Zhejiang University, College of Biosystems Engineering and Food Science, Fuli Institute of Food Science, Zhejiang Key Laboratory for Agro-Food Processing, Zhejiang R&D Center for Food Technology and Equipment, Hangzhou 310058, China; Laboratory of Quality & Safety Risk Assessment for Agro-products on Storage and Preservation, Minstry of Agriculture, Hangzhou 310058, China.
Zhejiang University, College of Biosystems Engineering and Food Science, Fuli Institute of Food Science, Zhejiang Key Laboratory for Agro-Food Processing, Zhejiang R&D Center for Food Technology and Equipment, Hangzhou 310058, China; Laboratory of Quality & Safety Risk Assessment for Agro-products on Storage and Preservation, Minstry of Agriculture, Hangzhou 310058, China.
J Ethnopharmacol. 2016 Jul 1;187:205-12. doi: 10.1016/j.jep.2016.04.049. Epub 2016 Apr 27.
Osmanthus fragrans var. thunbergii (O. fragrans) flower has been consumed as folk medicine for thousands of years. O. fragrans flower extract is a well-characterized phenylethanoid glycoside-rich extract, which has been used as a natural anti-oxidant. The aim of this study was to evaluate the safety of O. fragrans flower phenylethanoid glycoside-rich extract (OFFE).
The OFFE was extracted by 80% (v/v) aqueous ethanol with 0.01% sodium isoascorbate (w/v) from the O. fragrans flower and purified on HPD300 resins. The total phenylethanoid glycosides content and individual phenylethanoid glycosides was determined by photocolorimetric method and reversed phase UPLC respectively. An acute oral toxicity study, reverse mutation test, bone marrow cell micronucleus test, and sperm abnormality test as well as a 90-day oral toxicity study were performed on experimental animals.
The total content of phenylethanoid glycosides in OFFE was 73.4g acteoside equivalent per 100g of extract, include acteoside (52.5g per 100g of extract), salidroside (13.8g per 100g of extract), and isoacteoside (2.6g per 100g of extract) and so on. No acute lethal effect at the maximal tested OFFE dose of 10g/kg body weight (bw) in either rats or mice was observed, suggesting that OFFE can be considered nontoxic. No evidence for mutagenicity was detected in any of the three mutagenic tests. Administration at levels of 0.50, 1.00, and 2.00g/kg bw to rats for 90 days failed to induce any significant hematological, clinical, chemical, or histopathological changes. The no-observed adverse-effect-level for OFFE was >2.00g/kg bw for the study on subchronic toxicity.
The results showed that consuming OFFE has no adverse effects and poses no health risk in the acute oral toxicity study, subchronic oral toxicity study, and in the micronucleus test, which may provide supportive evidence for the safety of OFFE powder that has been used in medicine as well as in functional foods, and dietary supplements.
桂花（Osmanthus fragrans var. thunbergii）花作为民间药物已被使用了数千年。桂花花提取物是一种特征明确的苯乙醇苷类丰富提取物，被用作天然抗氧化剂。本研究旨在评估桂花苯乙醇苷类丰富提取物（OFFE）的安全性。
用 80%（v/v）乙醇水溶液（含 0.01%抗坏血酸钠）从桂花中提取 OFFE，并通过 HPD300 树脂进行纯化。采用分光光度法和反相 UPLC 分别测定总苯乙醇苷含量和单体苯乙醇苷。对实验动物进行急性经口毒性试验、回复突变试验、骨髓细胞微核试验、精子畸形试验及 90 天经口毒性试验。
OFFE 中苯乙醇苷总含量为 73.4g 毛蕊花糖苷当量/100g 提取物，包括毛蕊花糖苷（52.5g/100g 提取物）、红景天苷（13.8g/100g 提取物）和异毛蕊花糖苷（2.6g/100g 提取物）等。在大鼠或小鼠最大测试剂量为 10g/kg 体重时，未观察到 OFFE 有急性致死作用，提示 OFFE 可认为无毒。在三项致突变试验中均未发现致突变证据。在 90 天的大鼠经口毒性试验中，0.50、1.00 和 2.00g/kg bw 剂量组未引起任何显著的血液学、临床、化学或组织病理学变化。在亚慢性毒性研究中，OFFE 的无观察到不良效应水平（NOAEL）>2.00g/kg bw。
结果表明，在急性经口毒性试验、亚慢性经口毒性试验和微核试验中，摄入 OFFE 无不良影响，不会对健康造成危害，这可能为已在医学、功能性食品和膳食补充剂中使用的 OFFE 粉末的安全性提供支持证据。
