■由枯草芽孢杆菌制成的益生菌具有广泛的健康益处,特别是在治疗腹泻和胃肠道问题。在这里,我们采用体外和体内范例来评估枯草芽孢杆菌UBBS-14的潜在不良反应和毒性。
■根据经济合作与发展组织(OECD)423和407的要求,在雄性和雌性Sprague-Dawley大鼠中进行了临床前研究。在5,000mg/kg体重(bw)的单次口服(PO)给药后检查急性毒性,即相当于每kgbw500亿菌落形成单位(CFU)。单一施用B.subtilisUBBS-14显示无死亡或不良反应,直到14天的观察期,表明LD50>5,000mg/kgbw。
■用Caco2,HT29和Raw264.7细胞系孵育枯草芽孢杆菌UBBS-14,显示无细胞毒性作用。还发现这种益生菌菌株对大多数抗生素有反应。对于28天的重复剂量毒性研究,每天一次给大鼠施用100、500和1,000mg/kgbw(10、50和1000亿CFU/kgbw/天,分别)剂量的枯草芽孢杆菌UBBS-14。在形态学上没有看到明显的变化,体重,和关键内脏器官的组织病理学。血液学,生物化学,电解质(钠,钾,氯化物,和钙),和尿液分析结果在正常范围内,与媒介物治疗组相当.
■B因此,在28天口服给药后,枯草杆菌UBBS-14的未观察到的效应水平(NOEL)被确定为>1,000mg/kgbw/天。
UNASSIGNED: Probiotics made from Bacillus subtilis provide a wide spread of health benefits, particularly in the treatment of diarrhea and gastrointestinal problems. Herein, we employed in vitro and in vivo paradigms to assess the potential adverse effects and toxicity of B. subtilis UBBS-14.
UNASSIGNED: According to Organization for Economic Co-operation and Development (OECD) 423 and 407 requirements, a preclinical investigation was conducted in male and female Sprague-Dawley rats. Acute toxicity was examined following a single peroral (PO) administration of 5,000 mg/kg body weight (bw) i.e. equivalent to 500 billion colony-forming units (CFU) per kg bw. Single administration of B. subtilis UBBS-14 showed no mortality or adverse effects until the 14-day observation period, indicating LD50 is >5,000 mg/kg bw.
UNASSIGNED: Incubation of B. subtilis UBBS-14 with Caco2, HT29, and Raw 264.7 cell lines, showed no cytotoxic effects. This probiotic strain was also found responsive to the majority of antibiotics. For a 28-day repeated dose toxicity study, rats were administered 100, 500, and 1,000 mg/kg bw daily once (10, 50, and 100 billion CFU/kg bw/day, respectively) doses of B. subtilis UBBS-14. No notable changes were seen in the morphology, weight, and histopathology of the critical internal organs. The haematological, biochemical, electrolyte (sodium, potassium, chloride, and calcium), and urine analytical results were within the normal range and equivalent to the vehicle-treated group.
UNASSIGNED: B. subtilis UBBS-14\'s no-observed-effect level (NOEL) was thus determined to be >1,000 mg/kg bw/day following a 28-day oral dosing.