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近期在中药新药审评过程中,遇到一些特殊形式的外用制剂,其不同于中国药典收载的常见外用剂型,也不是正在开发的经皮给药系统的新剂型。本文详细描述了这些制剂的特殊表现,并就其在研究过程中需要关注的内容进行了阐述。
In the recent review of new drugs in traditional Chinese medicine, we encountered some special forms of topical preparations, which are different from the common topical dosage forms contained in the Chinese Pharmacopoeia nor are new dosage forms of transdermal delivery systems under development. This article describes the specific performance of these agents in detail and describes the areas of concern they require in the course of the study.