目的 探讨我国药用辅料细菌内毒素质量控制和标准研究的指导原则及《中国药典》标准收载格式。方法 通过调研我国现行药用辅料细菌内毒素质量控制相关标准,结合国际相关进展等,分析存在问题,提出适合我国国情的药用辅料细菌内毒素质量控制和标准研究的指导原则、标准收载格式。结果 本研究结合药用辅料的特点和使用途径,对药用辅料细菌内毒素标准设定、限值计算、生产过程中药用辅料细菌内毒素控制策略等进行探讨,同时给出《中国药典》药用辅料细菌内毒素标准收载格式建议。结论 提出了药用辅料细菌内毒素质量控制和标准研究的指导性意见和规范性要求,有助于在我国药品与药用原辅料和包装材料关联审批的制度下,完善药用辅料质量标准体系,确保制剂安全。
Abstract
OBJECTIVE To explore the guidelines for quality control of bacterial endotoxin for pharmaceutical excipients and standard styles in Chinese Pharmacopeia. METHODS Based on the status survey and the international progress, the existing problems in China were analyzed, and the guiding principles and standard styles of bacterial endotoxin standard for pharmaceutical excipients were proposed. RESULTS Based on the characteristics and usage of excipients, we discussed the setting of endotoxin specifications for pharmaceutical excipients, the calculation of the endotoxin limits, and the control strategy of bacterial endotoxin during the manufacturing of parenteral products. The styles for standard specifications in Chinese Pharmacopeia were also advised. CONCLUSION The guidelines and normative requirements for quality control and standard research of bacterial endotoxin for pharmaceutical excipients are put forward for the first time,which is helpful to improve the quality standard system of pharmaceutical excipients and ensure the safety of drugs under the situation of the associated review and approval policy in China.
关键词
《中国药典》 /
药用辅料 /
质量标准 /
细菌内毒素
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Key words
Chinese Pharmacopeia /
pharmaceutical excipient /
quality standard /
bacterial endotoxin
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中图分类号：
R917
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脚注
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基金
《中国药典》2025年版编制大纲规划项目资助
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