吸入粉雾剂产业化过程中的质量控制

Quality control in the industrialization process of dry powder inhalations

吸入制剂尤其是吸入粉雾剂结构和功能的特殊性,决定其在产业化过程中质量控制的特异性。讨论吸入粉雾剂产业化过程中原辅料、包材、中间体、终产品及稳定性考察过程中的质量控制特异性考察项目及标准设定。

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.