典》2010年版附录方法进行了相关的实验。结果:驱虫斑鸠菊注射液的异常毒性检查限值为1.25 g.kg-1,热原检查限值为0.05 g.kg-1,过敏反应物质检查限值为0.42 g.kg-1,溶血与凝聚检查限值为0.05 mg.mL-1,无菌检查采用薄膜过滤法。结论:本研究为驱虫斑鸠菊注射液质量标准的完善和提高提供了科学依据。
Objective： The safety testing items of Quchongbanjiuju Injection were established according to the requisition from Chinese Pharmacopoeia Commission. Methods： Testing items of abnormal toxicity, pyrogen, allergic response, hemolysis and coacervation and sterility validation and their limiting values were set separately. The correlative experiments were carried out based on the methods from Chinese Pharmacopoeia （2010 edition） appendix then. Results： The limiting values were as follows respectively： abnormal toxicity test was 1.25 g·kg^-1, pyrogen test was 0. 05 g·kg^-1, allergic response test was 0. 42 g·kg^-1, hemolysis and coacervation test was 0. 05 mg· mL^-1, membrane filtration method test could be adopted in sterility test. Conclusion： The scientific basis was provided by the experiments for the improvement of the quality standard of Quchongbanjiuju Injection.
出处
《中国药品标准》
CAS
2011年第4期255-257,共3页
Drug Standards of China
关键词
驱虫斑鸠菊注射液
异常毒性
热原
过敏反应
溶血与凝聚
无菌
Quchongbanjiuju Injection
abnormal toxicity
pyrogen
allergic response
hemolysis and coacervation
sterility
