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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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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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