98-105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

中藥材為我國傳統藥物，具有悠久使用歷史，然因品種繁多、外觀相近、同名異物或同物異名等因素，而有混淆及誤用的可能，然藥材藥性各有不同，因此，中藥製劑使用中藥材的正確與否就顯得格外重要。針對中藥查驗登記時送驗藥材之正確性，本調查彙整98至105年度之檢驗結果，分別依誤用藥材、夾雜物過多、含量不足及炮製方法有誤等4大面向進行分析，且進一步探討藥材基原變動情形。結果顯示，98至105年間發現新誤用之中藥材共有52品項，其誤用藥材案件數、品目及次數均有逐年下降趨勢，誤用案件比例也明顯由15.8降至3.7%，顯示中藥從業人員對藥材之判斷能力及敏銳度已有提升。惟枳實、菟絲子、沉香及花椒等藥材在各年間仍持續出現錯誤，推估原因，可能因價格高或藥材細小分離時需耗費大量人工等因素所致。本調查提供中藥材之正確基原及可能發生之混誤用情形等資訊，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 have been used since ancient times. However, the confusion and misuse of herbs may occur due to the large variety of species, similar outward appearances, homonymic names for different herbs and multiple names for a single herb. As different herbs have different innate properties, it is important to use the right herb in Chinese herbal preparations. This study collated the investigation results for Chinese herbs submitted for registration by pharmaceutical companies from 2009 to 2016. An analysis was done based on four aspects including the misuse of herbs, the presence of excessive impurities, insufficient content and incorrect processing of a herb. In addition, the changes in the origins of certain herbs were also explored. According to the results, a total of 48 new misuse items were found in 2009 to 2016. However, the number of cases, items and frequencies had fallen over the years. The proportion of misuse cases had also significantly declined from 15.8% to 3.7%, indicating that the personnel involved have become more competent in the identification of Chinese herbs. It was observed that the misuse of herbs such as Aurantii Immaturus Fructus, Cuscutae Semen, Aquilariae Resinatum Lignum and Zanthoxyli Pericarpium continued throughout the years. Their misuse might be due to the high pricing or huge effort needed in the isolation of the smaller herbs. 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.