OBJECTIVE： To observe the effects of Xingnaojing injection on the efficacy and safety of patients with acute cerebral infarction merge blood stasis syndrome. METHODS： 70 patients with acute cerebral infarction merge blood stasis syndrome were randomly divided into observation group （35 cases） and control group （35 cases）. Control group received conventional treatment according to 2014 edition of Chinese guideline for diagnosis and management of acute ischemic stooke. Patients within thrombolysis time window were given intravenaus infusion of rt-PA， and those out of thrombolysis time window orally received 0.3 g Aspirin tablet every evening， then 0.1 g after 1 week+40 mg Atorvastatin calcium tablet every evening，and if patients have arfficulty suallowing，gavage administiation was implemented. Observation group additionally received 30 ml Xingnaojing injection， adding into 250 ml 0.9％ Sodium chloride injection， intravenous infusion， once a day. The treatment course for both groups was 14 d. Clinical efficacy， γ-interferon （IFN-γ）， interleukin-13 （IL-13）， interleukin-4 （IL-4）， high-sensitivity C-reactive protein （hs-CRP） levels， the US National Institutes of Health Stroke Scale （NIHSS） rating， improved Barthel index （BI）， infarction size before and after treatment and the incidence of adverse reactions in 2 groups were observed. RESULTS： There was no significant difference in the total effective rate and incidence of adverse reactions in 2 groups （P＞0.05）. Before treatment， there were no significant differences in IFN-γ， IL-13， IL-4， hs-CRP levels， the NIHSS rating， BI and infarction size in 2 groups （P＞0.05）. After treatment， the IFN-γ， hs-CRP levels， the NIHSS rating and infarction size in 2 groups were significantly lower than before， and observation group was lower than control group， IL-13， IL-4 and BI were significantly higher than before， and observation group was higher than control group， the differences were statistically significant （P＜0.05 or P＜0.01）. CONCLUSIONS： Based on conventional treatment， Xingnaojing injection shows obvious efficacy the efficacy and safety of patients with acute cerebral infarction merge blood stasis syndrome， it can reduce the levels of inflammatory cytokines， improve neurological deficits， daily living skills and infarct volume， with good safety.