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To observe the single dose toxicity and repeated dose toxicity of benvitimod, and to provide evidence for clinical administration and drug safety.
Single dose toxicity: The animals were given benvitimod 2 000 mg·kg-1 (mice) or 500 mg·kg-1 (rabbits) by subcutaneous injection. After administration, the animals were continuously observed for 14~15 days, and the toxic reaction and deaths were recorded. Repeated dose toxicity: benvitimod was administered subcutaneously to rats at doses of 40, 100, and 200 mg·kg-1·d-1 and to rabbits at doses of 30, 60, 150 mg·kg-1·d-1 for 6 months and observed for 1 month after the end of administration. The general conditions of the experimental animals were observed daily, and the body weight and food intake of the experimental animals were measured weekly. Twenty-four hours after the last administration, 50% of the animals (male and female) in each group were taken for hematology, blood biochemistry and pathology examination. The remaining animals were discontinued for 1 month, and the corresponding indexes were checked as before.
In the study of single dose toxicity, the NOAEL dose of benvitimod was 2 000 mg·kg-1 on mice and 500 mg·kg-1 on rabbit. In the study of repeated dose toxicity, after 6 months of subcutaneous injection, the NOAEL dose of benvitimod was 200 mg·kg-1 on rats and 150 mg·kg-1 on rabbit.
The results indicated that benvitimod had good safety in the clinical dosage.
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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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