本文選題：安立生坦片 + 溶出曲線　； 參考：《中國藥房》2015年15期

【摘要】：目的:建立測定安立生坦片體外溶出度的方法,并將安立生坦片仿制與原研藥的溶出曲線進(jìn)行比較。方法:采用高效液相色譜法。色譜柱為Phenomenex Gemini C18,流動相為乙腈-0.02%三氟乙酸水溶液(60∶40,V/V),流速為1.2 ml/min,檢測波長為220 nm,柱溫為40℃,進(jìn)樣量為100μl。溶出度測定以水、0.1 mol/L鹽酸溶液(p H=1.0)、醋酸鹽緩沖液(p H=5.0)、磷酸鹽緩沖液(p H=6.8)為溶出介質(zhì),轉(zhuǎn)速為50 r/min,5~120 min分別取樣。結(jié)果:安立生坦質(zhì)量濃度在1.14~6.83μg/ml范圍內(nèi)與峰面積呈良好線性關(guān)系(r=0.999 9);精密度、穩(wěn)定性、重復(fù)性試驗(yàn)的RSD均0.3%;平均回收率為99.38%,RSD為0.50%(n=9);在4種溶出介質(zhì)中,仿制與原研安立生坦片的溶出曲線相似因子(f2)均50,酸值(AV)均15。結(jié)論:仿制與原研安立生坦片的體外溶出行為一致。該方法可用于安立生坦片仿制藥的一致性評價(jià)。
[Abstract]:Aim: to establish a method for the determination of dissolution of Anlishentan tablets in vitro and compare the dissolution curve between the imitated tablets and the original tablets.Methods: high performance liquid chromatography was used.The chromatographic column was Phenomenex Gemini C18, the mobile phase was acetonitrile-0.02% trifluoroacetic acid solution 60: 40V / V / V, the flow rate was 1.2 ml / min, the detection wavelength was 220nm, the column temperature was 40 鈩，

本文編號：1741278