Title: |
Acute and repeated toxicological study of Myelophil, an ethanol extract of a mixture of Astragali Radix and Salviae Miltiorrhizae Radix, in beagle dogs |
Authors: |
Jin-Yong Joung, Jin-Seok Lee, Jung-Hyo Cho, Dong-Soo Lee, Chang-Gue Son |
Source: |
BMC Complementary and Alternative Medicine, Vol 19, Iss 1, Pp 1-8 (2019) |
Publisher Information: |
BMC, 2019. |
Publication Year: |
2019 |
Collection: |
LCC:Other systems of medicine |
Subject Terms: |
Myelophil, Astragali Radix, Salviae Miltiorrhizae Radix, Safety, Toxicological study, NOAEL, Other systems of medicine, RZ201-999 |
More Details: |
Abstract Background To evaluate the pharmaceutical safety of Myelophil, an ethanol extract of a mixture of Astragali Radix and Salviae Miltiorrhizae Radix, using both acute and repeated toxicological studies. Methods A total of 40 beagle dogs (20 each male and female) were fed doses up to 5,000 mg/kg for the acute study and up to 1,250 mg/kg for the 13-week repeated dose toxicological study. Adverse effects were examined intensively by comparing the differences between normal and drug-administered groups using clinical signs, autopsies, histopathological findings, hematology, urinalysis, and biochemical analysis. Results No mortality or drug-related clinical signs were observed in the Myelophil-treated groups, except for vomiting due to an excessive dose (5,000 mg/kg). Likewise, in the repeated toxicity test, compound-colored stools in the Myelophil-treated groups and soft stools in all groups, including the control, were observed. No drug-related abnormalities were found in the histopathology, hematology, urinalysis, and biochemical analyses for any doses of Myelophil. Conclusion These results support the safety of Myelophil with a no observed adverse effect level (NOAEL) of 1250 mg/kg in beagle dogs, which corresponds to a human equivalent dose (HED) of 694 g/kg. |
Document Type: |
article |
File Description: |
electronic resource |
Language: |
English |
ISSN: |
1472-6882 |
Relation: |
http://link.springer.com/article/10.1186/s12906-019-2588-3; https://doaj.org/toc/1472-6882 |
DOI: |
10.1186/s12906-019-2588-3 |
Access URL: |
https://doaj.org/article/fb038820743646d09e3f9a94846e1c6a |
Accession Number: |
edsdoj.fb038820743646d09e3f9a94846e1c6a |
Database: |
Directory of Open Access Journals |