【作者】 李恒； 梁毅；

【Author】 Li Heng,Liang Yi (International Business School,China Pharmaceutical University Nanjing,210009)

【机构】 中国药科大学国际医药商学院；

【摘要】 目的提出内包材验证重要性及实施方案。方法通过对头孢曲松钠不良反应主因即丁基胶塞不相容问题进行分析,对内包装验证概念、重要性及实施方案进行阐述,给出内包材确认的操作程序。结果与结论内包装验证对于完善包装系统、提高药品质量有重要意义,应予以重视。更多还原

【Abstract】 Objective:To put forward the importance and practice methods of inner packaging validation.Method:through the analysis on the major reason of the ADR of Ceftriaxone Sodium for Injection,namely the incompatibility between butyl rubber stopper and the injection,the concept and the importance as well as practice methods of inner packaging validation have been discussed,also adviced procedures has been given.Results and Conclusion:the inner packaging validation must been attached importance to,for it plays significant role in improving drug packaging system and promoting quality of medicine.更多还原