试论微生态中药制剂——风险评估与机理探讨  

Microecological Chinese Medicine Preparation-Risk Assessment and Mechanism Exploratory Study

作　　者：黄叶[1] 

机构地区：[1]河北省石家庄市中医院生物转化中药研究室,河北石家庄050051

出　　处：《中国药业》2012年第14期15-20,共6页China Pharmaceuticals

摘　　要：中药的全成分生物转化是一个复杂的、模糊的化合物变化过程。该文借助哲学思维、逻辑方法和现阶段对医学科学的认知,对微生态中药制剂的发酵工艺进行风险性评估,从而为其构筑一条可行性生产工艺底线。根据医学微生态学理论,结合国内外学者对中药药效基础物质在人体内的代谢研究成果,探讨微生态中药制剂发酵工艺的作用机理,并在多年对发酵中药制剂的探索和实践基础上,作者提出了微生态中药理论假说,认为"微生态中药制剂较相应的传统中药制剂可望具有提高药物的生物利用度、减少患者个体对药物代谢的差异性、丰富产品营养结构、改善产品口感和延长产品有效期(或保质期)等5个方面的优势。微生态中药制剂对肠道微生态失衡的老弱多病患者,存在营养风险的重症患者,大手术后康复期患者,或放化疗癌症患者,尤其具有重要的临床意义"。另外,开发、推广微生态中药制剂还可望大为提高中药生产中对中药材的综合利用率。Whole composition bio-transformation of Chinese medicine is a complex and ambiguous changing process of compounds. In this article, with the help of philosophical thinking, the logical way and current knowledge of medical science, the risk assessment on fermentation of the microecological Chinese medicine preparation（MCMP）was made,and thus build a feasibility bottom line to its pro- duction process. According to medical mieroecology theory, combined with research achievements from domestic and foreign scholars on metabolism of Chinese medicines effective substances in the human body, author explored the mechanism of fermentation process of MCMP（the microeeologieal Chinese medicine preparation）, and on the bases of exploration and practice for many years on fermentation Chinese medicine preparation to advance a theoretical assumption of microecological Chinese medicine that MCMP（the mieroecology Chi- nese medicine preparation） compared with the corresponding traditional Chinese medicine preparation is expected to have five advantages： increase drug bioavailability, reduce the individual patient differences in drug metabolism, enrich product nutritional structure, improve product taste and extend expiration period （or shelf life）. MCMPs（the mieroecological Chinese medicine preparations） have important clinical significance to old, weak and sick patients with the intestinal microecological imbalance, patients with severe nutritional risk,patients during the rehabilitation after major surgery,or cancer patients under radiotherapy and chemotherapy. In addition,the development,promotion of MCMPs （the microecological Chinese medicine preparations） is expected to greatly improve the comprehensive utilization of Chinese medicinal herbs in Chinese medicine production.

关 键 词：益生细菌 生物转化 风险评估 作用机理 微生态中药理论假说 

分 类 号：TQ461[化学工程—制药化工] R2-03[医药卫生—中医学]