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As the continuous in-depth research on prophylactic mRNA vaccines, new questions have been raised about lipid nanoparticles in aspects of structures and morphologies. Based on the principle of ICH Q6B, the characteristics and changes of the structures of lipid nanoparticles were preliminarily discussed from the perspective of pharmaceutical evaluation, and the additional study for the structural characteristics were also addressed for providing a reference for the quality assessment and control of prophylactic mRNA vaccines.

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随着预防用mRNA疫苗研究不断深入，发现了脂质纳米颗粒结构/形态等新问题。 根据ICH Q6B理念，从药学评价角度对脂质纳米颗粒的结构特点、变化趋势等进行初步探讨，对其结构特征表征需要额外开展的研究工作也进行了一些探索与思考，以期为预防用mRNA疫苗质量研究及质量控制提供参考。

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杨丹，女，助理研究员，研究方向：疫苗药学技术评价。联系电话：(010)80996178，E-mail: yangdan@cde.org.cn。

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杨丹，女，助理研究员，研究方向：疫苗药学技术评价。联系电话：(010)80996178，E-mail: yangdan@cde.org.cn。

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