The Pharmaceutical Study On Suspending Granules Of Cefixime

Cefixime, an effective third-generation cephalosprins, is a broad spectrum antibiotic, which has an effect of being against gram negative and gram positive bacterium. There are many kind of preparations of Cefixme in the clinical application, including pills, capsule and graules. Currently, The Cefixme and its different formulation have been loaded by The ChP 2010 and the qualities of standards are highly improved.There was no uniform quality of standard to the preparation of Cefixime before. In such circumstances, there has many defects in the application of Cefixime granules, and the quality does not meet the requirement of ChP 2010. Therefore, the study is going to develop the formulation and technology of granules of Cefixime in order to meet the requirement of the new quality standard.The research is basing on the basic guiding principle of reserchr of the Pharmaceutical Preparation, meanwhile, making a reference to the prescription of the originator in order to redesign an better preparation prescription and procedure for Cefixime granules.In addition, selected the originator product for reference, and made a methodological studies for the testion conditions. Made a comparison in the quality of two different prescription by the stardard of ChP 2010. To determine the dissolution percentage by authorized methods from ChP 2010, the methods were authenticated in different mediums introduced, and the similary of dissolution curve was evaluated by f2 factor.Some defects was found out in the reference produce, such as drug suspension, related substance over the limit.To solve these problems,the addintion of suspending agent is essential. In addition, Optimizated the prescription and the formulation of preparation. Finally a best prescription process was found. To compare with Cefixime granules of Reference Product, the similarity factors of the dissolution curve from manufacturers were 56.66,69.24,69.46 and 77.64 in mediums of aid, water, PBS6.8 and PBS7.2 respectively.The preparation and quality standards of Cefixime Granules is reasonable suitable for industrial mass production, and the dissolution of characteristics of the test product was similar to the reference product.