黄连(味连)"有限成分组合质量标准"的研究

目的：制定黄连(味连)“有限成分组合质量标准”;探索建立评价中药材质量的方法学体系及其在中成药质量评价中的应用可行性。方法：分析味连各主产地样品成分,比较各样品在成分组成和药效上的差异,确定质量评价指标,并测定其在以黄连为主药的中成药中的含量。结果：制定了以小檗碱、黄连碱、药根碱、巴马汀及总生物碱含量上下限为指标的味连“有限成分组合质量标准”;提出了制定中药材质量标准的方法及操作规程;该方法可间接应用于中成药的质量标准制定。

Study on Quality Standards of Composition of Major Constituents of Rhizoma Coptidis

Objective:To establish the quality standards of the composition of major constituents of Rhizoma Coptidis and probe into the establishment of a methodological system for the assessment of the quality of Chinese medicinal materials and the feasibility of their application to the assessment of the quality of Chinese patent medicines. Method: To analyze the constituents of the samples of Rhizoma Coptidos produced in different main regions and compare their difference in the composition of constituents and in effectiveness so as to define the indeces for the assessment of their quality and identify their content in the Chinese patent medicines with Rhizoma Coptidos as principale element. Result: The quality standards of the composition of constituents of Rhizoma Coptidis with the upper and lower limits of the contents of Berberine, Coptisine, Jatrorrhizine, Palmatine and the total alkaloids of them as indeces are established and the methods and operational regulations in the establishment of quality standards of Chinese medicinal materials are put forward. This method can be indirectly used to formulate the quality standards of Chinese patent medicines.