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� ”发背景与监管地位 — Evidence Review

By Editorial Desk · published 2026-01-06 · last reviewed 2026-02-11 · Topic

Everything below concerns 鼻内给药. We keep the language plain, cite what the science says, and separate well-supported claims from open questions.

Updated 2026-02-11. Numbers and descriptions here follow the published literature rather than marketing material.

研发背景与监管地位

当时的短肽研究普遍关注能否穿越血脑屏障、在低剂量下产生中枢效应,Semax 属于这一路线。鼻内给药是其主要使用方式,俄语文献报道的适应症涵盖缺血性卒中、短暂性脑缺血发作、认知功能减退以及视神经病变。这些研究大多发表在当地期刊上,样本规模与终点设置同西方试验惯例存在差异,国际同行对其临床证据的强度看法不一。

各国监管态度分化明显。俄罗斯按处方药管理,部分东欧国家留有使用记录;欧盟与美国未批准其作为药物上市,市面流通品通常标注为研究用化学品。身份差异意味着标示含量、纯度与无菌性缺少统一核查。体育领域还牵涉反兴奋剂名录,跨境携带则受目的地药品法规约束。

Background and Development

Semax is a synthetic heptapeptide developed in the Soviet Union during the 1980s by researchers at the Institute of Molecular Genetics in Moscow. It was designed as a truncated analog of adrenocorticotropic hormone, retaining only the fragment spanning residues four through ten. Investigators sought a peptide that would preserve the cognitive effects associated with ACTH while eliminating the hormonal stimulation of the adrenal cortex. The compound entered clinical use in Russia during the following decade.

Russian regulatory authorities approved the peptide for nasal administration, and it remains listed in the national pharmacopoeia under several trade names. Documented indications include acute ischemic stroke, transient ischemic attacks, traumatic brain injury, and certain ophthalmological and neurological conditions. Physicians also prescribe it for cognitive complaints in older patients, although the evidence base for that use is thinner. Outside Russia and a few neighboring states, the substance is not an approved medicine and is sold instead as a research chemical.

Later generations of the molecule include an N-acetylated form and an amidated form, both marketed online alongside the parent peptide. These variants differ in terminal chemistry and stability, and they are frequently discussed in the same breath even though they have not been compared in controlled trials. Supply outside formal healthcare systems comes largely from laboratories that synthesize peptides to order. Purity and identity of these materials vary widely, and no single body oversees the international trade.

Semax at a glance

PropertyValueNotes
结构类别线性合成七肽无环化结构,不含二硫键
氨基酸序列Met-Glu-His-Phe-Pro-Gly-ProN 端为甲硫氨酸
分子量约 814 Da游离碱形式的计算值
外观白色至类白色粉末具吸湿性
溶解性易溶于水亦可溶于甲醇等极性溶剂

Semax Origin and Molecular Structure

Semax is a synthetic heptapeptide with the sequence Met-Glu-His-Phe-Pro-Gly-Pro. It is described in the literature as an analogue of the ACTH(4–10) fragment, a short N-terminal portion of adrenocorticotropic hormone that retains some neurotropic activity without the full hormonal effects of the parent peptide. The molecule carries a methionine residue at the N-terminus and two proline residues near the C-terminus, features that shape both its interactions with receptor systems and its chemical stability. The free peptide corresponds to the formula C37H51N9O10S and a molecular mass near 813.9 Da.

The compound was developed in the 1980s at the Institute of Molecular Genetics in Moscow, where it emerged from research on short ACTH fragments and their effects on the central nervous system. Russian pharmaceutical listings describe it as a nootropic and neuroprotective agent, most often formulated as nasal drops. It is not a marketed medicine in the United States or the European Union, and no pharmacopoeial monograph covers it. Consequently, most published clinical experience with the substance originates from a small number of research centres, mainly in Russia and neighbouring countries.

Pharmacological accounts link semax to melanocortin signalling and to modulation of neurotrophic factor expression, particularly brain-derived neurotrophic factor and nerve growth factor. Much of this evidence comes from rodent studies using intranasal delivery, a route chosen because it allows peptides to reach the central nervous system with limited systemic exposure. Whether the same mechanisms operate in humans at comparable magnitude remains an open question. The precise receptor or receptors responsible for the reported behavioural and neuroprotective effects have not been conclusively identified.

