前列宁肠溶胶囊的制备工艺及释放度研究  

Reseach on preparation process,quality standard and the release of Qianliening Enteric-coated Capsules

作　　者：李煌[1] 徐伟[1] 洪振丰[1] 林久茂[1] 周建衡[1] 

机构地区：[1]福建中医药大学,福州350108

出　　处：《中华中医药杂志》2011年第10期2357-2359,共3页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：福建省科技厅重点项目(No.2009I0011);福建省中西医结合老年性疾病重点实验室开放课题基金资助项目;2008年陈可冀中西医结合发展基金(No.2008J1004-17CKJ2008054)~~

摘　　要：目的:研究前列宁肠溶胶囊的制剂工艺及质量标准,并考察复方中有效成分大黄素的体外释放度。方法:采用HPLC法测定前列宁肠溶胶囊中大黄素的含量,并进一步考察其在体外的释放度。结果:制备的3批前列宁肠溶胶囊在酸性介质中释放度小于10%,而在模拟胃肠道环境中可迅速释放药物,50min药物累积溶出量可达90%以上。结论:本品处方及制备工艺合理,制剂稳定、质量标准可靠,能达到肠溶目的,可作为其他肠溶中药胶囊剂的参考。Objective： To reseach the preparation process and its quality standard of Qianliening Enteric-coated Capsules,meanwhile,inspect the release of emodin in vitro.Methods： HPLC was used for determining the content of emodin in compound,and further investigation of the in vitro release.Results： The drug release of the artificial gastric juice of Qianliening Enteric-coated Capsules would be lower than 10%,but in simulated human gastroenteric environment can rapidly release,accumulate more than 90% after 50min later.Conclusion： The parameters of technology and formulation are reasonable and stable.The quality standard is reliable.So it may be a good reference for the other enteric-coated capsules.

关 键 词：肠溶胶囊 质量标准 药物释放 

分 类 号：R283[医药卫生—中药学]