Acute and repeated toxicological study of Myelophil, an ethanol extract of a mixture of Astragali Radix and Salviae Miltiorrhizae Radix, in beagle dogs

Bibliographic Details
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
More Details
ISSN:14726882
DOI:10.1186/s12906-019-2588-3
Published in:BMC Complementary and Alternative Medicine
Language:English