阿齐沙坦片的制备及质量研究.doc

阿齐沙坦片的制备及质量研究
王林森(莒南县食品药品监督管理局 276600)
【摘要】目的采用湿法制粒制备阿齐沙坦片,并对其进行质量评价。方法以溶出度为考察指标,采用正交试验设计对处方进行优化,以处方中乳糖的用量、微晶纤维素内外加的比例、低取代羟丙基纤维素的用量及粘合剂的浓度为因素进行处方的优化。对优化后处方所制片剂进行体外溶出度验证试验及影响因素( 高温、强光、高湿) 考察。结果最佳处方乳糖的用量10%(W/W)、微晶纤维素内外加的比例1: 3、低取代羟丙基纤维素的用量5%(W/W)%。%,影响因素试验中光照条件下制剂的稳定性均较好。结论各考察指标均符合规定,该处方工艺可靠。
【关键词】阿齐沙坦制备正交试验
【中图分类号】R94【文献标识码】A 【文章编号】2095-1752(2012)31-0119-03
Preparation and Quality of Azilsartan Dispersible Tablets
Wang Lin-sen(Junan Food And Drug Administration, Junan 276600, China)
【ABSTRACT】 OBJECTIVE: Azilsartan Tablets were prepared by granulation method, and to control its : The formulation of Azilsartan Tablets was optimized by orthogonal design using dissolution ratio as the main evaluation amount of lactose and low-substituted hydroxypropyl cellulose ,the ratio of internal and external MCC and the concentration of HPMC were used as factors. Then vertification test on the in vitro drug dissolution characteristics of the optimized tablets were performed and the influencing factors(high temperature, high light, and high moisture)were investigated as well. RESULTS:The optimized formulation of Azilsartan Tablets was as follows: 10%lactose, the ratio of internal and external MCC 3:1,
5%L-HPC and the concerntration of HPMC %. The drug dissolution was %. In the influencing factor test, the tablets were stable