���发背景与监管地位 — Practical Notes

By Editorial Desk · published 2026-02-12 · last reviewed 2026-03-03 · Data

鼻内给药 raises a handful of sensible questions. This page answers them in order, starting with the fundamentals and moving to applications.

This page was last updated on 2026-03-03 and is reviewed periodically as new material appears.

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。

Semax 是人工设计的七肽，序列为 Met-Glu-His-Phe-Pro-Gly-Pro，骨架取自促肾上腺皮质激素片段 ACTH(4-10)。它于二十世纪八十年代在苏联的分子遗传学研究机构内合成。设计目标是保留该片段与注意力和记忆相关的活性，同时剔除促皮质激素释放等内分泌作用。此后俄罗斯将其登记为药品并进入临床使用。

Semax Peptide Structure and Origin

Semax is a synthetic heptapeptide with the sequence Met-Glu-His-Phe-Pro-Gly-Pro. Its design combines the ACTH(4-7) core fragment with a C-terminal Pro-Gly-Pro extension, a modification intended to improve stability and prolong activity. The molecule is hydrophilic, carries no lipid chains or glycosylation, and has a theoretical mass just over 810 daltons in its free form. All seven residues are proteinogenic amino acids, so no non-natural building blocks appear in the backbone. A free N-terminal methionine and C-terminal proline define the unmodified parent peptide.

The compound was developed during the 1980s at the Institute of Molecular Genetics in Moscow as part of research on fragments of adrenocorticotropic hormone. Early work examined short ACTH-derived sequences that retained neurotrophic effects while lacking the endocrine activity of the full hormone. Semax entered clinical use in Russia during the 1990s, where it received registration for several neurological indications. Outside that region it remained primarily a laboratory research material rather than an approved therapeutic. English-language literature on it grew more slowly and frequently cited the original Russian studies.

Semax at a glance

Semax Background And Mechanism

Semax is a synthetic heptapeptide with the sequence Met-Glu-His-Phe-Pro-Gly-Pro. It was derived from the ACTH(4-10) fragment, a short segment of adrenocorticotropic hormone that lacks the hormonal activity associated with the full-length peptide. Researchers at the Institute of Molecular Genetics in Moscow developed the compound during the 1980s. It has been registered as a pharmaceutical product in Russia and several neighbouring countries, where it is supplied as a nasal solution, and it is also sold internationally as a research chemical.

The proposed mechanism centres on neurotrophic signalling rather than direct receptor activation. Semax is reported to increase expression of brain-derived neurotrophic factor and nerve growth factor in several brain regions, and to shift the balance between excitatory and inhibitory neurotransmitter systems. Interaction with melanocortin receptors has been suggested because of the parent ACTH fragment. Many of these findings come from rodent studies, and the extent to which they translate to human physiology remains an open question.

Scientific literature on semax is unevenly distributed. A substantial share of published work originates from a small number of laboratories in Russia, while independent replication elsewhere is limited. Human data consist mostly of small trials with short follow-up, and several reported outcomes rely on subjective rating scales. Questions about how much intact peptide reaches the central nervous system after nasal administration, and how long it persists there, are still unresolved. The compound is best described as an active research subject rather than a settled pharmacological agent.

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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.

Semax Structure and Research Background

Clinical evidence consists largely of small trials with modest sample sizes, often without independent replication. Reported endpoints include cognitive scores, recovery after stroke, and visual function, but study designs vary widely and few trials meet contemporary reporting standards. Systematic reviewers have noted a high risk of bias in several of these reports. No large multicenter trial conducted outside Russia has been published. The compound is therefore best described as investigational in most jurisdictions, with its clinical role still unresolved.

Semax is a synthetic heptapeptide with the sequence Met-Glu-His-Phe-Pro-Gly-Pro. Its chain combines the first seven residues of corticotropin with a C-terminal proline-glycine-proline extension, a modification intended to slow enzymatic breakdown. The free peptide has a molecular mass near 813.9 daltons. It belongs to the class of ACTH-derived fragments studied for central nervous system activity rather than for adrenal steroid stimulation. This structural relationship to a natural hormone fragment is the usual starting point for describing the compound in the literature.

Semax Peptide Background and Identity

Development is attributed to researchers at the Institute of Molecular Genetics in Moscow during the early 1980s, building on earlier Soviet work with ACTH fragments. Russian regulatory approval followed for intranasal use, and the compound has remained commercially available there for decades. Most published human data originate from Russian and, later, some Eastern European clinical reports, which are not always accessible in English translation. Outside that region the material is generally handled as a research chemical rather than a licensed medicine.

