Improvement Of Quality Standard Of Polaprezinc Raw Materials And Evaluation Of Consistency Of Its Rreparation

This paper for Polaprezinc API related substances determination method for improvement,and the structure of main impurities in polaprezinchas carried on the appraisal,analysis of the potential sources,for the improvement of syn thesis process,provides the direction,and for Jilin Broadwell pharmaceutical production of polaprezinc particles and the consistency of the original drug quality was evaluated.The identification and analysis of main impurities in the cluster of polaprezinc were carried out.Enrichment of mother liquor and directional synthesis method is used in the preparation of poly(polaprezinc raw material possible impurities,by nuclear magnetic resonance(NMR)and ultraviolet spectrum identification of impurities,and its purity is determined,in order to establish the quality standard of active pharmaceutical ingredients.And researched on the material gathered polaprezinc API method,to re-examine the specificity of the method,found the original standard method for flow phase,and the irrational proportion of organic phase unable to detect each of these major impurities,shows the mobile phase for the improvement,and methodology verification.The improved method:chromatographic column with kuyt,C18 chromatographic column(250 mm x 4.6 mm,5 μm),water phase[take heptane 1.2 g sodium sulfonate,add water right amount of dissolved and diluted to 1000 ml,add 50 ml potassium hydrogen phosphate solution(174.17 g/L),blender,add 1 ml trifluoroacetic acid,blending,with phosphoric acid tone pH3.00]-acetonitrile(95:5)as mobile phase A,acetonitrile as mobile phase B,detection wavelength of 215 nm,flow rate of 1.0 ml/min,column temperature 30℃,gradient elution.The chromatographic conditions were established to detect all the impurities in the raw materials.The method was used to determine the simple and specific properties of the polaprezinc,and the results were accurate and reliable.In order to make the research more comprehensive,and finally for Jilin Broadwell pharmaceutical production of polaprezinc particles of generic drugs and the consistency of the original drugs in vitro dissolution curve is evaluated.Chose four different dissolution medium(pH=1.2,pH=5.0,pH=6.8)and water,adopt oar method,the speed of 50 respectively r/min,the high performance liquid chromatography(HPLC)method is adopted,the dissolubility in reference substance method to calculate,and draw the dissolution curve.Comparing the similarity factor method(f2)of Jilin pharmaceutical production and of great polaprezinc particles and the consistency of the original drug dissolution curve,the results show that we deal with the original prescription for further optimization,get the optimal prescription,and in a quality consistency evaluation,results show that the f2 factor was 70.32,88.31,73.66 and 70.32,respectively,the four curve of f2 are improved.