ABSTRACT
OBJECTIVE:To optimize the preparation technology for enteric-coated changbiqing granules.METHODS:The concentration of acrylic resin and the four factors like the quantity of castor oil,pulvis talci and methylsilicone oil on the yield of changbiqing enteric-coated granules were determined by orthogonal test design;The effects of the enteric-coated granule plasticizer on the quantity of castor oil and the weight increment of the coating were determined by the release rate test.RESULTS:The optimized formula of the coating solution was described as follows:the concentration of acrylic resin was5%,the relative amount of castor oil to acrylic resin was35%,the dosages of pulvis talci and methylsilicone oil were3%and1%,respectively,the weight increment of the coating was30%.CONCLUSION:Changbiqing enteric-coated granules pre?pared on the optimized technology are in line with the quality requirements and which have ideal enteric soluble drug releasing characteristics.