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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 a biosafety inspection standard for elemene injection. Methods According to the requirements of the first edition of the 2010 edition of the Chinese Pharmacopoeia and the relevant appendices of the Second Division, the Guiding Principles of Pharmaceutical Research Technology (2005) and the First Edition of the Pharmacology Experimental Methodology, the pyrogen, hemolysis, and Coagulation, abnormal toxicity, hypotensive substances, allergic reactions, vascular irritation, and peritoneal mucosa irritation test were studied. The results of the establishment of pyrogen, hemolysis and coagulation, abnormal toxicity, allergic reactions, vascular irritation, abdominal mucosa irritation test, can not establish the test of bacterial endotoxin and antihypertensive substances. Conclusion This study provides experimental basis for improving and improving the quality standard of elemene injection.