Department of Herbal Pharmacology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Department of Herbal Pharmacology, College of Korean Medicine, Gachon University, 1342 Seongnamdae-ro, Sujeong-gu, Seongnam-si, Gyeonggi-do, 13120, Republic of Korea.
BMC Complement Med Ther. 2020 Jul 17;20(1):226. doi: 10.1186/s12906-020-02998-1.
The roots of Pueraria lobata and Scutellaria baicalensis, herbal medicines with a long history of widespread use, have been traditionally prescribed in combination to treat stroke, diabetes, and acute infectious diarrhea in East Asia. Nevertheless, toxicological data on these herbs and their combination are limited. This study investigated the acute and 13-week subchronic toxicity of root extract of P. lobata and S. baicalensis (HT047) for stroke treatment in male and female Sprague-Dawley rats.
In the acute toxicity study, HT047 was administered orally at a single dose of 5000 mg/kg. In the subchronic toxicity study, HT047 was administered orally at repeated daily doses of 800, 2000, and 5000 mg/kg/day for 13 weeks, followed by a 4-week recovery period.
In the acute toxicity study, there were no deaths or toxicologically significant changes in clinical signs, body weight, and necropsy findings. In the subchronic toxicity study, HT047 at all doses caused no death and no treatment-related adverse effects on food consumption; organ weight; ophthalmologic, urinalysis, and hematological parameters; and necropsy findings of both rat sexes. There were some treatment-related alterations in clinical signs, body weight, and serum biochemistry and histopathological parameters; however, these changes were not considered toxicologically significant because they were resolved during the recovery period or resulted from the pharmacological effects of P. lobata and S. baicalensis.
The oral approximate lethal dose (the lowest dose that causes mortality) of HT047 was greater than 5000 mg/kg in male and female rats. The oral no-observed-adverse-effect level of HT047 was greater than 5000 mg/kg/day in rats of both sexes, and no target organs were identified. The present findings support the safety of an herbal extract of P. lobata and S. baicalensis as a therapeutic agent for stroke and further confirm the safety of the combined use of P. lobata and S. baicalensis in clinical practice.
葛根和黄芩是两种具有悠久应用历史的草药，传统上联合用于治疗东亚地区的中风、糖尿病和急性感染性腹泻。然而，关于这些草药及其组合的毒理学数据有限。本研究旨在调查用于中风治疗的葛根和黄芩根提取物（HT047）在雄性和雌性 Sprague-Dawley 大鼠中的急性和 13 周亚慢性毒性。
在急性毒性研究中，HT047 经口给予单次剂量 5000mg/kg。在亚慢性毒性研究中，HT047 经口给予重复每日剂量 800、2000 和 5000mg/kg/天，共 13 周，随后进行 4 周恢复期。
在急性毒性研究中，无死亡或毒理学上有意义的临床体征、体重和尸检发现变化。在亚慢性毒性研究中，所有剂量的 HT047 均未引起死亡，也未引起与治疗相关的摄食量、器官重量、眼科、尿液分析、血液学参数和雌雄大鼠尸检发现的不良影响。一些与治疗相关的临床体征、体重和血清生物化学和组织病理学参数的改变；然而，这些变化被认为没有毒理学意义，因为它们在恢复期得到解决或归因于葛根和黄芩的药理学作用。
雄性和雌性大鼠中 HT047 的口服近似致死剂量（引起死亡率的最低剂量）大于 5000mg/kg。雄性和雌性大鼠中 HT047 的口服无观察到不良作用水平大于 5000mg/kg/天，且未确定靶器官。本研究结果支持葛根和黄芩草药提取物作为中风治疗剂的安全性，并进一步证实葛根和黄芩联合使用在临床实践中的安全性。
