光纤药物溶出原位过程监测仪评价茶苯海明片的体外溶出度

目的:使用光纤药物溶出原位过程监测仪实时监测不同厂家及批号的茶苯海明片的体外溶出度,以评价其工艺质量。方法:监测仪设置条件为测定波长278nm、基准校正波长550nm,光纤探头规格为2mm,温度37℃,转速50r·min-1,数据采集间隔时间30s,介质为水900mL;采用桨法测定各样品溶出度,并与《中国药典》法比较。结果:监测仪测定结果表明,茶苯海明片所有样品溶出度均符合《中国药典》的相关规定,但溶出曲线不同,即溶出过程存在差异;同一批号的样品采用监测仪及药典法测定虽然45min时的溶出度结果比较无显著性差异,但溶出曲线有差异。结论:与《中国药典》法比较,光纤药物溶出实时监测仪可准确连续地反映药物的溶出过程,获得的数据更加完整、真实,可用于评价产品的体外溶出过程。

Evaluation of in Vitro Dissolution of Dimenhydrinate Tablets by Fiber-optic Dissolution Monitor

OBJECTIVE： To monitor the in vitro dissolution of Dimenhydrinate tablets from different manufacturers by Fiber-optic dissolution monitor, and to investigate the quality of it. METHODS： Detection wavelength was set at 278 nm and calibration wavelength was 550 nm. The dissolution was monitored with 2 mm fiber optic probe at rotation speed of 50 r·min-1. Each dimenhydrinate tablet was dissolved in 900 mL of water at 37 ℃. Dissolution data were collected every 30 seconds. The paddle method was used to determine the dissolution of samples and compared with the method stated in Chinese Pharmacopeia. RESULTS： The results of dissolution monitoring showed the dissolutions of different batches of samples were qualified to the standards of Chinese Pharmacopoeia, but a significant difference was observed in their dissolution curves, i.e there was difference in dissolution process. There was no significant difference in the dissolution of same batches of samples at 45 min using monitor and the method of Chinese Pharmacopeia. But the dissolution curves of them were different from one another. CONCLUSION： Compared with the method of Chinese Pharmacopeia, the fiber-optic dissolution monitor is capable of monitoring the real dissolution process of drug and supplying more complete and accurate details of the dissolution process. It can be used to evaluate in vitro dissolution process of drug.