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Subchronic toxicity studies of Radix Astragali extract in rats and dogs
Shu-Yi Yu1, Hong-Tao Ouyang, Ju-Yun Yang
1School of Biosciences and Technologies of Central South University, 172 Tongzipo Road, Changsha 410013, China.
Abstract:
Radix Astragali extract (RAE) is obtained from Astragalus membranaceus. It consists of Astragalus polysaccharide and Astragalus membranaceus saponins. In the study, we observed the subchronic toxicity of RAE in Sprague-Dawley rats and beagle dogs to evaluate the safety dosage range in clinical application. These subjects were daily administered of RAE by intra-peritoneum or vein for three consecutive months. General index were observed such as food-intake, behavior, body weight, hematological parameters, etc. Body weight, the weight of principal organ and hematology index are normal in experimental groups and control groups. The hematological biochemistry examination and histopathology examination of experimental groups are similar to control groups. In conclusion, our studies clearly demonstrated that RAE was safe without any distinct toxicity and side effects, the safety dosage range is 5.7-39.9g/kg for rats and 2.85-19.95g/kg for beagle dogs, which is equal to 70 or 35 times of that of human (0.57g/kg, say, average BW 70kg), respectively.
Insights
Radix Astragali extract (RAE) is safe for use. Subchronic toxicity studies in rats and dogs showed no adverse effects, establishing a wide safety dosage range for clinical applications.
Area of Science:
- Pharmacology
- Toxicology
- Natural Products
Background:
- Radix Astragali extract (RAE), derived from Astragalus membranaceus, contains bioactive compounds like polysaccharides and saponins.
- Understanding the safety profile of RAE is crucial for its clinical application.
Purpose of the Study:
- To evaluate the subchronic toxicity of Radix Astragali extract (RAE).
- To determine the safety dosage range of RAE for clinical use in humans.
Main Methods:
- Subchronic toxicity study conducted over three months in Sprague-Dawley rats and beagle dogs.
- Administration of RAE via intra-peritoneum or intravenous routes.
- Monitoring of general indices including food intake, behavior, body weight, hematological parameters, hematological biochemistry, and histopathology.
Main Results:
- No significant differences were observed in body weight, principal organ weights, or hematological parameters between RAE-treated groups and control groups.
- Hematological biochemistry and histopathology examinations revealed no distinct toxicity or adverse effects in experimental groups compared to controls.
- Established safety dosage ranges: 5.7-39.9 g/kg for rats and 2.85-19.95 g/kg for beagle dogs.
Conclusions:
- Radix Astragali extract (RAE) demonstrates a favorable safety profile with no discernible toxicity or side effects.
- The determined safety dosage ranges in animal models are substantially higher than the anticipated human clinical dose.
- RAE is considered safe for clinical application based on these subchronic toxicity findings.
