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The Research / Development and Medical Applications of Isotope and Radiation Technology in Taiwan

台灣醫用同位素與輻射技術之研發與應用

摘要


核能研究所自民國82年建立了H-/D-中型迴旋加速器並成功研製醫用同位素,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尿素幽門螺旋桿檢測劑已獲衛生署藥品許可證,並供應國內各大醫院使用。核研所中型迴旋加速器及同位素生產設施之運作系通過國際TUV USO-9001 (2000年版),核醫藥物生產設施與製程按衛生署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-ADM,碘-123-IBM,碘-123-MIBG及銦-DTPA-Octreotide等,同時亦供應醫學、農業及工業等三面,亦可應用於藝術及科技研究上。核研所鈷-60照射廠已獲國際TUV ISO-9001(2000年版)品質認證。核研所在非核家園之理念下,繼續推動醫用同位素及輻射之民生應用,增進民生福祉。

並列摘要


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

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