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《Chinese Pharmaceutical Affairs》 2009-10
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Some Thoughts on Changing Dosage Form of Chinese Medicine for the Oral Gel Under the New Legislation

Li Jiping,Huang Fanghua,Zhu Feipeng and Lv Jiakang(The Center of Drug Evaluation,The State Food and Drug Administration,Beijing 100038)  
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.
【Fund】: 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)
【CateGory Index】: R283
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