摘要
目的:考察苯磺酸左旋氨氯地平片在盐酸溶液(9→1000)、醋酸-醋酸钠缓冲液(pH4.5)、磷酸盐缓冲液(pH6.8)、水等介质中的溶出度。方法:采用《中国药典》2010年版二部附录XC第三法操作,转速为50r/min,以紫外分光光度法测定溶液的光密度并计算溶出度。结果:两厂家苯磺酸左旋氨氯地平片在不同溶出介质中的溶出曲线基本一致,在盐酸溶液(9→1000)中的累积溶出度最高。结论:苯磺酸左旋氨氯地平片为碱性物质,溶出速率受介质的pH影响较大。
Objective: To evaluate the dissolution properties of levamlodipine besylate tablets in four different media, including hydrochloric acid solution (9→1 000), acetic acid-sodium acetate buffer (pH 4.5), phosphate buffer (pH 6.8) and water. Methods: The third dissolution method in Chinese pharmacopoeia was adopted to dissolve tablets at 50 r/min. Optical density of the solution was determined by UV spectrophotometry at wave length of 238 nm and then dissolution was calculated. Results: The dissolution profiles of levamlodipine besylate tablets from 2 different manufacturers in different media were basically same. The accumulated dissolution in hydrochloric acid solution was the highest. Conclusion: levamlodipine besylate tablets are alkaline substances and the dissolution rate is strongly affected by pH of the medium, so hydrochloric acid solution (9→1 000) was chosen as the dissolution medium of levamlodipne besylate tablets.
出处
《上海医药》
CAS
2012年第23期50-52,共3页
Shanghai Medical & Pharmaceutical Journal