DoubleRainbow Biosciences Inc., Lexington, MA 02421, USA.
GRAS Associates-Nutrasource Pharmaceutical and Nutraceutical Services, Guelph, ON N1G 0B4, Canada.
Nutrients. 2022 Jun 1;14(11):2330. doi: 10.3390/nu14112330.
Bioactive phytochemicals such as salidroside have been studied to understand the beneficial effects of , an herbaceous plant used in traditional medicine to increase energy and treat a variety of health issues. However, Rhodiola plants are often slow-growing, and many are endangered in their native habitats. Thus, there is a need for safe, alternative supplies of key phytochemicals from Rhodiola. The salidroside subject of this safety study is a synthetic biology product from fermentation of a bioengineered that produces salidroside. Here, we present comprehensive test results that support the safety of salidroside manufactured via a patented sustainable bioengineering manufacturing process. In vitro bacterial reverse mutation assays with the bioengineered salidroside show no mutagenicity in any of the concentrations tested. In vivo toxicity studies in rats show no adverse effects from the salidroside product. Based on the results of these studies, we conclude that the bioengineered salidroside discussed here is not genotoxic and demonstrates a no-observed-adverse-effect level (NOAEL) at least 2000 mg/kg bw/day in male and female Sprague-Dawley rats. This study supports that the salidroside compound produced using bioengineered is a viable alternative to salidroside produced from harvested Rhodiola plants for use as a dietary supplement, food ingredient, or potentially as a pharmaceutical product.
生物活性植物化学物质,如红景天苷,已被研究用于了解其有益作用。这种草本植物被用于传统医学中,以增加能量并治疗各种健康问题。然而,红景天植物的生长通常较为缓慢,许多在其原生栖息地都处于濒危状态。因此,需要从红景天中安全、替代地获取关键植物化学物质。本安全性研究的红景天苷主题是发酵生物工程化产生红景天苷的产生的产物。在此,我们提供了全面的测试结果,支持通过专利可持续生物工程制造工艺生产的红景天苷的安全性。生物工程化红景天苷的体外细菌回复突变试验在所有测试浓度下均未显示出致突变性。大鼠体内毒性研究表明,红景天苷产品无不良影响。基于这些研究的结果,我们得出结论,本文讨论的生物工程化红景天苷没有遗传毒性,并且在雄性和雌性 Sprague-Dawley 大鼠中至少 2000mg/kg bw/day 的剂量下没有观察到不良效应水平(NOAEL)。这项研究支持使用生物工程化生产的红景天苷化合物作为膳食补充剂、食品成分或潜在的药物产品,是从收获的红景天植物中生产的红景天苷的可行替代品。