新法规下关于中药改剂型为口服凝胶剂的一些思考  

Some Thoughts on Changing Dosage Form of Chinese Medicine for the Oral Gel Under the New Legislation

作　　者：李计萍 黄芳华 朱飞鹏 吕佳康 

机构地区：[1]国家药品食品监督管理局药品审评中心,北京100038

出　　处：《中国药事》2009年第10期962-964,共3页Chinese Pharmaceutical Affairs

基　　金：国家科技支撑计划课题"中药研发与上市前技术评价标准的研究"(编号2006BAI21B10)

摘　　要：目的探讨新法规下关于中药改剂型为口服凝胶剂的合理性研究内容。方法结合申报情况,对照新法规对中药改剂型为口服凝胶剂研究中存在的问题,从剂型选择的必要性、合理性、凝胶特性的研究、辅料的选择及用于口服的安全性、质量研究等方面进行了讨论。结果与结论建议应对其剂型选择的必要性进行充分考虑,对辅料的适用性进行深入研究,建立符合凝胶制剂特性的质量控制指标。Objective To study the reasonableness of research content for the traditional Chinese medicine formulations to change the oral gel under the new regulations.Methods Combining with the new regulations situation,problems in the research to change the oral dosage form of Chinese medicine were discussed from gel formulations selected from the necessity and rationality,the research of gel properties,the choice of accessories and safety and quality research for oral gel and so on.Results and Conclusions It is suggested that the necessity of choice of dosage formsshould be fully considered, the applicability of the accessories should be in-depth studied, and quality control index according with properties of gel should be established.

关 键 词：中药 改剂型 凝胶剂 口服凝胶剂 

分 类 号：R95[医药卫生—药学] R288