Abstract: To prepare ultrafine glimepiride powders and improve the dissolution in vitro of glimepiride tablets, ultrafine glimepiride powders were made by jet mill. The dissolution curve of glimepiride tablets was determined by the method of high performance liquid chromatography. The similarity was evaluated with the reference preparation glimepiride tablets using the similarity factor f₂ method referred by the U. S. Food and Drug Administration. The results show that the median diameter d₅₀ of ultrafine powders is 1.30 μm. The distribution of particle size is between 0.40 and 5.85 μm. The similarity factors of dissolution curves of three batches of tablets are respectively 54.0，57.7 and 53.6. The dissolution in vitro of glimepiride tablets is improved by micronization. The dissolution action is similar with that of the reference preparation.

Keywords： micronization; glimepiride tablet; dissolution curve; similarity factor

中图分类号：R944.4       文献标志码：A

文章编号：1008-5548（2014）02-0031-04

DOI:10.13732/j.issn.1008-5548.2014.02.007

收稿日期：2013-06-06， 修回日期：2013-07-09，在线出版时间：2014-05-04。

第一作者简介：肖亚宝（1963—），男，工 程 师，研究方向为药物制剂研发。 电话：13957321979，E-mail:xyb6129928@163.com。

通信作者简介：文君（1967—），男，高级工程师，研究方向为药物制剂研发及质量标准。 电话：0573-86120154，E-mail：18857373377@139.com。