不同厂家苯磺酸氨氯地平片溶出度考察

目的:对7厂家苯磺酸氨氯地平片进行溶出度实时监测,考察各产品的质量。方法:采用光纤药物溶出度实时测定仪(桨法),进行溶出度测定,对实时溶出数据和相对溶出百分率(C)与溶出时间(t)图进行分析。结果:一厂家的2批次苯磺酸氨氯地平片的溶出度测定结果未达到国家药品标准[WS_1-(X-010)-2001Z]要求.其他均符合要求。结论:建议对需长期服用、治疗窗较窄或起效时间短的药品进行溶出度实时监测。

Study on dissolution of amlodipine besylate tablets from different pharmaceutical factories

Objective:To study the quality of amlodipine besylate tablets from seven different pharmaceutical facto- ries with the new method for fiber-optic real time dissolution test system.Method:By using fiber-optic real time dissolution test system to carry out the dissolution test and analyze the relative data.Results:The dissolution of am- lodipine besylate tablets from six of pharmaceutical factories fulfilled the requirements of national drug standards. Conclusion:This paper suggests using the fiber-optic real time dissolution test system to monitor the medicine which need long-term usage,narrow therapeutic window or need effect immediately.