根据遗传学、遗传药理学、分子生物学原理,结合中医药学科属性与中药药效物质作用的本质,分析中药材质量稳定性规律应遵循生物多态性规律的科学内涵;同时根据中药现代化的要求,提出了中药材质控的现代化模式及其研究方法。与西药相比,中药为自然界的产物,多由动植物组成,其有效成分为一个有机整体,在初生、次生代谢酶系,特别是CYP450酶系的作用下合成,进入人体内能被人体的代谢酶系代谢并与原植物代谢酶相似的人体内受体酶靶点产生诱导、抑制和不可逆等反应。按质量作用定律,人体必然向与中药药性相同的方向移动,达到中医学的反治互补的效应作用,体现"网通虹势"现象,中药与人体的作用本质是双重遗传药理学的作用。中药材质量稳定性规律研究首先应遵循中药材自身的生物多态性规律,其次应受人体遗传药理学个性化用药原理指导。中药及人体的遗传多态性是客观存在,不同地域的植株成分信息熵变频率的正态概率分布曲线的均值与方差不同,在满足各品种单次投药量的前提下,中药材的质量是稳定的,体现Hardy-Weinberg平衡时的群体质量。

Objective To analyze the scientific contexts that the quality control of traditional Chinese medicinal materials (TCMM) is abided by biogenetic polymorphic regularity, according to the principle of genetics, pharmacogenetics, molecular biology, and natural pharmacodynamic mechanism in Chinese materia medica (CMM), as well as combining with the property of the traditional Chinese medicine (TCM). Simultaneously to point out the modernization model of quality control and the method of TCMM, followed by the thoughts and requirements of CMM′s modernization. Compared with the western medicine, CMM, as an integer, carried out with the original biogenetic polymorphic information, synthesized out under primary and secondary metabolic enzymes, especially CYP450 enzymes, imported into human body, and metabolized by these enzymes, takes place the inductive, inhibitive, and irreversible reaction at the end with receptors, which is similar to the metabolic enzymes in primary channels of human being and impersonated with the "counter-treatment and complementation" effects in TCM theoretical term. The deficient patients treated by reinforcing CMM, as well as the conversion action, and the "co-network compatibility and rainbow potency" regularity by mass law, as a result from the duple pharmacogenetic reaction. The stability research on the quality control of TCMM must obey to the biogenetic polymorphism rules and the personal administration in pharmacogenetics. The information entropy varied with different regions, expressed by the curve of normal probability distribution as two parameters of the mean and variance for every original plant strains. There is a stable quality in colonials of the Hard-Weinberg equilibrium of TCMM.