中药脐部给药制剂的研究进展

该文通过查阅近年来国内外发表的脐部给药制剂相关文献,以国家食品药品监督管理总局(CFDA)批准上市的用于脐部给药的制剂作为主要参考,对中药脐部给药制剂的剂型、品种以及临床应用等方面进行了梳理分析,综述了其研究进展,并对所面临的主要问题进行了探讨。阐述了中药脐部给药制剂作为中医药外治法的重要组成部分,具有独特的优势,但仍存在生产工艺粗糙、缺乏国际公认的质量控制标准和科学的药理临床证据、生物药剂学研究匮乏等问题,并提出了相关的对策与建议。

Research progress on Chinese medicines with topical administration in umbilical region

Based on the Chinese medicines with topical administration in umbilical region approved by China Food and Drug Administration (CFDA), this paper would comb and analyze their dosage forms, varieties and clinical applications. On the other hand, through consulting literature materials, the research progress was reviewed and the main challenges faced by the medicines were discussed in detail as well. This paper elaborates that the preparations with topical administration in umbilical region, as an important branch in Chinese medicine external therapy, have unique advantages. However, there are still some problems such as rough workmanship, lacking internationally accepted quality control standards, scarcity of pharmacological and clinical evidences and biopharmaceutical researches. Meanwhile, proper measures and suggestions are put forward.