Fuad Aalina Sakiinah Mohd, Arzmi Mohd Hafiz, Bakar Muhammad Ekmal, Taib Izatus Shima, Khuda Fazle, Nasruddin Nurrul Shaqinah
Cluster of Cancer Research Initiative IIUM (COCRII), International Islamic University Malaysia, Kuantan Campus, Pahang, Malaysia.
Cluster of Cancer Research Initiative IIUM (COCRII), International Islamic University Malaysia, Kuantan Campus, Pahang, Malaysia; Department of Fundamental Dental and Medical Sciences, Kulliyyah of Dentistry, International Islamic University Malaysia, Kuantan Campus, Pahang, Malaysia; Melbourne Dental School, The University of Melbourne, Swanston Street, 3053, Victoria, Australia.
J Ayurveda Integr Med. 2025 Jan-Feb;16(1):101037. doi: 10.1016/j.jaim.2024.101037. Epub 2024 Dec 15.
The combination of S. salivarius K12 and M. acuminata are being used as synbiotic, but its safety evaulation is required.
This study aimed to determine the LD50 of synbiotic containing probiotic Streptococcus salivarius K12 and prebiotic Musa acuminata peel extract.
The determination of LD50 is done according to the Acute Oral Toxicity test No. 425 (AOT425). For limit test, five female Sprague Dawley rats were given a limit dose of 2000 mg/kg of the synbiotic mixture once orally, and observed for 12 days. For subacute toxicity test, twenty female Sprague Dawley rats were randomised into 4 groups (n = 5). Control group received saline, others received synbiotic mixture at doses 175 mg/kg, 550 mg/kg, and 2000 mg/kg, respectively, and observed for 14 days. Animals were euthanised on day-15, blood was collected, and subjected to haematological and biochemical analyses. Kidney and liver were preserved for histopathological examination.
No significant changes on the average body weight of the animals throughout the study. Haematological parameters and biochemical analysis do not depict any changes related to acute toxicity. Histopathology analysis depicted mild changes on kidney and liver.
Based on the data, the LD50 of the synbiotic formulation is higher than 2000 mg/kb, with no sign of acute toxicity observed on all parameters.
唾液链球菌K12和香蕉被用作合生元，但需要对其安全性进行评估。
本研究旨在确定含有益生菌唾液链球菌K12和益生元香蕉皮提取物的合生元的半数致死量（LD50）。
根据第425号急性经口毒性试验（AOT425）测定LD50。进行限度试验时，对5只雌性斯普拉格-道利大鼠一次性经口给予2000mg/kg的合生元混合物限量剂量，并观察12天。进行亚急性毒性试验时，将20只雌性斯普拉格-道利大鼠随机分为4组（每组n = 5）。对照组给予生理盐水，其他组分别给予175mg/kg、550mg/kg和2000mg/kg剂量的合生元混合物，并观察14天。在第15天对动物实施安乐死，采集血液并进行血液学和生化分析。保存肾脏和肝脏用于组织病理学检查。
在整个研究过程中，动物的平均体重没有显著变化。血液学参数和生化分析未显示与急性毒性相关的任何变化。组织病理学分析显示肾脏和肝脏有轻微变化。
根据数据，合生元制剂的LD50高于2000mg/kb，所有参数均未观察到急性毒性迹象。
