WO2017101887A1 - Healthcare pharmaceutical preparation having magnesium supplementation and anti-oxidation effects, and preparation method for healthcare pharmaceutical preparation - Google Patents

Healthcare pharmaceutical preparation having magnesium supplementation and anti-oxidation effects, and preparation method for healthcare pharmaceutical preparation Download PDF

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WO2017101887A1
WO2017101887A1 PCT/CN2017/071165 CN2017071165W WO2017101887A1 WO 2017101887 A1 WO2017101887 A1 WO 2017101887A1 CN 2017071165 W CN2017071165 W CN 2017071165W WO 2017101887 A1 WO2017101887 A1 WO 2017101887A1
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magnesium
pharmaceutical preparation
hydrogen
preparation
healthcare
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PCT/CN2017/071165
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French (fr)
Chinese (zh)
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袁广银
裴佳
丁文江
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上海交通大学
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • A61K9/2826Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds

Definitions

  • the invention relates to the field of pharmaceutical preparations, in particular to a health care medicine preparation which supplements magnesium and has anti-oxidation effect.
  • magnesium which participates in the synthesis of all energy metabolism proteins in the body, activates and catalyzes various enzyme systems, regulates the nervous system, ensures normal contraction of the myocardium, enhances immune function, and protects bones. Health and other effects. Magnesium deficiency in the human body may cause symptoms such as cardiovascular and cerebrovascular diseases, hypertension, diabetes, osteoporosis, migraine, anxiety and depression, which seriously endanger human health. Therefore, proper supplementation of magnesium is of great significance to human health.
  • magnesium salts such as magnesium oxide, magnesium gluconate, magnesium citrate, magnesium salicylate, magnesium hydroxide, magnesium chloride and magnesium sulfate.
  • the use of magnesium salt injection may cause problems such as pain, dizziness and muscle paralysis at the injection site. Therefore, it is necessary to develop a new magnesium source preparation which has safe non-toxic side effects, high magnesium content and high absorption conversion efficiency.
  • hydrogen has a strong penetrability, easy to enter any part of the cell such as the nucleus and mitochondria. These lay the important features that hydrogen can be used to treat diseases. Hydrogen has protection against various types of nervous system damage, has extensive effects on organ damage and diseases such as cardiovascular and digestive system, and has some human diseases such as diabetes and tumor radiation. Treatment, systemic red pull lupus skin damage, rheumatoid arthritis and other therapeutic effects. Therefore, the right amount of hydrogen supplementation has certain benefits for the human body. In recent years, hydrogen ion-rich Hydrogen Water has received widespread attention in the international market. However, hydrogen-rich water is limited by the low solubility of hydrogen. The hydrogen content is generally only about 0.1-1 ppm, and the highest is only about 5 ppm. The low hydrogen concentration and poor stability are the biggest problems that restrict the effect of hydrogen supplement products.
  • Patent CN1840497A “Hydrogen-rich water production method and hydrogen-rich water generator” and the patent CN201785234U “hydrogen water generator” have the same active ingredients as above, all of which are metallic magnesium, and therefore all of the above problems exist.
  • the patent CN102557227B "a calcium magnesium hydrogen-rich water additive and a preparation method thereof” is similar to the above-mentioned hydrogen-rich water rod principle, and the hydrogen-generating agent is a magnesium elemental substance or a calcium-magnesium alloy, except that an additional pH adjusting agent is added to improve the dissolution of magnesium.
  • the above question 2) remains unresolved.
  • the object of the present invention is to provide a health care pharmaceutical preparation which has both magnesium supplementation and antioxidant activity, and is characterized in that magnesium hydride MgH 2 micro-nano powder particles are used as main active ingredients (magnesium and hydrogen).
  • Source after taking into the human body, through the reaction with the body water, directly converted into magnesium ions in the body and simultaneously produce hydrogen, providing a new way for the human body to absorb magnesium and hydrogen uptake.
  • Long-term use of this preparation can effectively prevent symptoms caused by magnesium deficiency in the body, and is also beneficial for delaying aging and preventing diseases.
  • the invention provides a health care medicine preparation which has both magnesium supplementation and anti-oxidation effect, and the medicine preparation comprises a main active ingredient magnesium agent and an auxiliary material, the magnesium agent is MgH 2 micro-nano powder, and the auxiliary material is a common pharmaceutical preparation auxiliary material. .
  • the MgH 2 micro-nano powder has a size of from 100 nm to 100 ⁇ m.
  • MgH 2 exists in the form of micro-nano powder.
