Prescription Process Optimization And Quality Standard Assessment Of Troxerutin Tablets

Troxerutin is an improved material from Rutin,which exhibits a variety of pharmacological effects.It exhibits inhibition effects of erythrocyte and platelet aggregation.It can prevent thrombosis,dredge blood vessels,increase the oxygen concentration in blood,improve microcirculation,and promote neovascularization to enhance the collateral circulation.It is widely used in the treatments of phlebosis,cerebrovascular disease,and diabetes.Good therapeutic effects were achieved in clinic.It has a significant effect on analgesia.Troxerrutin Tablet is suitable for the treatments of occlusion syndrome,thrombotic phlebitis,capillary hemorrhage etc.It is commonly used in clinical treatment of occlusive cerebrovascular disease.The advantages of this drug are mild effect,less adverse reaction,convenient usage and so on.The quality standards of Troxerrutin Tablets were updated in 2014."Disintegration" and "Other Luding hydroxyethyl derivatives" were eliminated,and "Dissolution" and "Other components" were added.After the inspection of product with original prescription process,it was found that the dissolution of the project was close to the upper limit.It was needed to carry on the research of prescription improvement and process optimization.This paper could be divided into four parts.First,it was proved that the prescription process should be optimized through the evaluation of the original process and quality standards.In the second step,prescription and preparation process of Troxerrutin Tablets were investigated.Oral solid preparation of dissolution was affected by many factors,such as drug crystalline particles size,crystal form,disintegration agent adding method,filler,lubricant,and surface active agent.Disintegration agent,lubricant and surfactant were investigated to improve the preparation process.In addition,the optimized formulation and preparation process were confirmed.Three batches of pilot-plant production(process validation)were manufactured.In the third phase,three batches productions were carried out with identification,dissolution,weight difference,content determination,and other components(the largest single impurity,other single miscellaneous,total miscellaneous)studies.The method of Pharmacopoeia was confirmed.The quality standard of Troxerrutin Tablets was improved.In the fourth part,accelerate and long-term stability of the three batches of amplified products(process validation)were carried out with stress testing,accelerated test and long-term stability test studies.The results indicated that the optimized formulation was good quality and preparation process was stable.