中国药房2016，Vol.27Issue(33)：4739-4741,4742,4.DOI:10.6039/j.issn.1001-0408.2016.33.44
光纤药物溶出实时测定仪结合f2法评价阿折地平片自制制剂与原研制剂溶出曲线的相似性
Evaluation of the Similarity of Dissolution Curves in vitro of Azelnidipine Tablet between the Self-prepared and Original Preparations by Fiber-optic Dissolution Tester and f2
张晖 1张伟 2郭庆明 1萧伟2
作者信息
- 1. 江苏康缘药业股份有限公司，江苏连云港 222001
- 2. 中药制药过程新技术国家重点实验室，江苏连云港 222001
- 折叠
摘要
Abstract
OBJECTIVE:To evaluate the similarity of dissolution curves in vitro of Azelnidipine tablet between the self-pre-pared and original preparations,and provide reference for its quality control and clinical application. METHODS:Paddle method was used at rate of 50 r/min,and dissolution test was conducted with media of 500 ml pH1.2 Hydrochloric acid sodium chloride so-lution,pH4.0 Acetate buffer solution,pH6.8 Phosphate buffer solution,fiber-optic dissolution tester was used to detect the cumula-tive dissolution the main ingredients in Azelnidipine tablet between the self-prepared and original preparations at different time points,and compared with the results of UV-visible spectrophotometry,then dissolution curve was plotted,f2 was used to evaluate the similarity of their similarity. RESULTS:There was no obvious difference in the results between fiber optic drug dissolution re-al-time detector and UV-visible spectrophotometry. f2 Similarity factors were more than 50 and the dissolution curves of the self-pre-pared and original preparations were similar in the different dissolution media,while the dissolution was relatively low in the last 3 media. CONCLUSIONS:Fiber-optic dissolution tester can accurately and conveniently provide the real-time dissolution and reflect its dynamic dissolution process,which provides an effective way to investigate the inner quality of drug completely. However,the formulation and technology of the self-prepared preparation of Azelnidipine tablet need to be further studied.关键词
阿折地平片/光纤药物溶出实时测定仪/溶出曲线/相似因子法/评价Key words
Azelnidipine tablet/Fiber-optic dissolution tester/Dissolution curve/f2/Evaluation分类
医药卫生引用本文复制引用
张晖,张伟,郭庆明,萧伟..光纤药物溶出实时测定仪结合f2法评价阿折地平片自制制剂与原研制剂溶出曲线的相似性[J].中国药房,2016,27(33):4739-4741,4742,4.
