国内外透皮贴剂申报上市进展及药学研究探讨Progress and pharmaceutical research of transdermal patch in China and abroad
刘孟斯,姜典卓,岳志华,周誉
LIU Mengsi,JIANG Dianzhuo,YUE Zhihua,ZHOU Yu
摘要(Abstract)：
目的透皮贴剂是经皮给药的一种剂型,通过局部作用达到全身给药效果,具有更好的患者顺应性。方法本文作者结合国内外透皮贴剂的开发及申报情况,从处方工艺、质量控制等多方面对透皮贴剂的药学研究进行探讨。透皮贴剂的处方组成可影响透皮贴剂的黏附性、经皮渗透及生物利用度等,应与原辅料各自的功能进行关联研究。结果生产工艺应考虑设备能力与参数、物料加入顺序等,应关注中控,同时对批量变化而引起的放大效应进行相应的评估。结论应对透皮贴剂的关键质量属性进行研究与控制,重点关注透皮贴剂的体外药物释放、体外皮肤渗透和黏附性。
Objective Transdermal patch, as a dosage form for transdermal administration, achieves systemic administration effect through local action, which has better patient compliance.Methods Based on the development and application of transdermal patches at home and abroad, this paper discusses the pharmaceutical research of transdermal patches from various aspects such as formulation, manufacturing process, quality control and so on.The formulation composition of the transdermal patch can affect its adhesion, skin permeation and bioavailability, which should be correlated with the respective functions of the drug substance and excipients.Results The manufacturing process should consider equipment capabilities and parameters, the order of material addition, etc.,and attention should be paid to the in-process control, and the corresponding evaluation of the scale-up effect due to batch scale changes should be made at the same time.Conclusion The critical quality attribute of transdermal patches should be investigated and controlled, focusing on the in vitro drug release, in vitro skin permeation and adhesion of transdermal patches.
关键词(KeyWords)：
透皮贴剂;药学研究;生产工艺;质量控制
transdermal patch;pharmaceutical research;manufacturing process;quality control
基金项目(Foundation):
作者(Author):
刘孟斯,姜典卓,岳志华,周誉
LIU Mengsi,JIANG Dianzhuo,YUE Zhihua,ZHOU Yu
DOI: 10.14066/j.cnki.cn21-1349/r.2020.1297
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