Abstract: The safety of traditional Chinese medicine injection (TCMI) has become the hot question in the society. Correct understanding of the adverse reactions of TCMI can effectively avoid the misunderstanding or misperception among the public. At present， the raw materials， production process and quality control were the key points which influence the safety of TCMI injections. According to the clinical problems of various varieties， it should concentrate on strengthening basic research， standardization the instructions and drug compatibility， enhance the safety control of the related substances， insoluble particles， pyrogen and allergens to ensure the safe usage of TCMI.