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目的:考察3个厂家酮洛芬缓释胶囊的释放度,为质量控制提供依据。方法:采用转篮法,转速100 r.min-1,以磷酸盐缓冲液(pH6.8)1 000 mL为溶出介质,分别采用FODT-601FX光纤溶出度仪和紫外分光光度法测定释放度。结果:不同厂家同一规格和同一厂家不同规格样品的溶出曲线存在差异,2种测定方法无显著差异(P>0.05)。结论:光纤溶出仪可对缓释制剂的释放过程实时、连续监测,操作简便,结果可信。
OBJECTIVE: To investigate the release of ketoprofen sustained-release capsules from three manufacturers to provide basis for quality control. Methods: The spinach method was used with 100 r.min-1 rotation speed and 1 000 mL phosphate buffer (pH 6.8) as dissolution medium. The release rate was measured by FODT-601FX optical fiber dissolution tester and UV spectrophotometry. Results: The dissolution profiles of different manufacturers with the same specifications and different specifications of the same manufacturer were different. There was no significant difference between the two methods (P> 0.05). Conclusion: The optical fiber dissolution apparatus can monitor the release process of sustained-release preparations in real time and continuously, with simple operation and credible results.