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TRH-03肠溶微丸的制备及其处方优化
引用本文:贾娜,冒华,胡凯莉,奉建芳.TRH-03肠溶微丸的制备及其处方优化[J].中南药学,2011,9(10):736-739.
作者姓名:贾娜  冒华  胡凯莉  奉建芳
作者单位:1. 上海中医药大学穆拉德中药现代化研究中心,上海201203;广西中医学院药学院,南宁510004
2. 苏州天人合生物技术有限公司,江苏苏州,215021
3. 上海中医药大学穆拉德中药现代化研究中心,上海,201203
摘    要:目的研究TRH-03肠溶微丸的处方优化及制备工艺。方法采用流化床包衣法,以载药量及释放量为考察指标,对TRH-03肠溶微丸的处方、上药和包衣工艺进行了优化。结果制得的3批肠溶微丸圆整度好,其载药率分别为35.63%、35.04%、35.64%;在人工胃液中保持不释药,人工肠液中45min内释放率分别为89.58%、88.96%、88.36%,载药量稳定且重现性好,体外释放度符合中国药典2010年版二部的要求。结论本方法制备工艺简单易行,重复性好,适合进一步的工业化生产。

关 键 词:TRH-03  肠溶微丸  流化包衣

Preparation and formulation optimization of enteric-coated TRH-03 pellets
JIA Na,MAO Hua,HU Kai-li,FENG Jian-fang.Preparation and formulation optimization of enteric-coated TRH-03 pellets[J].Central South Pharmacy,2011,9(10):736-739.
Authors:JIA Na  MAO Hua  HU Kai-li  FENG Jian-fang
Institution:JIA Na1,2,MAO Hua3,HU Kai-li1,FENG Jian-fang1(1.Murad Research Center for Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,2.School of Pharmaceutical Sciences,Guangxi College of Traditional Chinese Medicine,Nanning 530001,3.Suzhou Tianrenhe Biotech Ltd,Suzhou Jiangsu 215021)
Abstract:Objective To study the preparation and formulation optimization of the enteric coated TRH-03 pellets.Methods The enteric-coated TRH-03 pellets were prepared with fluid bed coating technology.The drug loading rate and dissolution of the pellets were used as indexes to optimize the coating formulation.Results The prepared TRH-03 pellets had excellent geometric roundness and a drug loading rate of 35.63%,35.04%,and 35.64%.The TRH-03 pellets were stable in artificial gastric juice while in artificial intestinal...
Keywords:TRH-03  enteric coated pellet  airflow coating method  
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