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Annals of Nuclear Medicine and Molecular Imaging

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篇名 國內放射性碘膠囊溶離曲線比較
卷期 14:1
並列篇名 A Comparison of Dissolution Profiles for Domestically Available Radioiodide Capsules
作者 余明德劉武龍彭敬成程紹智黃文盛
頁次 27-32
關鍵字 放射性碘膠囊配方放射性碘 131溶離試驗Radioiodide capsuleFormulationIodide 131Dissolution test
出刊日期 200103

中文摘要

背景:目前診斷與治療甲狀腺功能亢進症及甲狀腺癌以放射性碘為首選。因膠囊提供方便與安全之給藥途徑,所以膠囊為放射性碘之較佳劑型。本溶離試驗旨在檢視國內供應放射性碘膠囊,並觀察溶離試驗結果是否受儲存時間與溫度影響。
方法:三種國內供應診斷用100微居里碘-131碘化鈉膠囊以美國藥典24版方法進行溶離試驗。
結果:所有受試放射性碘膠囊均在15分鐘內溶離90%,並在實驗結束(140分鐘)前完全溶解。室溫儲存1週及2週者也在15分鐘溶離90%,溶離結果無明顯改變。35℃儲存者之溶離試驗結果也是如此,無統計差異(P>0.05, student-newman-keul test)。
結論:三種國內獲得的放射性碘膠囊,其演離試驗結果均符合規格。室溫儲存至2週以及35℃下儲存1天均不影響其溶離結果。

英文摘要

Objective: Radioactive sodium iodide has been the drug of choice for both diagnosis and therapy in patients with thyroid cancer and hyperthyroidism. Due to providing more convenient and safer administration of radioiodide than liquid, the capsule has been the superior dosage from for radioiodide delivery. The aim of this study was to evaluate the in vitro dissolution profiles for domestically available sodium iodide capsules and to determine if the dissolution profiles affected by storage time and storage temperature.
Methods: Diagnostic capsules with 100 μCi of 131I-sodium iodide provided from three domestic vendors were tested for in vitro dissolution by the USP XXIV method.
Results: All testing capsules showed >90% release of radioiodide in 15 min and complete dissolution in 140 min when the test was finished. Acceptable resolution profiles were also found with the capsules store at ambient temperature for 1 or 2 weeks, and at 35℃ for 1 h and 1 day. There was no significant difference among observed dissolution profiles (P>0.05, student-newman-keul test).
Conclusion: Three domestically available radioiodide capsules meet the requiremnets of dissolution test. There was no significant change of dissolution profile when the capsules stored at ambient temperature for up to 2 weeks or at 35℃ for up to 1day.

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