中药新药新制剂的质量 药理和临床研究方法——规范研制现代中药新药新制剂的创新设计(2)

Quantity Pharmacology and Clinics Study Methods of The New medicine and Preparation of The Chinese Herbal Medicine

目的:探索现代中药新药新制剂的质量标准、药理实验和临床观察实验方法。方法:根据《药品非临床研究质量管理规范》(GLP)、《药品临床试验管理规范》(GCP)、《中药新药临床研究指导原则》、《中药命名原则要求》和《医疗机构制剂注册管理办法》(试行)的要求,对中药新药新制剂质量标准、药理实验和临床观察实验方法进行了系统研究。结果:找出了规范制定制剂质量标准、规范开展药理实验和临床观察的实验方法。结论:对提高我国药厂和医院制剂室开发新药新制剂的研制水平具有重要的参考作用。

Objective： Investigate the modem Chinese herbal medicine new medicine quantity standard, pharmacology of the new- made experiment and clinics observes to experiment the method. Methods： According to （the drugs are not clinical to study the quantity management norm ）（GLP）, （the drugs clinical trial management norm ）（ GCP）, （the Chinese herbal medicine new medicine clinic research guideline ）, （the Chinese herbal medicine assigns name to the principle request ） and （the medical treatment organization product registers to manage the way ）（ try the line） of request, experiment to the new medicine a quantity standard, pharmacology of Chinese herbal medicine to observed to experiment the method to carry on the system research with clinic. Results ： Finding out the norm establishment product quantity standard, norm opens the experiment method of the exhibition pharmacology experiment and clinical observation. Conclusion ： Our country to the exaltation pharmaceutical factory and the hospital product room development new the new - made of medicine researches to manufacture the level to have the important reference fimction.