Study On The Application Of Tablets Coated With Aqueous Hydroxypropyl Methylcellulose Phthalate(HPMCP) Nanoparticles

This essay studied the application of aqueous hydroxypropyl methylcellulose phthalate (HPMCP) nanoparticles in tablets enteric coating by means of erythromycin as a model drug.The best formulation of erythromycin plain tablet and erythromycin enteric tablet coating solution were determined. The best technology of tablet coating was also determined.As comparable,we found the acid resistance , the entero-dissolvability and the quality stabilization of erythromycin enteric tablet prepared by new formulation were obviously improved.Firstly, the clinical application and quality criteria successive changes of erythromycin at the every pharmacopoeia edition was briefly introduced, the various kinds of problems of commonly used coating material and coating technologies used in preparing erythromycin enteric tablets were discussed. The quality problem of erythromycin enteric tablets could fundamentally solved by using aqueous hydroxypropyl methylcellulose phthalate (HPMCP) nanoparticles to carry out enteric coating.Secondly,the preparing technology of aqueous hydroxypropyl methylcellulose phthalate (HPMCP) nanoparticles was studed.The different diameter HPMCP nanoparticles were prepared by controlling the reaction conditions.Thirdly, the assay method of erythromycin enteric tablet core was determined by detection wavelength choice, linear relationship consideration, precision experiment and recovery test .the formulation of erythromycin plain tablets was screened by orthogonal design method,and the best formulation of per ten thousand tablets was: L-HPC 90g, CMSNa 40g, Tween-80 8g. The rationality of formulation was validated by reproducibility experiment. Fourthly, the formulation of erythromycin enteric tablet coating solution and coating technology was screened. The best formulation: HPMCP nanoparticles diameter was 122nm , coating solution solid contention was 20%, PEG6000 as plasticizer. The best technology: spray gun speed was 10ml.min^-1, airblast pressure was 0.4mPa, increasing weight was 5%. The erythromycin enteric tablet was prepared by the best formulation and technology.At last, the stability and quality of erythromycin enteric tablet prepared by new and old formulation were compared.The result indicated that the acid resistance , the entero-dissolvability and the quality stabilization of erythromycin enteric tablet prepared by new formulation were advanced than the old one.