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.
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)
关键词
三七总皂苷
肠溶微丸
包衣液处方
PNS
enteric-coated pellets
liquid coating prescription
