中藥材供食品使用之條件與規範-安全性評估基準之建立

陳易宏
元培科技大學
中藥材的特色是有長久的人體使用經驗，其安全性係建立於長久歷史的使用經驗而來，因此，異於西藥的安全性評估。西藥在上市前，會進行毒理學試驗以確認安全性，並且參考人體臨床試驗中，受試者不良作用發生的情形，以判斷藥物的安全性作為上市審查之依據。若將特定的中藥材開放食用，這些特定的中藥材將由民眾自行購買食用，不受限於中醫師調劑而後始能取得。這些特定中藥材在開放食用後，民眾對該藥材使用頻率會更高，使用劑量也可能更大，亦即人體暴露量將會比由中醫師調劑時來的更高，其安全性必須要求得更為嚴格。以毒理學的觀點而言，必須選擇不能產生嚴重毒性，且具有高度安全係數(safety margin)的藥材。中藥材若原本已為社會大眾所食用者，由政府明定開放食用後，其安全性問題較小，但也可能因明定開放食用，造成使用量較大，故政府衛生單位仍應於開放前謹慎評估。若中藥材原為中醫師調劑使用而將開放大眾使用者，則開放後，勢必使用的情形將超過傳統的使用經驗（傳統為中醫師調劑用），由於在該藥材開放食用後，將超過歷史使用的經驗，故理應對這類中藥材的安全性再以現代毒理學的試驗加以確認。本計劃將參考:1.國際醫藥法規協合會(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH) 所規定的新藥各種安全性試驗(毒理學試驗)2.美國FDA所公佈之"Guidance for Industry Botanical Drug Products"所規定的藥理毒理試驗要求3.歐盟EMEA 的規範“Guideline on the Non-Clinical Documentation for Mixed Marketing Authorisation Applications ”4.我國及他國健康食品申請許可辦法及健康食品安全性評估方法5.各國新穎性食品對於安全性評估的規範並以上述植物藥及健康食品法規為主體架構，草擬我國中藥材食用安全性評估基準，以上述新藥及新穎性食品安全性規範作參考事項，協助基準之建立，並召開專家座談會，討論該草案。本計劃另將蒐集常用的神農本草經上品藥材文獻上之毒理學資料，並依照上述基準將以探討何種藥材適合作為食用。
關鍵字：中藥材；毒理學；安全性評估；食品

The requirements and guidances for traditional Chinese medicine (TCM) products to be used as foods- establishing guidances for safety assessments

Cheng, Yi-Hung
YuanPei University
Traditional Chinese Medicine (TCM) is a system of healing that has long been utilized in the Chinese culture; this long-term human experience serves as the basis for the safety of TCM. Thus, safety assessments for TCM differ from those used in any Western medicines, which undergo series of toxicology studies to characterize levels of safety. Any adverse effects experienced by clinical trial subjects also serve as important indicators of the safety of Western drugs.In regard to any TCM products that are intended to be used as foods, safety should be strictly enforced. This is because members of the public are able to freely access these materials without prescriptions from doctors of Chinese medicine. Such access will increase the frequency and dosage of these TCM products, and consequently their exposure. In consideration of toxicology, TCMs deemed suitable for use as foods are those which lack severe toxicity and have high safety margins.Allowing TCMs to be used as foods will result in levels of exposure that exceed historical experience. Toxicology studies are therefore necessary, to thoroughly investigate the safety levels of these TCMs.
關鍵字：Traditional Chinese Medicine；toxicology；safety assessment；foods