【摘要】 目的:建立骨架型芬太尼透皮贴剂中芬太尼释放度测定的方法。方法:采用中国药典释放度测定第3法的仪器装置,释放介质为2.5mmol·L^-1的磷酸和2.5mmol·L^-1磷酸二氢钠等体积混合溶液900mL;使用以 ZORBAX SB-C₁₈为同定相的Agilent 色谱柱（250mm×4.6mm,5μm）,含0.2%三乙胺和0.2%磷酸的5mmol·L^-1的辛烷磺酸钠与乙腈的混合溶液（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:芬太尼浓度在0.8～400μg·mL^-1浓度范围内线性关系良好,相关系数0.9999,回收率99.7%,最低检测限为0.23ng;使用 ChP 第3法在0～24h 所得的芬太尼释放曲线与 USP 第7法所得曲线一致。结论:本法仪器简便,适合同情,检测结果较为满意。更多还原

【Abstract】 Objective:To establish a method for the analysis of release of fentanyl in Matrix Transdermal Drug De- liver System（TDDS）.Method:Used paddle on disk method,the release media was the mixture of 2.5 mmol·L^-1 phosphoric acid and 2.5 mmol·L^-1 monobasic sodium phosphate（1:1）,the volume was 900 mL.Used Agilent col- umn which packed ZORBAX SB-C₁₈ as solid phase（250 mm×4.6 mm,5 μm）,used the mixture of acetonitrile and 5 mmol·L^-1 sodium octanesulfonate solution（1:1.3）as mobile phase,sodium octanesulfonate solution con- tained 0.2% phosphate acid and 0.2% triethylamine.The flow rate was 1.0 mL·min^-1.Kept column temperature 25℃ and the detective wavelength was 210 nm.Result:The linear correlation of fentanyl in TDDS was observed from the concentrations of 0.8-400 μg·mL^-1（r=0.9999）.The recoveries of fentanyl was 99.7%.The LOD was 0.23 ng.The profile of fentanyl in ChP method Ⅲ was same as that in USP method Ⅶ.Conclusion:The method is fastness and convenience.更多还原