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目的:比较光纤法与进口药品注册标准法对甲磺酸多沙唑嗪缓释片的释放度测定结果。方法:采用FODT-601型光纤药物溶出度实时测定仪,以氯化钠的盐酸水溶液为溶出介质,桨法,转速75 r·min-1,246 nm作为测定波长,550 nm作为参比波长,测定光程为5.0 mm。比较光纤法与进口药品注册标准法的释放度。结果:甲磺酸多沙唑嗪在0.468 1~11.700 0μg·ml-1浓度范围内线性关系良好,r均大于0.999 5,日内、日间精密度RSD(n=6)分别为1.6%和2.0%,平均加样回收率为99.0%,RSD为1.4%(n=9);比较光纤法与进口药品注册标准法,两者的释放度测定结果有一定差异。结论:光纤法获得的数据信息完整,实时反映,药物的体外溶出过程,在速释和缓、控释制剂的释放度测定中优势尤为突出,但该方法尚不能替代进口药品注册标准法。
OBJECTIVE: To compare the results of determination of release of doxazosin mesylate sustained release tablets by optical fiber method and imported drug registration standard method. Methods: FODT-601 optical fiber drug dissolution real-time detector, sodium chloride aqueous solution as the dissolution medium, paddle method, speed 75 r · min-1,246 nm as the determination wavelength, 550 nm as the reference wavelength, the determination of light The distance is 5.0 mm. Comparison of optical fiber method and imported drug registration standard method of release. Results: Doxazosin mesylate had a good linearity in the concentration range of 0.468 1 ~ 11.700 0μg · ml-1, r> 0.999 5, intra-day and interday precision RSD (n = 6) were 1.6% and 2.0 %, The average recovery was 99.0%, the RSD was 1.4% (n = 9). There was some difference between the two methods in the comparison of optical fiber method and imported drug registration standard method. Conclusion: The data obtained by the optical fiber method is complete and real-time information. The in vitro dissolution process of the drug is particularly advantageous in the determination of release from controlled release and immediate release. However, this method can not replace the Imported Drug Registration Standard.