Regulatory status differs sharply between jurisdictions. In Russia the peptide is registered as a prescription nasal preparation, while agencies such as the United States Food and Drug Administration have not approved it for any indication. Products sold elsewhere are typically labeled for laboratory research only, and such labels shift responsibility for safe handling to the purchaser. Because the same name covers pharmaceutical-grade nasal drops and bulk research powder, identity and purity documentation becomes the main practical concern when comparing sources.

Reference notes

=== Prewar and postwar eras === The club came close to reaching the First Division in their early years. In the 1921–22 season, they missed out on promotion by goal difference. During the 1930s and 1940s years, the club found themselves sliding between the Second and Third Division. In 1949, the club signed Danny Blanchflower from Glentoran, and he impressed at Oakwell that two years later he was signed by First Division side Aston Villa, later signing for Tottenham Hotspur and being voted FWA Player of the Year twice, as well as being the captain of the 20th century's first league and cup double winning team in 1960–61. Around the time of Blanchflower's departure, a young centre-forward called Tommy Taylor broke into the Barnsley team, scoring 26 goals in 44 games. In April 1953, he became one of the most expensive players in English football at the time when Sir Matt Busby signed him for Manchester United for a fee of £29,999. Taylor went on to be a prolific goalscorer at the highest level over the next five years, winning two league titles and scoring 16 goals in 19 appearances for the England national football team, before losing his life in the Munich air disaster on 6 February 1958. When the Northern and Southern sections of the Third Division were replaced by national Third and Fourth Divisions for the 1958–59 season, Barnsley were still in the Second Division, but went down to the Third Division at the end of the season. In 1965, Barnsley were relegated to the Football League Fourth Division for the first time, winning promotion three years later.

== Evolution == The OR gene family in vertebrates has been shown to evolve through many gene duplications and gene losses, evolutionary dynamics known as a "birth-and-death" process. Evidence of a role for tandem duplication is provided by the fact that many OR genes belonging to the same phylogenetic clade are located in the same gene cluster. To this point, the organization of OR genomic clusters is well conserved between humans and mice, even though the functional OR count is vastly different between these two species. Such birth-and-death evolution has brought together segments from several OR genes to generate and degenerate odorant binding site configurations, creating new functional OR genes as well as pseudogenes. Compared to many other mammals, primates have a relatively small number of functional OR genes. For instance, since divergence from their most recent common ancestor (MRCA), mice have gained a total of 623 new OR genes, and lost 285 genes, whereas humans have gained only 83 genes, but lost 428 genes. Mice have a total of 1035 protein-coding OR genes, humans have 387 protein-coding OR genes. The vision priority hypothesis states that the evolution of color vision in primates may have decreased primate reliance on olfaction, which explains the relaxation of selective pressure that accounts for the accumulation of olfactory receptor pseudogenes in primates. However, recent evidence has rendered the vision priority hypothesis obsolete, because it was based on misleading data and assumptions.

== Function == G protein-coupled receptors (GPCRs, or GPRs) contain 7 transmembrane domains and transduce extracellular signals through heterotrimeric G proteins. A 26-amino acid RF-amide peptide, P518 functions as a high-affinity ligand of GPR103. Both GPR103 and P518 precursor mRNA exhibited highest expression in brain. The 43-amino acid QRFP peptide, a longer form of the P518 peptide is necessary to exhibit full agonistic activity with GPR103. Intravenous administration QRFP caused release of aldosterone, suggesting that QRFP and GPR103 regulate adrenal function.

Sources: en.wikipedia.org

Reference notes

== History == The term gynaecomastia was coined by Galen. He also recognised glandular enlargement of the male breast; however, this wasn't a condition of gynaecomastia according to him. A surgical procedure for treatment of gynaecomastia was described by Albucasis in his second book of Kitab al-Tasrif.

=== Irreversible pulpitis === Pulpitis is established when the pulp chamber is compromised by bacterial infection. Irreversible pulpitis is diagnosed when the pulp is inflamed and infected beyond healing. Removal of the aetiological agent does not permit healing, and a root canal is often indicated. Irreversible pulpitis follows reversible pulpitis absent early intervention. While the pulp is still vital and vascularised, it is not classified as 'dead pulp'. Irreversible and reversible pulpitis are distinguished by the pain responses to thermal stimulation. If the condition is reversible, the pulp's pain response lasts a few seconds upon exposure to cold or hot. If the pain lingers from minutes to hours, the condition is classified as irreversible. This is a common presenting complaint that facilitates initial diagnosis. Irreversible puplitis may be symptomatic or asymptomatic. Asymptomatic irreversible pulpitis results from transition of symptomatic irreversible pulpitis into an inactive/quiescent state. This is due to its aetiology; inflammatory exudate can be quickly removed, e.g. through a large carious cavity or previous trauma that caused painless pulp exposure. The build-up of pressure in a confined pulp space initiates pain reflexes. When this pressure is relieved, pain subsides. As the names imply, these diseases are largely characterised by their symptoms: pain duration and location, and exacerbating and relieving factors.

