丹参注射液安全性检查方法的建立

Study on the safety of Radix et rhizoma salviae miltiorrhizae Injection

目的建立丹参注射液过敏反应、异常毒性检查限值及检查方法。方法通过丹参注射液最大无毒性反应剂量研究,确定过敏反应检查限值;通过丹参注射液半数致死量的研究确定异常毒性检查限值;检查方法均沿用《中国药典》2005年版(一部)。结论限值设置合理,方法准确,能如实反应药品的安全性。

OBJECTIVE To establish detection limits and detection methods of allergic reactions and abnormal toxicity of Radix et rhizome salviae miltiorrhizae Injection.METHODS By studying on the Maximum NOAEL of Radix et rhizome salviae miltiorrhizae Injection determined the detection limit;By studying on the LD50 of this injection identified abnormal toxicity detection limit;Detection methods have been using in the Chinese Pharmacopoeia 2005 Edition 1.CONCLUSION The limits setted is reasonable;The method is accurate and can responses to the drug＇s safety really.