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流化床混悬液上药法制备非诺贝特速释微丸的工艺研究

Formulation Study of Fenofibrate Immediate-release Pellets by Suspension layering

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【作者】 舒欣王明浩杨晖黄春玉谢俊周建平

【Author】 SHU Xin;WANG Ming-hao;YANG Hui;HUANG Chun-yu;XIE Jun;ZHOU Jian-ping;Department of Pharmaceutics, China Pharmaceutical University;Technology Center,Jinling Pharmaceutical Co., Ltd;

【机构】 中国药科大学药剂学教研室南京金陵药业股份有限公司技术中心

【摘要】 目的:采用流化床混悬液上药法制备非诺贝特速释微丸。方法:以上药效率、脆碎度、粘连率为评价指标,考察并优化混悬液上药法制备非诺贝特速释微丸的处方。结果:确定FNBT/HPMC-E5/SDS=160∶20∶1.6为最佳配比处方,选定固含量为20%,上药效率为95%,溶出度为15 min达90%。结论:流化床混悬液上药法制备非诺贝特微丸,上药效率高,方法简便可靠,溶出迅速。

【Abstract】 Objective: To prepare immediate-release pellets of fenofibrate by suspension layering.Methods: Drug-Loading efficacy, friability and agglomerates were selected as main indexes to evaluate and optimize the formulation of fenofibrate pellets prepared by suspension layering. Results: The optimized formulation was as follows: FNBT/HPMC-E5/SDS=160∶20∶1.6, solid content was 17.5%, drug-loading efficacy was about 95%, 15 min dissolution was about 90%. Conclusion: Suspension layering can prepar pellets with high drug-loading efficacy, acceptable friability and fast dissolution.

  • 【文献出处】 药学与临床研究 ,Pharmaceutical and Clinical Research , 编辑部邮箱 ,2015年01期
  • 【分类号】R943
  • 【被引频次】2
  • 【下载频次】315
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