Woo-Young Jeon1, Chang-Seob Seo2, Hyekyung Ha3, Hyeun-Kyoo Shin4, Jae-Woo Cho5, Da Hee Kim6, Mee-Young Lee7. 1. Herbal Medicine Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea. Electronic address: ssamggun85@kiom.re.kr. 2. Herbal Medicine Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea. Electronic address: csseo0914@kiom.re.kr. 3. Herbal Medicine Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea. Electronic address: hkha@kiom.re.kr. 4. Herbal Medicine Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea. Electronic address: hkshin@kiom.re.kr. 5. Korea Institute of Toxicology, 30 Baekhak 1-Gil, Jeongeup-si, Jeollabuk-do, 56212, Republic of Korea. Electronic address: cjwoo@kitox.re.kr. 6. Korea Institute of Toxicology, 30 Baekhak 1-Gil, Jeongeup-si, Jeollabuk-do, 56212, Republic of Korea. Electronic address: kimdh@kitox.re.kr. 7. Herbal Medicine Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea. Electronic address: cozy11@kiom.re.kr.
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE: Bojungikki-tang is a traditional herbal medicine used to boost immunity and reduce fatigue. However, there is not enough scientific evidence about its toxicological safety profile to support its continued clinical application. AIM OF THE STUDY: The objective of this study was to investigate the subchronic toxicity profile of Bojungikki-tang water extract (BITW) in Sprague Dawley rats who were exposed to it in multiple doses and various concentrations. MATERIALS AND METHODS: BITW was administered to rats orally, once daily at doses of 0, 500, 1000, or 2000 mg/kg/day for 13 weeks. We checked toxicological parameters including general observations, organ/body weights, food consumption, ophthalmological signs, hematological and serum biochemical values, urinalysis values and histopathological findings. RESULTS: The 13 week repeated oral administration of BITW to rats at doses at doses levels of less than or equal to 2000 mg/kg/day caused no significant toxicological changes and only minor nonsignificant changes. CONCLUSIONS: Our findings indicate that administration of BITW for up to 13 weeks may be safe and nontoxic, with a no-observed-adverse-effect-level of >2000 mg/kg/day for both male and female rats.
ETHNOPHARMACOLOGICAL RELEVANCE: Bojungikki-tang is a traditional herbal medicine used to boost immunity and reduce fatigue. However, there is not enough scientific evidence about its toxicological safety profile to support its continued clinical application. AIM OF THE STUDY: The objective of this study was to investigate the subchronic toxicity profile of Bojungikki-tang water extract (BITW) in Sprague Dawley rats who were exposed to it in multiple doses and various concentrations. MATERIALS AND METHODS: BITW was administered to rats orally, once daily at doses of 0, 500, 1000, or 2000 mg/kg/day for 13 weeks. We checked toxicological parameters including general observations, organ/body weights, food consumption, ophthalmological signs, hematological and serum biochemical values, urinalysis values and histopathological findings. RESULTS: The 13 week repeated oral administration of BITW to rats at doses at doses levels of less than or equal to 2000 mg/kg/day caused no significant toxicological changes and only minor nonsignificant changes. CONCLUSIONS: Our findings indicate that administration of BITW for up to 13 weeks may be safe and nontoxic, with a no-observed-adverse-effect-level of >2000 mg/kg/day for both male and female rats.
Authors: Su Won Lee; Jin Kwan Choi; Yee Ran Lyu; Won Kyung Yang; Seung Hyung Kim; Je Hyun Kim; Si Yeon Kim; Weechang Kang; In Chul Jung; Beom Joon Lee; Jun Yong Choi; Taesoo Kim; Yang Chun Park Journal: Evid Based Complement Alternat Med Date: 2022-06-20 Impact factor: 2.650