Study On Thepreparation Of Lansoprazole Polymer Micelleand Its Tablet

Objective:Lansoprazole is a proton pump inhibitor with strong inhibitory effect on gastric acid secretion.Lansoprazole is characterized by poor solubility in water,short half-life,sensitivity to light,humidity and heat,and poor stability.It is made into a new dosage form of micelles.Methods:The LPZ content was determined by HPLC and LPZ-PM was prepared by emulsion solvent evaporation method.The optimal formulation and preparation process of lansoprazole polymer micelles were optimized according to single factor and Design Expert experiments,and characterized by differential scanning.And quality evaluation,determination of critical micelle concentration;using a single factor method,according to the physical and chemical properties of the model drug,select freeze-dried into powder;using BT-2001 laser particle size distribution analyzer to determine the particle size distribution,through differential thermal scanning(DSC The phase identification is carried out;the optimum prescription and preparation process of the lansoprazole polymer micelle sheet are optimized by taking the appearance,hardness and dissolution of the tablet;the establishment of the kansolinazole polymer micelle sheet The quality standard was compared with the dissolution rate of the lansoprazole polymer micelle sheet and the commercially available preparation.Result: HPLC determination of LPZ content is feasible;the best preparation method of lansoprazole polymer micelles is emulsion solvent evaporation method,the amount of carrier is 0.78 g,the pH value of buffer is 10.7,the type of organic solventis anhydrous ethanol,organic solvent The dosage is 2ml,the preparation temperature is 40 °C,triethanolamine is an alkaline stabilizer,and the spherical shape is spherical;the particle size distribution is uniform,the polydispersity coefficient is 0.774,the encapsulation efficiency is 84.24%,and the drug loading is 13.46 mg/g..DSC proved that lansoprazole is present in the micelle in an amorphous rather than crystalline state,with a critical micelle concentration of 0.0050g/100 ml,a pre-freezing temperature of-80 ° C,freeze drying to a temperature of-80 ° C,and a pressure of 0.08 pa.24 hours,lansoprazole polymer micelles were prepared by powder direct compression method with starch as filler;the quality standard of lansoprazole polymer micelles was established;lansoprazole polymer micelles and The tablet has good stability.Compared with the commercially available lansoprazole tablets,the dissolution rate of the polymer micelle sheet is at 150 minutes,while the commercial dosage form of lansoprazole is dissolved.The dissolution rate was 85.65%,which was less than the dissolution rate of the new dosage form,and its action time was also smaller than the new dosage form.Conclusion:The preparation of LPZ-PM is simple and reproducible.The solubility of LPZ is effectively improved,the property of light decomposition is improved,the bioavailability thereof is remarkably improved,and the preparation process of LPZ-PM sheet is well.For the future research of lansoprazole,laid the theoretical and experimental basis.Provide new ideas for the study of poorly soluble drugs.