中药制剂单用确定性与合用调配性的关键理论技术问题研究  

Study on Key Theoretical and Technological Issue of Combination Compatibility and Single Determinacy for Administration of Chinese Materia Medica Preparations

作　　者：贺福元[1,2,3] 邓凯文[4] 刘文龙[5] 杨岩涛[5] 石继连[5] 

机构地区：[1]湖南中医药大学药学院中药药性与药效国家中医药管理局重点实验室,长沙410208 [2]湖南中医药大学现代中药制剂制备与评价实验室,长沙410208 [3]湖南中医药大学中医药超分子机理与数理特征化实验室,长沙410208 [4]湖南中医药大学第一附属医院,长沙410007 [5]湖南中医药大学药学院/中药药性与药效国家中医药管理局重点实验室,长沙410208

出　　处：《世界科学技术-中医药现代化》2013年第4期790-798,共9页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家自然科学基金委面上项目(81073142):中药复方有效性数学模型的建立及对补阳还五汤的研究;负责人:贺福元;国家自然科学基金委面上项目(81173558):中药复方成分群提取过程动态迁移与稳态性规律的研究;负责人:罗杰英;湖南省自然基金委重点项目(11JJ2055):中药注射剂(类)致敏成分筛查技术的研究;负责人:贺福元;教育部国家博士点基金项目(20124323110002):中药注射剂与类致敏原网络靶点的关联性研究;负责人:贺福元

摘　　要：目的:通过分析中药制剂研究特点,明确该学科的长期发展方向,并提出本学科亟待解决的关键问题及对策。方法:根据中药制剂研究的发展轨迹,结合中医药基础理论、现代新药研究技术与本人从事中医药现代化研究经验,从中药制剂发展方向、特点、亟需解决的关键问题与对策等方面进行探讨。结果:建立以结构与作用明确的多成分群为原料,按中医药基础理论或现代网络医药为指导,以来源方便的动、植、矿物为原料,单用确定性(有效、稳定、可控),合用可调性(可预、最优效、最低毒)整体相统一的单个、群体与中药复方制剂体系。在实现上述目标时,需解决成分有效性归属、遗传稳态性与一次投料量、成分间理化性质迁移规律、提取过程动态性与稳态性规律、制备时整体模型受控与紊湍受控规律、体内外的评价规律、微观质量与宏观质量、单用的确定性与合用的调配性等关键技术问题。结论:中药制剂是体现单用确定性与合用调配性高度统一的整体有效成分群制剂。This study was aimed to analyze characteristics of Chinese Materia Medica（CMM） preparations in order to identify the long-term development direction of this discipline and suggest key questions and strategies to solve the problems.According to the development track of CMM preparation,traditional Chinese medicine（TCM） basic theories and modern new drug research techniques were combined with the author＇s experiences on modernization study of TCM.This article discussed key issues of CMM preparation development direction,characteristics and issues need to be solved and their countermeasures.The results showed that the development direction for CMM preparation discipline should entirety unify CMM preparation system.The medical resource should be convenient which include animal,plant and mineral products.The single determinacy（effectiveness,stability and controlled） and compatibility（prediction,optimization and lowest toxin） will be applied in the guidance of CMM preparation system.In order to achieve goals mentioned above,key issues need to be solved are efficiency categories for ingredients,genetical stabilities and one sampling charge,emigration rules of properties among ingredients,the kinetic and stable rules of ingredient extraction,controlled rules for integral models or for disorder and torrent,evaluation rules in vivo and in vitro,microscopic and macroscopic qualities,determinacy for single administration and compatibility for combination applications.It was concluded that the CMM preparation is a series of integral unified effective ingredient preparations that behave the determinacy for single administration and compatibility for combination applications.

关 键 词：中药制剂 确定性 调配性 网通虹势 超分子 免疫芯片 网络谱效动力学 

分 类 号：R283[医药卫生—中药学]