Nonclinical Safety Pharmacology Study of the Herbal Product HAD-B1

HAD-B1 is a Korean herbal formula designed to treat solid tumors, and through cell experiments, it has proven to have an anticancer effect. The current study aims to test the safety of HAD-B1. This experiment is under the regulation of ICH. In order to find if HAD-B1 has any effect on the CNS, 0, 50...

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Autores principales:	Soo-Dam Kim, Jae-Ho Yang, Eun-Bin Kwag, Ji-Hye Park, So-Jung Park, Hwa-Seung Yoo
Formato:	article
Lenguaje:	EN
Publicado:	Hindawi Limited 2021
Materias:	Other systems of medicine RZ201-999
Acceso en línea:	https://doaj.org/article/3aa9d6a638064f50a1c591ce8fa13361
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spelling	oai:doaj.org-article:3aa9d6a638064f50a1c591ce8fa133612021-11-22T01:10:09ZNonclinical Safety Pharmacology Study of the Herbal Product HAD-B11741-428810.1155/2021/2162986https://doaj.org/article/3aa9d6a638064f50a1c591ce8fa133612021-01-01T00:00:00Zhttp://dx.doi.org/10.1155/2021/2162986https://doaj.org/toc/1741-4288HAD-B1 is a Korean herbal formula designed to treat solid tumors, and through cell experiments, it has proven to have an anticancer effect. The current study aims to test the safety of HAD-B1. This experiment is under the regulation of ICH. In order to find if HAD-B1 has any effect on the CNS, 0, 500, 1000, and 2000 mg/kg/day of HAD-B1 were orally administered to male and female rats once. To discover any effect on the respiratory system, 0, 500, 1000, and 2000 mg/kg/day of HAD-B1 were orally given to male rats followed by measuring the respiratory rate, tidal volume, and minute respiratory volume. To assess the possibility of a delayed QT period as a result of the drug administration, hERG analysis was conducted at 0, 0.1, 0.3, and 1 μg/ml. To assess any effect on the cardiovascular system, 0, 500, 1000, and 2000 mg/kg/day of HAD-B1 were orally given to male beagle dogs once followed by temperature, blood pressure, ECG, and heart rate analyses. There were no clinically significant changes in both male and female rats on assessing any effects on the CNS. There were no clinically significant changes in male rats’ respiratory assessment. There were no clinically significant changes in hERG analysis results. There were no clinically significant changes in the cardiovascular system of male beagle dogs. Our results demonstrate that HAD-B1 is a safe herbal formula that does not have a clinically significant effect on the CNS, respiratory, and cardiovascular systems.Soo-Dam KimJae-Ho YangEun-Bin KwagJi-Hye ParkSo-Jung ParkHwa-Seung YooHindawi LimitedarticleOther systems of medicineRZ201-999ENEvidence-Based Complementary and Alternative Medicine, Vol 2021 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Other systems of medicine RZ201-999
spellingShingle	Other systems of medicine RZ201-999 Soo-Dam Kim Jae-Ho Yang Eun-Bin Kwag Ji-Hye Park So-Jung Park Hwa-Seung Yoo Nonclinical Safety Pharmacology Study of the Herbal Product HAD-B1
description	HAD-B1 is a Korean herbal formula designed to treat solid tumors, and through cell experiments, it has proven to have an anticancer effect. The current study aims to test the safety of HAD-B1. This experiment is under the regulation of ICH. In order to find if HAD-B1 has any effect on the CNS, 0, 500, 1000, and 2000 mg/kg/day of HAD-B1 were orally administered to male and female rats once. To discover any effect on the respiratory system, 0, 500, 1000, and 2000 mg/kg/day of HAD-B1 were orally given to male rats followed by measuring the respiratory rate, tidal volume, and minute respiratory volume. To assess the possibility of a delayed QT period as a result of the drug administration, hERG analysis was conducted at 0, 0.1, 0.3, and 1 μg/ml. To assess any effect on the cardiovascular system, 0, 500, 1000, and 2000 mg/kg/day of HAD-B1 were orally given to male beagle dogs once followed by temperature, blood pressure, ECG, and heart rate analyses. There were no clinically significant changes in both male and female rats on assessing any effects on the CNS. There were no clinically significant changes in male rats’ respiratory assessment. There were no clinically significant changes in hERG analysis results. There were no clinically significant changes in the cardiovascular system of male beagle dogs. Our results demonstrate that HAD-B1 is a safe herbal formula that does not have a clinically significant effect on the CNS, respiratory, and cardiovascular systems.
format	article
author	Soo-Dam Kim Jae-Ho Yang Eun-Bin Kwag Ji-Hye Park So-Jung Park Hwa-Seung Yoo
author_facet	Soo-Dam Kim Jae-Ho Yang Eun-Bin Kwag Ji-Hye Park So-Jung Park Hwa-Seung Yoo
author_sort	Soo-Dam Kim
title	Nonclinical Safety Pharmacology Study of the Herbal Product HAD-B1
title_short	Nonclinical Safety Pharmacology Study of the Herbal Product HAD-B1
title_full	Nonclinical Safety Pharmacology Study of the Herbal Product HAD-B1
title_fullStr	Nonclinical Safety Pharmacology Study of the Herbal Product HAD-B1
title_full_unstemmed	Nonclinical Safety Pharmacology Study of the Herbal Product HAD-B1
title_sort	nonclinical safety pharmacology study of the herbal product had-b1
publisher	Hindawi Limited
publishDate	2021
url	https://doaj.org/article/3aa9d6a638064f50a1c591ce8fa13361
work_keys_str_mv	AT soodamkim nonclinicalsafetypharmacologystudyoftheherbalproducthadb1 AT jaehoyang nonclinicalsafetypharmacologystudyoftheherbalproducthadb1 AT eunbinkwag nonclinicalsafetypharmacologystudyoftheherbalproducthadb1 AT jihyepark nonclinicalsafetypharmacologystudyoftheherbalproducthadb1 AT sojungpark nonclinicalsafetypharmacologystudyoftheherbalproducthadb1 AT hwaseungyoo nonclinicalsafetypharmacologystudyoftheherbalproducthadb1
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Nonclinical Safety Pharmacology Study of the Herbal Product HAD-B1

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