Genotoxicity assessment of a herbal formula, Ojeok-san

Ha, Hyekyung; Lee, Jun Kyoung; Lee, Ho‐Young; Seo, Chang-Seob; Lee, Mee-Young; Huh, Jung-Im; Shin, Hyejin

doi:10.1016/j.jep.2011.03.024

Cited by 13 publications

(8 citation statements)

References 9 publications

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“…Thus, 4-week repeated oral administration of YMJ caused no subacute toxic effects in rats. Consistent with the results of other toxicity studies [ 23 , 24 ], the NOAEL was estimated to be 2000 mg/kg/day. In the pharmacokinetic aspect, the metabolism rate in small animals including mouse and rat is faster than in humans [ 25 ].…”

Section: Discussionsupporting

confidence: 87%

Subacute Oral Toxicity of Yukmijiwhang‐Tang in Crl:CD Sprague‐Dawley Rats and Its Cytotoxicity

Jeong

Seo

Huh

et al. 2014

Evidence-Based Complementary and Alternative Medicine

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Background. The traditional herbal formula Yukmijiwhang-tang (YMJ) consists of six medicinal herbs and has been used to treat dysuria, diabetic mellitus, and neurosis in Korea, China, and Japan. Here we report safety information on its subacute toxicity and the cytotoxicity. Methods. YMJ extract was administered to SD rats at various dosages for 4 weeks. We monitored clinical signs, mortality, body and organ weights, food intake, and hematological and serum biochemistry factors. For cytotoxicity testing, each cell line was treated with various concentrations of YMJ for 24 h. Results. YMJ treatment had no significant effects on changes in clinical signs, body weight, or food intake in male or female rats. In male rats, YMJ treatment decreased the absolute weights of the epididymides and serum Na levels. In female rats, YMJ significantly reduced the prothrombin time (PT) and serum creatine level. However, the changes were not severe and were considered to be in the normal physiological range for rats. The no-observed-adverse-effect-level (NOAEL) was estimated to be 2000 mg/kg/day. YMJ extract did not exert any cytotoxicity against 23 tested cell lines. Conclusions. Our data provide scientific evidence on the safety of YMJ for potential development as a prescription drug.

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Section: Discussionsupporting

confidence: 87%

Subacute Oral Toxicity of Yukmijiwhang‐Tang in Crl:CD Sprague‐Dawley Rats and Its Cytotoxicity

Jeong

Seo

Huh

et al. 2014

Evidence-Based Complementary and Alternative Medicine

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“…Ojeok‐san, which consists of 17 herbal medicines, is used for various indications, including the treatment of illnesses associated with fatigue, pain and fever, owing to its analgesic, anti‐inflammatory and antipyretic effects . Among the 56 traditional herbal formulae which have been supplied by the National Health Insurance Corporation in Korea, Ojeok‐san has been reported as the most frequently used herbal medication; it is also the main herbal medicine preparation provided in Korean medical clinics .…”

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confidence: 99%

Effects of Ojeok‐san on the Pharmacokinetics of Celecoxib at Steady‐state in Healthy Volunteers

Park

et al. 2018

Basic Clin Pharma Tox

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Ojeok-san is a frequently used herbal medication for the management of osteoarthritic pain. We evaluated the effect of Ojeok-san on the pharmacokinetics of celecoxib at steady-state in healthy individuals. An open-label, fixed-sequence, two-period, two-treatment cross-over study was conducted. In period I, the individuals received celecoxib capsule 200 mg once daily for 4 days. In period II, only Ojeok-san (14.47 g/pack, three times daily) was administered for 4 days, followed by co-administration with celecoxib for 4 days. On the fourth (final) day of administration, Ojeok-san was administered as a single dose. The blood samples for pharmacokinetic evaluation were collected for up to 48 hr after the administration of celecoxib in each study period. Of the 22 enrolled individuals, 20 individuals completed the study. In the presence of Ojeok-san, the systemic exposure of celecoxib was decreased. The geometric mean ratios ([celecoxib + Ojeok-san]/celecoxib) and the 90% confidence intervals for the maximum plasma concentration (C ) and the area under the plasma concentration-time curve during dosing interval (AUC ) of celecoxib at steady-state were 0.725 (0.620-0.848) and 0.885 (0.814-0.962), respectively. The changes in the mean of the C and AUC of celecoxib were greater in intermediate metabolizers of cytochrome 2C9 (CYP2C9) than in normal metabolizers. Our results suggested that the C and AUC of celecoxib were reduced by Ojeok-san co-administration. This finding may be beneficial to determine the required adjustment of celecoxib dosage when co-administered with Ojeok-san.

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“…Mice in the negative control group received only the vehicle (distilled water) by gavage. CPA in normal saline (10 mL kg −1 ) was administered via intraperitoneal injection at a dose of 70 mg kg −1 and served as a positive control [18, 19]. Each group contained six females and six males.…”

Section: Methodsmentioning

confidence: 99%

Absence of Genotoxic and Mutagenic Effects ofZingiber zerumbet(L.) Smith (Zingiberaceae) Extract

Chang

Tzeng

Liou

et al. 2012

Evidence-Based Complementary and Alternative Medicine

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The present study evaluated the potential genotoxicity of the ethanol extracts from the rhizome of Zingiber zerumbet (L.) Smith (EEZZR) using a standard battery of tests. Chemical analysis with liquid chromatography-tandem mass spectrometry revealed that EEZZR contained Zerumbone (200.3 ± 0.37 μg/g) and 6-gingerol (102.5 ± 0.28 μg/g). There were no increases in the number of revertant colonies with EEZZR at concentrations of 150–5000 μg per plate, regardless of the metabolic activation system (S-9 mix) used in the histidine-dependent auxotrophic mutants of Salmonella typhimurium (strains TA97, TA98, TA100, TA102, and TA1535) compared to the vehicle control. Furthermore, EEZZR at doses of 150–5000 μg mL−1 did not increase the number of structural aberrations in Chinese hamster lung cells in the presence or absence of S-9 mix. An oral administration of EEZZR to ICR mice, with doses of up to 2000 mg/kg, caused no significant increases in the number of micronucleated polychromatic erythrocytes (MNPCEs) and mean ratio of polychromatic erythrocytes to total erythrocytes. Lastly, RZZEE did not increase the incidence of MNPCEs in bone marrow. Based on these findings, it may be concluded that the use of EEZZR in traditional medicine poses no risk of genotoxicity.

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Genotoxicity assessment of a herbal formula, Ojeok-san

Cited by 13 publications

References 9 publications

Subacute Oral Toxicity of Yukmijiwhang‐Tang in Crl:CD Sprague‐Dawley Rats and Its Cytotoxicity

Subacute Oral Toxicity of Yukmijiwhang‐Tang in Crl:CD Sprague‐Dawley Rats and Its Cytotoxicity

Effects of Ojeok‐san on the Pharmacokinetics of Celecoxib at Steady‐state in Healthy Volunteers

Absence of Genotoxic and Mutagenic Effects ofZingiber zerumbet(L.) Smith (Zingiberaceae) Extract

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