利拉萘酯乳膏皮肤渗透试验方法及样品测定

Establishment of transermal release and content determination of the liranaftate ointment

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 the transermal release system and to determine the content of the liranaftate ointment release solution. METHODS Human skin and the auto pereeutanous absorption technique were used to establish the liranaftate ointment transermal release system. The HPLC method was used to determine the content of the liranaftate ointment release solution, a mixture of aeetonitrile and 0. 025 mol. L^-1 NaAC buffer solution （85： 15） was used as mobile phase, detecting wave- length was at 286 nm. RESULTS The liranaftate ointment transermal release system could satisfy the demand of the study. The determination linear range of liranaftate ointment release solution by HPLC was 0. 02 16 mg·L^-1. The average recovery was 98. 93% and RSD was 2. 10%. CONCLUSION The liranaftate ointment transermal release system established in this paper is proper and the content determination using HPLC is rapid, simple and accurate.