文章摘要
赵燕君,许新新,仪忠勋,孙会敏,杨会英.药用气雾剂辅料抛射剂质量标准概述[J].中国药事,2019,33(6):637-648
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
投稿时间:2019-03-04  
DOI:10.16153/j.1002-7777.2019.06.006
中文关键词: 药用辅料  抛射剂  质量标准  药用气雾剂
英文关键词: excipient  propellant  quality standard  pharmaceutical aerosol
基金项目:
作者单位E-mail
赵燕君 中国食品药品检定研究院, 北京 100050  
许新新 中国食品药品检定研究院, 北京 100050  
仪忠勋 中国食品药品检定研究院, 北京 100050  
孙会敏 中国食品药品检定研究院, 北京 100050 sunhm@126.com 
杨会英 中国食品药品检定研究院, 北京 100050  
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中文摘要:
      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。
英文摘要:
      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.
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