苯磺酸氨氯地平分散片的制备及质量考察.pdfVIP

安 徽 医 药 Anhui Medical and Pharmaceutical Journal 2010 Oct ;14 (10) ·114 1 · 苯磺酸氨氯地平分散片的制备及质量考察 徐玉萍 ( ， 231500) 安徽省庐江县中医院 安徽庐江 : ， 。 摘要 目的 研究苯磺酸氨氯地平分散片的制备工艺 并建立其溶出度测定方法和质量考察 方法 采用正交实验选择出以 (PH101) ， ， 羧甲基淀粉钠和微晶纤维素 为崩解剂 崩解剂内加和外加相结合的方法制成分散片 并采用紫外分光光度法测定其 。 ， ， ， 。 溶出度 结果 研制的苯磺酸氨氯地平分散片制备工艺简单 质量稳定 分散性能良好 检测方法可行 结论 该制剂处方合 ， ， ， 。 理 制备工艺简单 稳定性好 质量可控 : ; ; ; ; 关键词 苯磺酸氨氯地平 分散片 正交设计 溶出度 紫外分光光度法 Preparation and quality study of amlodipine besylate dispersible tablets XU Yu-ping (Hosp ital of Traditional Chinese Medicine ，Luj iang ，Anhui 231500 ，China) Abstract :Aim To develop a preparation process for amlodipine besylate dispersible tablets and establish its dissolution method． Meth- ods Amlodipine besylate dispersible tablets were prepared by using amlodipine besylate as principal agents with CMS-Na ，MCC (PH101)as supplementary materials． Disintegrants were added by the combination of internal addition and external addition ，the dissolu- tion of which was determined by UV spectrophotomery． Results The technology of preparation for dispersible tablets of amlodipine be- sylate is simple ，stable ，well dispersed and quick ，with feasible detection methods． Conclusion The recipe of the preparation is reasona- ble ，the technique is simple ，the products are stable and the quality is easy to be controlled． Key words :amlodipine besylate ;dispersible tablet ;orthogonal test ;dissolution ;UV spectrophotomery ， ， 、 、 (