  • the magnesium powder of 100 nm-100 ⁇ m alone has very high oxidation activity, and it is easy to cause oxidative exothermic reaction in air and even cause dangerous accidents such as explosion.
  • Mg portion and the hydrogen to form a micro-nano powder of the MgH 2 compound, it becomes very stable and safe.
  • MgH 2 is also a stable and reliable source of hydrogen.
  • MgH 2 micro-nano powder enters the human body through the gastrointestinal tract, it passes through the following chemical reaction MgH 2 +H 2 O ⁇ Mg 2+ +2OH - +2H 2 , which reacts to form human-absorbable Mg 2+ and hydrogen. Produces a health benefit that is beneficial to the human body.
  • a range of sizes from 100 nm to 100 ⁇ m is selected, which is the most economical process and is also easily absorbed by the body.
  • the preparation cost is sharply increased with particles below 100 nm; the size exceeding 100 ⁇ m is also unfavorable for human body absorption.
  • the pharmaceutical preparation has a magnesium content of 40-400 mg/dose.
  • the pharmaceutical preparation produces a hydrogen content of from 72 to 720 mL per dose when administered.
  • the pharmaceutical preparation is in the form of a tablet, a pill or a capsule.
  • the invention also provides a preparation method of a health care medicine preparation which simultaneously supplements magnesium and hydrogen, wherein the preparation method comprises: uniformly mixing a certain amount of MgH 2 micro-nano powder with an appropriate amount of common medicinal auxiliary materials, and weighing the material by weighing , compacted, sterilized and packaged after processing.
  • the present invention has the following beneficial effects:
  • This supplement of magnesium and hydrogen preparations can simultaneously supplement the essential trace element magnesium and hydrogen which neutralizes oxygen free radicals.
  • reaction equation of the present invention is improved as follows:
  • MgH 2 has a hydrogen production efficiency higher than that of metallic magnesium, which is twice as high. Moreover, the magnesium source MgH 2 is directly converted into a soluble magnesium salt in the body after administration, instead of the magnesium hydroxide which is insoluble in the prior art. Therefore, the conversion absorption efficiency can be greatly improved.
  • the preparation reaction metabolite has no toxic side effects or adverse reactions, and is safe and reliable; at the same time, the preparation is convenient for storage and administration, and can greatly improve the convenience of use and the user's feeling.
  • the main active ingredient of the preparation magnesium hydride MgH 2 micro-nano powder, has low production cost and is convenient for large-scale production.
  • the magnesium hydride is prepared into a fine powder having a scale of 100-200 nm, 250 g of the powder is taken, 500 g of pregelatinized starch, 250 g of microcrystalline cellulose are added, and uniformly mixed, and then pressed into 1000 tablets, which is obtained. Each piece weighs 1g, 2 tablets per day for adults, swallows 1-2 times a day, and children take 1 tablet once a day. After taking 1-2 weeks in a row, the muscle pain in the leg muscles caused by mountaineering or long-distance running will be effectively alleviated and disappeared due to the effective supplementation of magnesium.
  • the magnesium hydride was prepared into a fine powder of 400-600 mesh, 150 g of the powder was taken, 150 g of mannitol, 120 g of micro-silica gel, and 80 g of alginic acid were added, and the mixture was finely sieved, uniformly mixed, and then placed in a capsule to obtain 1,000 tablets.
  • Each capsule weighs 0.5g, 2-3 capsules per day for adults, and is swallowed 1-3 times a day. Children take 1-2 capsules a day, taking 1-2 times. It was confirmed by animal experiments that the mice with pneumonia continuously took the above-mentioned capsule powder for 2 weeks, and one powder was mixed into the rat diet every day.
  • the pneumonia inflammation of the mice played an effective anti-inflammatory effect due to hydrogen entering the body fluid, and the pneumonia symptoms. It was effectively treated and alleviated at 2 weeks, and pneumonia completely healed after 3 weeks.
  • the magnesium hydride was prepared into a fine powder of 500 nm to 1 ⁇ m, 200 g of the powder was taken, 150 g of lactose, 100 g of dextrin, and 50 g of CMC were added, and the mixture was uniformly mixed and processed into pellets, and a total of 1000 particles were obtained. Each weight is 0.5g, 1-2 adults per day, 1-2 children per day, swallowed 1-2 times. It has been confirmed by animal experiments that guinea pigs with hepatitis continuously take the above pills for one month, and one pill dose of powder per day is mixed into the rat diet. The inflammatory inflammation of guinea pigs has an effective anti-inflammatory and anti-oxidative effect due to hydrogen entering the body fluid. Symptoms were effectively treated and alleviated in ten days, and hepatitis completely healed after 4 weeks.
