Genotoxicity studies on the root extract of Polygala tenuifolia Willdenow
Introduction
A number of medicinal plants have a long history of traditional use, and they have played many important roles for humans since the dawn of civilization (Pankaj et al., 2009), because medicinal herbs are used for the prevention and treatment of diseases (Firenzuoli and Gori, 2007, Wang et al., 2009). The use of herbal products as primary therapeutics or supplements for improving health-related conditions is popular worldwide (Seeff et al., 2001). Interestingly, medicinal plants have provided high opportunities for the development of herbal food products, dietary supplements, and functional foods (Chau and Wu, 2006). Recently, concerns have been raised over the lack of quality control and of scientific evidence for the efficacy and safety of these products (Firenzuoli and Gori, 2007, Rousseaux and Schachter, 2003). Especially, people become more interested in the food safety and well-being in recent years, so the demand for functional food from natural sources is increased (Lee et al., 2003), because medicinal plants have undesirable side effects (Chan and Cheung, 2000). In traditional oriental medicine, the root of Polygala tenuifolia Willdenow has been prescribed in Asia for thousands of years, because of its expectorant, tonic, tranquilizer, and antipsychotic properties (Spelman et al., 2006, Wang et al., 2007, Nagai and Suzuki, 2001, Klein et al., 2012, Jin et al., 2012). Previously, we reported that the root extract of P. tenuifolia can enhance memory and cognitive function in two animal models or two human models (Park et al., 2002, Lee et al., 2009, Shin et al., 2009a, Shin et al., 2009b) and the acute or subchronic toxicity of the root extract was not toxic to dogs and rats (Shin et al., 2014). Several researchers have demonstrated the effects of P. tenuifolia, but information on its safety is lacking. Therefore, systematic evaluation of the safety of the root extract of this herb is necessary for development of new foods or drugs. In this study, we evaluated the potential genotoxicity of the dried root extract of P. tenuifolia was conducted using the standard battery of tests recommended by OECD and the Korea Food and Drug Administration (KFDA). The test included the bacterial reverse mutation test (Ames test), the chromosomal aberrations test and the micronucleus tests to assure its safe use in dietary supplements or functional ingredients.
Section snippets
Extraction of Polygala tenuifolia
The dried root extract of P. tenuifolia (500 g) was refluxed with 75% ethanol for 4 h in a boiling water bath. This procedure was repeated twice and the ethanol solution was concentrated under vacuum. The concentrated ethanol fraction (125 g) of the plant root, obtained as described above, was used for this study (Park et al., 2002).
Bacterial mutation assay (Ames test)
The Ames test was carried out in according to the methods described in OECD (1997a) and the KFDA Notification No. 1999-61 (KFDA, 1999). Two strains of Salmonella
Bacterial mutation assay (Ames test)
There was neither increase of colonies nor cytotoxicity in S. typhimurium TA100, TA1535, TA98 and TA1573 at any dose level of test substance both in the presence and absence of metabolic activation system. In WP2 uvrA, there was neither increase of colonies nor cytotoxicity at any dose level of the test substance both in the presence and absence of metabolic activation system. The background lawn was also normal in all strains. There was significant increase in the number of colonies in all
Discussion
P. tenuifolia Willdenow is a perennial herbaceous plant distributed widely in China and Korea.
In particular, the root of the herb is used against insomnia, neurasthenia, amnesia, depression, palpitations with anxiety, restlessness, and disorientation, dementia, and memory failure (Huang, 1993, Liu et al., 2010). The extract has been shown to contain C-glycosides, triterpene saponins, sucrose esters, and oligosaccharide esters (Ikeya et al., 2004, Ling et al., 2013). It also contains various
Conflict of interests
The authors declare that there are no conflicts of interest.
Acknowledgements
This study was supported by SNUH-GLP (Non-Clinical Research Center, Biomedical Research Institute, Seoul National University Hospital) and Preclinical Research Center, ChemOn Inc., respectively.
References (44)
Is there a continuing role for the intraperitoneal injection route of exposure in short-term rodent genotoxicity assays
Mutat. Res.
(1985)- et al.
The development of regulations of Chinese herbal medicines for both medicinal and food uses
Trends Food Sci. Technol.
(2006) - et al.
Tenuigeninprotes cultured hippocampal neurons against methlglyoxal-induced neurotoxicity
Eur. J. Pharmacol.
(2010) - et al.
The bone marrow micronucleus test
- et al.
The extracts of FructusAkebiae, a preparation containing 90% of the active ingredient hederagenin:serotomin, norepinephrine and dopamine reuptake inhibitor
Pharmacol. Biochem. Behav.
(2012) - et al.
Assessment of herbal medicinal products: challenges, and opportunities to increase the knowledge base for safety assessment
Toxicol. Appl. Pharmacol.
(2010) - et al.
Effects of BT-11 on memory in healthy humans
Neurosci. Lett.
(2009) - et al.
Analysis and detection of the chemical constituents of radix polygalae and their matabolites in rats after oral administration by ultra high-performance liquid chromatography coupled with electrospray ionization quadrupole time-of flight tandem mass spectrometry
J. Pharm. Biomed. Anal.
(2013) - et al.
Potential antidepressant properties of radix polygalae (Yuan Zhi)
Phytomedicine
(2010) - et al.
Differences in perceived risks and benefits of herbal, over-the-counter conventional, and prescribed conventional, medicines, and the implications of this for the safe and effective use of herbal products
Compl. Ther. Med.
(2007)
Revised methods for the Salmonella mutagenicity test
Mutat. Res.
Onjisaponins, from the root of Polygala tenuifolia Wulldeow, as effective adjuvants for nasal influenza and diphtheria–pertussis–tetanus vaccines
Vaccine
The micronucleus test
Mutat. Res.
Complementary and alternative medicine in chronic liver disease
J. Hepatology.
BT-11 is effective for enhancing cognitive functions in the elderly humans
Neurosci. Lett.
In vitro and in vivo evaluation of the genotoxicity Gumiganghwal-tang, a traditional herbal prescription
J. Ethnopharmacol.
Quality and safety of Chinese herbal medicines guided by a systems biology perspective
J. Ethnopharmacol.
Examples of interactions between Chinese herbal medicinal products and orthodox drug
Tenuigenun promotes proliferation and differentiation of hippocampal neural stem cells
Neurochem. Res.
Assays for the detection of chemically-induced chromosome damage in cultured mammalian cells
New tables for multiple comparisons with a control
Biometrics
Herbal medicine today: clinical and research issues
Evid. Based Compl. Altern. Med.
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