【摘要】 目的:采用HPLC法测定替硝唑-聚癸二酸酐控释制剂的含量,并研究其释药特性。方法:色谱条件为色谱柱:Shim-Pack VP-ODS柱(250mm×4.6mm,5μm);柱温:室温;流动相:甲醇-水(20∶80);流速:1mL.min-1;检测波长:310nm;进样量:10μL。将替硝唑-聚癸二酸酐控释制剂置于0.1mol.L-1,pH7.4的磷酸缓冲液(PBS)中,37℃恒温振荡,每24h更换一次缓冲液,测定并计算缓冲液中药物浓度及药物累计释放百分率。结果:替硝唑含量在5.0~100.0mg.L-1范围内,浓度与吸收度之间线性关系良好(r=0.999 9);样品的平均回收率为101.84%,RSD为0.54%(n=4)。释药结果表明,聚癸二酸酐对替硝唑的释放呈一级释放动力学特征,拟合方程:Y=8.058 3+34.455 8t-3.192 5t2。结论:该方法灵敏,专属,准确,操作简便,可供该制剂的含量测定。更多还原

【Abstract】 OBJECTIVE To develop an HPLC method for the determination of tinidazole-poly（sebacic anhydride） controlledreleasing preparations,and study the drug release characteristic.METHODS Chromatographic conditions included column: Shim-Pack VP-ODS（150 mm×（4.6） mm）;column temperature: room temperature;mobilephase: methanol-water（20∶80）;flowrate: 1 mL·min^-1;detector: UV 310 nm;injection volume: 10 μL.TinidazolePoly（sebacic anhydride） controlled-releasing preparations were put in（0.1） mol· L^-1,pH（7.4） PBS,vibrating at（37 ℃）.The buffer was changed once in every 24 h,and was determinated and calculated drug concentration and cumulative release percent.RESULTS The calibration curve was linear（r=（0.999 9）） in the range of（5.0）-（100.0） mg·L^-1 for tinidazole,the mean recovery was（101.84%）,with RSD of （0.539 4%）（n=4）.The results of drug release demonstrated that the tinidazole-poly（sebacic anhydride） controlled-releasing preparations followed first order release kinetics,the regression equation was Y=（8.058 33）+（34.455 83）t-（3.192 5） t².CONCLUSION The method is sensitive,specific,accurate,simple and was suitable for the determination of tinidazole preparations.更多还原