  • the magnesium hydride was prepared into a fine powder of 1-10 micrometers, 350 g of the powder was taken, 300 g of mannitol and 150 g of microcrystalline cellulose were added, mixed uniformly, and then compressed into tablets, and the surface was coated with sugar, and 1000 pieces of sugar-coated tablets were obtained. Each piece weighs 0.8g and is swallowed by 1 tablet per day for adults. After 2 weeks of continuous use, the insomnia caused by neurological disorders can be effectively alleviated and disappeared due to the effective supplementation of magnesium.
  • the magnesium hydride is prepared into a fine powder of 1000-1500 mesh, and 40 g of the powder is obtained, which is commercially available as a trace element additive.
  • the magnesium hydride was prepared into a micro powder of 1000-1500 mesh, 30 g of the powder was taken, and 100 pieces of commercially available calcium tablets were added as a trace element additive, and the mixture was finely mixed and then re-compressed into tablets, and a total of 100 tablets were obtained. 1 swallow per day for adults.
  • supplementation with magnesium can help patients with osteoporosis to enhance the absorption and utilization of calcium.
  • the symptoms of fatigue, fatigue, cramps, backache, allergies, and flu caused by calcium deficiency and magnesium deficiency in adults can be effectively supplemented by magnesium and calcium and anti-inflammatory and anti-oxidation of hydrogen. The effect is effectively relieved and cured.

Abstract

A healthcare pharmaceutical preparation having magnesium supplementation and anti-oxidation effects, and a preparation method for the healthcare pharmaceutical preparation. The healthcare pharmaceutical preparation comprises a main effective component, which is a magnesium agent, and an excipient, the magnesium agent being an MgH2 micro/nanopowder, the excipient being a commonly used pharmaceutical preparation excipient.

Description

一种补镁兼具抗氧化作用的保健药品制剂及其制备方法Health medicine preparation with magnesium supplementation and antioxidation effect and preparation method thereof 技术领域Technical field
本发明涉及医药制剂领域,具体涉及一种补镁兼具抗氧化作用的保健药品制剂。The invention relates to the field of pharmaceutical preparations, in particular to a health care medicine preparation which supplements magnesium and has anti-oxidation effect.
背景技术Background technique
随着人们生活水平的提高和人口老龄化、及生活方式的改变,保健日益受到人们的重视。一些微量元素对人体健康起着非常重要的作用,如镁元素,参与体内所有能量代谢蛋白质的合成,激活和催化多种酶系统,调节神经系统,保证心肌正常收缩,增强机体免疫功能、保护骨骼健康等作用。人体缺镁可能引发心脑血管疾病、高血压、糖尿病、骨质疏松、偏头痛、焦虑症和抑郁症等症状,严重危害人体健康。因此,适量补充镁对人体健康具有重要意义。根据中国营养学会建议,成年男性每天约需镁350毫克,成年女性约300毫克,孕妇及哺乳期女性约450毫克。但大多情况下,仅靠饮食难以充分弥补不足,还需要采用镁营养补充剂。目前市面最常见的镁保健营养品是氧化镁、葡萄糖酸镁、柠檬酸镁、水杨酸镁、氢氧化镁、氯化镁、硫酸镁等镁盐。存在主要问题包括普遍镁含量欠低;转化吸收效率欠低(50-70%);可引起肠胃不适、腹泻,严重时还会引起胸部紧张、血便、嘴巴、面部和舌头肿胀、腹部绞痛等副作用。而采用镁盐注射液,可能会引起注射部位疼痛、眩晕、肌肉麻痹等问题。因此,需开发安全无毒副作用、镁含量及吸收转化效率更高的新的补镁源制剂。With the improvement of people's living standards and the aging of the population and the changes in lifestyle, health care has received increasing attention. Some trace elements play a very important role in human health, such as magnesium, which participates in the synthesis of all energy metabolism proteins in the body, activates and catalyzes various enzyme systems, regulates the nervous system, ensures normal contraction of the myocardium, enhances immune function, and protects bones. Health and other effects. Magnesium deficiency in the human body may cause symptoms such as cardiovascular and cerebrovascular diseases, hypertension, diabetes, osteoporosis, migraine, anxiety and depression, which seriously endanger human health. Therefore, proper supplementation of magnesium is of great significance to human health. According to the recommendations of the Chinese Nutrition Society, adult males need about 350 mg of magnesium per day, about 300 mg for adult women, and about 450 mg for pregnant and lactating women. However, in most cases, it is difficult to fully compensate for the deficiency by diet alone, and magnesium nutritional supplements are also needed. At present, the most common magnesium health nutrition products on the market are magnesium salts such as magnesium oxide, magnesium gluconate, magnesium citrate, magnesium salicylate, magnesium hydroxide, magnesium chloride and magnesium sulfate. There are major problems including the general low magnesium content; low conversion efficiency (50-70%); can cause stomach upset, diarrhea, severe chest tension, bloody stools, mouth, face and tongue swelling, abdominal cramps, etc. side effect. The use of magnesium salt injection may cause problems such as pain, dizziness and muscle paralysis at the injection site. Therefore, it is necessary to develop a new magnesium source preparation which has safe non-toxic side effects, high magnesium content and high absorption conversion efficiency.
