中藥是中醫治療疾病的重要方法之一，隨著現代科學技術的發展，檢測技術不斷提高，中藥的毒副作用逐漸被關注，且與用藥劑量、用藥時間密切相關。
自從1993年比利時的馬兜鈴酸腎病變（Aristolochic acid nephropathy，AAN）被報導後，世界各地亦陸續發生類似之中藥腎病變事件，中藥使用的安全性包含中藥本身的藥理作用及其產品可能的混誤用情形皆受到全球的關注。諸多中藥中毒事件突顯中藥的管理有許多改善空間，唯有正確的管理才能避免中藥中毒事件一再重演。
本研究主要以馬兜鈴酸為例，進行臺灣中藥使用細辛之風險評估，以風險評估的方法分析與檢討中藥細辛之科學中藥及生藥用藥安全。風險結果分析後，據以檢討中藥細辛的法令規範，並提出相關規範或建議，以作為主管機關制定中藥管理法規之參考。
第一階段，以HPLC-UV檢測市售科學中藥及飲片細辛之馬兜鈴酸Ⅰ含量，檢測結果皆為未檢出，接著用1/2偵測極限推估短期及長期暴露者之暴露劑量與致癌風險，然而計算之短期及長期暴露之致癌風險皆大於10-2~10-4。因此於第二階段以更精密之LC-MS/MS檢測市售科學中藥及飲片細辛之馬兜鈴酸含量，計算之短期及長期暴露之致癌風險大約落在10-4~10-5，細辛之用藥安全也需要關注。由此研究結果可得知，目前中藥之法規管理未結合風險評估的概念，正確的做法應該以科學的數據回推合理的劑量及攝食時間，在仿單上做合理規範，建立正確的管理，才能防止憾事再發生，讓民眾對中藥安全更有信心。
敏感性分析結果顯示，HPLC-UV組對於風險的二項重要影響因子為攝食量與體重，攝食量敏感度介於74-90%，體重的敏感度約介於9-25%；在LC/MS-MS檢測組對於風險的三項重要影響因子為攝食量、體重及細辛中馬兜鈴酸Ⅰ濃度，最高敏感度的變因為馬兜鈴酸Ⅰ濃度，成人或兒童馬兜鈴酸Ⅰ濃度之敏感度皆大於80%，其次為攝食量，最後為體重。影響細辛之馬兜鈴酸Ⅰ致癌性風險評估最主要風險結果之因子為馬兜鈴酸Ⅰ濃度，因此，中藥的管理顯得更重要。
本研究分別從制度面與實務面出發，用食品安全風險評估的科學標準分析中藥細辛馬兜鈴酸Ⅰ之風險，檢討中藥的法令規範後，以中醫師的角度，給予相關建議，以作為主管機關制定中藥管理法規之參考，亦能了解目前科學中藥的仿單使用現況，使法規能緊扣藥品製造的各個環節，讓臨床中醫師開立中藥處方時可依據一定的標準為之，提升民眾用藥安全。

Since the publication of the Aristolochic Acid Nephropathy (AAN) in Belgium in 1993, the safety of Traditional Chinese medicines, including the side effects and the possible misuse of these herbs, have attracted worldwide attention. Only correct management can prevent the recurrence of Chinese medicine poisoning incidents. This research starts from the institutional and practical aspects and uses the scientific standards of food safety risk assessment to analyze the risk of Aristolochic Acid I in traditional Chinese medicine Asarum. The analysis of this study follows the methods of US EPA Human Health Risk Assessment Protocol (HHRAP) for analyzing the Aristolochic Acid I concentration of the concentrated herbal extracted powder and crude drug of Asarum samples in Taiwan. In the first stage, we used HPLC-UV to detect aristolochic acid I of Asarum samples according to the administrative order issued for Asarum on February 27,2004 in Taiwan, and no aristolochic acid I component was detected in any of samples. The calculated short-term and long-term exposure to carcinogenic risk by HPLC-UV is between 10-2 to 10-4, need to be paid attention. In the second stage, the calculated short-term and long-term exposure to carcinogenic risk by LC/MS-MS detection is about 10-4 to 10-5, which also needs to be paid attention. It can be known that the current regulation and management of traditional Chinese medicine is not in accordance with the concept of risk assessment from this study. Therefore, the formulation and management of traditional Chinese medicine regulations should be combined with the concept of scientific risk assessment to ensure the safety of the public medications.

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