OBJECTIVE To evaluate the safety characteristics of Rehmannia glutinosa leaf total glycosides capsules in juvenile Wistar rats, and provide reference for the use of Rehmannia glutinosa leaf total glycosides capsules in child and adolescent patients. METHODS Twenty-seven-day-old Wistar rats were randomly divided into control and low-, medium-, and high-dosage groups. Each dosage group was given the Rehmannia glutinosa leaf total glycosides by gavage repeatedly for 8 weeks, followed by a 4 week recovery. The clinical symptoms, body weight, food consumption, hematological and serum biochemical indexes, central nervous system function, learning and memory ability, skeletal development, reproductive function, organ weight and histopathological changes of the rats was observed. RESULTS Rehmannia glutinosa leaf total glycosides capsules did not show significant effects on the clinical symptoms, body weight, food consumption, hematological and serum biochemical indexes, main organ weights, central nervous system function, bones, sexual cycle, sperm counts, vitality and form of the rats. No histopathological changes were observed associated with Rehmannia glutinosa leaf total glycosides capsules. CONCLUSION The no-observed-adverse-effect-level (NOAEL) for Rehmannia glutinosa leaf total glycosides capsules in juvenile rats is determined to be 750 mg·kg-1 in the 8 week feeding study. The data provides reference for the use of Rehmannia glutinosa leaf total glycosides capsules in child and adolescent patients.
| 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 |