基于生物效价检测的角类动物药品质评价方法的研究

项目名称： 基于生物效价检测的角类动物药品质评价方法的研究

项目编号： No.30873385

项目类型： 面上项目

立项/批准年度： 2009

项目学科： 生物科学

项目作者： 鄢丹

作者单位： 中国人民解放军第三０二医院

项目金额： 32万元

中文摘要： 角类动物药应用历史悠久、效誉卓著，但大多药效物质不清，现行的以"成分论"为核心的质控模式对角类动物药的内在品质评价几乎无能为力。角类动物药品质评价一直是中药质量标准研究的最难点之一。根据角类动物药的特点，结合中药与生物制品和化学药品质量管理模式的差异性和合理性，本项目借鉴生物制品质量控制模式，以羚羊角/山羊角、犀角/水牛角、鹿角/鹿茸为代表，运用生物热动力学、酶联免疫吸附测定等方法，建立基于生物效价检测（包括效价值和效应谱）的角类动物药品质评价方法，为保证角类动物药质量和药效提供新的技术支持，同时也为角类动物药类效品的合理代用提供新的科学依据。

中文关键词： 角类动物药；品质评价；生物效价

英文摘要： The animal cornu has a long history of medical application for their obvious efficacy. But most of its effective material are uncertain. The existing mode of quality control, focusing on only "ingredients", could not evaluate the internal quality for animal cornu totally. Quality evaluation of animal cornu has been one of the most difficult point in quality criteria research of the traditional Chinese medicine. The variability and rationality of quality management model of the traditional Chinese medicine, biologic product and chemicals were combined in this study. And the quality controlled pattern of biologic product was also used for reference. According to the characteristics of animal cornu, antelope's horn / goat horn, rhinoceros horn /buffalo horn and antler / pilous antler were studied as representative. Biothermodynamics and ELISA were applyed to establish the method of quality evaluation for animal cornu based on bio-potency assay, which included valence value and activity profile. It would provide a new technical support to ensure the quality and pharmacodynamic action of animal cornu. Meanwhile it also provided the new scientific evidence for the reasonable substitute of animal cornu.

英文关键词： animal cornu; quality evaluation; bio-potency