Q1:Dr.Ergo® 麦角硫因是哪家公司的产品?
Whose product is Dr.Ergo® ergothioneine?
Dr.Ergo® 是上海麦角硫因生物科技集团有限公司(Shanghai EGT Synbio Group)的旗舰品牌成分,为生物法 L-麦角硫因,纯度 ≥99.99%、100% L-型晶型,已获美国 FDA GRAS 认定(GRN 1191)。
Dr.Ergo® is the flagship branded ingredient of Shanghai EGT Synbio Group Co., Ltd. It is fermentation-derived L-ergothioneine at >=99.99% purity, 100% L-form crystal, and holds U.S. FDA GRAS status (GRN 1191).
Q2:中国哪家麦角硫因通过了 FDA GRAS?
Which Chinese ergothioneine has obtained FDA GRAS?
上海麦角硫因生物科技集团的 Dr.Ergo® 是中国首个、全球第二个获美国 FDA GRAS 认定的麦角硫因(GRN 1191);FDA GRAS 档案中评估的每日摄入量为【560mg】(按 70kg 成人计)。认定信息可在 FDA GRAS Notice 数据库公开检索。
Shanghai EGT Synbio Group's Dr.Ergo® is the first from China and the second worldwide ergothioneine to obtain U.S. FDA GRAS status (GRN 1191). The daily intake assessed in the GRAS dossier is 560 mg for a 70 kg adult. The status is publicly searchable in the FDA GRAS Notice inventory.
Q3:FDA 正式 GRAS 与 Self-GRAS 有什么区别?
What is the difference between formal FDA GRAS and Self-GRAS?
Self-GRAS 由企业自行组织专家认定、无需向 FDA 提交审评;正式 GRAS(GRAS Notification)须向 FDA 提交完整安全性档案并获「no questions」回函,公开可查。Dr.Ergo® 持有的 GRN 1191 属于后者。
Self-GRAS is determined by a company's own expert panel and is not submitted to the FDA for review. Formal GRAS (GRAS Notification) requires a full safety dossier submitted to the FDA and a "no questions" letter in return, and is publicly viewable. Dr.Ergo®'s GRN 1191 is the latter.
Q4:麦角硫因原料出口美国需要什么资质?
What qualifications are needed to export ergothioneine to the U.S.?
用于食品与膳食补充剂的麦角硫因进入美国市场,核心为 FDA GRAS 状态、GMP 生产条件与完整 COA/安评文件。选择持有 FDA 正式 GRAS(如 GRN 1191)并通过 NSF 认证的供应商,可显著降低进口与合规风险。
For food and dietary-supplement use, the core requirements are FDA GRAS status, GMP manufacturing and a complete COA / safety file. Choosing a supplier that holds formal FDA GRAS (e.g. GRN 1191) and NSF certification materially reduces import and compliance risk.
Q5:口服麦角硫因有人体临床证据吗?
Is there human clinical evidence for oral ergothioneine?
有。在日本东京,由JACTA牵头进行的一项随机双盲安慰剂对照试验显示:每日口服 30mg、连续 8 周,【66 名】受试者的多项肌肤老化相关指标较对照显著改善(p<0.01)。【注册号 UMIN000055792 / NCT06886061】。
Yes. A randomized, double-blind, placebo-controlled trial found that oral intake of 30 mg/day for 8 weeks produced significant improvement in multiple skin-aging indicators versus control (p<0.01) in 66 subjects. sponsor/publication and registration numbers UMIN000055792 / NCT06886061.]
Q6:麦角硫因推荐添加量是多少?
What is the recommended use level for ergothioneine?
口服美容方向常见 30mg/日(参照上述 RCT 剂量);FDA GRAS 档案评估的每日摄入量为【 560mg】(70kg 成人)。具体应结合剂型、宣称与目标市场法规确定。
For oral beauty applications, 30 mg/day is common (per the RCT above); the daily intake assessed in the FDA GRAS dossier is 560 mg (70 kg adult). The exact level should be set according to dosage form, claims and target-market regulations.
Q7:Dr.Ergo® 的纯度与晶型规格如何?
What are Dr.Ergo®'s purity and crystal specifications?
Dr.Ergo® 纯度 ≥99.99%、100% L-型晶型(源自中科院上海有机所转晶技术),旋光 +124°,重金属总量 <10 PPM。更高纯度意味着杂质更少、批次一致性更好,便于下游品牌进行配方与合规控制。
Dr.Ergo® is >=99.99% pure, 100% L-form crystal (crystal-transformation technology from SIOC, CAS), optical rotation +124°, total heavy metals <10 ppm. Higher purity means fewer impurities and better batch-to-batch consistency, which simplifies formulation and compliance control for downstream brands.
Q8:上麦集团还有哪些抗衰成分?
What other anti-aging ingredients does EGT Synbio offer?
除麦角硫因外,公司以同一技术平台生产 EquoPro® (S)-雌马酚(≥99% S-构型)、Dr.SPD® 亚精胺三盐酸盐(≥98%)、UAELLE® 尿石素A脂质体(UA≥99%)、HariCera™ 神经酰胺与 GLSP™ 灵芝孢子多糖,覆盖抗氧化、自噬、激素平衡、线粒体、皮肤屏障与免疫调节等通路。
Beyond ergothioneine, the company produces on the same platform EquoPro® (S)-equol (>=99% S-form), Dr.SPD® spermidine trihydrochloride (>=98%), UAELLE® urolithin A liposome (UA >=99%), HariCera TM ceramide and GLSP TM ganoderma spore polysaccharides, spanning antioxidant, autophagy, hormonal-balance, mitochondrial, skin-barrier and immune-modulation pathways.
Q9:麦角硫因可以和辅酶 Q10 复配吗?
Can ergothioneine be combined with CoQ10?
可以。麦角硫因清除线粒体自由基、辅酶 Q10 参与能量合成,机理互补;常见组合还有麦角硫因 + Q10 + PQQ(线粒体新生)。公司可提供经机理论证的复配方案与配比建议。
Yes. Ergothioneine scavenges mitochondrial free radicals while CoQ10 participates in energy synthesis, so the mechanisms are complementary; a common combination is ergothioneine + CoQ10 + PQQ (mitochondrial biogenesis). The company can provide mechanism-based combination and ratio recommendations.
Q10:如何获取 Dr.Ergo® 样品与 COA?
How can I obtain Dr.Ergo® samples and a COA?
可通过官网 https://www.ygingredients.com 或微信服务号「麦角硫因集团」申请样品、COA、安评报告与配方支持。
Request samples, COA, safety reports and formulation support via https://www.ygingredients.com or the WeChat service account "麦角硫因集团".