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目的:对透皮贴剂释放度测定中转筒法装置与中国药典桨碟法装置进行比较。方法:分别使用转筒法装置与中国药典桨碟法装置对丁丙诺啡透皮贴剂的释放曲线进行测定,释放介质为0.9%的氯化钠溶液900 mL;以TC-C18为固定相的Agi-lent色谱柱(250 mm×4.6 mm,5μm),0.05 mol·L-1的磷酸二氢钾溶液与乙腈的混合溶液(1.3∶1)为流动相,流速为1.0 mL·min-1,柱温为30℃,检测波长为220 nm。结果:丁丙诺啡在0.4～24μg·mL-1范围内线性关系良好(r=0.9999),回收率为102.1%。对于20 mg规格的透皮贴剂采用不同方法所得的丁丙诺啡释放曲线不存在差异,而对于5 mg规格和10 mg规格则存在差异。结论:中国药典桨碟法装置在测量透皮贴剂的释放度时不能完全替代美国药典转筒法装置。
OBJECTIVE: To compare the tumbling device in the determination of transdermal patch release with the Chinese Pharmacopoeia method. Methods: The release curve of buprenorphine transdermal patch was determined by using the drum method and the Chinese Pharmacopoeia and Paddle Device, respectively, and the release medium was 900 mL of 0.9% sodium chloride solution. Using TC-C18 as stationary phase (250 mm × 4.6 mm, 5 μm), a mixed solution of potassium dihydrogen phosphate (0.05 mol·L -1) and acetonitrile (1.3:1) was used as the mobile phase at a flow rate of 1.0 mL · min -1 The column temperature was 30 ℃ and the detection wavelength was 220 nm. RESULTS: Buprenorphine had a good linearity (r = 0.9999) in the range of 0.4-24 μg · mL-1 with a recovery of 102.1%. There are no differences in buprenorphine release curves for the 20 mg size transdermal patch with different methods, but for the 5 mg and 10 mg specifications. Conclusion: The Chinese Pharmacopoeia paddle device can not completely replace the United States Pharmacopoeia tumbling device when measuring the release of the transdermal patch.