【摘要】 数千年来,中药作为一种重要的补充药物,被广泛应用于各种疾病的治疗中。然而,人们始终未能就其质量控制问题达成一致。中药不同于化学药品,后者往往具有明确且有效的质量标准。现行做法是评估众多草药和制剂中的一种(或几种)化合物的含量,以此用作质量标志物。但所评估的化合物可能既不与药物疗效密切相关,也不具有整体代表性。本文基于临床用途、复方配伍以及中药的生产工艺,对之前提出的中药质量标志物的新概念进行了进一步讨论。同时,还阐述了用于中药(包括草药、炮制品和制剂)定性和定量分析的实用技术方法,以促进发现和鉴定用作质量标志物的特定化学物质,由此形成新的质量控制模式。此外,本文还描述了目前中药质量控制领域所取得的进展。这些进展为中药质量控制的前景提供了有用信息。更多还原

【Abstract】 As the most important complementary medication against a variety of diseases,traditional Chinese medicines(TCMs) have been extensively applied over thousands of years.Current quality control of herbal medicines,however,is in great dispute.Unlike chemical drugs,which have clear and validated quality standards,the content of only one(or a few) compounds of many herbs and preparations is currently assessed as an indicator of quality,even though the assessed compound(s) is neither closely associated with the efficacy nor representative of the medicine as a whole.Based on the clinical use,compatibility of multiple component prescriptions,and manufacturing process of TCM,the new concept of a TCM quality marker that was proposed in previous work is discussed further here.In addition,practical technological approaches are described for the qualitative analysis and quantification of TCMs including herbs,processed products,and preparations,which lead to the discovery and identification of specific chemicals as quality markers and new quality control patterns.The progress that has been made in TCM quality control is also addressed.This work provides useful information for the quality control of herbal medicines in the future.更多还原