Full
Outline
To explore the non-clinical safety evaluation method of Traditional Chinese medicine in juvenile rats, and observe the 4-week toxicity of Children Fengye Kechuanping Mixture, so as to provide reference for clinical medication in children.
A total of 120 juvenile SD rats were randomly divided into 4 groups according to bodyweight, with 30 rats in each group, half male and half female. Four groups were solvent control group, Children Fengye Kechuanping Mixture low (extract 7.0 g·kg-1), medium (extract 14.0 g·kg-1) and high (extract 22.5 g·kg-1) dose groups. Each group was given the medication once a day by gavage. PND21 were given for 4 weeks in total, and the solvent control group was given the same amount of deionized water. General status, bodyweight, food intake, growth and development, hematology, blood biochemistry, coagulation, urine, immunity, hormones, organs and histopathological changes were detected.
In high-dose group, the weight, food intake, hematological indexes (RET, RET% increase), organ weight or coefficient (thymus decrease, liver increase) changed. Growth retardation was observed in male juvenile rats (manifested as decreased top hip length, shortened tibia length, increased tibia total density and cortex density). No obvious toxic target organs were observed. The effect of the above expression in juvenile male rats was more obvious.
The safe dose of Children Fengye Kechuanping Mixture was 7.0 g·kg-1 (low dose, equivalent to raw dose 79.8 g·kg-1), 2.5 times of the equivalent dose and 14.9 times of the clinical dose in juvenile SD rats given by gavage for 4 weeks.
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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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