Abstract: OBJECTIVE To evaluate the possibility of allergic response test for Chinese medicine injections using human cell line activation test in vitro, and to explore the feasibility of in vitro test of type Ⅳ allergy reaction for traditional Chinese medicine injection. METHODS In terms of OECD Guideline 442E, 4 different Chinese medicine injections were tested both in human cell line activation test with human leukemia THP-1 cells in vitro and allergic response in vivo at the same time. RESULTS From the result of in vitro skin sensitization test, relative fluorescence intensity of specific surface antigen of dendritic cells CD86 was below 150 and CD54 below 200, which was negative according to the criteria. The results was the same as in vivo test. CONCLUSION In vitro test has its advantages of short cycle, relatively simple and objective, and is a good alternative method for allergic response test for Chinese medicine injections.