榄香烯注射液生物安全性检查标准研究

Establishment of A Safety Test Method of Elemene Injection

目的建立榄香烯注射液生物安全性检查标准。方法按中国药典2010年版一部、二部有关附录、《药物研究技术指导原则》(2005年)及《药理学实验方法学》第一版的要求对榄香烯注射液的热原、溶血与凝聚、异常毒性、降压物质、过敏反应、血管刺激性、腹腔黏膜刺激性试验进行研究。结果建立了热原、溶血与凝聚、异常毒性、过敏反应、血管刺激性、腹腔黏膜刺激性试验,不能建立细菌内毒素和降压物质检查试验。结论本研究为榄香烯注射液质量标准的完善和提高提供了实验依据。

OBJECTIVE To establish standards for safety tests of elemene injection. METHODS Study on pyrogen, bacterial endotoxins, haemolysis and blood cell agglutination, undue toxicity, depressor substance, systemic anaphylaxis, vascular stimulation and writhing tests by Ch.P（2010） Vol Ⅰ, Ⅱ, the guiding principles of drag and experimental methods in pharmacology. RESULTS Established the standard of pyrogen, haemolysis and blood cell agglutination, undue toxicity, systemic anaphylaxis, vascular stimulation and writhing tests. While bacterial endotoxins and depressor substance test standard not be established. CONCLUSION Provided experimental method for elemene injection.