刍议药包材的异常毒性检查和实验动物福利

Discussion on Test for Abnormal Toxicity in Pharmaceutical Packaging Standards and Laboratory Animal Welfare

目的研究2015版国家药包材标准(简称YBB标准)中异常毒性试验的变化,旨在关注实验动物福利。方法比较新旧YBB标准。结果发现2015版YBB标准除了滴眼剂瓶和聚乙烯/铝/聚乙烯复合药用软膏管外,其他塑料瓶和复合膜类均新增加了空白对照,而药用铝箔和硬片类、药用低密度聚乙烯膜、袋均未增加空白对照。结论药包材的异常毒性检查应按非生物制品试验,认为不需要设立空白对照。建议在相关的药包材标准修订时考虑舍去异常毒性试验的空白对照。

Objective To study the changes of abnormal toxicity test in 2015 edition of YBB standard in order to protect the welfare of laboratory animals. Method The new and old YBB standards were compared. Result It showed that blank controls were added to all plastic bottles and laminated films except bottles for eye drops and composite tube( PE/Al/PE) for ointment in the 2015 edition of YBB standards,while blank controls were not added to aluminum foil for medicine,sheets for solid preparation and LDPE films and pouches for pharmaceutical packaging. Conclusion Abnormal toxicity test in pharmaceutical packaging material standards should be based on non-biological product test,and it is not necessary to set up blank control. It suggested that the blank control of abnormal toxicity test should be taken into account when revising and updating the relevant pharmaceutical packaging material standards.