同意楼主的意见,前三个似乎与CP有对应的,而Tamper-proof container我觉得是防窃启容器,这个CP中没有提到。
USP32中的表述和EP差不多,但也有点差别
EP Well-closed container Airtight container Sealed container Tamper-proof container
USP Well-closed container tight container Hermetic Container Tamper-Evident Packaging
这几个应该是对应的吧
hyheying 发表:在中国药典(CP)凡例中有关于密闭与密封的定义,如下:
密闭:系指将容器密闭,以防止尘土及异物进入;
密封:系指将容器密封以防止风化、吸潮、挥发或异物进入。
熔封或严封:系指将容器熔封或用适宜的材料严封,以防止空气与水分的侵入并防止污染。
显然,“密封”的包装条件更严格一些,除了能满足密闭的要求外,还能防止气体的流通。
在EP中,关于密闭、密封的定义:
Well-closed container. A well-closed container protects the contents from contamination with extraneous solids and liquids and from loss of contents under ordinary conditions of handling, storage and transport. 这个似乎应该与CP中密闭相对应?
Airtight container. An airtight container is impermeable to solids, liquids and gases under ordinary conditions of handling, storage and transport. If the container is intended to be opened on more than 1 occasion, it must be so designed that it remains airtight after re-closure. 这个似乎应该与CP中密封相对应?
Sealed container. A sealed container is a container closed by fusion of the material of the container. 这个似乎应该与CP中熔封或严封相对应?
Tamper-proof container. A tamper-proof container is a closed container fitted with a device that reveals irreversibly whether the container has been opened. 这个好象没有对应的