中药配方颗粒研究进展(Ⅱ)——中药单煎与合煎对比研究概况

目的:概述中药单煎与合煎对比研究的现况。方法:检索万方数据、维普资讯和中国知网(CNKI)三大全文数据库,对去重后的中药单煎与合煎文献进行系统分析。结果:中药单合煎对比研究主要包括化学成分、药效和临床疗效3个方面,涉及单味中药、药对和复方,一种或多种指标性成分或有效成分,一种或多种药理效应和疾病种类,单合煎化学成分各有增减、效应各有强弱,临床效应各有大小,单合煎化学成分差异的机制十分复杂、影响因素众多,在药物代谢、药效和临床应用上有所异同。结论:以若干有效成分、药理效应指标或疾病的疗效为指标进行中药单合煎对比研究,不能全面反映中药单合煎的优劣,单合煎有效成分(尤其是指标性成分)种类与数量上的差异,无法推论出药效的强弱和适应症的差异,需进行中药单合煎化学-药动-药效/毒理-临床联合研究;中药单合煎对比研究方法在传统汤剂和配方颗粒优劣性的应用缺乏论证依据,不同剂型药物应进行药理等效性、生物等效性或临床非劣/优效性研究,现有文献体现了上述发展趋势。

Progress of Chinese Medicinal Dispensing Granule(Ⅱ)——Survey on Comparative Studies between Single-decoction and Mixed-decoction of Chinese Medicine

Objective: To overview the comparative studies between single-decoction and mixed-decoction of Chinese medicine. Method : The literatures which comparative studied the similarities and differences between single-and mixed-decoction of the chinese medicine collected by Wangfang data,VIP information and CNKI in 2001-2010 were analized. Result : The comparative studies between single-and mixed-decoction of Chinese Medicine related mainly to five areas: chemical composition, pharmacokinetics, pharmacodynamics and clinical efficacy,the medicine including single herbs,drug pairs and compounds,the related chemical composition included the index components and the effective components,one or more pharmacological effects and the diseases were observed; and the chemical compositions, effects and clinical effect increased and decreased both in single-and mixed-decoction,the mechanisms and related factors of the different chemical compositions in single-and mixed-decoction are very complicated,drug metabolism, efficacy and clinical application show both similarities and differences too. Conclusion : Using some quantitative active ingredients, pharmacological effects or efficacy for treating diseases, the comparative evaluation between single-and mixed-decoction is insufficient. The comparative studies on single-and mixed-decoction of Chinese medicine is not suitable for evaluation the traditional decoction and the Chinese medicine dispensing granule. The different formulations of drugs should be evaluated by the pharmacological equivalence, bioequivalence or clinical non-inferiority/ superiority researches, the current research reflects these trends.