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吸入胰岛素可避免注射胰岛素引起的患者对注射的恐惧、心理抵抗,一直是一个具有吸引力和挑战性的热门领域。本研究对深圳市创新慧生物技术开发有限公司研制的胰岛素吸入粉雾剂(Ins-P)进行了一期临床研究,以皮下注射常规胰岛素(RI)为对比,分析了Ins-P的相对生物利用度(F)以及其他药代学指标。一、对象与方法1．对象:本研究经国家药品监督管理局(批件号2002HL0212)和中山大学伦理委员会批准。研究
Insulin inhalation to avoid the fear of injection caused by insulin injections, psychological resistance, has been an attractive and challenging hot areas. In this study, Insulin P powder (Ins-P) developed by Shenzhen Chuangxin Hui Biotech Development Co., Ltd. was studied in a phase I study. The relative bioactivity of Ins-P was analyzed by subcutaneous injection of conventional insulin (RI) Utilization (F) and other pharmacokinetic parameters. First, the object and method 1. PARTICIPANTS: The study was approved by the State Drug Administration (Approval No. 2002HL0212) and Zhongshan University Ethics Committee. the study