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目的建立测定吲哚美辛亚微乳胶含量的高效液相色谱法,并评价其在离体大鼠皮肤中的渗透性。方法采用HypersilBDSC18柱(4.6mm×200mm,5μm);流动相为乙腈-水-冰乙酸(50∶50∶0.06);流速1.0mL·min-1,检测波长228nm,柱温40℃,外标法定量计算结果。改良Franz扩散池测定药物在离体大鼠皮肤中的渗透量。结果吲哚美辛在8.46~126.90μg·mL-1内线性关系良好(r=0.9999),平均回收率为99.60%,RSD为1.35%(n=9)。吲哚美辛亚微乳胶24h平均累积透过量为(1311.38±74.95)μg·cm-2,渗透系数为(54.17±4.91)μg·cm-2·h,渗透行为经拟合符合零级动力学过程。结论本试验建立的方法准确可靠、简单快速,适用于该制剂的含量测定及体外经皮特性研究。
OBJECTIVE To establish a HPLC method for the determination of indomethacin submicron latex and evaluate its permeability in isolated rat skin. Methods The column was Hypersil BDSC18 (4.6 mm × 200 mm, 5 μm). The mobile phase was acetonitrile-water-glacial acetic acid (50:50:0.06). The flow rate was 1.0 mL · min-1. The detection wavelength was set at 228 nm. Quantitative calculation results. Improved Franz diffusion cell assay of drug penetration in isolated rat skin. Results The indomethacin showed good linearity (r = 0.9999) in the range of 8.46 ~ 126.90μg · mL-1 with an average recovery of 99.60% and RSD of 1.35% (n = 9). The average cumulative permeation amount of indomethacin microemulsion was (1311.38 ± 74.95) μg · cm-2 and the permeability coefficient was (54.17 ± 4.91) μg · cm-2 · h, respectively, and the osmotic behavior fitted zero-order kinetics. Conclusion The method established in this study is accurate and reliable, simple and rapid, suitable for the determination of the content of the preparation and in vitro transdermal properties.