CAJ | 학술논문

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:Diamonsil C18色谱柱(150 mm×4.6 mm,5μm),流动相为pH 3.5磷酸盐缓冲液-乙腈-水(2∶53∶45),检测波长为253 nm,流速为1.0 mL·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18.157,17.973,20.001μg·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.
목적:건립동락분첩편체외투피석방방법학.방법:채용HPLC법측정석방액중동락분적함량,측정조건:Diamonsil C18색보주(150 mm×4.6 mm,5μm),류동상위pH 3.5린산염완충액-을정-수(2∶53∶45),검측파장위253 nm,류속위1.0 mL·min-1,주온25℃.이라서피부위실험피부,채용Frans확산지방법진행삼비동락분첩편양품적체외투피실험.결과:재해HPLC조건하,동락분여기타잡질분리량호,진양량재0.509~40.72μg·mL-1시,동락분농도여봉면적정량호적선성관계(r=0.9999),회수솔위101.09%,RSD위1.23%.삼비동락분첩편양품적투피석방속솔분별위18.157,17.973,20.001μg·cm-2·h-1,약물투피석방부합령급동역학과정.결론:본문건립적동락분첩편체외투피석방방법간편,중현성호,가이용우공제산품질량.
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 column (150 mm×4.6 mm, 5 μm) 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-1, and the detection wavelength was set at 253 nm, column temperature was 25 ℃. 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 20.001 μg·cm-2·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.