泼尼松缓释片中泼尼松的测定及其体外释放度研究

Determination and in vitro release of prednisone in Prednisone Sustained-release Tablets

目的制订泼尼松缓释片中泼尼松及其体外释放度的测定方法。方法采用高效液相色谱法,C18色谱柱(250mm×4.6 mm,5μm);流动相:乙腈–水(24∶76);UV检测器检测波长:240 nm;体积流量:1.0 mL/min;柱温:30℃。对泼尼松缓释片3批样品和1批参比制剂进行了泼尼松的测定。采用pH 6.8磷酸盐缓冲液500 mL作为释放介质,以第二法(桨法)装置,转速为75 r/min,分别在3、3.5、4、4.5、5、7 h取样,采用高效液相色谱法测定泼尼松缓释片中泼尼松的体外释放度。结果泼尼松的线性范围为5~100μg/m L。平均回收率为99.69%,RSD值为0.78%。泼尼松缓释片自制样品与参比制剂中泼尼松的测定结果一致。样品在3.5 h内无释放、7 h内释放基本完成;自制样品与参比制剂的体外释放度结果一致,且批间重现性良好。结论建立的泼尼松缓释片中泼尼松和体外释放度测定方法简便、快速,易于操作。样品和参比制剂中泼尼松测定和体外释放度测定结果均一致。

Objective To establish a method for the determination of prednisone in Prednisone Sustained-release Tablets and its release in vitro.Methods The separation by HPLC method was performed on C18 column(250 mm×4.6 mm,5μm)with mobile phase of acetonitrile-water(24:76).The UV detection wavelength was set at 240 nm.The flow rate was 1.0 mL/min,and the column temperature was 30℃.The contents of prednisone in 3 batches of Prednisone Sustained-release Tablets samples and 1 batch of reference preparation were determined.Phosphate buffer(pH 6.8)500 mL was used as the release medium,the second method(paddle method)device was carried on,and the speed was 75 r/min.The samples were collected at 3,3.5,4,4.5,5,and 7 h,and the in vitro release of prednisone in Prednisone Sustained-release Tablets was determined by HPLC method.Results The content of prednisone had good linear range of 5μg/mL to 100μg/mL.The average recovery was 99.69%with RSD value of 0.78%.The determination results of prednisone in the self-made Prednisone Sustained-release Tablets sample and the reference preparation were consistent.The sample was not released within 3.5 h,but it was released within 7 h.In vitro releases of the self-made samples were consistent with those of the reference preparations,and the reproducibility between batches was good.Conclusion The established method for the determination and its in vitro release of prednisone in Prednisone Sustained-release Tablets is simple,rapid,and easy to operate.Determination and in vitro release of prednisone in samples and reference preparations were consistent.