OBJECTIVE： To investigate the effects and safety of Xingnaojing injection combined with butylphthalide on neurological function， cognitive function， coagulation function and living activity. METHODS： A total of 106 patients with middle cerebral artery infarction in Wuhan University People’s Hospital during Jun. 2014-Dec. 2015 were divided into control group and observation group according to random number table， with 53 cases in each group. Besides routine symptomatic treatment， control group was given Butylphthalide soft capsules 0.2 g， po， tid. Observation group was additionally given Xingnaojing injection 20 mL added into 0.9％ Sodium chloride injection 250 mL， ivgtt， qd. Both groups were treated for 14 d. The neurological function score （NIHSS， NFDS）， cognitive function score （MoCA， MMSE）， coagulation function indexes （PT， APTT， FIB）， BI score were observed in 2 groups before and after treatment. The occurrence of secondary remote damage and ADR were recorded. RESULTS： Eight patients withdrew from the study， including 3 patients of control group and 5 of observation group. Before treatment， there was no statistical significance in neurological function scores （NIHSS， NFDS）， cognitive function scores （MoCA， MMSE）， coagulation function indexes or BI scores between 2 groups （P＞0.05）. After treatment， NIHSS， NFDS scores and FIB of 2 groups were decreased significantly compared to before treatment， and the observation group was significantly lower than the control group， with statistical significance （P＜0.05）. MoCA， MMSE， BI scores in 2 groups were increased significantly， and PT and APTT in 2 groups were prolonged significantly， and the observation group was significantly higher or longer than the control group， with statistical significance （P＜0.05）. The incidence of secondary remote damage in observation group （11.3％） was significantly lower than control group （41.5％）， with statistical significance （P＜0.05）. There was no statistical significance in the incidence of ADR between 2 groups （P＞0.05）. CONCLUSIONS： For middle cerebral artery infarction， the application of Xingnaojing injection combined with butylphthalide can reduce the risk of remote damage， promote the recovery of neurological function and cognitive function， and improve coagulation function and living activity with good safety.