研究表明人体的健康也与体内的氧自由基息息相关。过剩的氧自由基会导致细胞受损或老化坏死,最终导致机体的疾病和衰老。氢气是一种无色无味无嗅和无毒的气体,大量研究显示其具有选择性抗氧化性,可选择性的中和羟基自由基和亚硝酸阴离子,而后两者是氧化损伤的最重要介质,目前体内尚未找到内源性特异性清除途径。氢离子与活性氧结合后可被还原成水,排出体外,安全无毒副作用。并且氢气具有强大的穿透性,易进入细胞内如细胞核和线粒体等任何部位。这些奠定了氢气可用于治疗疾病的重要特征。氢对各类神经系统损伤具有保护,对心血管、消化系统等器官损伤和疾病具有广泛的效应,并对一些人类疾病如糖尿病、肿瘤放射 治疗、系统性红扳狼疮皮肤损伤、类风湿性关节炎等具有治疗作用。因此,适量补充氢对于人体有一定裨益。近年来,富含氢离子的水素水(Hydrogen Water)开始在国际市场上受到广泛的关注。但富氢水受氢气的低溶解度限制,含氢量一般仅在0.1-1ppm左右,最高也仅约为5ppm。含氢浓度低和稳定性差是目前制约补氢保健品效果的最大问题。Studies have shown that human health is also closely related to oxygen free radicals in the body. Excessive oxygen free radicals can cause cell damage or aging and necrosis, which can eventually lead to disease and aging in the body. Hydrogen is a colorless, odorless, odorless and non-toxic gas. A large number of studies have shown that it has selective oxidation resistance, can selectively neutralize hydroxyl radicals and nitrite anions, and the latter two are the most important media for oxidative damage. At present, no endogenous specific clearance pathway has been found in the body. Hydrogen ions combined with active oxygen can be reduced to water and excreted from the body, safe and non-toxic side effects. And hydrogen has a strong penetrability, easy to enter any part of the cell such as the nucleus and mitochondria. These lay the important features that hydrogen can be used to treat diseases. Hydrogen has protection against various types of nervous system damage, has extensive effects on organ damage and diseases such as cardiovascular and digestive system, and has some human diseases such as diabetes and tumor radiation. Treatment, systemic red pull lupus skin damage, rheumatoid arthritis and other therapeutic effects. Therefore, the right amount of hydrogen supplementation has certain benefits for the human body. In recent years, hydrogen ion-rich Hydrogen Water has received widespread attention in the international market. However, hydrogen-rich water is limited by the low solubility of hydrogen. The hydrogen content is generally only about 0.1-1 ppm, and the highest is only about 5 ppm. The low hydrogen concentration and poor stability are the biggest problems that restrict the effect of hydrogen supplement products.
