鞘内注射剂中药用辅料的安全性分析与选择

Safety analysis and selection of excipients for intrathecal drugs

摘要

目的: 防控鞘内注射剂中辅料的风险,加强药用辅料管理。方法: 综述国外已获批鞘内制剂的辅料信息,列举各国监管机构对鞘内注射剂的法规和质量控制要求,检索与梳理鞘内注射用辅料安全性的文献资料,分析鞘内注射剂中辅料对药品安全性的影响。结果: 鞘内注射制剂的质量要求比普通注射剂严格,已获批使用的辅料种类和数量远少于普通注射剂。各国监管机构均规定鞘内注射剂中不得使用抑菌剂,对细菌内毒素剂量的要求远低于普通注射剂。结论: 鞘内注射剂中辅料的安全性与其监管是保障该类高风险制剂临床使用安全的关键环节,建议药品监管机构及研发与生产企业共同加强对鞘内注射剂中辅料的关注。通过完善监管体系、推动安全性研究以及强化全生命周期监管,系统评估并控制辅料相关风险,以更好地保障患者用药安全。

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.

关键词

鞘内注射 / 药用辅料 / 抑菌剂 / 神经毒性 / 细菌内毒素 / 不良反应 / 药用辅料监管

Key words

intrathecal drugs / excipients / preservatives / neurotoxicity / bacterial endotoxins / adverse reactions / pharmaceutical excipients regulation

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