The Studies Of The Production Process And Quality Standards Of Cefprozil Tablets

Cefprozil tablets are second-generation cephalosporins,with broad-spectrum antibacterial action.The main ingredient of cefprozil tablets is cefprozil.Cefprozil as oral cephalosporin antibiotic,has high efficacy,side effects,broad spectrum antimicrobial,etc.Cefprozil with good antibacterial activity are commonly used drugs for the treatment of infections caused by susceptible bacteria diseases,against Gram-positive bacteria and gram-negative bacteria.Cefprozil clinical widely used,mainly for light-sensitive strains caused moderate infections,including respiratory tract,skin and soft tissue infections.The products are stable to β-lactamase,renal toxicity than the first-generation cephalosporins,high blood concentration.In this paper,cefprozil tablets were studied production processes and quality standards.In the production process,to determine its production process,the role of main ingredients,excipients and an excipient.Firstly,the production process of cefprozil tablets studied.According to the main content of cefprozil tablets determine choose to optimize their prescription,Cefprozil given specifications sheet 0.25g,their prescription is:cefprozil 131.5g,lactose 12.5g,microcrystalline cellulose 40.0g,starch 6.0g,cross-linked sodium carboxymethyl cellulose 2.5g,Magnesium stearate 1.5g,according to the production process of production 500 cefprozil tablets as a small test sample.Among them,the lactose as a filler in the formulation,both microcrystalline cellulose disintegration role in filling the role of another prescription,starch as a binder in the formulation,cross-linked sodium carboxymethyl cellulose as applied in the formulation collapse solution agent,magnesium stearate as a lubricant in the formulation.Secondly,we do some experiments about the qualitative and quantitative analysis to do make the quality standard.In the qualitative aspects,studied traits,identification,inspection etc..In the quantitative analysis,the content determination,system test of stability,and the method validation.Through the relevant provisions of the control and the Pharmacopoeia andcommercially available Cefprozil Tablets’s,determine the quality standardsand control index Cefprozil Tablets.During the experiment,we use HPLC to identify them.In the inspection items,the weight difference cefprozil,water,disintegration,friability,which adhere to the pharmacopoeia.Finally,we do the finished product stability studies.According to the basic requirements for stability,the stability of cefprozil tablets were investigated,were accelerated testing and long-term stay kind experiment.Accelerated test results showed that:accelerated test six months after study,no significant changes in the indicators,sterility test results meet the requirements.Cefprozil tablets was 12 months long stay kind study,no significant changes in the indicators,through a sterile examination,test results meet the requirements.Acceleration experiments and experimental results show that long-term stay like a good piece of cefprozil stability,reliable performance,suitable for industrial production.Through this research,production processes and quality standards to determine cefprozil tablets,to achieve a qualitative and quantitative control products,has laid a good foundation for the products of industrial production.