Safety analysis and selection of excipients for intrathecal drugs

ZHANG Xia; YAO Shang-chen; NING Bao-ming; LI Jin; SUN Hui-min

doi:10.20251/j.cnki.1003-3734.2026.14.001

Abstract：Objective:To prevent and control the risk of excipients in intrathecal drugs and strengthen their management.Methods:Information of excipients in approved intrathecal drugs abroad was collected,the quality requirements of regulatory agencies for intrathecal drugs in various countries were listed,literature on the safety of excipients in intrathecal drugs was searched and sorted out,and the impact of intrathecal drugs on medication safety was analyzed.Results:The quality requirements for intrathecal drugs are stricter than those for ordinary injections,with fewer types and quantities of excipients.Regulatory agencies in various countries specified that intrathecal drugs must not contain preservatives,and the threshold of bacterial endotoxin per kg of body mass in a single hour period is much lower than that for ordinary injections.The information on excipients for intrathecal drugs in the US"Inactive Ingredient Search for Approved Drug Products"is an important reference for excipient selection during formulation development.Conclusion:The safety and regulation of excipients in intrathecal injections are critical to ensuring the clinical safety of these high-risk formulations.It is recommended that drug regulatory agencies,research and development departments,and manufacturing enterprises collectively enhance their attention to the excipients used in intrathecal injections.By improving the regulatory framework,promoting safety research,and strengthening lifecycle management,the risk associated with excipients can be systematically assessed and controlled,thereby better safeguarding patient medication safety.