二胺氧化酶 (Diamine oxidase, 简称DAO)，是一种存在于人体内的能够催化组胺、腐胺、乙烯二胺等二胺类 氧化而生成醛的反应的酶，也称为含吡哆醛的胺氧化酶或组胺酶。在组胺和多种多胺代谢中起作用，其活性与粘膜细胞的核酸和蛋白合成密切相关，能够反映肠道机械屏障的完整性和受损伤程度。
但当身体的二胺氧化酶功能不足或活性过低时，就需要适当补充外源性二胺氧化酶。其中猪源二胺氧化酶是从动物组织猪肾中提取的酶类物质，用于协助分解食物中的组胺，缓解组胺不耐受 (Histamine Intolerance, HIT) 。
一、产品功效
作用原理
外源性二胺氧化酶的作用机制是弥补人体内源性二胺氧化 酶的不足，在肠道腔内发挥催化作用，以分解食物中的组 胺，从而防止其被吸收并引发组胺不耐受 (HIT) 症状 。
酶促降解路径
二胺氧化酶属于含铜胺氧化酶家族。它催化组胺降解的本质 是氧化脱氨反应，目的是将具有生物活性的组胺分子转化为 生物惰性的代谢产物，主要是咪唑乙醛、氨和过氧化氢。
作用位点
外源性二胺氧化酶必须在组胺被肠道吸收进入血液循环之前，在肠道腔内发挥高效的催化作用，从源头上减少进入门静脉和体循环的组胺量。
底物特异性
二胺氧化酶的底物特异性不仅限于组胺，它还可以催化其 他生物胺的降解，如腐胺(putrescine) 。
生物利用度
作为蛋白质类酶制剂，二胺氧化酶不被系统吸收 ，仅在消化道局部起效，避免全身性副作用。
多项临床研究支持外源性二胺氧化酶补充对组胺不耐受症状的有效管理:
• Sánchez-Pérez等人开展的一项双盲随机对照试验(n=400) 显示，餐前20分钟服用含猪源或植物源二胺氧化酶 (4.2mg/剂或 8.4mg/剂) 的 胃溶迷你片剂 (每日3次) ，联合低组胺饮食或地中海饮食，可显著改善组胺不耐受相关的胃肠、皮肤、呼吸及头痛症状（试验核心终点）， 效果优于单纯安慰剂联合常规饮食的干预方式。
• Maintz与 Novak (2007) 在一项系统性综述中指出，外源性补充二胺氧化酶可使80%以上组胺不耐受患者的饮食自由度显著提升，能够更 安全地摄入含适量组胺的食物，同时患者的生活质量评分 (涵盖胃肠、皮肤、神经等多系统症状改善) 得到统计学意义上的显著改善，为二 胺氧化酶补充剂用于组胺不耐受患者的症状管理提供了重要循证支持。
二、产品优势
法规状态
猪肾提取的二胺氧化酶具有成熟的法规应用基础。在美国，猪肾二胺氧化酶已获得了美国食 品药品监督管理局 (FDA) 的公认安全 (GRAS) 通知，例如GRN 000006和GRN 1125。
剂型适配性
适用于片剂、胶囊、口服液等多种剂型开发，确保酶在小肠 (二胺氧化酶主要作用部位) 释放并发挥功能。
三、产品安全性
权威监管机构评估
欧盟 (EFSA)：将“猪肾蛋白提取物（含 二胺氧化酶）”列为新资源食品 (Novel Food)。 美国 (FDA)：虽然没有作为药物审批，但在膳食补充剂（Dietary Supplement）框架下，符合 NDI（新 膳食成分） 或 GRAS（一般认为安全） 的合规要求，允许上市销售。
毒理学研究数据
为了验证其安全性，科学家进行了多项毒理学实验（主要针对高纯度的猪肾提取物）： 急性毒性：在大鼠实验中，即使给予极大剂量的猪源二胺氧化酶，也未观察到致死现象或明显的中毒反应。 亚慢性毒性：连续 90 天喂食高剂量二胺氧化酶的动物实验显示，实验动物的体重、血液指标、肝肾功能及器官组织均无病理改变。
临床试验与人体耐受性
在针对“组胺不耐受”患者及健康志愿者的人体临床试验中：
不良反应罕见：绝大多数受试者没有报告副作用。
轻微副作用：极少数报告的副作用主要是轻微的胃肠道反应（如轻度腹胀），且往往很难区分是酶本身引 起的，还是胶囊辅料引起的。
生命体征：长期监测显示，服用该酶对血压、心率等生命体征无影响。
Diamine oxidase (DAO), an enzyme present in the human body, catalyses the oxidation of diamines such as histamine, putrescine, and ethylenediamine to form aldehydes. It is also known as pyridoxal-containing amine oxidase or histamine oxidase. It plays a role in the metabolism of histamine and various polyamines. Its activity is closely linked to nucleic acid and protein synthesis in mucosal cells, reflecting the integrity and degree of damage to the intestinal mechanical barrier.