并且,国内尚未见同时可补镁和氢气的制剂或保健营养产品,唯有日本引入的Dr.水素水富氢水棒,其有效成分为金属镁,但存在的问题是1)遇水产生氢氧化镁,难溶于水,因此不能有效利用,进入人体的镁含量过低;2)遇水马上产生氢气易逃逸,不稳定,须即时服用,不便储存放置,且溶解于水的氢气浓度有限;3)金属镁粒子易被氧化成难溶物,阻止与水进一步反应,因此随着使用次数增加,效果明显下降。专利CN1840497A“富氢水生成方法及富氢水生成器”与专利CN201785234U“氢水发生器”有效成分如上同,都是金属镁,因此也都存在上述问题。而专利CN102557227B“一种钙镁富氢水添加剂及其制备方法”与上述富氢水棒原理相似,制氢剂为镁单质或钙镁合金,只是额外加入了pH调节剂以改善镁的溶解,但上述问题2)依然存在未解决。Moreover, there are no preparations or health-care products that can supplement magnesium and hydrogen at the same time. Only the Dr. water-rich water-rich water bar introduced in Japan has the active ingredient of magnesium metal, but the problem is that 1) hydrogen is produced by water. Magnesium oxide, hardly soluble in water, can not be effectively used, the magnesium content into the human body is too low; 2) Hydrogen is easily escaped when it is in contact with water, unstable, must be taken immediately, inconvenient to store, and the concentration of hydrogen dissolved in water is limited. 3) The metal magnesium particles are easily oxidized to poorly soluble substances, preventing further reaction with water, so the effect is significantly reduced as the number of uses increases. Patent CN1840497A "Hydrogen-rich water production method and hydrogen-rich water generator" and the patent CN201785234U "hydrogen water generator" have the same active ingredients as above, all of which are metallic magnesium, and therefore all of the above problems exist. The patent CN102557227B "a calcium magnesium hydrogen-rich water additive and a preparation method thereof" is similar to the above-mentioned hydrogen-rich water rod principle, and the hydrogen-generating agent is a magnesium elemental substance or a calcium-magnesium alloy, except that an additional pH adjusting agent is added to improve the dissolution of magnesium. However, the above question 2) remains unresolved.
发明内容Summary of the invention
针对现有技术中的缺陷,本发明的目的是提供了一种补镁兼具抗氧化作用的保健药品制剂,其特点是以氢化镁MgH2微纳米粉颗粒为制剂主要有效成分(镁及氢源),服用进入人体后,通过与体内水的反应,直接在体内转化成镁离子并同时产生氢,为人体对镁元素的吸收和氢的摄取提供了新的途径。长期服用该制剂,可有效预防因身体缺镁而引起的症状,对延缓衰老、预防疾病也有益处。In view of the defects in the prior art, the object of the present invention is to provide a health care pharmaceutical preparation which has both magnesium supplementation and antioxidant activity, and is characterized in that magnesium hydride MgH 2 micro-nano powder particles are used as main active ingredients (magnesium and hydrogen). Source), after taking into the human body, through the reaction with the body water, directly converted into magnesium ions in the body and simultaneously produce hydrogen, providing a new way for the human body to absorb magnesium and hydrogen uptake. Long-term use of this preparation can effectively prevent symptoms caused by magnesium deficiency in the body, and is also beneficial for delaying aging and preventing diseases.
本发明的目的是通过以下技术方案实现的:The object of the invention is achieved by the following technical solutions:
本发明提供了一种补镁兼具抗氧化作用的保健药品制剂,所述药品制剂包括主要有效成分镁剂和辅料,所述镁剂为MgH2微纳米粉,所述辅料为常用药物制剂辅料。The invention provides a health care medicine preparation which has both magnesium supplementation and anti-oxidation effect, and the medicine preparation comprises a main active ingredient magnesium agent and an auxiliary material, the magnesium agent is MgH 2 micro-nano powder, and the auxiliary material is a common pharmaceutical preparation auxiliary material. .
优选地,所述MgH2微纳米粉尺寸为100nm-100μm。Preferably, the MgH 2 micro-nano powder has a size of from 100 nm to 100 μm.
MgH2是以微纳米粉的形式存在的,单独的100nm-100μm的镁粉氧化活性非常高,在空气中很容易发生氧化放热反应,甚至导致爆炸等危险事故。而通过将Mg份和氢气的化合后形成MgH2化合物的微纳米粉,则就变得非常稳定和安全。同时MgH2也是一个稳定可靠的氢的来源。一旦MgH2微纳米粉通过胃肠道进入人体后,通过下面的化学 反应MgH2+H2O→Mg2++2OH-+2H2,即反应生成人体可吸收的Mg2+和氢,从而产生对人体有益的保健作用。MgH 2 exists in the form of micro-nano powder. The magnesium powder of 100 nm-100 μm alone has very high oxidation activity, and it is easy to cause oxidative exothermic reaction in air and even cause dangerous accidents such as explosion. On the other hand, by combining the Mg portion and the hydrogen to form a micro-nano powder of the MgH 2 compound, it becomes very stable and safe. At the same time, MgH 2 is also a stable and reliable source of hydrogen. Once the MgH 2 micro-nano powder enters the human body through the gastrointestinal tract, it passes through the following chemical reaction MgH 2 +H 2 O→Mg 2+ +2OH - +2H 2 , which reacts to form human-absorbable Mg 2+ and hydrogen. Produces a health benefit that is beneficial to the human body.
