Teh Bee Ping, Ahmad Norzahirah, Ibnu Rasid Elda Nurafnie, Zolkifli Nor Azlina, Sastu Zakaria Umi Rubiah, Mohamed Yusoff Norliyana, Zulkapli Azlina, Japri Norfarahana, Lee June Chelyn, Muhammad Hussin
Herbal Medicine Research Centre, Institute for Medical Research, National Institutes of Health, Ministry of Health Malaysia, Shah Alam 40170, Selangor Darul Ehsan, Malaysia.
Medical Resource Research Centre, Institute for Medical Research, Jalan Pahang, Kuala Lumpur 50588, Wilayah Persekutuan Kuala Lumpur, Malaysia.
Pharmaceuticals (Basel). 2021 Feb 10;14(2):142. doi: 10.3390/ph14020142.
A combined polyherbal formulation containing tongkat ali () and kacip fatimah () aqueous extracts was evaluated for its safety aspect. A repeated dose 28-day toxicity study using Wistar rats was conducted where the polyherbal formulation was administered at doses 125, 500 and 2000 mg/kg body weight to male and female treatment groups daily via oral gavage, with rats receiving only water as the control group. In-life parameters measured include monitoring of food and water consumption and clinical and functional observations. On day 29, blood was collected for haematological and biochemical analysis. The rats were necropsied and the organs were collected for histopathological examination. This study showed that the combined formulation did not induce any significant toxicity effect at any dose level in terms of morbidity, mortality, behaviour, functional observation, body weight, food and water consumption, whole blood haematology and serum biochemistry. However, there were some microscopic changes in the histopathological examinations of some organs given 2000 mg/kg body weight, which may suggest an early response to the polyherbal formulation. From this study, the no observed adverse effect level is estimated to be more than 500 mg/kg body weight but not exceeding 2000 mg/kg body weight. The observed effects at the highest dose indicate the need for further study of longer dosing duration.
对一种含有东革阿里（）和卡琪花蒂玛（）水提取物的复方多草药制剂进行了安全性评估。使用Wistar大鼠进行了为期28天的重复给药毒性研究，通过口服灌胃，将该复方多草药制剂以125、500和2000mg/kg体重的剂量每日给予雄性和雌性治疗组，仅给予水的大鼠作为对照组。所测量的在体参数包括食物和水消耗的监测以及临床和功能观察。在第29天，采集血液进行血液学和生化分析。对大鼠进行尸检，并收集器官进行组织病理学检查。该研究表明，在发病率、死亡率、行为、功能观察、体重、食物和水消耗、全血血液学和血清生化方面，该复方制剂在任何剂量水平下均未诱导任何显著的毒性作用。然而，在给予2000mg/kg体重的一些器官的组织病理学检查中存在一些微观变化，这可能表明对该复方多草药制剂有早期反应。从这项研究中，未观察到不良反应水平估计超过500mg/kg体重但不超过2000mg/kg体重。在最高剂量下观察到的效应表明需要对更长给药持续时间进行进一步研究。
