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金复康口服液二次开发总体研究思路与技术体系框架
引用本文:成旭东,封亮,贾晓斌,丁淑敏. 金复康口服液二次开发总体研究思路与技术体系框架[J]. 中国中药杂志, 2014, 39(5): 941-945
作者姓名:成旭东  封亮  贾晓斌  丁淑敏
作者单位:江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028;南京中医药大学, 江苏 南京210028;苏州海金沙生物科技有限公司, 江苏 苏州 215123;江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028;江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028;江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028;南京中医药大学, 江苏 南京210028
基金项目:苏州市2012年科技计划医疗器械与新医药专项(ZXY2012009);江苏省2013年度普通高校研究生科研创新计划项目(CXLX13_599)
摘    要:已上市中成药大多具有良好临床疗效和应用基础,但基础研究不足,物质基础不清,工艺水平落后,产品价值难以体现,质量控制指标选择不明,产品质量水平难以保持。中成药金复康口服液是临床中成药的典型代表。以金复康口服液作为模型药物,以中药整体观和系统论为指导,构建现代中药二次开发研究思路和技术体系。该体系包括“基础研究——明晰组分结构和作用机制”、“工艺提升——优化工艺提高质量”、“拓展产业——形成产业链”3个内容层次。该研究思路和技术体系立足现代中药物质基础与开发,以中药组分结构为向导,以临床需求为依归,为中药二次开发提供策略和方法。

关 键 词:金复康口服液  二次开发  研究思路
收稿时间:2013-08-19

Research thoughts and technology system framework of Jinfukang oral liquid secondary exploitation
CHENG Xu-dong,FENG Liang,JIA Xiao-bin and DING Shu-min. Research thoughts and technology system framework of Jinfukang oral liquid secondary exploitation[J]. China Journal of Chinese Materia Medica, 2014, 39(5): 941-945
Authors:CHENG Xu-dong  FENG Liang  JIA Xiao-bin  DING Shu-min
Affiliation:Key Laboratory of New Drug Delivery System of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China;Nanjing University of Chinese Medicine, Nanjing 210028, China;Suzhou ALG Bioscience Co., Ltd., Suzhou 215123, China;Key Laboratory of New Drug Delivery System of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China;Key Laboratory of New Drug Delivery System of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China;Key Laboratory of New Drug Delivery System of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China;Nanjing University of Chinese Medicine, Nanjing 210028, China
Abstract:Most Chinese medicine has good clinical efficacy and application. However, the material basis is vague for the lack of basic research, the value of Chinese medicine is hard to reflect for the low technology level and product quality is difficult to maintain for the quality control indicator selection is incorrect. Chinese medicine Jinfukang oral liquid is a typical product of Chinese medicines. Jinfukang oral liquid was selected as a model drug in this article. Based on the overall concept and systems theory of traditional Chinese medicine, the research idea and technology system for modern Chinese medicine secondary exploitation was formed. The system includes three parts, for the first, basic research to make clear the components structure and their action mechanism, for the second, technology upgraded to optimize process and improve the product quality, for the last, exploring the associated industry to form the industrial chain. The research ideas and technology system based on the material basis research and development of modern Chinese medicine, guided with component structure in Chinese medicine and aimed clinical needs. This research ideas and technology system provides strategies and methods for the development of modern Chinese medicine secondary exploitation.
Keywords:Jinfukang oral liquid  secondary exploitation  research thought
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