The invention discloses a nano-drug sustained release preparation for treating a malignant tumor and a preparation method thereof. The preparation is formed by an epidermal growth factor receptor tyrosine kinase inhibitor with the tumor growth inhibition effect, a high-molecular polymer and a freeze-drying protective additive. The preparation method is simple, suitable for the large-scale production, and particularly suitable for preparing an antitumor drug nano-preparation with the characteristics of long blood circulation time, biodegradation in vivo, slow release of drugs, and passive targeting. The antitumor nano-drug sustained release preparation prepared by the method is suitable for the management by using modes, such as intravenous injection, intramuscular injection, intratumor injection and peritumoral injection, and applied to the treatment of the malignant solid tumors, such as lung cancer, liver cancer, gastric cancer, intestinal cancer, esophagus cancer, nasopharyngeal cancer, uterus cancer, breast cancer, glioma cancer, ovarian cancer, and prostate cancer, and has the good application prospect.