== Initial proposal and development == Neutron capture therapy (NCT) was first proposed in the literature in 1936 by Gordon L. Locher, who observed that isotopes with large neutron capture cross sections, such as boron-10, could be accumulated in cancerous tissue and bombarded with thermal neutrons to induce destruction of the cancerous cells. Boron was seen as a qualified candidate for NCT because the alpha particles of 10B (4He2+), produced from boron's reaction with a neutron beam, can induce apoptosis with a relatively tight travel radius about the diameter of a cell. The proposition was that boron-10 containing delivery agents would take advantage of properties of cancer cells that are not present in normal tissue cells, such as overexpression of certain enzymes or the lack of blood brain barrier. This idea was attractive because it had the potential to be more selective than traditional chemo- and radiotherapies. However, BNCT requires a neutron beam to act as a source of thermal neutrons and a suitable boron-delivery agent; neither was available at the time of Locher's suggestion. Therefore, it was not until the 1950s, when nuclear reactors were available, that Locher's proposal was put into practice. Since neutrons have a low penetration range, only about 2–3 cm below the skin's surface, BNCT was proposed for head and neck cancers.

Sources: en.wikipedia.org

Reference notes

The complete blood count is interpreted by comparing the output to reference ranges, which represent the results found in 95% of apparently healthy people. Based on a statistical normal distribution, the tested samples' ranges vary with sex and age. On average, adult females have lower hemoglobin, hematocrit, and red blood cell count values than males; the difference lessens, but is still present, after menopause. CBC results for children and newborn babies differ from those of adults. Newborns' hemoglobin, hematocrit, and red blood cell count are extremely high to compensate for low oxygen levels in the womb and the high proportion of fetal hemoglobin, which is less effective at delivering oxygen to tissues than mature forms of hemoglobin, inside their red blood cells. The MCV is also increased, and the white blood cell count is elevated with a preponderance of neutrophils. The red blood cell count and related values begin to decline shortly after birth, reaching their lowest point at about two months of age and increasing thereafter. The red blood cells of older infants and children are smaller, with a lower MCH, than those of adults. In the paediatric white blood cell differential, lymphocytes often outnumber neutrophils, while in adults neutrophils predominate. Other differences between populations may affect the reference ranges: for example, people living at higher altitudes have higher hemoglobin, hematocrit, and RBC results, and people of African heritage have lower white blood cell counts on average.

== Etymology == The genus name, Salvia, was first used by Pliny for a plant that was likely Salvia officinalis (common sage) and is derived from the Latin salvere. The specific epithet, divinorum, was given because of the plant's traditional use in divination. It is often loosely translated as "diviner's sage" or "seer's sage". Albert Hofmann, who collected the first plants with Gordon Wasson, objected to the new plant being given the name divinorum: "I was not very happy with the name because Salvia divinorum means 'Salvia of the ghosts,' whereas Salvia divinatorum, the correct name, means 'Salvia of the priests'." It is now in the botanical literature under the name Salvia divinorum due to priority rules.

Biomimetics is a field that aims to produce materials and systems that replicate those present in nature. In the context of tissue engineering, this is a common approach used by engineers to create materials for these applications that are comparable to native tissues in terms of their structure, properties, and biocompatibility. Material properties are largely dependent on physical, structural, and chemical characteristics of that material. Subsequently, a biomimetic approach to system design will become significant in material integration, and a sufficient understanding of biological processes and interactions will be necessary. Replication of biological systems and processes may also be used in the synthesis of bio-inspired materials to achieve conditions that produce the desired biological material. Therefore, if a material is synthesized having the same characteristics of biological tissues both structurally and chemically, then ideally the synthesized material will have similar properties. This technique has an extensive history originating from the idea of using natural phenomenon as design inspiration for solutions to human problems. Many modern advancements in technology have been inspired by nature and natural systems, including aircraft, automobiles, architecture, and even industrial systems. Advancements in nanotechnology initiated the application of this technique to micro- and nano-scale problems, including tissue engineering.

Sources: en.wikipedia.org

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