【摘要】 目的制备盐酸美金刚缓释胶囊并对其含量进行测定。方法采用流化床上药包衣的方法制备盐酸美金刚缓释微丸。含量测定采用气相色谱系统,HP-5(agilent,30m×0.32mm×0.25μm)毛细管色谱柱,氢火焰离子(FID)检测器,载气为氮气,柱温为程序升温,不分流直接进样;以盐酸金刚烷胺为内标物,测定盐酸美金刚缓释胶囊含量。结果盐酸美金刚浓度在2.881~37.044μg·L-1范围内,与主成分和内标的峰面积比值呈良好的线性关系,r=0.9999;定量限为0.132ng;重复性试验RSD为1.35%(n=6);不同水平回收率的RSD为0.95%(n=9)。自制的三批样品平均含量分别为(99.67±0.58)%、(99.80±1.09)%、(100.31±1.20)%。结论盐酸美金刚缓释胶囊制备工艺稳定;气相色谱法准确、重复性好,可用于本品的含量测定。更多还原

【Abstract】 OBJECTIVE To prepare memantine hydrochloride extended release capsule and to establish a method for the determination of the content. METHODS The fluid-bed coating equipment was used to prepare pellets. The content of memantine hydrochloride extended release capsule was detected by GC chromatography with HP-5 capillary column( agilent,30 m × 0. 32 mm × 0. 25 μm) and FID detector,the carriers gas was nitrogen,column temperature was increased by programmed control and splitless injection mode was adopted. Amantadine hydrochloride was used as internal standard. RESULTS The calibration curves were linear in the range of 2. 881 ~ 37. 044 μg ·L-1,r = 0. 9999; the limit of quantiattion was 0. 132ng; the RSD for repeatition was 1. 35%( n = 6); The RSD of the recoveries at different levels was 0. 95 %( n = 9). The average contents of three batches of homemade samples were( 99. 67 ± 0. 58) %,( 99. 80 ± 1. 09) % and( 100. 31 ± 1. 20) %,respectively. CONCLUSION The preparation process of memantine hydrochloride extended release is stable. The gas chromatography is accurate and reproducible,which can be used for the determination of the content.更多还原