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（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 an HPLC method for determination of content and percutaneous absorption of selfmade terbinafine hydrochloride cream and original cream.METHODS Kromasil C18（5μm,4.6 mm×250 mm）was used as column,with methanol-acetonitrile-pH7.5 triethylamine acetate buffer（55∶35∶10）as mobile phase,flow rate at 1 ml·min-1and detection wavelength at 282 nm.In percutaneous absorption study,Franz intelligent instrument was used with in vitro suckling pig skin as transdermal barrier.The similarity of self-made creams to original cream was evaluated by cumulative amount of penetration and 24 h retention in skin.RESULTS The calibration curves were linear between4-150 ng·ml-1 and 20-400μg·ml-1（r=0.999 6,0.999 8）.The average recovery of terbinafine hydrochloride solution was 98.88% while the average recovery of terbinafine hydrochloride cream was 100.4%.The average content of three batches of seif-made creams was97.2%.The cumulative amount of penetration and 24 h retention in skin had no significant differences（P0.05）.CONCLUSION HPLC method is fast,accurate and can be used for content determination and percutaneous absorption of terbinafine hydrochloride.Transdermal absorption characteristics of self-made creams are similar to original creams,and the content meets the requirements.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2015年第6期518-522,共5页
Chinese Journal of Hospital Pharmacy
