Genotoxicity evaluation of Oryeong-san water extract using in vitro and in vivo tests.

Mee-Young Lee,Ji-Young Kim,Hyeun-Kyoo Shin,Chang-Sebo Seo

doi:10.1186/s12906-015-0804-3

Abstract

BackgroundOryeong-san, a mixture of five herbal plants, is a well-known therapy for renal-associated diseases such as those manifesting edema, dysuria, and oliguria.MethodsIn the present study, we investigatee the potential genotoxic effects of a water extract of Oryeong-san (ORSE) in three mutagenicity assays (an in vitro bacterial reverse mutation assay (Ames test) with Salmonella typhimurium and Escherichia coli strains, an in vitro mammalian chromosomal aberration test using Chinese hamster lung cells, and an in vivo micronucleus test using ICR mice bone marrow).ResultsORSE showed no genotoxicity in the Ames test up to 5000 μg/plate; the in vitro chromosome aberration test showed no significant structural aberrations with and without the S9 mix up to 5000 μg/mL, or the in vivo micronucleus test up to 2000 mg/kg body weight.ConclusionsIn conclusion, under the current test conditions, ORSE seems safe for use; however, other genotoxicity tests (e.g. sister-chromatid exchange or Comet) or chronic toxicity tests are warranted.

Highlights

Oryeong-san, a mixture of five herbal plants, is a well-known therapy for renal-associated diseases such as those manifesting edema, dysuria, and oliguria
HPLC analysis of ORSE Using established conditions, three components were eluted within 35 min in a sample analysis using mobile phases consisting of solvent A and solvent B
The contents of two components identified in ORSE were 0.37 mg/g and 0.05 mg/g (Table 2)

Summary

Introduction

Oryeong-san, a mixture of five herbal plants, is a well-known therapy for renal-associated diseases such as those manifesting edema, dysuria, and oliguria. The global demand for herbal medicinal products has increased significantly in recent years. Obidike and Salawu reported that despite the growing market demand for herbal medicines, there are still concerns associated with their use, and their safety. The primary purpose of toxicological assessment of any herbal medicine is to identify side effects and to determine limits of exposure at which such effects occur [2]. Less than 10% of herbal products in the world market are truely standardized to known major active components and quality control measures are not always diligently adhered to [3]. The traditional herbal medicine Oryeong-san ( known as Wulingsan in traditional Chinese medicine and as Gorei-san in Japanese Kampo medicine) is a mixture of five herbal preparations (Alisma orientale (Sam)

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