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目的:考察光纤化学传感仪实时、在线过程监测多潘立酮片体外溶出度测定方法的可行性。方法:采用DT-601型光纤传感药物溶出度/释放度原位过程监测仪,同时监测6片多潘立酮片体的药溶出过程,双波长法(284/350 nm)消除赋形剂干扰,计算机处理数据、实时显示药物溶出/释放曲线及打印结果,并与部颁标准WS1-(X-185)-97Z规定方法作比较。结果:本法自动监测药物溶出的全过程,实时显示完整的药物溶出曲线及数据,直接提取溶出度参数,与部颁标准方法比较,Td、T50及累积溶出百分率差异均无统计学意义(P>0.05)。结论:光纤药物溶出度过程监测法能够有效测定药物的溶出度。免除了补液、过滤、稀释等手续,减少人为操作误差,结果准确。
OBJECTIVE: To investigate the feasibility of the method for the determination of dissolution of domperidone tablets in vitro by a real-time on-line and optical fiber chemical sensor. Methods: The dissolution rate / release in situ process monitor was measured by DT-601 optical fiber. Meanwhile, the drug dissolution process of 6 domperidone tablets was monitored. The interference of excipients was eliminated by dual wavelength method (284/350 nm) The data was processed, drug dissolution / release curves and print results were displayed in real time and compared to the method prescribed in the ministerial standard WS1- (X-185) -97Z. Results: The method automatically monitors the whole course of drug dissolution, displays the complete dissolution curve and data in real time and directly extracts the dissolution parameters. There is no significant difference in Td, T50 and cumulative dissolution percentage between the two methods (P > 0.05). Conclusion: The optical fiber drug dissolution process monitoring method can effectively determine the drug dissolution. Eliminate the rehydration, filtration, dilution procedures, reduce human error, the result is accurate.