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Compound amino acid injection, as the source of nitrogen in parenteral nutrition, is administrated to patients with compromised gastrointestinal function or those whose nutritional needs cannot be met through gastrointestinal tract. Therefore, compound amino acid injection plays an important role in nutritional therapy and support. The active pharmaceutical ingredients of compound amino acid injection are complicated, and some amino acids are sensitive to light, heat, and oxygen, etc., which brings certain challenges to the research and development of such drugs. Based on literature research and evaluation experience in recent years, this paper discusses some issues which may need to consider during the development of generic drugs of compound amino acid injection from the aspects of API quality control, formulation design, manufacturing process development, quality research and control, selection of container enclosure system and stability studies in order to provide reference for researchers in this field.

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复方氨基酸注射液是肠外营养中氮的来源，广泛应用于不能经胃肠道给予或经胃肠道给予不能满足营养需求的患者，在营养治疗和支持中起重要作用。复方氨基酸注射液活性成分复杂，部分氨基酸对光、热、氧等敏感，给该类药物的研发带来一定的挑战。本文结合文献调研及近年审评经验，从原料药质量控制、处方开发、工艺研究、质量研究和控制、包装材料和容器的选择以及稳定性研究等方面，对复方氨基酸注射液仿制药药学研究中可能需要关注的问题进行探讨，以期为研发者提供一定参考。

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吴小飞，男，工程师，主要从事药品技术审评工作。联系电话：(010)85242673，E-mail: wuxf@ced.org.cn。

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吴小飞，男，工程师，主要从事药品技术审评工作。联系电话：(010)85242673，E-mail: wuxf@ced.org.cn。

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