用盐酸小檗碱作为黄连等中药质量评价指标探讨临床用药的安全性和有效性

Safety and Effectiveness of Berberine Hydrochloride as Quality Indexes of Rhizoma Coptidis Chinensis in Clinical Medication

目的:探讨用盐酸小檗碱作为化学对照品评价多种中药质量时确定的质控标准的合理性,及指导临床用药的安全性和有效性,提出关注药效组分中单一组分质控指标的建立与其临床疗效的对应性。方法:采用HPLC法测定盐酸小檗碱的含量,通过饮片、药对和复方制剂3层次药效与含量的对照,探讨质量评价指标的合理性及临床用药的安全性和有效性。结果:盐酸小檗碱的含量:黄连及含有黄连的药对和成方中含量为(5.52%±0.065%)～(0.12%±0.007%),黄柏及含有黄柏的药对和成方中的含量为(3.39%±0.065%)～(0.13%±0.005%)。结论:中药是一个药效组分,中药传承的标准物质是药效组分。黄连和黄柏及其药对、复方制剂中盐酸小檗碱的含量均低于现行临床用药标准。临床用药可能存在有效性和安全性的问题。关注药效组分中单一组分质控指标与其临床疗效的对应性。

Objective：Explore safety and effectiveness of medicine in clinical and reasonableness of content limitation to evaluate quality of various Chinese materia medica by berberine hydrochloride as reference substance,and propose an attention to establish quality specification corresponding to the clinical effects.Method：Berberine hydrochloride was determined by HPLC,and he safety and effectiveness in clinical and rationality of quality indexes were discussed by comparing assay and effect in intervention levels of traditional decoction,drugs compatibility and veritaserum.Result：Content of berberine hydrochloride was：（5.52%±0.065%）-（0.12%±0.007%） in the solution extracted traditional decoction,drugs compatibility and veritaserum of Rhizoma Coptidis Chinensis,（3.39%±0.065%）-（0.13%±0.005%） in the solution extracted traditional decoction,drugs compatibility and veritaserum of Cortex Phellodendri Chinensis.Conclusion：Chinese materia medica is the active components alignment,and the reference standard to evaluate Chinese materia medica should be the active components alignment.The content of berberine hydrochloride is lower than the current standard in clinical,and the dose in clinical would lead to effectiveness and safety problem.So should pay attention to the counterparts with the specification of single component in the active components alignment and its clinical effects.