Preparation and Quality Control of Duzhong Pingya Dispersible Tablets / 中国药房

ABSTRACT

OBJECTIVE:To prepare Duzhong pingya dispersible tablets and establish their quality control.METHODS:The ratios of the excipients were optimized with disintegrating time,dispersible uniformity and compressibility as indexes.The Duzhong pingya dispersible tablets were prepared by trituration,and the content of chlorogenic acid was determined by HPLC.RESULTS:The optimized ratios of the excipients were as follows:manicol 60 g,microcry stalline cellulose 40 g,low-substituted hydroxypropyl cellulose 30 g,gum arabic 20 g,crospovidone 4 g,magnesium stearate 2 g,edulcorant 2 g,and plasdone vis quantum.The optimized Duzhong pingya dispersible tablets were brown in color and up to the standard in dispersible uniformity.The linear range of chlorogenic acid was 1.882～18.820 ?g(r=0.999 9)and its average recovery rate was 99.2%(RSD=1.63%,n=6).CONCLUSION:The ratios of the excipients were up to the standard required for the preparation technology,and the established quality standard is applicable for the quality control of Duzhong pingya dispersible tablets.