Study On The Formulation And Quality Of Lansoprazole Tablet

Peptic ulcer severely endangers human’shealthy and affects quality of human life.As theinvestigation on secretionfunction of parietal cell and defense function of asstric mucousmembranecell develops,anti-peptic ulcer medicine has been greatly upgraded from themedicine of anti acid spasmolysis to the medicine with capability of restraining gastric acidsecretion function of parietalcell and intensify parietalcell defense function.The protor pumpinhibitor(PPI)restrains gastric acid secretion function through restraining protor pump(H+/K+-ATP enzyme).Lansoprazole is the compand of Fluoro-benzimidazole.It is the second PPI.Thepurpose of this experiment is to design a more stable formulation of Lansoprazole enteric-tablets. The main content of this paper includes the lansoprazole tablets before prescribingresearch and material stability, enteric-coated tablets preparation process research, qualityresearch, stability and research content, ultimately selected prescription has the advantages ofsimple process, stable is suitable for industrial production requirements of the prescriptionprocess and quality control standard.We optimized the formulation of Lansoprazole tabletsby an orthogonal design. The study by uniform design using form U5(54)with the drugrelease ate as the evaluation quota to decide the best preparing condition.The final formulation is: Lansoprazole15mg, MCC33.8mg, Mannito72mg, CMS-Na6.7mg, Poloxamer1.4mg, Mg stearate1.4mg,Na2CO3/NaHCO38mg/2mg.According to theBP2010,we confirmed the quality standard of the Lansoprazole Tablet and investigated thetablets stability of3lots product.The result as following:(1)the Lansoprazole tablets havestability quality after6months accelerated test,18monthslong-term test.The easilymanipulated and stable formulation process of Lansoprazole tablets was achieved.