选择100nm-100μm的尺寸范围,这一尺寸范围制备工艺最经济,同时也便于被人体吸收。低于100nm的微粒,制备成本急剧增加;超过100μm尺寸,也不利于人体的吸收。A range of sizes from 100 nm to 100 μm is selected, which is the most economical process and is also easily absorbed by the body. The preparation cost is sharply increased with particles below 100 nm; the size exceeding 100 μm is also unfavorable for human body absorption.
优选地,所述药品制剂中镁元素的重量含量为40-400mg/剂。Preferably, the pharmaceutical preparation has a magnesium content of 40-400 mg/dose.
优选地,所述药品制剂服用时所产生的氢气含量为72-720mL/剂。Preferably, the pharmaceutical preparation produces a hydrogen content of from 72 to 720 mL per dose when administered.
优选地,所述药品制剂为片剂、丸剂或胶囊形式。Preferably, the pharmaceutical preparation is in the form of a tablet, a pill or a capsule.
本发明还提供了一种同时补充镁及氢的保健药品制剂的制备方法,所述制备方法为:将一定量的MgH2微纳米粉与适量常用药用辅料进行均匀混合,经称量分料、压实、灭菌处理和包装加工后制得。The invention also provides a preparation method of a health care medicine preparation which simultaneously supplements magnesium and hydrogen, wherein the preparation method comprises: uniformly mixing a certain amount of MgH 2 micro-nano powder with an appropriate amount of common medicinal auxiliary materials, and weighing the material by weighing , compacted, sterilized and packaged after processing.
与现有技术相比,本发明具有如下的有益效果:Compared with the prior art, the present invention has the following beneficial effects:
1、本补镁及氢制剂一次服用可同时补充人体必需的微量元素镁和中和氧自由基的氢。1. This supplement of magnesium and hydrogen preparations can simultaneously supplement the essential trace element magnesium and hydrogen which neutralizes oxygen free radicals.
2、现有技术的反应方程式如下:2. The reaction equation of the prior art is as follows:
Mg+2H2O→Mg(OH)2+H2 Mg+2H 2 O→Mg(OH) 2 +H 2
而本发明的反应方程式改进如下:The reaction equation of the present invention is improved as follows:
MgH2+H2O→Mg2++2OH-+2H2 MgH 2 +H 2 O→Mg 2+ +2OH - +2H 2
如反应式所示,MgH2产氢效率比金属镁高,是其2倍。且补镁源MgH2是在服用后直接在体内转化成可溶性镁盐,而不是现有技术中难溶的氢氧化镁。因而,转化吸收效率可得到较大程度提高。As shown in the reaction formula, MgH 2 has a hydrogen production efficiency higher than that of metallic magnesium, which is twice as high. Moreover, the magnesium source MgH 2 is directly converted into a soluble magnesium salt in the body after administration, instead of the magnesium hydroxide which is insoluble in the prior art. Therefore, the conversion absorption efficiency can be greatly improved.
3、与富氢水/水素水受氢溶解度低所限不同,所述制剂补充的氢是在进入人体后产生,因而补充的氢浓度得到极大提高,可更好的发挥氢的抗氧化的保健治疗效用。3. Unlike hydrogen-rich water/water-based water, which is limited by the low solubility of hydrogen, the hydrogen supplemented by the preparation is produced after entering the human body, so the supplemental hydrogen concentration is greatly improved, and the hydrogen oxidation resistance can be better exerted. Health care utility.
4、所述制剂反应代谢产物无毒副作用或不良反应,安全可靠;同时,所述制剂便于储存及服用,可极大改善使用便利和使用者感受。4. The preparation reaction metabolite has no toxic side effects or adverse reactions, and is safe and reliable; at the same time, the preparation is convenient for storage and administration, and can greatly improve the convenience of use and the user's feeling.
5、所述制剂主要有效成分氢化镁MgH2微纳米粉生产成本较低,且便于大规模化生产。5. The main active ingredient of the preparation, magnesium hydride MgH 2 micro-nano powder, has low production cost and is convenient for large-scale production.
具体实施方式 detailed description
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人员进一步理解本发明,但不以任何形式限制本发明。应当指出的是,对本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进。这些都属于本发明的保护范围。The invention will now be described in detail in connection with specific embodiments. The following examples are intended to further understand the invention, but are not intended to limit the invention in any way. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the inventive concept. These are all within the scope of protection of the present invention.
