Heimbach James T, Sebestyen Gyula, Semjen Gabor, Kennepohl Elke
JHeimbach LLC, Port Royal, Virginia 22535, USA.
Int J Toxicol. 2007 May-Jun;26(3):253-9. doi: 10.1080/10915810701369709.
"Avemar pulvis" is a powder consisting of an aqueous extract of fermented wheat germ, with the drying aids maltodextrin and silicon dioxide, standardized to contain approximately 200 microg/g of the natural constituent 2,6-dimethoxy-p-benzoquinone. The results of toxicological and clinical studies of this product demonstrate its safety for its intended use as a dietary supplement ingredient in the United States. Avemar pulvis has been used in Hungary since 1998 and is approved in that country, as well as in the Czech Republic, Bulgaria, and Romania, as a "medical nutriment for cancer patients." Acute and subacute toxicity studies using rodents orally administered Avemar pulvis showed that dose levels (2000 to 3000 mg/kg body weight [bw]/day) exceeding the normal recommended oral dosage (8.5 g/day or 121 mg/kg bw/day for a 70-kg individual) by up to approximately 25-fold caused no adverse effects. The test substance showed no evidence of mutagenicity or genotoxicity in vitro or in vivo. Clinical studies using Avemar pulvis as a supplement to drug therapy in cancer patients at doses of 8.5 g/day not only showed no evidence of toxicity, but also showed a reduction in the side effects of chemotherapy. Overall, it was concluded that Avemar pulvis would not be expected to cause adverse effects under the conditions of its intended use as an ingredient in dietary supplements.
“Avemar散剂”是一种由发酵小麦胚芽水提取物制成的粉末，添加了麦芽糊精和二氧化硅作为干燥助剂，其标准化含量约为每克含200微克天然成分2,6 - 二甲氧基对苯醌。该产品的毒理学和临床研究结果表明，在美国作为膳食补充剂成分按预期使用时它是安全的。自1998年以来，Avemar散剂一直在匈牙利使用，并在该国以及捷克共和国、保加利亚和罗马尼亚被批准作为“癌症患者的医学营养品”。对啮齿动物口服Avemar散剂进行的急性和亚急性毒性研究表明，剂量水平（2000至3000毫克/千克体重/天）超过正常推荐口服剂量（对于70千克个体为8.5克/天或121毫克/千克体重/天）多达约25倍时，未产生不良影响。受试物质在体外或体内均未显示出致突变性或遗传毒性。使用Avemar散剂作为癌症患者药物治疗补充剂，剂量为8.5克/天的临床研究不仅未显示出毒性证据，还表明化疗副作用有所减少。总体而言，得出的结论是，在其作为膳食补充剂成分的预期使用条件下，预计Avemar散剂不会产生不良影响。
