Study On Preparation, Quality Control And Stability Of Arginine Ibuprofen Rapidly Disintegrating Tablets

Objective: To select optimal composing of the prescription of arginine ibuprofen rapidly disintegrating tablets; to establish a method to determine the assay and the dissolution for arginine ibuprofen rapidly disintegrating tablets; evaluate the stability of the agent rudimentary.Methods: Using the disintegrating time and dissolubility for selecting the best amount of arginine ibuprofen rapidly disintegrating tablets and using a HPLC method for the quality standard, an Kromasol-C18(250mm×4.6mm, 5μ) column was used with a mobile phase consisted of mixer of methanol-phosphate buffer(adjusted to pH=3 with phosphate acid)(75: 25), detected at 220nm, flow rate 1.0 mL.min^-1; using acceleration experiment, factors influencing experiment and long-term experiment to analyze the stability.Results: The surface of the tablets is smooth, the disintegration time of the rapidly disintegrating tablets were not exceeded 1 minute; the linear range of arginine ibuprofen was 4-80μg.mL^-1(r =1.000), the average recovery of arginine ibuprofen was 101.2% (n=9, RSD=0.99%); the rapidly disintegrating tablets was stable.Conclusion: The method of preparing the arginine ibuprofen rapidly disintegrating tablets is feasible and the method of quality control is simple and reliable. The rapidly disintegrating tablets is expected to be an ideal agent.