在大鼠体内对枯草杆菌 UBBS-14 益生菌进行的体外和临床前测试表明,它没有毒性。

IF 2.2 4区 医学 Q3 TOXICOLOGY
Toxicology Research Pub Date : 2024-02-22 eCollection Date: 2024-02-01 DOI:10.1093/toxres/tfae021
Ankit Negi, Tulasi Pasam, Syed Muhammad Farqadain, Y Mahalaxmi, Manoj P Dandekar
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引用次数: 0

摘要

导言:由枯草芽孢杆菌制成的益生菌具有广泛的健康益处,尤其是在治疗腹泻和胃肠道问题方面。在此,我们采用体外和体内范例来评估枯草芽孢杆菌 UBBS-14 的潜在不良影响和毒性:根据经济合作与发展组织(OECD)423 和 407 的要求,我们对雄性和雌性 Sprague-Dawley 大鼠进行了临床前调查。单次口服给药 5,000 毫克/千克体重(即相当于每千克体重 5,000 亿个菌落形成单位(CFU))后,对急性毒性进行了检测。单次服用枯草芽孢杆菌 UBBS-14 在 14 天的观察期内没有出现死亡或不良反应,表明半数致死剂量大于 5,000 毫克/千克体重:结果:将枯草杆菌 UBBS-14 与 Caco2、HT29 和 Raw 264.7 细胞系培养,未发现细胞毒性作用。这种益生菌株对大多数抗生素也有反应。在一项为期 28 天的重复剂量毒性研究中,大鼠每天一次分别服用 100、500 和 1,000 毫克/千克体重的枯草杆菌 UBBS-14(分别为 100、500 和 1,000 亿 CFU/千克体重/天)。重要内脏器官的形态、重量和组织病理学未见明显变化。血液学、生物化学、电解质(钠、钾、氯化物和钙)和尿液分析结果均在正常范围内,与车辆处理组相当:结论:因此,在口服 28 天后,枯草芽孢杆菌 UBBS-14 的无观测效应水平(NOEL)被确定为大于 1,000 毫克/千克体重/天。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
In-vitro and preclinical testing of bacillus subtilis UBBS-14 probiotic in rats shows no toxicity.

Introduction: 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.

Materials and methods: 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.

Results: 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.

Conclusion: 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.

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来源期刊
Toxicology Research
Toxicology Research TOXICOLOGY-
CiteScore
3.60
自引率
0.00%
发文量
82
期刊介绍: A multi-disciplinary journal covering the best research in both fundamental and applied aspects of toxicology
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