实施例1Example 1
将氢化镁制备成尺度为100-200纳米的微粉,取粉体250g,加入预胶化淀粉500g、微晶纤维素250g,混合均匀后压制成片剂1000片,即得。每片重量1g,成人每日2片,分1-2次吞服,儿童每日1片,每日一次。经连续服用1-2周,登山或长跑造成的腿部肌肉酸疼因镁的有效补充会得到有效缓解和消失。The magnesium hydride is prepared into a fine powder having a scale of 100-200 nm, 250 g of the powder is taken, 500 g of pregelatinized starch, 250 g of microcrystalline cellulose are added, and uniformly mixed, and then pressed into 1000 tablets, which is obtained. Each piece weighs 1g, 2 tablets per day for adults, swallows 1-2 times a day, and children take 1 tablet once a day. After taking 1-2 weeks in a row, the muscle pain in the leg muscles caused by mountaineering or long-distance running will be effectively alleviated and disappeared due to the effective supplementation of magnesium.
实施例2Example 2
将氢化镁制备成400-600目的微粉,取粉体150g,加入甘露醇150g、微粉硅胶120g、海藻酸80g,研细过筛,混合均匀后装入胶囊内即得,共制1000粒。每个胶囊重量0.5g,成人每日2-3粒,分1-3次吞服,儿童每日1-2粒,分1-2次服用。经动物实验证实,患有肺炎的小白鼠连续服用上述胶囊内药粉2周,每天1粒药粉混入鼠粮中服用,小白鼠肺炎炎症因氢进入体液内起到了有效的抗炎作用,其肺炎症状在2周时得到有效治疗和减轻,服用3周后肺炎完全痊愈。The magnesium hydride was prepared into a fine powder of 400-600 mesh, 150 g of the powder was taken, 150 g of mannitol, 120 g of micro-silica gel, and 80 g of alginic acid were added, and the mixture was finely sieved, uniformly mixed, and then placed in a capsule to obtain 1,000 tablets. Each capsule weighs 0.5g, 2-3 capsules per day for adults, and is swallowed 1-3 times a day. Children take 1-2 capsules a day, taking 1-2 times. It was confirmed by animal experiments that the mice with pneumonia continuously took the above-mentioned capsule powder for 2 weeks, and one powder was mixed into the rat diet every day. The pneumonia inflammation of the mice played an effective anti-inflammatory effect due to hydrogen entering the body fluid, and the pneumonia symptoms. It was effectively treated and alleviated at 2 weeks, and pneumonia completely healed after 3 weeks.
实施例3Example 3
将氢化镁制备成500纳米-1微米的微粉,取粉体200g,加入乳糖150g、糊精100g、CMC 50g,混合均匀后加工成丸剂,共得1000颗。每颗重量0.5g,成人每日1-2颗,儿童每日1-2颗,分1-2次吞服。经动物实验证实,患有肝炎的豚鼠连续服用上述丸剂1月,每天1颗丸剂量的药粉混入鼠粮中服用,豚鼠肝炎炎症因氢进入体液内起到了有效的抗炎抗氧化作用,其肝炎症状在十天时得到有效治疗和减轻,服用4周后肝炎完全痊愈。The magnesium hydride was prepared into a fine powder of 500 nm to 1 μm, 200 g of the powder was taken, 150 g of lactose, 100 g of dextrin, and 50 g of CMC were added, and the mixture was uniformly mixed and processed into pellets, and a total of 1000 particles were obtained. Each weight is 0.5g, 1-2 adults per day, 1-2 children per day, swallowed 1-2 times. It has been confirmed by animal experiments that guinea pigs with hepatitis continuously take the above pills for one month, and one pill dose of powder per day is mixed into the rat diet. The inflammatory inflammation of guinea pigs has an effective anti-inflammatory and anti-oxidative effect due to hydrogen entering the body fluid. Symptoms were effectively treated and alleviated in ten days, and hepatitis completely healed after 4 weeks.
实施例4Example 4
将氢化镁制备成1-10微米的微粉,取粉体350g,加入甘露醇300g、微晶纤维素150g,混合均匀后压制成片剂,并在表面包上糖衣,共得糖衣片1000片。每片重量0.8g,成人每日1片吞服。经连续服用2周,因神经功能紊乱造成的失眠现象因镁的有效补充会得到有效缓解和消失。The magnesium hydride was prepared into a fine powder of 1-10 micrometers, 350 g of the powder was taken, 300 g of mannitol and 150 g of microcrystalline cellulose were added, mixed uniformly, and then compressed into tablets, and the surface was coated with sugar, and 1000 pieces of sugar-coated tablets were obtained. Each piece weighs 0.8g and is swallowed by 1 tablet per day for adults. After 2 weeks of continuous use, the insomnia caused by neurological disorders can be effectively alleviated and disappeared due to the effective supplementation of magnesium.
