论文部分内容阅读
中药复方制剂是在中医药理论指导下组成的方药,具有长期的临床应用经验,具有物质基础多、作用环节多等特点。中药复方创新药物开发过程中需特别注重选择和加快具有临床价值的药物研发,需要对立项论证、工艺确定、质控标准建立、药效和毒理评价和申报等严格按照新药研发的法规和技术要求进行全过程管理。该文针对中药复方新药研究过程中药效学研究方法提出建议:在工艺筛选中药效的配合需选择与临床定位有效性关联性高的终点观察指标;临床前药效学研究在正确应用疾病模型的基础上,应探索和应用符合中医药临床特点的动物模型和观察指标;同时对特殊人群——儿童用药应提供符合儿童生理特点的用药信息,进行药效毒理研究需用幼鼠并按儿童体重进行剂量设计等。总之,临床用药特点应是中药复方新药药效评价的重要依据。
Traditional Chinese medicine compound prescription is composed of prescriptions under the guidance of Chinese medicine theory, has long-term clinical experience, with more material basis, the role of links and more. Chinese medicine compound innovative drug development process should pay special attention to the selection and speed up the clinical research and development of drugs, the need for argument, process determination, quality control standards established, efficacy and toxicology evaluation and reporting in strict accordance with the laws and regulations of new drug research and development Requires full process management. In this paper, the traditional Chinese medicine compound new drug research process pharmacodynamics research methods are proposed: screening in the process of efficacy should be selected with the clinical relevance of the effectiveness of the positioning of the endpoint; pre-clinical pharmacodynamic studies in the proper application of the disease Model should be based on the exploration and application of traditional Chinese medicine should be to explore the clinical characteristics of animal models and observation indicators; the same time for special populations - children should provide medication in line with children’s physiological characteristics of drug information for pharmacodynamic studies require pups and According to children’s weight dose design. In short, the characteristics of clinical medication should be an important basis for the evaluation of new drug efficacy of traditional Chinese medicine compound.