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題名 | 中藥材及製劑中重金屬檢驗(2)=Survey on Heavy Metals in Raw Material of Traditional Chinese Medicine (2) |
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作者 | 賴齡; 曾人和; 陳儀驊; 羅吉方; 林哲輝; Lai, Ling; Tseng, Jern-Her; Chen, Yi-Hua; Lo, Chi-Fang; Lin, Jer-Huei; |
期刊 | 藥物食品檢驗局調查研究年報 |
出版日期 | 20061200 |
卷期 | 24 民95.12 |
頁次 | 頁242-256 |
分類號 | 412.36 |
語文 | chi |
關鍵詞 | 電漿耦合質譜儀; 鉛; 銅; 鎘; 汞; 砷; 80%位數值; 中藥材; 大陸中藥製劑; ICP/MS; Pb; Cu; Cd; Hg; As; 80th percentile; Traditional Chinese medicine; |
中文摘要 | 中藥材重金屬限量標準係中藥材品質管制重要規範之ㄧ,本計畫於中藥廠及中藥房價購浙貝母、防風、薏苡仁、白芷、山梔子、連翹、菊花、鉤藤、丁香、懷牛膝、益母草、黃芩、薑黃、玄參、鬱金等15種中藥材各20件及大陸中藥製劑100件,以感應耦合電漿質譜儀(ICP/MS)進行鉛(Pb)、銅(Cu)、鎘(Cd)、汞(Hg)、砷(As) 等五種重金屬含量背景值調查,最低偵測極限分別為鉛0.02 ppm、銅0.3 ppm、鎘0.005 ppm、汞0.01 ppm及砷0.003 ppm。15種藥材中五種重金屬含量之80%位數值範圍分別為鉛:0.10 ~ 7.65 ppm、銅:2.70 ~ 24.49 ppm、鎘:<0.015 ~ 1.88 ppm、汞:N.D. ~ 0.36 ppm及砷:0.02 ~ 1.39 ppm。100件大陸中藥製劑五種重金屬含量範圍則分別為鉛:<0.05 ~ 1176.90 ppm、銅:N.D. ~ 55.93ppm、鎘:N.D. ~ 4.81 ppm、汞:N.D. ~ 11892.70 ppm、砷:0.01 ~ 268.73 ppm。有3件含汞量過高係因組成分中含有硃砂,顯示超量問題依然存在,本結果可提供行政管理單位制訂限量標準之重要參考。 |
英文摘要 | The limitation of heavy metals in raw materials of traditional Chinese medicine (TCM) is an important regulation issue for the implementation of GMP in Chinese pharmaceuticals. Mostly purchased from Chinese pharmaceutical manufactors, twenty raw materials of TCM including Fritillariae Thunbergii Bulbus, Saposhnikoviae Radix, Coicis Semen, Angelicae Dahuricae Radix, Gardeniae Fructus, Forsythiae Fructus, Chrysanthemi Flos, Uncariae Ramulus Cumuncus, Caryophylli Flos, Achyranthis Bidentatae Radix, Leonuri Herba, Scutellariae Radix, Curcumae Longae Rhizoma, Scrophulariae Radix and Curcumae Radix were monitored for the survey. The amounts of lead (Pb), copper (Cu), cadmium (Cd), mercury (Hg) and arsenic (As) in the TCM were determined by ICP/MS method. The detection limit for Pb, Cu, Cd, Hg and As was about 20, 300, 5, 10, and 3 ppb, respectively. The 80th percentile of each heavy metal in TCM lied in range of 0.10 ~ 7.65 ppm for Pb, 2.70 ~ 24.49 ppm for Cu, .005 ~ 1.88 ppm for Cd, N.D. ~ 0.36 ppm for Hg, and 0.02 ~ 1.39 ppm for As, respectively. These results could provide limitation assessment of heavy metals in raw materials of TCM for the regulatory authority. Furthermore, each of heavy metals in 100 herbal preparations produced in Mainland China were also investigated and detected in range of <0.05 ~ 1176.90 ppm for Pb, N.D. ~ 55.93 ppm for Cu, N.D. ~ 4.81 ppm for Cd, N.D. ~ 11895.70 ppm for Hg, and 0.01 ~ 268.73 ppm for As, respectively. 9 samples surpassed 100 ppm and 3 samples were detected to contain excessive mercury owe Cinnabaris. Problem of excess heavy metal in Chinese herbal preparations from Mainland China still exists. The result can serve as reference for health authority to establish limitation guidelines. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。