核能研究所同位素及輻射的民生應用簡介

The Peaceful Applications of Isotopes and Radiations in INER

10.6623/chem.2004033

沈立漢(Lie-Hang Shen)；廖美秀(Mei-Hsiu Liao)；傅應凱(Ying-Kai Fu)；楊昭義(Chao-Yie Yang)

醫用同位素 ； 核醫藥物 ； 迴旋加速器 ； 輻射照射 ； 放射腫瘤治療 ； medical isotopes ； radiopharmaceuticals ； cyclotron ； Co-60 irradiation ； radiation oncology

化學

62卷3期（2004 / 09 / 01）

409 - 422

繁體中文

行政院原子能委員會核能研究所(簡稱核研所)自民國82年起建立了H^-/D^-中型迴能加速器並成功地研製醫用放射性同位素，包括碘-123，鉈-201，鎵-67，及氟-18…等，至今共有12項核醫藥物及碳-13尿素幽門螺旋桿菌檢測劑已獲得衛生署的藥物許可證，並供應國內各大醫院使用。核研所中型迴旋加速器及放射性同位素生產設施之運作係通過國際TUV ISO-9001 (2000年版)認證，核醫藥物生產設施與製程則按衛生署GMP/cGMP規範。供應醫院主要產品為短半衰期的氟-18-FDG及較長半衰期的鉈-201-氯化亞鉈。另有多項新核醫藥物已研製成功，正進行臨床前或人體臨床試驗中，包括碘-123-ADAM、碘-123-IBZM、碘-123-MIBG、鎝-99m﹒HL-91及銦-111-DTPA-octreotide等，同時也供應醫院數種「即用組套」，以利核醫藥局或醫院以鎝-99m標幟而應用於核醫造影診斷。另鎝-99m-TRODAT-1及鍶-89-Cl_2則正申請查驗登記中。核研所鈷-60照射廠主要應用於醫學、農業及工業等三面，也可應用於藝術及科技研究上。鈷-60照射廠已獲國際TUV ISO-9001 (2000年版)品質認證，在非核家園的理念下，本所繼續推動醫用放射性同位素及輻射照射的民生應用，以增進民生福祉。

Since the installation of H^-/D^- cyclotron in 1993, INER (Institute of Nuclear Energy Research) has successfully developed radioisotopes such as I-123, Tl-201, Ga-67, and F-18. Up to now, 12 radiopharmaceutica1s including C-13 urea for testing helicobacter pylori infection were produced by INER and were licensed by the Department of Health for commercial production and distribution in Taiwan. The INER's cyclotron and radiopharmaceutical facilities were operated according to ISO-9001 and GMP/cGMP protocols. Tl-201-TlCl and F-18-FDG were mainly supplied by INER to local hospitals. Some radiopharmaceuticals are produced for preclinical and clinical trials, such as 1-123-ADAM, I-123-IBZM, I-123-MIBG and In-111-DTPA-Octreotide, etc. INER also supplied several cold kits to the domestic market for Tc-99m labeled radiopharmaceuticals. The Co-60 irradiation facility of INER is applied in several fields in Taiwan, including medicine, agriculture, and industry. Another application of irradiation is in fine arts and sciences. Recently, the Co-60 facility obtained ISO-9001 certification. In conclusion, the prospects of the isotope and radiation application in Taiwan are promising, and will continuously benefit the people and the society in our country.