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透皮贴剂的技术及质量控制进展

Research Progress in Technology and Quality Control of Transdermal Patches

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【作者】 黄婷张靖杨锐肖新月孙春萌邹健汪晴

【Author】 Huang Ting;Zhang Jing;Yang Rui;Xiao Xinyue;Sun Chunmeng;Zou Jian;Wang Qing;China Pharmaceutical University;National Institutes for Food and Drug Control;NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients;Dalian University of Technology;

【通讯作者】 邹健;汪晴;

【机构】 中国药科大学中国食品药品检定研究院国家药品监督管理局药用辅料质量研究与评价重点实验室大连理工大学

【摘要】 目的:介绍透皮贴剂的上市药品进展、剂型技术进展与质量控制要求。方法:检索并梳理归纳透皮贴剂上市情况以及贴剂类型、基质种类、皮肤吸收、促渗技术、质量控制方面的研究文献和相关技术指导原则。结果与结论:综述了透皮贴剂的剂型特点、技术进展以及系统总结了透皮贴剂的质量控制指标,建议应重点关注透皮贴剂的体外药物释放度、皮肤渗透性、黏附力、冷流和药物残留等关键质量属性。

【Abstract】 Objective: To introduce the development of transdermal patches in the market, the progress of dosage forms technology and the requirements of quality control. Method: The patches marketing status, the relevant research literature and the technical guidelines of patches type, matrix type, skin absorption, penetration enhancement, and quality control were searched and summarized. Results and Conclusion: The dosage forms characteristics, technological progress of transdermal patches were reviewed, and the quality control indicators of transdermal patches were summarized systematically. It was suggested that more attention should be paid on the key quality attributes of transdermal patches such as in vitro drug release, skin permeability, adhesion, cold flow,and drug residue.

  • 【文献出处】 中国药事 ,Chinese Pharmaceutical Affairs , 编辑部邮箱 ,2023年09期
  • 【分类号】R944.9
  • 【下载频次】67
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