Sanzyme Bio-Analytical Laboratory, Sanzyme Private Limited, Hyderabad, India.
Sanzyme Biologics, Hyderabad, India.
Regul Toxicol Pharmacol. 2020 Feb;110:104538. doi: 10.1016/j.yrtph.2019.104538. Epub 2019 Nov 18.
Bacillus coagulans SNZ 1969 is a rod-shaped, slightly acidophilic, gram-positive, spore forming and highly resilient bacteria. B. coagulans SNZ 1969 has GRAS (Generally Recognized As Safe) status for use as a probiotic in foods (US FDA number GRN-597). The present study was aimed to assess the safety of a proprietary strain Bacillus coagulans SNZ 1969 by conducting acute and sub-acute 28 days repeated dose oral toxicity studies in Wistar Rats. In the acute toxicity study, the rats were orally fed with 2000 mg/kg body weight (BW) (5 × 10 CFU/g) of B. coagulans SNZ 1969 as a single dose to determine the LD50 values. In the sub-acute repeated dose toxicity study, six groups of experimental rats received 250, 500, 1000 mg/kgBW/day (5 × 10 CFU/g) of the test item for 28 consecutive days. The control animals received only water. Four groups of rats were sacrificed after 28 days and the remaining two groups were kept as recovery groups and sacrificed after 42 days. The results of these study indicate that there were no treatment related changes in any of the parameters studied i.e. clinical signs, body weight, food intake, urinalysis, hematological examinations, clinical biochemistry, gross pathology and histopathology after 28 days of repeated administration. Based on the results it was concluded that the LD50 of Bacillus coagulans SNZ 1969 is more than 2000 mg/kg body weight and the NOAEL derived from this study was 1000 mg/kg/day for 28 days, this corresponds to the 5 × 10 CFU/kg.
凝结芽孢杆菌 SNZ1969 是一株杆状、微嗜酸、革兰氏阳性、产芽孢、高度弹性的细菌。凝结芽孢杆菌 SNZ1969 因其作为食品益生菌的安全性（美国 FDA 注册号 GRN-597）被认定为 GRAS（一般认为安全）。本研究旨在通过对 Wistar 大鼠进行急性和亚急性 28 天重复剂量口服毒性研究，评估专利菌株凝结芽孢杆菌 SNZ1969 的安全性。在急性毒性研究中，大鼠单次口服 2000mg/kg 体重（BW）（5×10CFU/g）的凝结芽孢杆菌 SNZ1969，以确定 LD50 值。在亚急性重复剂量毒性研究中，6 组实验大鼠连续 28 天每天接受 250、500、1000mg/kgBW/天（5×10CFU/g）的试验物质。对照组动物仅给予水。28 天后处死 4 组大鼠，其余 2 组作为恢复期大鼠，42 天后处死。这些研究的结果表明，在任何研究参数中均未观察到与治疗相关的变化，即临床症状、体重、食物摄入量、尿液分析、血液学检查、临床生物化学、大体病理学和组织病理学。基于这些结果，得出结论，凝结芽孢杆菌 SNZ1969 的 LD50 大于 2000mg/kg 体重，该研究的无可见不良作用水平（NOAEL）为 28 天 1000mg/kg/天，相当于 5×10CFU/kg。
