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OBJECTIVE To prepare and calibrate the first batch of national standard (NS) of pormestriene for the sake of fulfilling the requirement of quality control on it and related drug products in domestic. METHODS The structure of candidate pormestriene was confirmed by MS, NMR, IR and UV. Physical-chemical analysis was carried out. According to different national drug standard methods, the purity of the candidate was determined, the value was assigned by mass balance method, and the uniformity and stability of the candidate were investigated. RESULTS The candidate was homogenous with promestriene, and the content was 99.6% measured by mass balance method.Uniformity inspection met the requirements. The product should be stored at 10-30 ℃, shaded and sealed. CONCLUSION The candidate was confirmed to be promestriene, which can be used as the first national standard, the content is 99.6%, and it can be used as a reference for the identification and content determination of promestriene and related preparations.
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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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