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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
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| 篇名： | 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 |
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| 摘要： | 目的：评价阿折地平片自制制剂与原研制剂溶出曲线的相似性，为其质量控制和临床使用提供参考。方法：采用桨法，转速为50 r/min，分别以500 ml的pH1.2盐酸-氯化钠缓冲液、pH4.0乙酸盐缓冲液、pH6.8磷酸盐缓冲液和水为溶出介质进行溶出度试验，用光纤药物溶出实时测定仪测定阿折地平片自制制剂与原研制剂中主成分在不同时间点的累积溶出度，并与紫外-可见分光光度法测定结果进行比较，进而绘制溶出曲线，采用相似因子（f2）法评价二者溶出曲线的相似性。结果：光纤药物溶出实时测定仪测定的累积溶出度结果与紫外-可见分光光度法测定结果无明显差异。阿折地平片自制制剂与原研制剂在各溶出介质中溶出曲线的f2均＞50，说明二者溶出曲线具有相似性，但在后3种溶出介质中自制制剂较原研制剂溶出度略低。结论：采用光纤药物溶出实时测定仪能够准确、方便地提供药物的实时溶出度数据，反映药物的动态溶出过程，为全面考察药物的内在质量提供有力的检测手段。而阿折地平片自制制剂的处方和工艺仍有待进一步研究。 |
| ABSTRACT： | OBJECTIVE： To evaluate the similarity of dissolution curves in vitro of Azelnidipine tablet between the self-prepared 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 solution， pH4.0 Acetate buffer solution， pH6.8 Phosphate buffer solution， fiber-optic dissolution tester was used to detect the cumulative 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 real-time detector and UV-visible spectrophotometry. f2 Similarity factors were more than 50 and the dissolution curves of the self-prepared 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. |
| 期刊： | 2016年第27卷第33期 |
| 作者： | 张晖，张伟，郭庆明，萧伟 |
| AUTHORS： | ZHANG Hui，ZHANG Wei，GUO Qingming，XIAO Wei |
| 关键字： | 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 |
| KEYWORDS： | Azelnidipine tablet； Fiber-optic dissolution tester； Dissolution curve； f2； Evaluation |
| 阅读数： | 321 次 |
| 本月下载数： | 0 次 |
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