Kim Soo-Dam, Yang Jae-Ho, Kwag Eun-Bin, Park Ji-Hye, Park So-Jung, Yoo Hwa-Seung
East West Cancer Center, Daejeon Korean Medicine Hospital, Daejeon University, 75, 176 Bun-Gil, Daedeok-Daero, Seo-Gu, Daejeon 35-235, Republic of Korea.
East West Cancer Center, Seoul Korean Medicine Hospital, Daejeon University, 32, Beobwon-Ro 11-Gil, Songpa-Gu, Seoul 05-836, Republic of Korea.
Evid Based Complement Alternat Med. 2021 Nov 9;2021:2162986. doi: 10.1155/2021/2162986. eCollection 2021.
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 g/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.
HAD - B1是一种用于治疗实体瘤的韩国草药配方，通过细胞实验已证明其具有抗癌作用。当前研究旨在测试HAD - B1的安全性。本实验遵循国际人用药品注册技术协调会（ICH）的规定。为了确定HAD - B1对中枢神经系统是否有任何影响，将0、500、1000和2000毫克/千克/天的HAD - B1分别一次性口服给予雄性和雌性大鼠。为了发现其对呼吸系统的任何影响，将0、500、1000和2000毫克/千克/天的HAD - B1口服给予雄性大鼠，随后测量呼吸频率、潮气量和每分钟呼吸量。为了评估给药导致QT间期延长的可能性，在0、0.1、0.3和1克/毫升的浓度下进行了人乙醚 - 去极化相关基因（hERG）分析。为了评估对心血管系统的任何影响，将0、500、1000和2000毫克/千克/天的HAD - B1分别一次性口服给予雄性比格犬，随后进行体温、血压、心电图和心率分析。在评估对中枢神经系统的任何影响时，雄性和雌性大鼠均未出现临床显著变化。在雄性大鼠的呼吸评估中未出现临床显著变化。hERG分析结果未出现临床显著变化。雄性比格犬的心血管系统未出现临床显著变化。我们的结果表明，HAD - B1是一种安全的草药配方，对中枢神经系统、呼吸系统和心血管系统没有临床显著影响。
