中药口服制剂质量评价研究进展  

Research Progress of Quality Evaluation on Oral Traditional Chinese Medicine Preparation

作　　者：韩继红[1] 刘勇钢[2] 姚东云[1] 张静[1] 安静[1] 

机构地区：[1]河北化工医药职业技术学院,河北石家庄050031 [2]华北制药集团新药研究开发有限责任公司,河北石家庄050015

出　　处：《煤炭与化工》2015年第1期37-40,共4页Coal and Chemical Industry

基　　金：河北省中医药管理局科研计划项目(NO.2013086)

摘　　要：中药复方制剂质量评价的现代化是实现中药现代化的关键领域之一。综述了近年来中药口服制剂质量评价的研究进展,介绍了中药口服制剂质量评价方面的一些新成果及有价值的经验。提出目前中药质量评价的主流仍然是以化学成分为中心,如指标性成分含量测定和指纹图谱,但是由于中药成分的复杂性,以化学成分为中心的评价方法显示出其局限性,多种对剂型、药效、代谢的评价方法应运而生,并均表现出一定的优势,如体外评价(溶出度检测、生物活性测定)及体内评价(血清药物化学法、代谢组学法);指纹图谱技术、药效学、血清化学等多学科交叉融合,将有助于进一步阐释中药复方的内在质量及其作用机理,逐步向药效物质基础控制的模式转变。Modernization of the quality evaluation of traditional Chinese medicine （TCM） preparations is one of the key areas d modernization of Chinese medicine. The latest progress of quality evaluation on oral TCM preparation was summarized, some new achievements of quality evaluation on oral TCM preparation and valuable experience were introduced. It was pointed out that at present, the mainstream of oral TCM preparation quality evaluation is still mainly based on chemical constituent, such as, index component content assay and fingerprints. Because the complicated composition of TCM, the evaluation method that centering on chemical constituent shows its limitation. A variety of evaluation methods on formulations, efficacy and metabolic have emerged, and have shown some advantages, such as, in vitro evaluation （dissolution determination, bioactivity assay） and in vivo evaluation （serum pharmacochemistry, metabonomic method）; Interdisciplinary integration of fingerprints, pharmacodynamics and serum chemistry will help further explain the intrinsic quality and action mechanism of TCM, and gradually shift to effective substance control mode basis.

关 键 词：中药 质量评价 口服制剂 研究进展 

分 类 号：R284.1[医药卫生—中药学]