盐酸特比萘芬乳膏的透皮吸收和含量测定

发布时间：2018-06-22 10:20

本文选题：盐酸特比萘芬乳膏 + 高效液相色谱法　；参考：《中国医院药学杂志》2015年06期

【摘要】：目的:建立盐酸特比萘芬乳膏HPLC分析方法,并使用该方法进行自制乳膏和原研制剂的透皮吸收考察和自制乳膏的含量测定。方法:采用Kromasil C18柱(4.6 mm×250 mm,5μm),甲醇-乙腈-pH7.5的醋酸三乙胺缓冲液(55∶35∶10)为流动相,流速1 ml·min-1,检测波长282 nm。体外透皮实验采用Franz智能透皮吸收仪,以实验用离体乳猪皮为透皮屏障,通过累计渗透量和皮肤滞留量评价自制乳膏与原研制剂的透皮相似性。结果:盐酸特比萘芬质量浓度在4~150 ng·ml-1、20~400μg·ml-1范围内线性关系良好(r=0.999 6,r=0.999 8),盐酸特比萘芬溶液平均回收率为98.88%,制剂加样平均回收率为100.4%。3批自制乳膏的平均含量为97.2%,累计渗透量和24 h皮肤滞留量与原研制剂差异无显著性(P0.05)。结论:所建立HPLC方法快速、准确,可同时用于盐酸特比萘芬乳膏的透皮吸收考察和含量测定。自制乳膏的透皮吸收特性与原研制剂相似,含量达到要求。
[Abstract]:Objective: to establish a HPLC method for the analysis of terbinafine hydrochloride cream. Methods: a Kromasil C18 column (4.6 mm 脳 250mm ~ 5 渭 m), methanol-acetonitrile-pH 7.5 triethylamine acetate buffer (55:35:10) was used as the mobile phase, the flow rate was 1ml min-1, and the detection wavelength was 282nm. In vitro transdermal experiments were conducted with Franz intelligent transdermal absorptiometer and in vitro porcine skin was used as skin barrier. The transdermal similarity between self-made cream and original preparation was evaluated by accumulative osmotic capacity and skin retention. Results: the linear range of terbinafine hydrochloride was 400 渭 g ml-1 (r = 0.999 6). The average recovery of terbinafine hydrochloride solution was 98.88. The average recovery rate of terbinafine hydrochloride was 100.4.3. The average content of self-made cream was 97.2and the cumulative permeation rate was 97.2. There was no significant difference between the dosage and 24 h skin retention compared with the original preparation (P 0.05). Conclusion: the established HPLC method is rapid and accurate, and can be used for the determination of terbinafine hydrochloride cream by transdermal absorption. The transdermal absorption characteristics of the self-made cream are similar to those of the original preparation, and the content reaches the requirements.
【作者单位】：南京工业大学药学院;
【分类号】：R927.2

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