Study On The Preparation And Quality Control Of WUJIA-SHENGHUA Film Coating Tablet

In this paper,based on the recipe of WUJIA-SHENGHUA capsule sourced from the ancient book《FU QING ZHU NU KE·CHAN HOU BIAN》,the WUJIA-SHENGHUA film coating tablets were prepared with the modern dosage forming technique on Traditional Chinese Medicine(TCM) and the relevant quality control standards were established.Extract powder was prepared by spray drying method.Then granulated and pressed to the core for film coating tablets.Then the influences of the factors as concentration of the coating material spraying speed,inlet air temperature on the product were examined.HPLC was used in the establishment of assay of ferulic acid and quality control standard.As the results showed:at the relative density of extract of 1.13,inlet air temperature 110℃and adjuvant air temperature 75℃,the qualified powder for granulating was prepared.At the parameters of 30%of moistening agent and of 85℃of inlet air temperature,the qualified granule for pressing the tablet was prepared.At the parameters of 4.0%～4.5%of moisture content,0.5%-0.8%of Mg-St,and pressure of 65 kN,the tablet core prepared meet the requirement for film coating.At the following parameters:coating liquid 16%(w/w),coating speed of 140 g/min,inlet air temperature 70℃,the optimal film coating tablet was prepared.The assay and quality control standard were established by HPLC at the conditions of:SHIMADZU VP-ODS -C₁₈(150 L×4.6 mm) column,methanol-1%glacial acetic acid(27:73),the detection wave 316nm,column temperature 35℃.There is a good linear relation between the quantity of ferulic acid and the peak area at the quantity of 0.04112～0.205 6μg.The method for assay of ferulic acid was sensitive,accuracy and with good repeatability.As a summary,the manufacture technology establish in the experiment was stable and the quality control standard was reliable.Those ensured the scaled production of the film-coating tablet of ferulic acid.