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[目的]对美国药典与中国药典透皮贴剂释放度桨碟法测定装置进行比较。[方法]分别使用美国药典与中国药典桨碟法装置对芬太尼透皮贴剂的释放曲线进行测定,释放介质为2.5mmol·L-1的磷酸和2.5mmol·L-1磷酸二氢钾等体积混合溶液900ml;以TC-C18为固定相的Agilent色谱柱(250mm×4.6mm×5μm),含0.2%三乙胺和0.2%磷酸的5mmol·L-1辛烷基磺酸钠溶液与乙腈的混合溶液(1.3︰1)为流动相,流速为1.0ml·min-1,柱温为25℃,检测波长为210nm。[结果]对于2.1mg规格的透皮贴剂采用不同方法所得的释放曲线存在差异。[结论]中国药典桨碟法装置在测量透皮贴剂释放度时不能完全替代美国药典桨碟法装置。
[Objective] To compare the device of the United States Pharmacopoeia and Chinese Pharmacopoeia transdermal patch release device. [Method] The release curves of fentanyl transdermal patch were determined by using the United States Pharmacopoeia and the Chinese Pharmacopoeia, respectively. The releasing medium was 2.5 mmol·L-1 phosphate and 2.5 mmol·L-1 potassium dihydrogen phosphate 900ml mixed solution of the same volume; TC-C18 as the stationary phase of the Agilent column (250mm × 4.6mm × 5μm), containing 0.2% of triethylamine and 0.2% phosphoric acid solution of 5mmol · L- 1 octane sulfonate and Acetonitrile (1.3︰1) as the mobile phase at a flow rate of 1.0ml · min-1. The column temperature was 25 ℃ and the detection wavelength was 210nm. [Result] There were differences in the release curves obtained by different methods for the transdermal patch of 2.1 mg specifications. [Conclusion] The Chinese Pharmacopoeia paddle device can not totally replace the American Pharmacopoeia and Paddle Device when measuring the release of transdermal patch.