吸入制劑尤其是吸入粉霧劑結(jié)構(gòu)和功能的特殊性，決定其在產(chǎn)業(yè)化過程中質(zhì)量控制的特異性。討論吸入粉霧劑產(chǎn)業(yè)化過程中原輔料、包材、中間體、終產(chǎn)品及穩(wěn)定性考察過程中的質(zhì)量控制特異性考察項目及標(biāo)準(zhǔn)設(shè)定。

The particularity of the structure and function of inhalation preparation, especially the dry powder inhalation, determines the specificity of its quality control in the process of industrialization. The purpose of this paper is to discuss the quality control specific inspection items and standard setting of API, excipients, packaging materials, intermediates, final products and stability study in the industrialization of dry powder inhalation.