106-110年度中藥製劑查驗登記中藥材混誤用狀況分析   全文下載

Analysis of the Confusion and Misuse of Chinese Herbs in the Registration of Chinese Medicinal Preparations

中藥材分為植物、動物及礦物3大類，種類繁多，外觀相近，各地使用方式及名稱皆有些許不同，且從種植、養殖、開採、炮製至運送、儲存等過程，經歷人為及環境等多重因素影響，易造成混用及誤用情形，然而藥材藥性各有不同，因此中藥材正確與否實屬重要且刻不容緩的議題。本調查針對中藥查驗登記時送驗藥材之正確性，彙整106-110年度之檢驗結果，分別依誤用藥材、夾雜物過多、炮製方法有誤及其他類型混誤用等4大面向進行分析。結果顯示，5年間發現新混誤用之中藥材共有17品目，而藿香、石斛及五加皮等27品目藥材在此年間仍持續出現錯誤。整體案件數雖下降，惟混誤用案百分比仍有2.4-4.4%，顯示中藥從業人員對部分藥材之判斷能力仍有待提升。本調查提供中藥材之正確基原，希藉此提升中藥製劑品質，及供衛生相關單位管理與稽查之參考。

Traditional Chinese herbs can be divided into three categories: plants, animals and minerals. However, the confusion and misuse of herbs may occur due to the large variety of species, similar outward appearances, the usage and names may be different in various regions. As each herb has different innate properties, precise use of herb is important in Chinese herbal preparations. This study collated the investigation results for Chinese herbs submitted for registration by pharmaceutical companies from 2017 to 2021. An analysis was done based on four aspects including the misuse of herbs, excessive impurities, improper processing and the others. According to the results, a total of 17 new misuse items were found. Besides, some herbs such as Agastachis Herba, Dendrobii Caulis, and Acanthopanacis Cortex have been misused year after year, and the misuse percentage is still 2.4 to 4.4%. The study provides information on the correct origin and the probable confusion or misuse of Chinese herbs. It helps to enhance the quality of Chinese herbal preparations, and serves as a reference to the relevant health departments in their management and inspections.