三七总皂苷肠溶微丸的包衣液处方优选  

Liquid Coating Prescription Optimizing of PNS Enteric-coated Pellets

作　　者：彭伟[1] 廖婉[1] 傅超美[1] 高飞[1] 林大胜 罗妮妮[1] 

机构地区：[1]成都中医药大学药学院中药材标准化教育部重点实验室中药资源系统研究与开发利用省部共建国家重点实验室培育基地,四川成都611137 [2]成都华神集团股份有限公司制药厂,四川成都610225

出　　处：《成都中医药大学学报》2014年第3期16-18,89,共4页Journal of Chengdu University of Traditional Chinese Medicine

基　　金：成都市科技计划项目:三七通舒胶囊国际化(欧盟)药品注册合作研究(编号:07GGYB074SF)

摘　　要：目的:优选三七总皂苷肠溶微丸的包衣液处方。方法:采用单因素法,考察不同包衣材料比例、溶剂系统、包衣材料浓度、着色剂和增塑剂等对肠溶微丸外观、收得率、释放度等的影响,优化包衣液处方。结果:三七总皂苷肠溶微丸包衣液处方为尤特奇(EUDRAGIT)L100∶S100:1∶4,溶于75%乙醇后总浓度为6%,柠檬酸三乙酯相对尤特奇树脂用量为20%,柠檬黄用量为0.03%。结论:按优选出的包衣液处方制备的肠溶微丸表面光滑,圆整度好,色泽光鲜,收得率高,释放度符合要求。Objective： To optimise the liquid coating prescription of PNS enteric-coated pellets. Methods： The influencing factors including coating materials, coating liquid solvents, the concentration of coating material on the appearance and acquired rate and release rate of enteric-coated pellets were studied by single factor method. Then the coating fluid prescription was optimized. Results： The optimized formula of the coating solution of PNS enteric-coated pellets was described as follows ： the ratio of EUDRAGIT L100 and EUDRAGIT S100 was 1：4, the total concentration of EUDRAGIT L100 and EUDRAGIT S100 was 6% when they were dissolved in 75% ethanol, the relative amount of triethyl citrate to EUDRAGIT resin was 20%, the amount of tartrazine was 0. 03%. Conclusion： The enteric-coated pellets prepared on the optimized prescription have smooth surface, good roundness, bright color and high yield, at the same time, release rate meets the requirements.

关 键 词：三七总皂苷 肠溶微丸 包衣液处方 

分 类 号：R283.69[医药卫生—中药学] R282.71[医药卫生—中医学]