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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(P>0.05)。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。
OBJECTIVE: To establish HPLC method for the determination of terbinafine hydrochloride cream and to study the transdermal absorption and the content of homemade cream by using this method. Methods: Kromasil C18 column (4.6 mm × 250 mm, 5 μm) and methanol-acetonitrile-pH 7.5 acetate buffer (55:35:10) were used as the mobile phase at the flow rate of 1 ml · min-1. Wavelength 282 nm. In vitro transdermal experiment using Franz smart transdermal absorption apparatus, with experimental suckling pig skin as a transdermal barrier, through the cumulative amount of permeate and the amount of skin retention evaluation of homemade cream and transdermal similarity of the original preparation. Results: Terbinafine hydrochloride had a good linearity (r = 0.999 6, r = 0.999 8) in the range of 4-150 ng · ml-1 and 20-400 μg · ml-1, mean of terbinafine hydrochloride solution The recovery rate was 98.88%. The average recovery of the preparation was 100.4%. The average contents of three batches of homemade creams were 97.2%. There was no significant difference between the cumulative cream and the original preparations (P> 0.05). Conclusion: The established HPLC method is rapid and accurate and can be used for the determination and determination of transdermal absorption of terbinafine hydrochloride cream. Self-made cream transdermal absorption characteristics and the original research agent similar to meet the requirements.