头孢克肟颗粒剂的研究

目的研究制备头孢克肟颗粒剂。方法筛选头孢克肟颗粒的处方工艺，建立质量控制方法，进行稳定性考察和人体相对生物利用度试验。结果样品的装量差异、粒度、干燥失重及含量等均符合质量标准要求；经加速试验(40℃，RH75％)6个月和室温(25℃，RH60％)留样考察24个月，各项考察指标(性状、粒度、微生物学检查、含量测定、有关物质)符合质量标准规定。与日本藤泽药品工业株式会社进口的世福素颗粒相比，相对生物利用度为105．6％。结论本品的制备工艺简单，质量稳定，与进口产品世福素生物等效。

The research and preparation of cefixime granules

OBJECTIVE To study and prepare cefixime granules.METHOD To study the formulation and preparation of cefixme granules, develop the methods of control quality, and test the stability and relative bioavailability.RESULTS The results of stability complied with the requirements of quality, and the human relative bioavailability was 105.6%, as compared with the control granules.CONCLUSION The preparation of cefixime granules is simple, the quality can be controlled, and it is bioequivalent with import granules.