肠必清肠溶颗粒包衣处方及制备工艺研究

目的:优选肠必清肠溶颗粒制备工艺。方法:采用正交试验设计,考察丙烯酸树脂浓度和蓖麻油、滑石粉、甲基硅油用量4种因素对肠溶颗粒收率的影响;采用释放度试验,考察肠溶颗粒增塑剂蓖麻油用量及包衣增重量。结果:包衣液处方丙烯酸树脂浓度为5%,蓖麻油相对丙烯酸树脂用量为35%,滑石粉及甲基硅油用量分别为3%、1%,包衣增重为30%,即为最佳制剂工艺。结论:由最佳工艺制备的肠必清肠溶颗粒质量符合要求,具有理想的肠溶释药特性。

Study on the Formula and Preparation Technology of Enteric- coated Changbiqing Granules

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 preˉpared on the optimized technology are in line with the quality requirements and which have ideal enteric soluble drug releasing characteristics.