长沙上禾生物 蜕皮激素 Ecdyterone中英文简介

长沙上禾生物科技有限公司

Changsha Sunho Bio-Tech Co., Ltd.

公司简介 | Company Profile

长沙上禾生物科技有限公司是一家专注于高纯度植物活性成分研发、生产与销售的国家高新技术企业。我们依托现代色谱分离技术与生物转化工艺，深耕于蜕皮激素、植物甾酮等天然代谢活性物质的规模化、标准化生产。公司拥有从原料种植、提取纯化到制剂应用研究的完整产业链，建立了严格的质量控制体系，执行cGMP和ISO9001质量管理标准，致力于为全球运动营养、功能食品、膳食补充剂、特殊医学用途配方食品及化妆品领域提供优质、安全、高效的天然解决方案。

Changsha Sunho Bio-Tech Co., Ltd. is a national high-tech enterprise specializing in the R&D, production, and sales of high-purity plant active ingredients. Leveraging modern chromatographic separation and biotransformation technologies, we focus on the large-scale and standardized production of natural metabolic actives such as ecdysterone (ecdysone) and phytoecdysteroids. The company operates a complete industrial chain from raw material cultivation, extraction, and purification to formulation application research. We have established a rigorous quality control system adhering to cGMP and ISO9001 standards, and are committed to providing high-quality, safe, and effective natural solutions for the global sports nutrition, functional foods, dietary supplements, medical foods, and cosmetics industries.

主打产品：蜕皮激素 Ecdysterone

产品概述 | Product Overview

蜕皮激素，又称蜕皮甾酮、β-蜕皮激素 或20-羟基蜕皮酮，是一类广泛存在于昆虫、甲壳类动物及多种植物中的天然甾体激素。在植物界，这类化合物被统称为植物蜕皮激素 或植物甾酮，其中以筋骨草、露水草、牛膝、桑叶、土牛膝等植物含量最为丰富。蜕皮激素是昆虫生长、发育和蜕皮的关键调节因子。在哺乳动物及人体中，大量研究证实其不具有内源性激素活性，但能作为一种强效的合成代谢与适应原物质，通过激活MAPK/ERK、Akt/mTOR、AMPK 等信号通路，促进蛋白质合成、抑制蛋白质分解、增强糖原储备、改善脂肪代谢、提升运动表现、加速体能恢复、并具有神经保护与抗疲劳作用。因其显著的增肌、增力、促恢复、无雄激素副作用的特性，被誉为“天然、安全的合成代谢剂”，已成为全球运动营养、增肌塑形及抗衰老领域的明星原料。

Ecdysterone, also known as ecdysone, β-ecdysone, or 20-hydroxyecdysone, is a class of natural steroid hormones widely found in insects, crustaceans, and various plants. In the plant kingdom, these compounds are collectively referred to as phytoecdysteroids or phytoecdysones, with particularly high concentrations in plants like Ajuga turkestanica, Cyanotis arachnoidea, Achyranthes bidentata, Morus alba leaves, and Achyranthes aspera. Ecdysterone is a key regulator of insect growth, development, and molting. In mammals and humans, extensive research confirms that it lacks endogenous hormonal activity but acts as a potent anabolic and adaptogenic substance. It functions by activating signaling pathways such as MAPK/ERK, Akt/mTOR, and AMPK, promoting protein synthesis, inhibiting protein breakdown, enhancing glycogen storage, improving fat metabolism, boosting exercise performance, accelerating physical recovery, and offering neuroprotective and anti-fatigue effects. Due to its notable properties of muscle building, strength gain, recovery enhancement, and absence of androgenic side effects, it is hailed as a "natural and safe anabolic agent" and has become a star ingredient in the global sports nutrition, muscle building, and anti-aging sectors.

产品规格 | Product Specifications

我们提供全系列含量规格，满足不同应用需求 | We Offer a Full Range of Specifications for Diverse Application Needs

通用质量标准 (以高纯度单体为例) | General Quality Standards (High-Purity Monomer Example)

核心作用机制与功效应用 | Core Mechanism of Action & Efficacy Applications

1. 核心作用机制 | Core Mechanisms

• 无激素活性，促合成代谢：蜕皮激素不与哺乳动物雄激素或雌激素受体结合，因此无性激素相关副作用（如男性乳房发育、前列腺增生、女性男性化、肝毒性）。其促合成代谢作用主要通过激活MAPK/ERK 和 Akt/mTOR 信号通路，上调肌肉蛋白质合成相关基因，下调肌肉蛋白质分解通路，并促进卫星细胞活化与增殖。

• Non-hormonal, Anabolic Action: Ecdysterone does not bind to mammalian androgen or estrogen receptors, thus free from sex hormone-related side effects (e.g., gynecomastia, prostate enlargement, virilization in females, hepatotoxicity). Its anabolic effects primarily occur via activation of the MAPK/ERK and Akt/mTOR signaling pathways, upregulating genes related to muscle protein synthesis, downregulating muscle protein breakdown pathways, and promoting satellite cell activation and proliferation.

