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目的建立丙酸氟替卡松乳膏中体外透皮接收液的高效液相色谱(HPLC)测定方法,研究丙酸氟替卡松乳膏的透皮能力。方法采用Hypersil ODS C18色谱柱(250 mm×4.6 mm,5μm),流动相:甲醇-0.01 mol.L-1磷酸氢二胺(用磷酸溶液调pH至3.5)-乙腈(55∶35∶15),柱温为55℃;检测波长为240 nm,流速1.0 mL.min-1。体外透皮实验采用改良的Franz扩散池,以体外乳猪皮作为透皮屏障,比较自制乳膏与市售乳膏的透皮结果,分别在不同时间点取样测定透皮接收液中丙酸氟替卡松浓度,计算累积透皮量。结果丙酸氟替卡松在0.050 2～1.003 0μg.mL-1浓度范围内峰面积与浓度之间呈良好的线性关系(r=0.999 8),回归方程为A=47 709.364 7×C+300.774 4,平均回收率99.58%。自制乳膏与市售乳膏的透皮结果差异无统计学意义。结论该检测方法操作简便,快速准确,是考察丙酸氟替卡松乳膏体外透皮吸收量较理想的方法。
OBJECTIVE To establish a HPLC method for the determination of fluticasone propionate cream in vitro and to study the transdermal ability of fluticasone propionate cream. Methods The mobile phase was Hypersil ODS C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol-0.01 mol·L-1 dihydrogen phosphate (adjusted to pH 3.5 with phosphoric acid) -acetonitrile (55:35:15) The column temperature was 55 ℃. The detection wavelength was 240 nm and the flow rate was 1.0 mL.min-1. In vitro transdermal experiments using improved Franz diffusion cell, in vitro piglets as a transdermal barrier, compared with homemade cream and the cream of the transdermal results, respectively, sampling at different time points Determination of transdermal receiving fluid fluticasone propionate Concentration, calculated cumulative transdermal volume. Results The concentration of fluticasone propionate in the concentration range of 0.050 2 ~ 1.003 0μg.mL-1 showed a good linear relationship (r = 0.999 8), the regression equation was A = 47 709.364 7 × C + 300.774 4, the average Recovery rate of 99.58%. There was no significant difference in the transdermal results between self-made and commercially available creams. Conclusion The method is simple, rapid and accurate. It is an ideal method to evaluate the transdermal absorption of fluticasone propionate cream in vitro.