摘要
目的比较3个厂家苯磺酸氨氯地平片体外溶出度。方法采用药典溶出度测定法[1]测定苯磺酸氨氯地平片的体外溶出度(转速分别为100和50 r.min-1),采用HPLC法测定溶出量,检测波长为236 nm[2],计算累积溶出百分率,并进行溶出参数(m,td,t50)分析。结果转速为100 r.min-1时,3个厂家苯磺酸氨氯地平片在30 min均溶出95%以上;转速为50 r.min-1时,3个厂家苯磺酸氨氯地平片在30 min均溶出85%以上。结论3个厂家生产的苯磺酸氨氯地平片均符合质量标准,但统计学分析表明厂家之间有差异。
OBJECTIVE To compare the dissolution of amlodipine besylate tablets from 3 Manufacturers. METHODS The content of amlodipine besylate was determined by HPLC with the detection wavelenghth at 236 nm. With a paddle rotated at 100 and 50 r · min^- 1 , the accumulated release percentage was calculated, and the dissolution parameters （m,td,t50） was compared. RESULTS The accumulative release percentage of amlodipine besylate tablets from 3 manufacturers at 30 min was over 95% and 85% when the paddle rotated at 100 r· min^-1 , and 50 r · min^-1 ,respectively. CONCLUSION Amlodipine besylate tablets from 3 manufacturers are within the quality standards, but there is quality difference among them.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2007年第4期326-328,共3页
Chinese Journal of Modern Applied Pharmacy
