Research About Prescription And Quality Standard Of Repaglinide Tablets

OBJECTIVE:This research aimed at optimizing the prescription and preparation technology. Prepared qualified repaglinide tablets and Established HPLC method to determine repaglinide tablets for quality standard.METHOD:1. Screening and optimization:through the material compatibility, single actor such as diluent, adhesives, disintegrating agent, lubricant and the L9(34) orthogonal design selected the best prescription.2.Preparation technology:with wet granulation, dissolution and content uniformity as the main index to exame the influence of different process of repaglinide table and determine the best process.3. Quality standard research:pilot production of three groups of samples and tested its dissolution, content uniformity, related substances, isomeride and content, and established its quality standard by researching methodology Researched preparation stability by influencing factor test, accelerated test and long-term test.RESULT:1.Screening and optimizing:through single factor and orthogonal test screened the best repaglinide tablets prescription. Rg1.0g PS q.s (10%-25%) MCC67.7g PVP K305.0g CMS-Na5.0g ME q.s(<0.5%) Magnesium stearate0.3g Made1000pieces,100mg.2. preparation technology:by different process of investigation, finally determined the optimum preparation process for:repaglinide, PS and ME superfine grinding for25min,MCC\PVP-K30and CMS-Na sieved100mesh according to the prescriptions, poured into the blender stirring, and added water into superfine mixture made of soft material, with24mesh granulating, in50℃dried for2h, with20mesh granulating, joined magnesium stearate then mixed, preformed with6.5mm membrane mode, the weigh of tablets was100mg, including repaglinide1mg per piece.3. Quality standard research:established a HPLC method,determined the dissolution,content and content uniformity, related substances of repaglinide tablets, through the methodology validation, this method was accurate and feasible. Influencing factors, accelerated test and long-term test showed that the formulation stability was good. CONCLUSION:After optimization of prescription and process the preparation of repaglinide dissolution and content uniformity accorded with the USP and import standards, related substances and isomeride were not detected in three batches of samples.The parameters characteristics of repaglinide consistented with the original development agent.Figure32,table57,references46.