102-104年度中藥製劑之重金屬調查

Investigation of Heavy Metals in Chinese Medicinal Preparations, 2013-2015

為了解台灣中藥製劑中重金屬含量之現況，本計畫於102 - 104年間收集中藥製劑包括濃縮製劑、傳統單方製劑及傳統複方製劑共516件，以感應耦合電漿質譜儀（ICP/MS）檢測中藥製劑中鉛、鎘、汞、砷及銅等五種元素含量。檢測結果顯示341件濃縮製劑均符合限量規範標準，149件傳統複方製劑有8件檢品之重金屬含量偏高，超出率為5.4%。本結果已提供行政管理單位制訂或修正限量標準及管理之參考。

In order to survey the contents of heavy metals of Chinese medicinal preparations in Taiwan, 516 samples including concentrated Chinese medicinal preparations, traditional single herbal preparations and traditional multiple herbal preparations were collected during 2013-2015. The amounts of lead (Pb), cadmium (Cd), mercury (Hg), arsenic (As) and copper (Cu) in the Chinese medicinal preparations were determined by inductively coupled plasma mass spectrometry (ICP/MS). The results indicated that all 341 concentrated Chinese medicinal preparations met the required tolerance limits, and 8 of 149 (5.4%) traditional multiple herbal preparations contained higher levels of heavy metals. This survey provided reference to set up or revise the tolerance limit of heavy metals for the administration authority.