| 王晓曦,葛渊源,张景辰,陈桂良.吸入三联药物的研究现状及展望[J].中国药事,2021,35(10):1173-1180 |
| 吸入三联药物的研究现状及展望 |
| Research Status and Prospect of Inhaled Triple Drugs |
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| DOI：10.16153/j.1002-7777.2021.10.013 |
| 中文关键词: 吸入制剂 吸入三联药物 慢性阻塞性肺疾病 哮喘 |
| 英文关键词: inhaled agents inhaled triple drugs chronic obstructive pulmonary disease asthma |
| 基金项目:上海市科委项目“糠酸莫米松富马酸福莫特罗吸入气雾剂制剂研究及质量评价”(编号 18DZ1910602) |
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| 中文摘要: |
| 目的：长效抗胆碱能药物、长效β2受体激动剂、吸入性糖皮质激素组成的吸入三联药物在全球陆续上市，用于治疗慢阻肺急性加重患者，与常规上述两个成分的复方吸入药物相比，三联药物在改善急性加重患者的肺功能上有更好的临床优势。本文通过分析已上市三联药物的技术特点并对其发展进行展望，以期为吸入三联药物立项及研究带来一定的启示。方法：汇总分析已上市的吸入三联药物 (Trelegy Ellipta、Breztri Aerosphere和Trimbow)的药品审评报告、相关文献及专利内容，并查询国内外药品数据库、临床登记网站，总结对比三联药物技术特点，分析吸入三联药物国内外研发进展情况。 结果与结论：已上市的吸入三联药物Trelegy Ellipta、Breztri Aerosphere和Trimbow，三者在原料药控制、制剂技术、装置及药物质量控制方面各具特色，其中Trelegy Ellipta对原料药进行微粉化，Breztri Aerosphere采用共悬浮递送技术，Trimbow采用超细颗粒气溶胶技术，具体的技术细节值得进一步深入探讨。目前国外在吸入三联药物的给药装置、递送技术、联合用药方面开展了各项研究，国内则以仿制药为主，吸入制剂的市场尚是一片蓝海。未来，国内企业选择吸入的二联或三联药物研发路径将是加速国产替代化的技术突破。 |
| 英文摘要: |
| Objective: Inhaled triple drugs composed of long-acting Muscarinic Antagonist (LAMA), Longacting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) have been marketed worldwide for the treatment of patients with COPD exacerbations. Compared with the conventional compound inhaled drugs with the above two components, the triple drugs have better clinical advantages in improving lung function of patients with COPD exacerbations. The technical characteristics of inhaled triple drugs were analyzed and the development was explored in order to provide some enlightenment for the project and research of inhaled triple drugs. Methods: The drug review reports, relevant literature and patent contents of the marketed inhaled triple drugs (Trelegy Ellipta, Breztri Aerosphere and Trimbow) were summarized and analyzed, and the technical characteristics of the triple drugs were compared and summarized by consulting the domestic and foreign drug databases and clinical registration websites. Researches on progress of the inhaled triple drugs at home and abroad were carried out, too. Results and Conclusion: Trelegy Ellipta, Breztri Aerosphere and Trimbow, whichhave been marketed as inhaled triple drugs, have their own characteristics in API control, formulation technology, device and drug quality control. API of Trelegy Ellipta was micronized, co-suspension delivery technology was adopted in the process of manufacturing Breztri Aerosphere and ultra-fine particle aerosol technology was adopted in the process of manufacturing Trimbow were further studied and analyzed. At present, foreign countries have carried out various studies on the administration device, delivery technology and combined use of inhaled triple drugs, while domestic reseaches focus on generic drugs. In future, the development paths of dual or triple drugs chosen by domestic enterprises for inhalation will be the technical breakthrough to domestic substitution. |
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