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Semax 的分子背景与结构

Semax 是一种人工合成的七肽,氨基酸序列为 Met-Glu-His-Phe-Pro-Gly-Pro,单字母缩写记作 MEHFPGP。它被归类为促肾上腺皮质激素片段 ACTH(4-10) 的结构类似物,但并不天然存在于生物体内。母体片段 ACTH(4-10) 的序列为 Met-Glu-His-Phe-Arg-Trp-Gly,Semax 替换了中间两个残基,并在羧基端延长了 Pro-Gly-Pro 三肽。这种延长被普遍认为能提升分子对肽酶的耐受性。

该化合物于二十世纪八十年代在俄罗斯被开发,相关工作由俄罗斯科学院分子遗传学研究所的研究团队主导。开发目标并非复制 ACTH 的完整激素活性,而是寻找保留其神经作用方向、同时去除促肾上腺皮质激素释放效应的短肽片段。研究记录显示,这一方向促成了多个相关短肽的合成与筛选,而 Semax 是其中被研究最广泛的一个。当地文献常以 Семакс 这一名称指代它。

Further detail

Rickets, a childhood disease, is characterized by impeded growth and soft, weak, deformed long bones that bend and bow under their weight as children start to walk. Maternal vitamin D deficiency can cause fetal bone defects from before birth and impairment of bone quality after birth. Rickets typically presents between 3 and 18 months of age. This condition can be caused by vitamin D, calcium or phosphorus deficiency. Vitamin D deficiency remains the main cause of rickets among young infants in most countries because breast milk is low in vitamin D, and darker skin, social customs, and climatic conditions can contribute to inadequate sun exposure. A post-weaning Western omnivore diet characterized by high intakes of meat, fish, eggs and vitamin-D–fortified milk is protective, whereas low intakes of those foods and high (unfortified) cereal/grain intake contribute to risk. For young children with rickets, supplementation with vitamin D plus calcium was superior to the vitamin alone for bone healing.

The news media focused on Nixon's militaristic tone, describing his announcement with variations of the phrase "war on drugs". The day after Nixon's press conference, the Chicago Tribune proclaimed, "Nixon Declares War on Narcotics Use in US". In England, The Guardian headlined, "Nixon declares war on drug addicts." The US anti-drug campaign came to be commonly referred to as the war on drugs; the term also became used to refer to any government's prosecution of a US-style prohibition-based drug policy. Facing reelection, with drug control as a campaign centerpiece, Nixon formed the Office of Drug Abuse Law Enforcement (ODALE) in late 1971. ODALE, armed with new federal enforcement powers, began orchestrating drug raids nationwide to improve the administration's watchdog reputation. In a private conversation while helicoptering over Brooklyn, Nixon was reported to have commented, "You and I care about treatment. But those people down there, they want those criminals off the streets." From 1972 to 1973, ODALE performed 6,000 drug arrests in 18 months, the majority of the arrested black. In 1972, the Shafer Commission released its report, "Marihuana: A Signal of Misunderstanding", comprising a review of the medical literature and a national drug survey. It recommended decriminalization for personal possession and use of small amounts of cannabis, and prohibition only of supply. The conclusion was not acted on by Nixon or by Congress.

Since lithium-ion batteries are intercalation batteries, information on the chemistry and electronic structure going on in the bulk during operation are of interest. For this, soft x-ray information can be obtained using hard X-ray Raman scattering. Fixed energy methods (FEXRAV) have been developed and applied to the study of the catalytic cycle for the oxygen evolution reaction on iridium oxide. FEXRAV consists of recording the absorption coefficient at a fixed energy while varying at will the electrode potential in an electrochemical cell during the course of an electrochemical reaction. It allows to obtain a rapid screening of several systems under different experimental conditions (e.g., nature of the electrolyte, potential window), preliminary to deeper XAS experiments. The soft X-Ray regime (i.e. with photon energy < 1000 eV) can be profitably used for investigating heterogeneous solid-gas reaction. In this case, it is proved that XAS can be sensitive both to the gas phase and to the solid surface states.

Sources: en.wikipedia.org

Supporting material

Hydrophilic interaction chromatography (or hydrophilic interaction liquid chromatography, HILIC) is a type of liquid chromatography that uses a hydrophilic stationary phase and a high-organic mobile phase for the separation of analytes by polarity. While it is not as popular as some other types of liquid chromatography, the number of scientific publications using HILIC have greatly increased since the early 2000s. HILIC is similar to reverse phase chromatography in its mobile phase composition, and also to normal phase chromatography, with its polar stationary phase. It also has overlap with ion exchange chromatography. Sometimes, HILIC is considered to be a hybrid of these techniques. HILIC was named in 1990 by Andrew Alpert, who described it as a type of liquid-liquid partition chromatography. He suggested that analytes elute in order of increasing polarity, a conclusion supported by review and re-evaluation of published data. The mechanism for HILIC is still not entirely understood, but it is thought to rely on analytes partitioning between the organic-rich mobile phase and a water-enriched layer that forms of the surface of the polar stationary phase, in a liquid-liquid extraction system. More polar analytes will have stronger interactions with the water-enriched layer and with the column itself, therefore being retained on the column for longer.

