吸入粉霧劑是藥械組合藥品，制劑和裝置共同決定了產品的質量和霧化性能。在裝置的開發(fā)中，需要關注使用裝置的類型，與制劑處方聯(lián)合開發(fā)；在制劑開發(fā)中，要關注粉體的粒度分布、顆粒形態(tài)、流動性、比表面積、多晶型及結晶度，提高對物化性質的認識。在產品的檢測中，不僅要關注質量標準的檢測項目，還要從患者的角度出發(fā)考察產品的霧化性能，以滿足不同患者的使用。從裝置的開發(fā)、制劑處方的研發(fā)以及質量控制3個方面闡述了吸入粉霧劑產品開發(fā)中需要重點關注的內容，以提高粉霧劑產品研發(fā)速度和質量。

Dry Powder Inhalations (DPIs) are a combination of drug substance and container closure system, which determine the quality and performance of the products. It's the focus that the type of device, which is the connection point between the patient and the preparation. The physicochemical properties of API and excipients, involved particle size distribution, shape, flow properties, specific surface area, polymorphism and crystallinity, are the critical research content. In the detection of DPIs, we should not only pay attention to the items of quality standards, but also the atomization performance of products from the perspective of patients. The development of device, formulation and the quality control of DPIs were discussed in the review. Focusing on these aspects can improve the progress of development and the quality of DPI products.

國家科技部重大專項（2017ZX09201002）