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As a new solid-state form of drugs, pharmaceutical co-crystals can improve the physicochemical properties of drugs (such as melting point, stability, solubility, hygroscopicity, compressibility, permeability, bioavailability, etc), thereby changing drug performance or enhancing therapeutic efficacy, providing new ideas for drug development. In recent years, pharmaceutical co-crystals has attracted much attention as a hot topic in the research of crystalline drugs, but there is currently no specialized guiding principle for pharmaceutical co-crystals research in China. This article mainly investigates the technical documents on pharmaceutical co-crystals research released by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), elaborates on the regulatory requirements for pharmaceutical co-crystals in foreign countries, compares and analyzes the regulatory requirements of FDA and EMA, in order to provide references for the research and regulation of pharmaceutical co-crystals in China.
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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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