基于临床用药特点的中药复方新药药效评价思路与方法探讨(1)
[摘要]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。
[关键词] 中药复方制剂； 临床用药特点； 药效評价
[Abstract] The Chinese herbal compound formula preparation was made based on theory of Chinese medicine， which was confirmed by long period clinical application， and with multi-compound and multi-target characteristics. During the exploitation process of innovation medicine of Chinese herbal compound formula， selecting and speeding up the research development of drugs with clinical value shall be paid more attention， and as request of rules involved in new drug research and development， the whole process management should be carried out， including project evaluation， manufacturing process determination， establishment of quality control standards， evaluation for pharmacological and toxic effect， as well as new drug application process. This reviews was aimed to give some proposals for pharmacodynamics research methods involved in exploration of Chinese herbal compound formula preparation， including： ①the endpoint criteria should meet the clinical attribution of new drugs； ②the pre-clinical pharmacodynamics evaluation should be carried on appropriate animal models according to the characteristics of diagnosis and therapy of Chinese medicine and observation indexes； ③during the innovation of drug for infants and children， information on drug action conforming to physiological characteristics of infants and children should be supplied， and the pharmacodynamics and toxicology research shall be conducted in immature rats according to the body weight of children. In a summary， the clinical application characteristics are the important criteria for evaluation of pharmacological effect of innovation medicine of Chinese herbal compound formula.
, http://www.100md.com
[Key words] Chinese herbal compound formula preparation； clinical application characteristics； evaluation of pharmacological effect
中药复方制剂是在中医药理论指导下组成的方药，其处方组成符合配伍规律，具有中医理论对拟治疗病证的病因病机、治则治法和处方的论述。中药复方的优势是有中医医学理论指导及长期临床应用经验，中药复方具有物质基础多，作用环节多，对一些疑难杂症、慢病有其优势所在，故有好的开发应用前景，许多企业和研究单位均选择临床经验方研发为中药复方新制剂，即中成药。这是临床治疗应用的需要，鼓励加大研发力度和速度，以求更多更优的药物上市。
新药研发思路中很重要的环节是要重视选择和加快具有临床价值药物的研发，因此研究团队在研发全过程中要有顶层设计，从立项论证开始、经过工艺确定、质控标准的建立、药效和毒理评价到申报要全程管理到位，严格按新药研发的法规和技术要求进行。, 百拇医药(孙建宁 孙文燕 董世芬)
[关键词] 中药复方制剂； 临床用药特点； 药效評价
[Abstract] The Chinese herbal compound formula preparation was made based on theory of Chinese medicine， which was confirmed by long period clinical application， and with multi-compound and multi-target characteristics. During the exploitation process of innovation medicine of Chinese herbal compound formula， selecting and speeding up the research development of drugs with clinical value shall be paid more attention， and as request of rules involved in new drug research and development， the whole process management should be carried out， including project evaluation， manufacturing process determination， establishment of quality control standards， evaluation for pharmacological and toxic effect， as well as new drug application process. This reviews was aimed to give some proposals for pharmacodynamics research methods involved in exploration of Chinese herbal compound formula preparation， including： ①the endpoint criteria should meet the clinical attribution of new drugs； ②the pre-clinical pharmacodynamics evaluation should be carried on appropriate animal models according to the characteristics of diagnosis and therapy of Chinese medicine and observation indexes； ③during the innovation of drug for infants and children， information on drug action conforming to physiological characteristics of infants and children should be supplied， and the pharmacodynamics and toxicology research shall be conducted in immature rats according to the body weight of children. In a summary， the clinical application characteristics are the important criteria for evaluation of pharmacological effect of innovation medicine of Chinese herbal compound formula.
, http://www.100md.com
[Key words] Chinese herbal compound formula preparation； clinical application characteristics； evaluation of pharmacological effect
中药复方制剂是在中医药理论指导下组成的方药，其处方组成符合配伍规律，具有中医理论对拟治疗病证的病因病机、治则治法和处方的论述。中药复方的优势是有中医医学理论指导及长期临床应用经验，中药复方具有物质基础多，作用环节多，对一些疑难杂症、慢病有其优势所在，故有好的开发应用前景，许多企业和研究单位均选择临床经验方研发为中药复方新制剂，即中成药。这是临床治疗应用的需要，鼓励加大研发力度和速度，以求更多更优的药物上市。
新药研发思路中很重要的环节是要重视选择和加快具有临床价值药物的研发，因此研究团队在研发全过程中要有顶层设计，从立项论证开始、经过工艺确定、质控标准的建立、药效和毒理评价到申报要全程管理到位，严格按新药研发的法规和技术要求进行。, 百拇医药(孙建宁 孙文燕 董世芬)