Purkayastha Sidd, Markosyan Avetik, Prakash Indra, Bhusari Sachin, Pugh George, Lynch Barry, Roberts Ashley
PureCircle Limited, 915 Harger Road, Suite 250, Oak Brook, IL 60523, USA.
The Coca-Cola Company, One Coca-Cola Plaza, Atlanta, GA 30126, USA.
Regul Toxicol Pharmacol. 2016 Jun;77:125-33. doi: 10.1016/j.yrtph.2016.02.015. Epub 2016 Feb 27.
The safety of steviol glycosides is based on data available on several individual steviol glycosides and on the terminal absorbed metabolite, steviol. Many more steviol glycosides have been identified, but are not yet included in regulatory assessments. Demonstration that these glycosides share the same metabolic fate would indicate applicability of the same regulatory paradigm. In vitro incubation assays with pooled human fecal homogenates, using rebaudiosides A, B, C, D, E, F and M, as well as steviolbioside and dulcoside A, at two concentrations over 24-48 h, were conducted to assess the metabolic fate of various steviol glycoside classes and to demonstrate that likely all steviol glycosides are metabolized to steviol. The data show that glycosidic side chains containing glucose, rhamnose, xylose, fructose and deoxy-glucose, including combinations of α(1-2), β-1, β(1-2), β(1-3), and β(1-6) linkages, were degraded to steviol mostly within 24 h. Given a common metabolite structure and a shared metabolic fate, safety data available for individual steviol glycosides can be used to support safety of purified steviol glycosides in general. Therefore, steviol glycosides specifications adopted by the regulatory authorities should include all steviol glycosides belonging to the five groups of steviol glycosides and a group acceptable daily intake established.
甜菊糖苷的安全性基于几种单一甜菊糖苷以及最终吸收代谢产物甜菊醇的现有数据。现已鉴定出更多甜菊糖苷,但尚未纳入监管评估。证明这些糖苷具有相同的代谢命运将表明相同监管模式的适用性。使用莱鲍迪苷A、B、C、D、E、F和M以及甜菊糖苷和杜克苷A,在两种浓度下于24 - 48小时内对混合的人类粪便匀浆进行体外孵育试验,以评估各种甜菊糖苷类别的代谢命运,并证明可能所有甜菊糖苷都会代谢为甜菊醇。数据表明,含有葡萄糖、鼠李糖、木糖、果糖和脱氧葡萄糖的糖苷侧链,包括α(1 - 2)、β - 1、β(1 - 2)、β(1 - 3)和β(1 - 6)连接的组合,大多在24小时内降解为甜菊醇。鉴于共同的代谢产物结构和相同共享的代谢命运,单个甜菊糖苷的现有安全数据通常可用于支持纯化甜菊糖苷的安全性。因此,监管机构采用的甜菊糖苷规格应包括属于五类甜菊糖苷的所有甜菊糖苷以及确定的每日可接受摄入量。