基于全自动二维液相色谱的地奈德乳膏体外经皮渗透研究  

In vitro study of percutaneous absorption and content determination of desonide cream by 2D-LC-UV

作　　者：唐靖[1] 田娟 黄辉 丁劲松[3] 周彦彬[3] 

机构地区：[1]长沙医学院药学院,长沙410219 [2]长沙晶易医药科技有限公司,长沙410013 [3]中南大学药学院,长沙410013

出　　处：《中南药学》2015年第12期1242-1246,共5页Central South Pharmacy

摘　　要：目的建立乳膏及经皮渗透样品中地奈德的全自动二维液相色谱(2D-LC-UV)测定法,比较新研制的地奈德乳膏与原研制剂的体外经皮渗透性。方法采用ASTON RG C30色谱柱(4.6 mm×150 mm,5μm),流动相为四氢呋喃-水-乙腈=25:35:40,流速为1.0 m L·min^(-1),检测波长245 nm。体外透皮实验采用改良Franz扩散池,以离体乳猪皮为屏障,以累积渗透量和皮肤滞留量为指标,评价新研制的地奈德乳膏与原研制剂的经皮渗透规律。结果皮肤接收液和皮肤提取液样品中地奈德浓度分别在10~1000ng·m L^(-1)、10~300 ng·m L^(-1)内线性关系良好(r^2=0.999,r^2=0.997)。与原研制剂相比,新研制的地奈德乳膏在2、7、12、24 h的单位皮肤面积累积渗透量和2、24 h皮肤滞留量差异均无统计学意义(P>0.05)。结论所建立的2D-LC-UV方法快速、准确,可用于地奈德乳膏的含量测定及体外经皮渗透规律研究。新研制的地奈德乳膏的经皮渗透特性与原研制剂相似。Objective To establish a 2D-LC-UV method to determine the content and percutaneous absorption of new creative desonide cream and original cream. Methods Aston RG C30（4.6 mm×150 mm, 5 μm） was used as the analytical column, with tetrahydrofuran-acetonitrile-water（25 ∶ 35 ∶ 40） as the mobile phase, the flow rate at 1.0 m L·min-（-1） and the detection wavelength at 245 nm. In the percutaneous absorption study, modified Franz diffusion cells were used with in vitro suckling pig skin as the transdermal barrier. The similarity of self-made cream to original cream was evaluated by cumulative amount of penetration and retention in the skin. Results The calibration curves of receptor solution and extract solution were linear between 10- 1000 ng·m L-（-1） and 10- 300 ng·m L- 1（r-2= 0.999, r-2= 0.997）. The cumulative amount of penetration at 2, 7, 12 and 24 h and retention at 2 and 24 h in the skin had no significant difference（P〈0.05） in both creams. Conclusion The 2D-LC-UV method is fast, accurate and can be used for the content determination and percutaneous absorption of desonide cream. Transdermal characteristics of the new creative cream are similar to those of original cream, and the content meets the requirements.

关 键 词：地奈德乳膏 二维高效液相色谱法 体外透皮吸收 皮肤滞留量 含量测定 

分 类 号：R94[医药卫生—药剂学]