Preparation And Quality Evaluation Of Pantoprazole Sodium Enteric-Coated Tablets

Pantoprazole Sodium Enteric-Coated Tablets is generally applied in the treatment of duodenal ulcer,gastric ulcer and relieve moderately severe reflux esophagitis.Pantoprazole Sodium belongs to benzene and imidazoles drugs.It is sensitive to heat,humidity and light.Thus,pantoprazole sodium is easily prone to spoiling during the preparation of the enteric-coated tablets.To meet the market demand,according to the national drug registration management approach,we developed the pantoprazole sodium enteric-coated tablets.The quality of the enteric-coated tablets were evaluated with the reference to the prescription,specification and quality standards of the listed pantoprazole sodium enteric-coated tablets.Object: Optimization of the prescription of pantoprazole sodium enteric-coated tablets.And preparation of qualified pantoprazole sodium enteric-coated tablets.Method: The content of pantoprazole sodium was detected by HPLC method.The precision,stability and recovery of the test method were evaluated.Referring to listed Pantoprazole Sodium Enteric-Coated Tablets,the best prescript was got after screened with the types and dosage of auxiliary material.The hardness of the tablet,acid resistance and dissolution degree were used as indexes to evaluate the quality of the tablets.The prescription of pantoprazole sodium enteric-coated tablets was optimized by single factor experiment and RSM.The self-made pantoprazole sodium enteric-coated tablets was compared with the listed pantoprazole sodium enteric-coated tablets in the aspect of tablet traits,weight difference,pantoprazole sodium content,acid resistance and dissolution.The effects of light,heat and humidity on tablet traits,weight difference,pantoprazole sodium content,acid resistance and dissolution were investigated.The results showed that the light,heat and humidity had a certain effect on pantoprazole sodium enteric-coated tablets.Results: The HPLC method is simple,reliable,rapid and exact,which could be used to detect the content of pantoprazole sodium content.The coating experiments indicated that the acid resistance and dissolution of pantoprazole sodium enteric-coated tablets meet its standards with the film thickness of isolation layer and coating layer above 3.0% and 14%,respectively.The quality of self-made pantoprazole sodium enteric-coated tablets was evaluated.The results showed that the various indicators of self-made samples are in line with the drug standardsand domestic listed product.The result of damp heat acceleration test showed that pantoprazole sodium enteric-coated tablets was stable in the wet heat(RH 75%,Temp 40 oC)for 6 months.The result of long-term test showed that the pantoprazole sodium enteric-coated tablets kept stable under the temperature of(25 ± 2)oC and humidityof(RH 60% ± 10%)for 6 months.According to the above results and the approval of the listed products,the pantoprazole sodium enteric-coated tablets is valid for 24 months.Conclusion: After verification,the qualities of the self-made samples are in line with the drug standards and domestic listed product.