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目的:建立利拉萘酯(liranaftate)乳膏体外皮肤渗透试验模型及样品测定方法。方法:以离体皮肤为渗透屏障,采用高效液相色谱法,乙腈-0.025mol.L-1醋酸钠缓冲液(85∶15)为流动相,检测波长286nm,测定释放液中利拉萘酯的含量。结果:在本试验检测条件下,利拉萘酯含量测定在0.02～16mg.L-1范围内呈良好的线性关系,平均回收率为98.93%,RSD为2.10%。结论:本实验所建立的试验模型对利拉萘酯体外渗透研究科学合理;经皮渗透释放液中利拉萘酯含量检测灵敏,准确,方法重现性好。
Objective: To establish an in vitro skin penetration test model of liranaftate cream and to determine the method of sample preparation. Methods: The isolated skin was used as the permeation barrier. The mobile phase was acetonitrile-0.025 mol·L-1 sodium acetate buffer (85:15) with the detection wavelength of 286 nm. The release of liraglutide Content. Results: Under the test conditions, the content of liraglutide in the range of 0.02 ~ 16mg.L-1 showed a good linear relationship with the average recovery of 98.93% and RSD of 2.10%. CONCLUSION: The experimental model established in this study is scientific and reasonable for in vitro penetration of liraglutide. The detection of liraglutide ester in percutaneous dermal infiltration solution is sensitive and accurate, and the method has good reproducibility.