非注射给药的胰岛素制剂一直是药剂学研究的热点。肺部表面积大,血流丰富,酶活性相对较低,且药物经肺吸收可避免肝脏首过效应,因此吸入给药是胰岛素非注射给药最具前景的给药途径之一。本文综述已上市和经过临床研究的胰岛素吸入制剂的研究进展,主要包括制剂处方与工艺、吸入给药装置、药动学与药效学评价及安全性评价等方面,旨在为胰岛素吸入制剂开发提供参考。 Non-injectable insulin preparations has always been a hot topic in pharmacy research. Pulmonary surface area, rich in blood flow, relatively low enzyme activity, and drug absorption by the lungs to avoid the first pass of the liver effect, so the administration of insulin is one of the most promising routes of administration of insulin non-injection. This review summarizes the advances in the market and clinical studies of insulin inhalation formulations, including preparation of formulations and processes, inhalation devices, pharmacokinetics and pharmacodynamics evaluation and safety evaluation, etc., aimed at the development of insulin inhalation formulations for reference.