Genotoxicity Evaluation of an Ethanol Extract Mixture of Astragali Radix and Salviae miltiorrhizae Radix

Myelophil, a combination of Astragali Radix and Salviae Radix, is one of the most commonly used remedies for disorders of Qi and blood in traditional Chinese medicine. Based on the clinical applications of these plants, in particular to pregnant woman, this study aimed to evaluate the genotoxic potential of an ethanol extract mixture of the above two herbs, called Myelophil. Following the Organization for Economic Cooperation and Development (OECD) Guideline methods, a genotoxicity test was conducted using a bacterial reverse mutation test with Salmonella typhimurium (TA98, TA100, TA1535, and TA1537) and Escherichia coli (WP2μvrA), an in vitro mammalian chromosome aberration test using a Chinese hamster ovary cell line (CHO-K1), and an in vivo mammalian erythrocyte micronucleus test using ICR mouse bone marrow. In the Ames test, for both types of mutations (base substitution and frameshift) under conditions with/without an S9 mix up to 5,000 μg/plate, Myelophil did not increase the number of revertant colonies of all S. typhimurium strains as well as E. coli strain. For both short (6 h) and long tests with/without S9 mix, the chromosome aberration test did not show any significant increase in the number of structural or numerical chromosome aberrations by Myelophil. In addition, no significant change in the number of micronucleated polychromatic erythrocytes or polychromatic erythrocytes was observed in the bone marrow of an ICR mouse administered Myelophil orally at 2,000 mg/kg/day for 2 days, respectively. These results are the first to provide experimental evidence that Myelophil, an ethanol extract mixture of Astragali Radix and Salviae Radix, has no risk of genotoxicity.