光纤传感实时分析法用于萘普生钠缓释片溶出度的测定

Monitoring the Dissolution Test of sodium Naproxen Controlled-Release Tablets by Optic Fiber Chemical Sensor Dissolution Test System and UV Spectrophotometry

目的:建立萘普生钠缓释片溶出度的测定方法。方法:采用浆法,转速5 r·min^(-1),以pH6.8磷酸盐缓冲液为溶出介质。利用萘普生钠在330nm处的紫外吸收,分别用光纤化学传感药物溶出度实时分析系统及紫外分光光度法检测溶出浓度,以作相互对照。结果:在98.6-443.7μg·mL^(-1)范围内,吸收度与萘普生钠的浓度成线性关系。两种测定方法无显著性差异(P>0.05)。结论:光纤化学传感药物溶出度实时分析系统在位在线、连续定量地反映了药物体外缓释特性,更贴近缓释制剂溶出的监控目标,结果可信。

Objective: Fiber optic chemical sensor dissolution test system(FOCSDT) and UV Spectrophotometry Method has been developed for the dissolution of Naproxen controlled-release tablets. Method: The drug dissolution concentration was detected respectively using the FOCSDT system and UV in 330nm. The absorbance measurements of FOCSDT system are corrected for turbidity-related scatter using two wavelengths. Results: The concentration of Naproxen Tablets was linear with F_0/F when concentration was ranged between 98. 6-443. 7μg?mL^(-1). There is no distinctly difference when compared to the two methods. Conclusion: As a procession analysis, FOCSDT system can show the real dissolution of drug and obtain the total information.