以雙片薄層色層分析法檢測多巴胺轉運體造影劑鎝-99m-TRODAT-1之放射化學純度

A Dual-Strip Thin Layer Chromatography to Determine the Radiochemical Purity of 99mTc-TRODAT-1 for Dopamine Transporter Imaging

10.6332/ANMS.1404.008

廖美秀(Mei-Hsiu Liao)；張國平(Kwo-Ping Chang)；魏孝萍(Shiaw-Pyng Wey)；沈立漢(Lie-Hang Shen)

鎝-99m-TRODAT-1 ； 放射化學純度 ； 多巴胺轉運體造影 ； 核醫藥物 ； 99mTc-TRODAT-1 ； radiochemical purity ； dopamine transporter imaging ； radiopharmaceutical

核子醫學雜誌

14卷4期（2001 / 12 / 01）

223 - 230

繁體中文

背景：鎝-99m-TRODAT-1是第一個成功用於人體中樞神經多巴胺轉運體造影的鎝標幟核醫藥物。各國的臨床研究結果證實鎝-99m-TRODAT-1造影用於診斷帕金森病等神經退化性疾病的潛力與效能。為因應臨床使用鎝-99mTRODAT-1前快速檢驗放射化學純度需求，我們發展一套雙片薄層色層分析法（TLC）用以檢測鎝-99m-TRODAT-1放射化學純度，並與高效能液體色層分析法（HPLC）檢測結果比對確認其可信程度。方法：鎝-99m-TRODAT-1溶液分別混合鎝-99m-glucoheptonate及鎝-99m-過鎝酸鈉，以獲得主要不純物分別為鎝-99m-glucoheptonate或鎝-99m-過鎝酸鈉之14組試驗樣品（鎝-99m-TRODAT-1放射化學純度範圍為40～100%），分別以逆相HPLC及雙片TLC同時進行放射化學純度之測量，以線性迴歸（linear regression）分析HPLC與TLC之檢測數據。結果：不純物為鎝-99m-glucoheptonate之鎝-99m-TRODAT-1樣品，以HPLC與TLC檢測放射化學純度，其直線迴歸分析之Pearson's係數為0.9908。不純物為接99m-過鎝酸訥之鎝-99m-TRODAT-1樣品，以HPLC與TLC檢測放射化學純度，其直線迴歸分析之Pearson's係數為0.9875。不論主要放射化學不純物種為鎝-99m-glucoheptonate或鎝-99m-過鎔酸鈉，TLC法與HPLC法分析結果均有良好的線性關係。結論：雙片TLC分析法在不便使用HPLC的情況下，可以作為鎝-99m-TRODAT-1臨床使用前，快速進行藥物放射化學純度品管的替代方法。

Backgrounds: 99mTc-TRODAT-1 is the first 99mTc radiopharmaceutical successfully imaging dopamine transporters in human central nerve system. Worldwide clinical studies have revealed the potential values of 99mTc-TRODAT-1 imaging in diagnoses of abnormalities with neuron degeneration like Parkinson's disease. For fast determination of radiochemical purity (RCP) prior to administration of 99mTc-TRODAT-1 in routine clinical base, a dual-strip thin layer chromatography (TLC) approach was developed and validated by literature reported high performance liquid chromatography (HPLC) method.Methods: Fourteen samples of 99mTc-TRODAT-1 /99mTc-glucoheptonate mixture and fourteen samples of 99mTc-TRODAT-1 /99mTc-pertechnetate mixture were prepared with 99mTc-TRODAT-1 RCP range 40~100%. RCP of 99mTc-TRODAT-1 in each sample was simultaneously determined by TLC and HPLC. The data sets were analyzed between TLC and HPLC by linear regression.Results: The Pearson's coefficients of linear regression between RCP data of TLC and HPLC were 0.9908 and 0.9875 for 99mTc-TRODAT-1 with 99mTc-glucoheptonate and that with 99mTc-pertechnetate, respectively. The RCP data of TLC correlated well with those of HPLC, no matter when the radiochemical purity was 99mTc-glucoheptonate or 99mTc-pertechnetate.Conclusion: The dual-strip TLC method may serve as an alternative to determine the RCP of 99mTc-TRODAT-1 prior to administration, in case when HPLC is not available.