吸入粉雾剂中静电作用的影响因素概述  

A review of factors affecting electrostatic charging for dry powder inhalations

作　　者：李志万 王立宇 李岩峰 任树龙 韩昆颖 何光杰[2] LI Zhiwan;WANG Liyu;LI Yanfeng;REN Shulong;HAN Kunying;HE Guangjie(Tianjin Pharmaceutial Research Institute Co.,Ltd.,Tianjin 300462,China;Tianjin King York Group Co.,Ltd.,Tianjin 300450,China)

机构地区：[1]天津药业研究院有限公司,天津300462 [2]天津金耀集团有限公司,天津300450

出　　处：《药物评价研究》2019年第12期2337-2342,共6页Drug Evaluation Research

基　　金：国家科技部重大专项(2017ZX09201002)

摘　　要：应用于吸入粉雾剂(DPI)的药物活性成分通常是小粒径绝缘体,容易在制备与运输过程中携带电荷,增加药物之间以及药物-载体之间的黏附性,影响药物在肺部的沉积。了解DPI中粘性粉末静电作用的影响因素是至关重要的,影响因素包括粉末的电阻率、粒度分布、晶习、晶型、引湿性、环境因素、制备条件以及储存条件等。还探讨了静电力对DPI药物含量均一性、递送剂量、原料药与载体的黏附/解吸附能力以及药物在呼吸道的沉积行为的影响。对静电力的认知与理解有助于DPI产品的安全性、质量以及临床有效性的提高。Active pharmaceutical Ingredients of dry inhalation powers(DPI) are typically insulators consisting of relatively small particles and usually charging in the unit operation of preparation and transportation, thus the increasing adhesive and cohesive mixture powders affecting the efficiency of the pulmonary delivery of drugs. This article reviews the factors affecting the electrostatic charging of pharmaceutical powders with a focus on DPI. The influences of particle resistivity, size distribution, crystal morphology, polymorph, hygroscopicity, environmental conditions, pharmaceutical processing, and storage on the electrostatic charge behaviors of powder mixtures. Moreover, the influence of electrostatic charging on the drug content homogeneity, the passage of drug through in inhaler device, drug-carrier adhesion/detachment, and drug deposition on the respiratory airways were discussed.The understanding of electrostatic charging is crucial to improving the safety, quality and efficiency of the DPIs products.

关 键 词：静电作用 理化性质 吸入粉雾剂 制备工艺 

分 类 号：R944[医药卫生—药剂学]