注射用兰索拉唑制备、质量控制及稳定性考察___

Objective：To prepare lansoprazole for injection,establish its quality control and determine its stability.Methods：The type and dosage of the excipients in the formula were optimized the lansoprazole for injection，with its content determined by HPLC.Meanwhile its stability was tested.Results：50 mg per bottle mannitol solution was selected with 0.1 mol·L^-1 sodium hydroxide solution as the major excipient adjusting pH to 11.0;The linear range of lansoprazole was 20.51-205.1 μg·mL^-1,r=0.9999(n=5);No obvious changes were observed at 6 months of an accelerated test or 24 months of long-term storage test.Conclusion：The preparation is controllable and stable in quality，and the established method is reliable and specific for the quantitation of lansoprazole.