• 能量代谢与适应原作用：激活AMPK 通路，促进葡萄糖摄取与糖原合成，改善能量利用效率。同时具有适应原特性，可帮助机体应对运动、压力、疲劳等应激，维持内环境稳定。

• Energy Metabolism & Adaptogenic Action: Activates the AMPK pathway, promoting glucose uptake and glycogen synthesis, improving energy utilization efficiency. It also possesses adaptogenic properties, helping the body cope with stressors like exercise, stress, and fatigue, maintaining homeostasis.

2. 主要功效与应用领域 | Main Efficacy & Application Areas

我们的核心优势 | Our Core Advantages

• “专业、高纯度的蜕皮激素生产专家”：我们采用专属植物原料（如筋骨草、露水草），结合高效逆流色谱、制备型HPLC、结晶纯化等先进技术，实现从标准化提取物到高纯度单体的全系列生产。我们严格把控含量、有关物质、溶剂残留、重金属、农残等关键指标，产品批次稳定性高、质量可靠，满足运动营养、功能食品及高端研发的严苛要求。

• “运动营养与合成代谢科学的深度应用伙伴”：我们不仅是原料供应商，更是您在运动表现、增肌恢复、抗衰老领域的产品开发伙伴：

1. “增肌与体能表现专家”：我们提供基于最新临床与动物研究的剂量效应关系、用药周期、运动类型匹配、复配组合科学建议，支持您开发出真正有效的增肌、增力、促恢复产品。

2. “安全性与法规合规顾问”：我们可提供详尽的安全性研究数据、毒理学资料、兴奋剂检测报告，证明蜕皮激素的无激素活性、无兴奋剂风险，协助您完成产品的NSF Certified for Sport®、Informed-Choice、LGC Informed-Sport等运动禁药认证，或相关国家/地区的新食品原料、保健食品申报。

3. “配方与稳定性支持”：蜕皮激素在高温、高湿、极端pH下可能不稳定。我们提供针对固体饮料、片剂、胶囊、软糖、饮品、能量棒等不同剂型的稳定化配方建议、掩味方案、感官优化技术支持。

• “全产业链质量保证与可追溯性”：我们从规范化种植基地源头控制，确保原料无重金属、农残污染。生产全程在GMP洁净车间进行，采用在线检测与过程控制保证工艺稳定。成品通过HPLC、LC-MS/MS、IR、NMR、手性HPLC等进行多维确认。我们可提供全面的质量文件，包括COA、MSDS、稳定性研究报告、农残/重金属报告、HPLC图谱、第三方检测报告。

• “专业的定制化与全方位服务”：我们可根据客户需求提供：

• 规格定制：不同含量、不同植物来源、特定比例的植物甾酮复方、不同粒径。

• Specification Customization: Different potencies, plant sources, specific phytoecdysteroid blends, particle sizes.

• 复方开发：与肌酸、HMB、BCAAs、甜菜碱、β-丙氨酸、咖啡因、南非醉茄等成分的科学复配方案，实现协同增肌、促恢复、抗疲劳。

• Blend Development: Scientific formulation solutions combining with creatine, HMB, BCAAs, betaine, beta-alanine, caffeine, ashwagandha, etc., for synergistic muscle building, recovery, and anti-fatigue effects.

• 法规与市场准入支持：针对美国、欧盟、中国、澳大利亚等不同市场，提供新膳食成分申报、运动禁药合规证明、标签声称支持、安全性评估文件等一站式服务。

• Regulatory & Market Access Support: One-stop service for new dietary ingredient notifications, anti-doping compliance certification, label claim support, safety assessment documentation for markets like the USA, EU, China, Australia.

重要安全与法规信息 | Important Safety & Regulatory Information

• 安全性：现有研究表明，蜕皮激素在建议剂量范围内（通常每日50-800mg提取物，或纯品蜕皮激素每天≤50mg）具有良好的安全性和耐受性，无严重不良反应报告。常见副作用轻微，可能与胃肠道刺激有关，如恶心、胃部不适，空腹服用时可能出现。长期高剂量使用的安全性数据仍有限。关键优势在于其无雄激素/雌激素活性，因此无性激素相关副作用，不影响自身睾酮水平，不导致肝损伤，不被世界反兴奋剂机构列为禁用物质。然而，孕妇、哺乳期妇女、儿童、有严重肝病或肾病者、对产品成分过敏者应慎用或在医生指导下使用。最终产品的安全性需由制造商在特定配方、剂量、目标人群下进行评估。

