胰酶肠溶微丸的制备及体外释药特性研究  

Preparation and in vitro release characteristics of trypsin enteric coated pellets

作　　者：冯洋洋 陈章宝[1] FENG Yangyang;CHEN Zhangbao(School of pharmacy,Southwest University,Chongqing 400715,China;Nursing College of Xi’an Siyuan University,Xi’an 710038,China)

机构地区：[1]西南大学药学院,重庆400715 [2]西安思源学院护理学院,陕西西安710038

出　　处：《北方药学》2022年第3期6-10,共5页Journal of North Pharmacy

基　　金：重庆中药综合利用技术集成示范应用(cstc2013jcsf10009-3)。

摘　　要：目的:制备胰酶肠溶微丸,评价其体外释药特性。方法:采用挤出滚圆法和离心式包衣法制备胰酶肠溶微丸,并采用L_(9)(3^(4))正交设计试验对微丸的制备工艺进行优化,考察不同肠溶层包衣液处方用量对微丸体外释放特性的影响。结果:制备的胰酶肠溶微丸在pH 1.2的盐酸溶液中2h的累计溶出度小于10%,在pH 6.8的磷酸缓冲液中可迅速释放出药物,45min时累计释放度可达85%以上。结论:采用挤出滚圆工艺和离心式包衣法制备的胰酶肠溶微丸工艺简单易行,质量可靠,值得进一步地工业化生产。Objective:to prepare trypsin enteric coated pellets and evaluate their in vitro drug release characteristics.Methods:trypsin enteric coated pellets were prepared by extrusion spheronization method and centrifugal coating method,and the preparation process of the pellets was optimized by L _(9)(3^(4))orthogonal design test.The effects of different dosage of enteric coated solution on the in vitro release characteristics of the pellets were investigated.Results:the cumulative dissolution of trypsin enteric coated pellets was less than 10%in pH 1.2 hydrochloric acid solution for 2h,and the drug could be rapidly released in ph6.8 phosphate buffer,and the cumulative release could reach more than 85%in 45min.Conclusion:the technology of pancreatin enteric coated pellets prepared by extrusion spheronization and centrifugal coating is simple and reliable,which is worthy of further industrial production.

关 键 词：胰酶 肠溶微丸 挤出滚圆 离心式包衣 

分 类 号：R914[医药卫生—药物化学] R96[医药卫生—药学]