目的:为保证参附注射液质量稳定,控制风险隐患,降低风险损害。方法:在生产、GAP、研发、流通、临床使用、知识产权、紧急事件处理等一系列药品相关环节进行风险筛查、评估,并针对可能存在的风险采取控制和预防。结果:初步构建了参附注射液的风险控制体系。结论:风险控制体系的建立对于中药注射剂品种有着重要意义,今后风险控制的重点在对于风险控制战略的制定、组织架构的完善以及各个部门之间的协作、联动机制等。 Objective: To ensure the quality of Shenfu injection stable, control risks and reduce the risk of damage. Methods: To carry out risk screening and evaluation in a series of drug related links such as production, GAP, R & D, circulation, clinical use, intellectual property and emergency handling, and to control and prevent possible risks. Results: The risk control system of Shenfu injection was preliminarily constructed. Conclusion: The establishment of a risk control system is of great significance to the variety of Chinese traditional medicine injection. In the future, the focus of risk control is on the formulation of risk control strategies, the improvement of organizational structure and the cooperation and linkage mechanisms among various departments.