However, when endogenous diamine oxidase function is deficient or activity is insufficient, exogenous diamine oxidase supplementation becomes necessary. Porcine diamine oxidase, extracted from porcine kidney tissue, assists in breaking down histamine in food to alleviate histamine intolerance (HIT).
Product Efficacy
Mechanism of Action
Exogenous diamine oxidase compensates for endogenous deficiency by catalysing histamine degradation within the intestinal lumen. This prevents histamine absorption and subsequent histamine intolerance (HIT) symptoms.
Enzymatic Degradation Pathway
Diamine oxidase belongs to the copper-containing diamine oxidase family. Its catalysed degradation of histamine fundamentally involves an oxidative deamination reaction, converting biologically active histamine molecules into biologically inert metabolites— primarily imidazole aldehyde, ammonia, and hydrogen peroxide.
Site of Action
Diamine oxidase belongs to the copper-containing diamine oxidase family. Its catalysed degradation of histamine fundamentally involves an oxidative deamination reaction, converting biologically active histamine molecules into biologically inert metabolites—primarily imidazole aldehyde, ammonia, and hydrogen peroxide.
Substrate Specificit
The substrate specificity of diamine oxidase extends beyond histamine; it also catalyses the degradation of other biogenic amines, such as putrescine.
Bioavailability
As a protein-based enzyme preparation, diamine oxidase is not systemically absorbed. It exerts its effect locally within the digestive tract, thereby avoiding systemic side effects.
Multiple clinical studies support the effective management of histamine intolerance symptoms through exogenous diamine oxidase supplementation:
• Diamine oxidase belongs to the copper-containing diamine oxidase family. Its catalysed degradation of histamine fundamentally involves an oxidative deamination reaction, converting biologically active histamine molecules into biologically inert metabolites—primarily imidazole aldehyde, ammonia, and hydrogen peroxide.
• Maintz and Novak (2007) noted in a systematic review that exogenous diamine oxidase supplementation significantly increased dietary freedom in over 80% of histamine-intolerant patients, enabling safer consumption of foods containing moderate histamine levels. Concurrently, patients' quality of life scores (encompassing improvements in gastrointestinal, dermatological, neurological, and other multi-system symptoms) showed statistically significant enhancement. This provides crucial evidencebased support for the use of diamine oxidase supplements in symptom management for histamine intolerance patients.
Product Advantages
Regulatory Status
Diamine oxidase extracted from porcine kidney possesses a mature regulatory foundation. In the United States, porcine kidney diamine oxidase has obtained Generally Recognised as Safe (GRAS) notifications from the US Food and Drug Administration (FDA), such as GRN 000006 and GRN 1125.
Dosage Form Compatibility
Suitable for development in multiple dosage forms including tablets, capsules, and oral liquids, ensuring enzyme release and functional activity within the small intestine (the primary site of diamine oxidase action)
Product Safety
Authoritative Regulatory Evaluations
European Union (EFSA): Classified ‘Porcine kidney protein extract (containing diamine oxidase)’ as a Novel Food. United States (FDA): Although not approved as a medicinal product, it complies with NDI (New Dietary Ingredient) or GRAS (Generally Recognised as Safe) requirements under the Dietary Supplement framework, permitting market sale.
Authoritative Regulatory Evaluations
Acute toxicity: In rat studies, no lethal effects or significant toxic reactions were observed even at extremely high doses of porcine diamine oxidase. Subchronic toxicity: Animal studies involving 90 days of continuous high-dose diamine oxidase administration showed no pathological alterations in body weight, blood parameters, liver/kidney function, or organ tissues.
Clinical Trials and Human Tolerability
In human clinical trials involving subjects with ‘histamine intolerance’ and healthy volunteers:
Adverse reactions were rare: The vast majority of subjects reported no side effects.
Minor side effects: The very few reported side effects were primarily mild gastrointestinal reactions (such as slight abdominal bloating), and it was often difficult to distinguish whether these were caused by the enzyme itself or the capsule excipients.
Vital signs: Long-term monitoring showed that taking this enzyme had no effect on vital signs such as blood pressure and heart rate.
ZJ26F0434229
危险品化学品经营许可证（带存储）