Williams Lonnie D, Burdock George A, Jiménez Guillermo, Castillo Marisol
Burdock Group, Orlando, FL 32801, USA.
Regul Toxicol Pharmacol. 2009 Nov;55(2):236-46. doi: 10.1016/j.yrtph.2009.07.009. Epub 2009 Jul 23.
Bacillus cereus var. toyoi is a naturally occurring, non-toxigenic and non-pathogenic strain of B. cereus. Safety studies were conducted on a B. toyoi preparation (Toyocerin, including but not limited to enterotoxicity, eye irritation, genotoxicity, acute, subchronic and chronic toxicity studies and human clinical trials. In rabbits, Toyocerin did not exhibit enterotoxicity and was only slightly irritating to the eyes. It was non-mutagenic in an Ames assay at up to 10,000 microg/plate and did not exhibit clastogenic activity in a chromosomal aberration test at up to 450 mg/ml. It was non-toxic in acute and repeated-dose (30 and 60 days and 1 year) toxicity studies in rats and mice at up to 3 x 10(11)spores/kg bw/day. In an eight-day human clinical trial, Toyocerin did not cause any adverse effects in healthy male and female subjects at 1 x 10(9) and 1 x 10(10)spores/kg bw/day. In feeding trials, Toyocerin not cause any adverse effects in rabbits, pigs, chickens, turkeys and cattle at doses ranging from 8.5 x 10(7) to 4 x 10(9)spores/kg bw/day for durations of 2 weeks to 18 months. Taken together, these studies demonstrate that Toyocerin is safe at the doses tested.
蜡样芽孢杆菌东洋变种是蜡样芽孢杆菌的一种天然存在、不产毒素且无致病性的菌株。针对一种蜡样芽孢杆菌东洋变种制剂（酪酸梭菌，包括但不限于肠毒性、眼刺激性、遗传毒性、急性、亚慢性和慢性毒性研究以及人体临床试验）开展了安全性研究。在兔子身上，酪酸梭菌未表现出肠毒性，且仅对眼睛有轻微刺激。在高达10,000微克/平板的艾姆斯试验中，它无致突变性，在高达450毫克/毫升的染色体畸变试验中未表现出断裂活性。在大鼠和小鼠的急性和重复给药（30天、60天和1年）毒性研究中，剂量高达3×10¹¹孢子/千克体重/天，它无毒。在一项为期八天的人体临床试验中，酪酸梭菌在健康男性和女性受试者中，剂量为1×10⁹和1×10¹⁰孢子/千克体重/天时，未引起任何不良反应。在喂养试验中，酪酸梭菌在兔子、猪、鸡、火鸡和牛身上，剂量范围为8.5×10⁷至4×10⁹孢子/千克体重/天，持续时间为2周至18个月，未引起任何不良反应。综上所述，这些研究表明酪酸梭菌在所测试的剂量下是安全的。
