中藥材及製劑中重金屬檢驗(Ⅱ)

Survey on Heavy Metals in Raw Material of Traditional Chinese Medicine (Ⅱ)

賴齡(Ling Lai) ； 曾人和(Jern-Her Tseng) ； 陳儀驊(Yi-Hua Chen) ； 羅吉方(Chi-Fang Lo) ； 林哲輝(Jer-Huei Lin)

《藥物食品檢驗局調查研究年報》 24號 (2006/12) Pp. 242-256

https://doi.org/10.6946/ASRNL.200612.0242

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, ＜0.005~1.88 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.

關鍵字

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

並列摘要

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, ＜0.005~1.88 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.

並列關鍵字

ICP/MS ； Pb ； Cu ； Cd ； Hg ； As ； 80th percentile ； traditional Chinese medicine