肠必清肠溶颗粒包衣处方及制备工艺研究  

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

作　　者：刘圣[1] 陈礼明[1] 田莉[1] 陈象青[1] 胡世莲[1] 胡葆诚[1] 周书明[1] 

机构地区：[1]安徽省立医院,合肥市230001

出　　处：《中国药房》2005年第20期1539-1541,共3页China Pharmacy

基　　金：国家中医药管理局中医药科学技术研究基金课题(00-01KL01)

摘　　要：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。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 was 5%, the relative amount of castor oil to acrylic resin was 35%, the dosages of pulvis talci and methylsilicone oil were 3% and 1%, respectively, the weight increment of the coating was 30%. CONCLUSION： Changbiqing enteric-coated granules prepared on the optimized technology are in line with the quality requirements and which have ideal enteric soluble drug releasing characteristics.

关 键 词：肠必清肠溶颗粒 包衣处方 制备工艺 

分 类 号：R283[医药卫生—中药学] R943[医药卫生—中医学]