目的 制備格列齊特片，進(jìn)行體外溶出一致性評(píng)價(jià)。方法 通過(guò)單因素實(shí)驗(yàn)考察黏合劑的濃度、外加崩解劑的量、外加潤(rùn)滑劑和助流劑的量、顆粒的大小和片劑的硬度幾個(gè)因素對(duì)溶出的影響，進(jìn)行處方工藝的篩選。放大制備3批格列齊特片，考察在4種不同溶出介質(zhì)中自制片和參比制劑的溶出一致性。結(jié)果 3批自制片在磷酸鹽緩沖液（pH7.4）中15 min內(nèi)溶出大于85%，在水、pH1.2鹽酸溶液、pH6.0磷酸鹽溶液中的f₂均大于50。結(jié)論 在4種不同的溶出介質(zhì)中，自制片與參比制劑體外溶出一致。

Objective To prepare gliclazide tablets and to evaluate its consistency of dissolution tests. Methods The single factor experiments were applied to investigating several factors on the dissolution, such as the amount of the adhesive, the amount of lubricant, the particle size and tablet hardness.708-DS Dissolution Tester was used to conduct the dissolution tests which were carried on four different dissolution media. Then the similar factor (f₂) was adopted to evaluate the similarity of dissolution between the original drug and generic drug. Results Three batches of homemade-tablets were eluted more than 85% within 15 min in phosphate buffered saline (pH7.4), and the f₂ values were greater than 50 in water, pH 1.2 hydrochloric acid solution and pH 6.0 phosphate solution. Conclusion In four different dissolution media, self-made tablets and reference formulations in vitro dissolution consistent.

國(guó)家“重大新藥創(chuàng)制”科技重大專(zhuān)項(xiàng)資助項(xiàng)目（2012ZX09301003-001-009）