摘要
目的：建立酮洛芬贴片体外透皮释放方法学。方法：采用HPLC法测定释放液中酮洛芬的含量，测定条件：Diamonsilc18色谱柱（150mm×4．6mm，5μm），流动相为pH3．5磷酸盐缓冲液．乙腈．水（2：53：45），检测波长为253nm，流速为1．0mL·min-1，柱温25℃。以裸鼠皮肤为实验皮肤，采用Frans扩散池方法进行三批酮洛芬贴片样品的体外透皮实验。结果：在该HPLC条件下，酮洛芬与其他杂质分离良好，进样量在0．509～40．72μg·mL-1时，酮洛芬浓度与峰面积呈良好的线性关系（r=0．9999），回收率为101．09％，RSD为1．23％。三批酮洛芬贴片样品的透皮释放速率分别为18．157，17．973，20．001gg·cm-2．h-1，药物透皮释放符合零级动力学过程。结论：本文建立的酮洛芬贴片体外透皮释放方法简便，重现性好，可以用于控制产品质量。
Objective： To establish a test method for transdermal release of ketoprofen patch. Methods： An HPLC method was used to determine the content of ketoprofen. A Diamonsil C18 cohmm （150 mm ×4.6 mm, 5μm） was used for separation, the mobile phase consisted of phosphate buffer solution （pH3.5）-acetonitrile-water （2 ： 53 ： 45） at the flow rate of 1.0 mL. min-~, and the detection wavelength was set at 253 nm, column temperature was 25 ~C. The in vitro transdermal test was performed using nude mice skin and Frans diffusive pool, and three batch samples were verified by this method. Results： Ketoprofen was separated well from other impurity in this chromatogram condition. The calibration curve was linear in the range of 0.509 - 40.72 μg-mL-1 （r = 0.999 9）. The average recovery was 101.09% and the RSD was 1.23%. The transdermal release rates of ketoprofen in three batches of patches were 18.157, 17.973 and 20.001μg·cm2.h-1, respectively. The release of ketoprofen patch followed zero order kinetic model. Conclusion： The method was simple and reproducible, which can be used to control product quality.
出处
《中国药物应用与监测》
CAS
2012年第6期324-327,共4页
Chinese Journal of Drug Application and Monitoring
关键词
酮洛芬
贴片
体外
透皮释放速率
Ketoprofen
Patch
In vitro
Transdermal release rate
