生物评价技术在动物类中药质量评价中的应用进展

Research of bioassay in quality evaluation of animal traditional Chinese medicine

动物类中药在我国资源丰富,临床药用历史悠久,药用范围广阔,是中药的重要组成部分。其成分繁多,药理作用复杂,具有多成分、多途径、多靶点的作用特点。经过分类归纳,动物药的主要成分为蛋白质(酶)类、多肽类、脂类、氨基酸类、生物碱类及甾体类等,其中蛋白质等生物信息大分子物质加大了检测难度,质控标准相对落后。生物检定方法是将动物药物看做一个整体来检定其生物活性(药效、活力或毒力),可综合考虑有效成分外的杂质对检测结果可能存在的影响,因而准确性较好,较理化检定有显著优势。生物检定法分为体外检定及体内检定,体外检定又可分为离体动物器官检定法、细胞培养检定法、生化酶促反应检定法、免疫学活性检定法、DNA分子技术等。本研究对动物药生物检定相关方法进行归类综述,并分析各生物检定方法的选用与动物药主要成分、药理作用、检定目的之间的关系,进一步总结生物检定方法在动物药中应用的实例与不足之处,以期为中药动物药的质量评价提供参考和借鉴。

Animal traditional Chinese medicine is an important component part of traditional Chinese medicine,which is rich in resources and has a long history of clinical use.It has many components,complex pharmacological actions,with the function characteristics of multi-components,multi-pathways and multi-targets.The main components of animal traditional Chinese medicine are classified as protein(enzyme),poly-peptide,lipids,amino acid,alkaloid and steroid,etc.Protein and other bio-information macromolecular substances increase the difficulty of detection,and quality control standards are relatively backward.The method of bioassay is to examine the bioactivity(efficacy,activity or toxicity)of animal traditional Chinese medicine as a whole.The influence of impurities outside the active ingredient on the result of bioassay can be considered,so the accuracy is better,compared with physical and chemical examination,with obvious advantages.Bio-assay can be dividedinto in vitro and in vivo,and in vitro assay can be divided into animal organs in vitro,cell culture assay,biochemical enzyme reaction assay,immunological activity assay,DNA molecular technology,etc.In this study,the relevant bio-assay of animal traditional Chinese medicine was classified and summarized,and the relationship between the selection of bio-assay and the main components of animal drugs,pharmacological action,and purpose of verification was analyzed.The application examples and short comings of bio-assay in animal medicine were summarized,in order to provide reference for the quality evaluation of traditional Chinese medicine.