Abstract: As a new type of high-risk packaging container, the use of prefilled syringes is widespread increasingly, and the effectiveness, stability and safety of prefilled syringes in clinical use have become prominent increasingly. However, the leachable substances from prefilled syringes may cause harm to the human body in different degrees. Therefore, this paper reviews the research progress of leachable substances in prefilled syringes, which is not only of great significance for the quality control of prefilled syringes, but also contributes to the healthy development of the industry.