• Safety: Current research indicates that ecdysterone has good safety and tolerability within the recommended dosage range (typically 50-800mg extract daily, or ≤50mg pure ecdysterone daily), with no reports of serious adverse effects. Common side effects are mild, potentially related to gastrointestinal irritation, such as nausea or stomach discomfort, especially when taken on an empty stomach. Safety data for long-term, high-dose use remains limited. Its key advantage is the absence of androgenic/estrogenic activity, therefore it presents no sex hormone-related side effects, does not affect endogenous testosterone levels, does not cause liver damage, and is not listed as a prohibited substance by the World Anti-Doping Agency. However, pregnant and lactating women, children, individuals with severe liver or kidney disease, and those allergic to the product components should use with caution or under medical supervision. The safety of the final product must be evaluated by the manufacturer for the specific formulation, dosage, and target population.

• 法规状态：

• 全球：在美国、加拿大、欧盟、澳大利亚、英国等国家和地区，蜕皮激素（通常来源于筋骨草等植物）被广泛用作膳食补充剂原料，属于合法销售范围。其非激素、非兴奋剂的特性已被多个运动认证机构认可。在欧盟，需遵循新型食品法规，需确认具体来源是否获批。作为药品使用需进行完整的新药注册。

• Global: In countries and regions like the USA, Canada, EU, Australia, UK, ecdysterone (typically sourced from plants like Ajuga) is widely used as a dietary supplement ingredient and is legally marketable. Its non-hormonal, non-prohibited status is recognized by several sports certification bodies. In the EU, compliance with Novel Food regulations is required, and the approval status of the specific source must be confirmed. Use as a pharmaceutical drug requires full new drug registration.

• 中国：蜕皮激素未被列入现行《药典》，也未批准作为药品。作为保健食品原料，属于新原料，需要进行严格的安全性、功能评价、人体试食试验，并完成保健食品注册。作为普通食品原料，其安全性、食用历史等需符合新食品原料申报要求，目前尚未获批。作为化妆品原料，可以使用，但需符合相关安全评估要求。

• China: Ecdysterone is not included in the current Pharmacopoeia and is not approved as a drug. As a health food ingredient, it is considered a new ingredient requiring rigorous safety and functional evaluation, human trial studies, and completion of health food registration. As an ordinary food ingredient, its safety and history of use must meet the requirements for novel food ingredient application, which is currently not approved. As a cosmetic ingredient, it is permissible for use but must comply with relevant safety assessment requirements.

• 免责声明：本产品为原料，非供直接食用。所提供信息基于公开发表的科学文献，仅供参考和研发之用，不构成任何医疗建议、疗效承诺、安全保证或使用指导。客户应对其最终产品的研发、生产、质量控制、安全性、有效性、合规性、标签宣称承担全部法律责任。在开发面向消费者的产品前，必须依据目标市场的法规，完成必要的安全评估、稳定性研究、功效验证、注册备案，并获得相应的监管批准。

• Disclaimer: This product is a raw material and is not for direct consumption. The information provided is based on publicly available scientific literature, for reference and R&D purposes only, and does not constitute any medical advice, efficacy promises, safety guarantees, or usage guidance. The customer bears full legal responsibility for the R&D, production, quality control, safety, efficacy, compliance, and labeling claims of their final product. Before developing consumer-facing products, all necessary safety assessments, stability studies, efficacy verification, registration/filing must be completed, and corresponding regulatory approvals obtained, in accordance with target market regulations.

包装与储存 | Packaging & Storage

• 包装：采用药用级铝箔袋真空或充氮包装，内置干燥剂，置于HDPE瓶/桶中，外箱为瓦楞纸箱。标签清晰标明：产品名称、规格、批号、含量、生产日期、保质期、储存条件。可提供防潮、避光、小规格样品等定制化包装。

• Packaging: Packed in pharmaceutical-grade aluminum foil bags under vacuum or nitrogen, with desiccant, placed in HDPE bottles/drums, and then in corrugated boxes. Labels clearly indicate: product name, specification, batch number, assay, production date, shelf life, storage conditions. Customized packaging options include moisture-proof, light-proof, and small sample sizes.

• 储存：密封，置于阴凉、干燥、避光处保存。建议在2-8°C冷藏条件下长期储存，以保持最佳稳定性。避免高温、高湿和强光直射。开封后应尽快使用，并严格密封。

• Storage: Keep tightly sealed in a cool, dry, dark place. Long-term storage at 2-8°C refrigeration is recommended for optimal stability. Avoid high temperature, high humidity, and direct strong light. Use promptly after opening and keep tightly sealed.

联系我们 | Contact Us

长沙上禾生物科技有限公司

Charissa Liu

E-mail：sales05@staherb.cn    sales@staherb.cn

Whatsapp:+86-13657431735

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