药典中关于遮光、避光的知识汇总

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1.《中国药典2020版》凡例中定义了2个名词：避光和遮光。

• 遮光：用不透光的容器包装，例如，棕色容器或黑纸包裹的无色透明、半透明容器。
• 避光：避免日光直射。
  

2.《欧洲药典EP10.0》General notices 也定义了1个用词：Protected from light.

• Protected from light: 1) the product is stored in a container made of a material that absorbs actinic light sufficiently to protect the contents from change  induced by such light.2) stored in a container enclosed in an outer cover that provides such protection.3)stored in a place from which all such light is excluded.
  

3.《659-USP40》Packaging and Storage requirements 定义了2个用词：Light-resistant container & Protect from light
light-resistant container: A container-closure system that protects the contents from the efferts of light by virtue of the specific properties of the material of which it is composed, including any coating applied to it. A clear and colorless of transluent container may be made light-resistant by means of an opaque covering or by use of secondary packing, in which case the label of the containers bears a statement that the  opaque covering or secondary packaging is needed until the articles are to be used or administered. Where it is directed to " protect from light" in an individual monograph , preservation in a light-resistant container is intended.

小结，综上所述，EP及USP并没有像中国药典一样对避光和遮光进行不同的定义。从上述内容上看，无论是protected from light 还是preserved in light -resistant container 主要强调包装容器的遮光性。在之前的话题中看到楼主说USP中对避光的定义是“protected from excessive light”,为此，我特意翻了手边的USP42，在某一个专论中看到如下的关于避光的描述“Protected in  light-resistant containers, and avoid exposure to direct sunlight.”

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国内就遵循中国药典就行

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