用光纤过程监测不同厂家螺内酯片的溶出度

目的：对6个厂家生产的螺内酯片进行溶出度的实时监测,考察并评价其工艺质量。方法：采用光纤药物溶出度实时测定仪进行溶出度测定。采用桨法,以含0.1%十二烷基硫酸钠的0.1 mol/L盐酸溶液1 000 ml为溶出介质,设定水浴温度37℃,转速75 r/min,检测波长242 nm,参比波长550 nm,用3 mm探头监测螺内酯片的溶出曲线,对实时相对溶出百分率与溶出时间进行作图分析。结果：各厂家螺内酯片的溶出度均符合《中华人民共和国药典》规定,但溶出曲线和溶出速率存在差异。结论：利用光纤药物溶出度实时测定仪监测螺内酯片的溶出度,可以实时、连续、动态、定量地监测药物的溶出过程,直观地反映各厂家同种药品溶出过程的差异,为全面评价药品的内在质量提供参考。

Fiber-optic process monitoring of the dissolution of spironolactone tablets produced by different factories

Objective:To monitor the dissolution of spironolactone tablets produced by 6 factories and evaluate the quality of the tablets.Methods:The dissolution of the tablets was monitored by fiber-optic dissolution test system.Each spironolactone tablet was dissolved at 37 ℃ in 1 000 ml of 0.1 mol/L hydrochloric acid solution containing 0.1% sodium lauryl sulfate.The detection wavelength was set at 242 nm while the reference wavelength was 550 nm.Paddle method was used at the rotation rate of 75 r/min and the dissolution was monitored with 3 mm fiber-optic probe. Dissolution data and the relative dissolution rate-time curves were obtained and analyzed in the test.Results:The dissolution of spironolactone tablets produced by all of the 6 factories was up to the standard of Pharmacopoeia of the People's Republic of China,but differences were observed in the dissolution curves.Conclusion:The fiber-optic dissolution test system can provide real-time information and complete and accurate details during the dissolution process,so that the differences of dissolution among the same drug from different factories can be detected.An overall assessment of internal quality of drugs can be obtained by using fiber-optic dissolution test systerm.