格列齐特片(Ⅱ)溶出曲线的一致性评价研究  

Study on consistency evaluation curve of the dissolution of gliclazide tablets(Ⅱ)

作　　者：孔彬[1] 刘晓霞[1] 赵昕 KONG Bin;LIU Xiao-xia;ZHAO Xin(Department of Pharmacy,the Xinjiang Production and Construction Corps Hospital,Urumqi 830002,China;Pharmaceutical Instruments Supervision and Inspection Station,Shenyang Joint Logistics Support Center,Shenyang 110026,China)

机构地区：[1]新疆生产建设兵团医院药学部,新疆乌鲁木齐830002 [2]沈阳联勤保障中心药品仪器监督检验站,辽宁沈阳110026

出　　处：《实用药物与临床》2020年第10期920-922,共3页Practical Pharmacy and Clinical Remedies

基　　金：新疆生产建设兵团卫健委卫生科技计划项目。

摘　　要：目的通过光纤药物溶出度过程分析仪分析3个厂家格列齐特片(Ⅱ)的溶出曲线并采用f 2因子法评价相似性。方法选择测定光程为2 mm,采用光纤药物溶出度过程分析仪在测定波长226 nm处,测定3个厂家格列齐特片(Ⅱ)的溶出曲线,通过相似因子f 2法评价不同厂家溶出曲线的相似性。结果国内仿制药与原研格列齐特片(Ⅱ)实时溶出曲线相似,但存在片间差异。结论本实验选用的方法简便、数据真实可靠,可为缓释制剂体外溶出曲线的相似性提供参考方法。Objective To analyze the dissolution curves of gliclazide tablets of three different manufacturers(Ⅱ)by the real-time process monitoring method,and to evaluate the similarity by f 2 factor.Methods Dissolution curves of gliclazide tablets(Ⅱ)from three different manufacturers were attained by the fiber-optic dissolution process monitor at wavelength of 226 nm in different mediums against 2 mm in the detection length,and were evaluated with the f 2 similarity factor method.Results The two domestic products were all in line with the original tablet in the dissolution curve similarities,but there were differences between the domestic products and original tablet.Conclusion The method is convenient and the data is reliable,which provides a reference method for consistency evaluation of the dissolution curves in vitro of sustained release preparation.

关 键 词：格列齐特 溶出曲线 光纤药物溶出度过程监测仪 相似性 

分 类 号：R927[医药卫生—药学]