前言：[氟-18]多巴核醫藥物配合正子電腦斷層攝影（PET），已被公認是研究人體腦組織內多巴胺神經系統功能之最佳方法之一，此項技術現已被應用於多種中樞神經系統疾病的病程監控以及不同治療方法（例如巴金森氏症患者的胚胎中腦移植治療）的預後評估。
方法：利用迴旋加速器進行氖氣體靶氘子束照射產生□Ne（d，α）□F核反應，可獲得[氟-18]氟氣。將[氟-18]多巴之三甲基錫前驅物進行氟化脫錫、強酸水解及高壓液相層析分離化，可合成[氟-18]多巴化合物，再經中和、調節溶液等張度與過濾滅菌，即成為[氟-18]多巴核醫藥物。其化學純度、放射化學純度及比放射活度係利用高壓液相層析法分析，放射核種純度以配備Ge（Li）半導體偵檢器之多頻道脈高分析儀測定，而滅菌度和熱原則使用美國藥典第23版所載方法進行檢驗。
結果：已添加200μmolF□之氖氣體靶經60μAh的8.5MeV氘子束照射後，可生成約150mCi之[氟-18]氟氣。再使用本研究建立之方法合成[氟-18]多巴，平均每批次可得到16mCi之[氟-18]多巴核醫藥物，每次製備需時110分鐘（EOB），產品化學純度及放射化學純度均可達97%以上。使用自製之[氟-18]多巴核醫藥物進行動物（蘭嶼豬、臺灣彌猴）PET造影，明確顯示正常動物大腦紋狀體部位積聚之放射活度均較「巴金森氏症」動物為高，與文獻上之研究結果相符。
結論：我們已建立在鉛室中利用電腦控制機械臂，由三甲基錫前驅物經放射性氟化脫錫反應合[氟-18]多巴核醫藥物之半自動化生產製程，產品品質完全符合美國藥典第23版所載[氟1-18]多巴核醫藥物規格，並已於1998年三月獲行政院衛生署核准進行臨床研究。

Background: 6-[□F]Fluoro-L-DOPA is a biochemical probe used with positron emission tomography (PET) to evaluate the central dopaminergic function in human. The FDOPA/PET studies provide an unique, in-vivo, monitoring of the developmental sequelae of basal ganglia diseases and the effects of different therapies (e.g. fetal transplants for Parkinson's patients).
Methods: Radiolabeled [□F]F□ was produced via □Ne(d, α)□F nuclear reaction in an aluminium target body. 6-[□F]Fluoro-L-DOPA was synthesized in high yield with a radiofluorodestannylation procedure followed by an acidic hydrolysis. The solution obtained from HPLC purification was made isotonic with sodium chloride and then passed through a 0.22μm membrane filter into sterile multidose vials as final product. Its chemical purity, radiochemical purity and specific activity were determined by HPLC method. The radionuclide purity was analyzed with multichannel analyzer equipped with Ge(Li) semiconductor detector. The sterility and apyrogenicity tests were performed with the incubation and LAL methods described in USPXXIII.
Results: About 150mCi [□F]F□ was produced with an 8.5MeV deutron irradiation 60 μAh current integration) of Ne gas mixed with 200μmol of carrier F□. An average of 16mCi (without calibration) 6-[□F]fluoro-L-DOPA was obtained for ten runs. The total synthesis time was 110 min from EOB (end of bombardment). The chemical and radiochemical purity, analyzed by analytical HPLC (UV 282nm) and radio-HPLC, were>97%.
The animal study (pigs and monkeys) using 6-[□F]fluoro-L-DOPA prepared in this study along with PET imaging clearly showed the accumulation of radioactivity in striatum of normal animals is higher than that of the lesioned.
Conclusions: A semiautomated production of 6-[□F]fluoro-L-DOPA injection using the robotic system in a hot cell has been established. The radiochemical purity of the final product is >97%. The quality of the prepared 6-[□F]fluoro-L-DOPA meets all the specifications for [□F]FDOPA injection described in USPXXIII (1995).