基于病症条件的中药配伍禁忌毒效表征研究思路与方法

中药配伍禁忌历来是中药安全性研究的重要科学问题之一。以"十八反"为代表,从安全性评价、毒效物质、毒理毒代、药物相互作用、毒性机制等方面,我国学者对中药配伍禁忌进行过大量研究,但是由于在研究思路、研究模式、研究方法等方面缺乏系统的设计和持续深入,许多关键问题尚缺乏可靠结论,未在学科、行业内达成共识。基于"半娄贝蔹及攻乌"配伍禁忌毒效表征基础研究,发现配伍禁忌相关反药组合在功效发挥过程中引起的严重不良反应是中药配伍禁忌"毒性"的主要表现。中药配伍禁忌的形成具有条件性,与其组成配比、剂量、配伍环境等要素密切相关,其中病症条件是配伍禁忌的关键影响因素,提出了基于病症条件的中药配伍禁忌毒效表征研究模式,为中药毒与效的整合分析研究提供了新的策略和方法学参考。

Methodology of toxicity-effect characterization of Chinese materia incompatibility based on disease and symptom conditions

The incompatibility of Chinese materia medica(CMM) has always been one of the important scientific issues of CMM safety research. Extensive researches about CMM incompatibility have been carried out represented by "eighteen-antagonisms", mainly focused on the safety evaluation, toxic effects of substances, toxicology, toxicokinetics, drug interactions, toxicity mechanisms, etc. However, due to lack of system design on research ideas, model and methods, many key issues still lacked reliable conclusions, and did not reach a consensus within the industry. We completed the toxicity-effect characterization of the anti-drugs about "Pinelliae Rhizoma, Trichosanthis Fructus, Fritillariae Cirrhosae Bulbus, Ampelopsis Radix, and Bletillae Rhizoma attack Aconiti Radix" and proposed that the serious adverse reactions caused by related anti-drug combination therapy were because of the "toxicity" of CMM incompatibility. The formation of CMM incompatibility was closely related to its composition, dose, compatibility environment, etc, wherein the disease and symptom are the key factors of incompatibility. Eventually, the research model of toxicity-effect characterization of CMM incompatibility based on the desease and symptom was formed, it was viable to provide new strategies and methods for the clinical drug safety of CMM compatibility.