摘要
目的:研究难溶性药物格列喹酮的片剂工艺制备及提高溶出度测定结果的方法。方法:通过球磨机对原料进行不同程度的微粉化,通过三因素三水平正交设计法优化处方,并进行溶出度试验。结果:格列喹酮原料经过2、4和6h不同时间微粉化处理后进行观察,发现经4和6 h微粉化后其粒径能被控制在50μm以下,其中以4 h微粉化结果较好,不产生强吸附,易于进行制剂操作,且所制片剂较未微粉化原料所制片剂的溶出度有明显提高。结论:经4h微粉化处理格列喹酮后,粒径较小且可操作性强,明显提高了片剂的溶出度,工艺比较简单,适用于大生产。
OBJECTIVE To research the preparation of gliquidone tablets and improve the method of dissolution. METHODS Micronized the raw materials by pebble mill, optimized the preparations by orthogonal design and determined the dissolution. RESULTS The particle diameter could be controlled under the 50 μm after 4 and 6 hours by the micronization ; 4 - hour could be used easily and the dissolution of the tablets can be improved clearly. CONCLUSION The micronization can obviously improve the dissolution; the preparation is easy and suitable to production.
出处
《天津药学》
2007年第5期26-29,共4页
Tianjin Pharmacy
关键词
格列喹酮
正交设计
微粉化
溶出度
gliquidone, orthogonal design, micronization, insoluble dissolution