Also, solid lipid nanoparticles (SLNs) are lipid nanoparticles with a solid interior as shown in the diagram on the right. SLNs can be made by replacing the liquid lipid oil used in the emulsion process with a solid lipid. In solid lipid nanoparticles, the drug molecules are dissolved in the particle's solid hydrophobic lipid core, this is called the drug payload, and it is surrounded by an aqueous solution. Many SLNs are developed from triglycerides, fatty acids, and waxes. High-pressure homogenization or micro-emulsification can be used for manufacturing. Further, functionalizing the surface of solid lipid nanoparticles with polyethylene glycol (PEG) can result in increased BBB permeability. Different colloidal carriers such as liposomes, polymeric nanoparticles, and emulsions have reduced stability, shelf life and encapsulation efficacy. Solid lipid nanoparticles are designed to overcome these shortcomings and have an excellent drug release and physical stability apart from targeted delivery of drugs.

=== CANOPUS: Compound class prediction === CANOPUS is short for class assignment and ontology prediction using mass spectrometry. It predicts the compound classes from the molecular fingerprint predicted by CSI:FingerID. This approach is completely database-free, i.e. it is not even limited to molecules that are listed in structure databases. CANOPUS employs a deep neural network (DNN) to predict 2,497 compound classes. The DNN was trained on 4.10 million compound structures with compound classes assigned by ClassyFire. No MS/MS data was used for training, but instead simulated 'realistic' probabilistic fingerprints for the training molecular structures were used. The DNN predicts all compound classes simultaneously. For full biological datasets, CANOPUS provides a comprehensive overview of compound classes present in the sample and allows for comparisons between different cohorts at compound class level.

Sources: en.wikipedia.org

Supporting material

== History == Lipedema was first identified in the United States, at the Mayo Clinic, in 1940. Most attribute the original identification of lipedema to E. A. Hines and L. E. Wold (1951). Despite that, lipedema is barely known in the United States to physicians or to the patients who have the disease. Lipedema often is confused with obesity or lymphedema, and a significant number of patients currently diagnosed as obese are believed to have lipedema, either instead of or in addition to obesity.

Fish and shellfish have a natural tendency to concentrate inorganic and organic toxins and pollutants in their bodies, including methylmercury, a highly toxic organic compound of mercury, polychlorinated biphenyls (PCBs), and microplastics. Species of fish that are high on the food chain, such as shark, swordfish, king mackerel, albacore tuna, and tilefish contain higher concentrations of these bioaccumulates. This is because bioaccumulates are stored in the muscle tissues of fish, and when a predatory fish eats another fish, it assumes the entire body burden of bioaccumulates in the consumed fish. Thus species that are high on the food chain amass body burdens of bioaccumulates that can be ten times higher than the species they consume. This process is called biomagnification. Man-made disasters can cause localized hazards in seafood which may spread widely via piscine food chains. The first occurrence of widespread mercury poisoning in humans occurred this way in the 1950s in Minamata, Japan. Wastewater from a nearby chemical factory released methylmercury that accumulated in fish which were consumed by humans. Severe mercury poisoning is now known as Minamata disease. The 2011 Fukushima Daiichi Nuclear Power Plant disaster and 1947–1991 Marshall Islands nuclear bomb testing led to dangerous radionuclide contamination of local sea life which, in the latter case, remained as of 2008.

His contemporary Alfred Russel Wallace also noted these variations and the geographical separations between different forms leading to the study of biogeography. Wallace was influenced by the work of Philip Lutley Sclater on the distribution patterns of birds.

Sources: en.wikipedia.org

Frequently asked questions

Semax 在自然界中存在吗?

不存在。它是依据 ACTH 的一段序列人工设计的分子,天然蛋白质中找不到与之完全相同的七肽。名称属于研究代号,而非天然物质名。

它与 ACTH 的差别在哪里?

Semax 对应 ACTH 第 4 至第 10 位的片段,并在两端做了替换与延长,使其不再具备促肾上腺皮质激素的典型内分泌活性。这一改动同时改变了它在体内的稳定性与分布特征。

哪些地区可以合法获得?

俄罗斯将其列为处方药物,需要医生开具处方。多数其他国家把它当作研究化合物,不能作为药品销售或宣称疗效。具体合法性取决于当地法规。

Where was Semax developed?

It originated at the Institute of Molecular Genetics in Moscow during the 1980s. The work was carried out by a Russian research group that specialized in peptide neuropharmacology.

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