篇名 | The Establishments for Production and Medical Distribution of F-18 Sodium Fluoride Injection |
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卷期 | 26:1 |
作者 | Shiu, Yun-Shiuan 、 Chen, Hue-Yong 、 Wu, Yi-Chen 、 Chen, Tai-Been 、 Ding, Hueisch-Jy 、 Kao, Chih-Hao |
頁次 | 014-018 |
關鍵字 | bone metastasis 、 F-18 sodium fluoride 、 medical cyclotron 、 medical benefit 、 PET/CT |
出刊日期 | 201303 |
Background:The F-18 sodium fluoride (NaF) injection was used for skeletal imaging to evaluate bone metastasis, such as breast cancer, lung cancer and prostate cancer in 1970s, F-18 NaF Positron Emission Tomography/Computed Tomography (PET/ CT) scan has been more accurate and sensitivity than Tc-99m methylene diphosphonate (Tc- 99m MDP) bone scintigraphy. F-18 NaF injection offers an alternative bone metastasis scan with Mo-90/Tc-99m generators shortage. Methods:In this study we used the medical cyclotron (GE PET trace) to produce the F-18 NaF injection. The F-18 NaF fluoride was trapped on an anion exchange cartridge and mixed with normal saline to a total volume of 20ml. This protocol has been established in a simple manual module for preparation ofF-18 NaF injection. Results:The quality of prepared F-18 NaF injection such as pH, bacterial endotoxin, radiochemical purity, sterility, chemical purity, specific radioactivity residual solvents, and membrane filter integrity, met the requirements of European Pharmacopoeia (EP) and preparation has been approved by the Food and Drug Administration, ROC (TFDA). Conclusion:We prepared and offered the doses of F-18 NaF injection to the PET centers of the southern Taiwan hospitals to promote the health care quality and provide the medical benefit for the cancer patients.