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目的:采用光纤药物溶出度实时测定仪监测不同厂家生产的格列齐特片的体外溶出度,通过瞬时在线监测药片溶出情况,反映不同厂家生产的药片质量差异。方法:按照中华人民共和国卫生部部颁标准WS1-(X-103)-95Z规定检查格列齐特片溶出度的条件,利用光纤传感溶出度实时过程分析方法,对10个不同厂家的格列齐特片进行了实时监测。结果:所测10个厂家格列齐特片的溶出度均达到部颁标准要求,但它们的溶出曲线存在明显的差异,真实地反映出每片药物的溶出过程。结论:光纤药物溶出度原位在线监测反映了药物的体外溶出特性,为评价药品内在质量提供了更好的手段。
OBJECTIVE: To monitor in vitro dissolution of gliclazide tablets produced by different manufacturers by using optical fiber drug dissolution real-time detector to monitor the dissolution of tablets by instantaneous on-line to reflect the differences in the quality of tablets produced by different manufacturers. Methods: The condition of dissolution of gliclazide tablets was examined according to the standard of Ministry of Health issued by the Ministry of Health of People’s Republic of China WS1- (X-103) -95Z. The real-time optical fiber sensing dissolution process was used to analyze the dissolution rate of 10 different manufacturers Lizzy film for real-time monitoring. Results: The dissolution rates of Gliclazide tablets in 10 factories all met the ministry standard. However, there was a significant difference in their dissolution curves, which truly reflected the dissolution process of each drug. Conclusion: In-situ online monitoring of dissolution rate of optical fiber drug reflects the in vitro dissolution characteristics of the drug and provides a better means for evaluating the intrinsic quality of the drug product.