药用气雾剂辅料抛射剂质量标准概述

Overview of Quality Standards for Excipient Propellant of Pharmaceutical Aerosol

药用气雾剂是一种特别的药物剂型,在治疗支气管哮喘、慢性阻塞性肺病等呼吸系统疾病方面具有其他剂型不可替代的优势;抛射剂是药用气雾剂中药液雾化的动力,也是溶解或分散药物的介质,作为药用气雾剂中的重要辅料,抛射剂的质量直接影响到药品的安全性和有效性。现对几类常见的药用气雾剂辅料抛射剂国内外质量标准进行概括比较,为我国药用气雾剂辅料抛射剂质量标准的制修订工作提供参考。

Pharmaceutical Aerosol is a special dosage form and has an irreplaceable advantage for the treatment of respiratory diseases such as bronchial asthma and chronic obstructive pulmonary disease.Propellant is the driving force of medicine atomization in aerosol and is also the medium for dissolving or dispersing the medicine.As an important excipient of the pharmaceutical aerosol,quality of the propellant directly affects the safety and effectiveness of the medicine.This paper reviews and compares the quality standards for several common excipients propellants of pharmaceutical aerosols at home and abroad,and provides references for the drafting and revision of the quality standards for propellants for pharmaceutical aerosols in China.