格列齐特片的实时溶出度对比分析研究

Analysis and comparison on real-time dissolution of gliclazide tablets

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 investigate the difference in qualities among gliclazide tablets from different pharmaceutical factories with the new method for fiber-optic real time dissolution test system.Methods：According to the standards of the Ministry of Health（WS1-（X-103）-95Z）,the dissolution curves of Gliclazide tablets from ten pharmaceutical factories were determined by fiber-optic real time dissolution test system.Results：The dissolutions of gliclazide tablets from ten pharmaceutical factories met the requirements of national drug standards.Significant differences were observed in their dissolution curves.Conclusion：The real-time dissolution test can reflect the in-vivo dissolution characteristics of drugs,so the real-time dissolution curves provide good means of evaluating the intrinsic quality of medicines.