何首乌制剂不良反应研究进展与成因分析

Progress and Cause Analysis on Causes of Adverse Reactions of Polygoni Multiflori Radix Preparations

摘要:

通过研究何首乌制剂不良反应研究进展与成因分析，为从制备工艺影响毒性表达的角度开展后续研究，提供研究思路。查阅近年来国内外相关文献，对含何首乌制剂的化学成分、炮制减毒、复方配伍、制备工艺、不良反应及其毒副作用机制等方面的研究进行归纳、总结，并进行成因分析。从成分方面，何首乌主要含有二苯乙烯类、卵磷脂、蒽醌类、鞣质、微量元素等成分，二苯乙烯苷及蒽醌类为其主要活性成分，提出何首乌毒性的可能物质基础；从炮制方面，炮制工艺影响何首乌的成分组成，何首乌炮制前后的血药含量图谱有显著不同，致大鼠肝物质代谢途径的作用机制不同。从剂量、用法等方面，长期大量摄入何首乌可致可逆性肝损伤，主要表现为血清肝功能指标异常。在复方配伍方面，不同配伍是否会造成何首乌不良反应尚未达成共识。何首乌制剂临床不良反应提示，其对肝脏有不可忽视的毒副作用，现代制备工艺可能也是其不良反应的原因之一，但其发生肝毒性的规律特点、作用机制、物质基础均尚不清楚。在何首乌的化学成分及其炮制减毒机制方面研究基础上，应积极探索药学制备工艺对何首乌肝毒性的影响；在加强何首乌制剂安全性评价基础上，积极开展药学制备、复方配伍、药物相互作用对肝毒性的影响；探索临床合理用药模式，尽量避免患者因服用何首乌制剂导致的不良反应。

Abstract:

Progress and cause analysis of adverse reactions of Polygoni Multiflori Radix preparations were studied to conduct follow-up researches from the perspective of the effect of preparations in toxic expression and provide research ideas. Relevant literatures in recent years were consulted to study Polygoni Multiflori Radix preparations for their adverse reactions and toxicity mechanism and other aspects, in order to summarize and analyze the causes. In terms of components, Polygoni Multiflori Radix mainly containing stilbene, lecithin, anthraquinones, tannins, trace elements and other ingredients, with stilbene glucoside and anthraquinone class as its main active ingredients, which indicated the possible material basis of Polygoni Multiflori Radix toxicity; with respect to processing, processing methods had effects on the chemical composition of Polygoni Multiflori Radix, as evidenced by significant differences in Polygoni Multiflori Radix blood profiles before and after processing, which caused different liver substance metabolic mechanisms in rats. By dosage and usage, long-term intake of high-dose Polygoni Multiflori Radix can cause reversible liver damage, which was mainly reflected in liver function abnormalities. In terms of compound compatibility, it was still uncertain whether different combinations would result in Polygoni Multiflori Radix adverse reactions. Clinical adverse reactions of Polygoni Multiflori Radix preparations suggest toxic and side effects that cannot be ignored on liver. Modern preparation process may be one of the causes for the adverse reactions, but its regularity characteristics causing liver toxicity, mechanism of action and material basis were still unclear yet. In addition to the chemical constituents in Polygoni Multiflori Radix and the attenuating mechanism of processing, efforts shall be made to actively explore the impact of the effect of pharmaceutical process of Polygoni Multiflori Radix on its hepatotoxicity. In addition to strengthening safety evaluation of Polygoni Multiflori Radix preparations, efforts shall be made to actively study the effect of pharmaceutical processing, compound compatibility and drug interactions on hepatotoxic effects and explore rational clinical drug use patterns, in order to minimize the adverse reactions caused by taking of Polygoni Multiflori Radix preparations.