实施例5Example 5
将氢化镁制备成1000-1500目的微粉,取粉体40g,作为微量元素添加剂加入市售 叶酸片100片,研细混合均匀后再重新压制成片剂,共得100片。孕妇每日1片吞服。可帮助孕妇在补充叶酸的同时补充必需元素镁。连续服用1-2月,一些中老年人由于神经功能紊乱导致的腹部胀满、肠鸣、叹息、食少、呕吐、腹泻或便秘等胃肠功能不正常症状会因镁离子的定期补充和氢的抗氧化作用而得到有效缓解和消失。The magnesium hydride is prepared into a fine powder of 1000-1500 mesh, and 40 g of the powder is obtained, which is commercially available as a trace element additive. 100 pieces of folic acid tablets, finely mixed and then pressed into tablets, a total of 100 tablets. Pregnant women swallow 1 tablet daily. It can help pregnant women supplement the essential element magnesium while supplementing folic acid. Continuous taking for 1-2 months, some middle-aged and elderly people due to neurological disorders caused by abdominal fullness, bowel, sigh, eating less, vomiting, diarrhea or constipation and other symptoms of gastrointestinal abnormalities due to regular supplementation of magnesium ions and hydrogen The antioxidant effect is effectively relieved and disappeared.
实施例6Example 6
将氢化镁制备成1000-1500目的微粉,取粉体30g,作为微量元素添加剂加入市售补钙片100片,研细混合均匀后再重新压制成片剂,共得100片。成人每日1片吞服。同时补充镁可帮助骨质疏松患者加强对钙的吸收利用。连续服用1-3个月,成年男性因缺钙和缺镁造成的倦怠、乏力、抽筋、腰酸背疼、易过敏、易感冒等症状会因镁、钙的有效补充和氢的抗炎抗氧化作用得到有效缓解和治愈。The magnesium hydride was prepared into a micro powder of 1000-1500 mesh, 30 g of the powder was taken, and 100 pieces of commercially available calcium tablets were added as a trace element additive, and the mixture was finely mixed and then re-compressed into tablets, and a total of 100 tablets were obtained. 1 swallow per day for adults. At the same time, supplementation with magnesium can help patients with osteoporosis to enhance the absorption and utilization of calcium. After taking 1-3 months in a row, the symptoms of fatigue, fatigue, cramps, backache, allergies, and flu caused by calcium deficiency and magnesium deficiency in adults can be effectively supplemented by magnesium and calcium and anti-inflammatory and anti-oxidation of hydrogen. The effect is effectively relieved and cured.
以上详细描述了本发明的具体实施方式。应当理解,本领域内的普通技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此,凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案,皆应在由权利要求书所确定的保护范围内。 The specific embodiments of the present invention have been described in detail above. It will be appreciated that many modifications and variations can be made in the present invention without departing from the scope of the invention. Therefore, any technical solution that can be obtained by a person skilled in the art based on the prior art based on the prior art by logic analysis, reasoning or limited experimentation should be within the scope of protection determined by the claims.

Claims (6)

  1. 一种补镁兼具抗氧化作用的保健药品制剂,其特征在于,所述药品制剂包括主要有效成分镁剂和辅料,所述镁剂为MgH2微纳米粉,所述辅料为常用药物制剂辅料。A health care pharmaceutical preparation supplementing magnesium and having an antioxidant effect, characterized in that the pharmaceutical preparation comprises a main active ingredient magnesium agent and an auxiliary material, the magnesium agent is a MgH 2 micro-nano powder, and the auxiliary material is a commonly used pharmaceutical preparation auxiliary material. .
  2. 如权利要求1所述的补镁兼具抗氧化作用的保健药品制剂,其特征在于,所述MgH2微纳米粉尺寸为100nm-100μm。The health care pharmaceutical preparation according to claim 1, wherein the MgH 2 micro/nano powder has a size of from 100 nm to 100 μm.
  3. 如权利要求1所述的补镁兼具抗氧化作用的保健药品制剂,其特征在于,所述药品制剂中镁元素的重量含量为40-400mg/剂。The health care pharmaceutical preparation according to claim 1, wherein the magnesium content of the pharmaceutical preparation is 40-400 mg/dose.
  4. 如权利要求1所述的补镁兼具抗氧化作用的保健药品制剂,其特征在于,所述药品制剂服用时所产生的氢气含量为72-720mL/剂。The health care pharmaceutical preparation according to claim 1, which has an antioxidant effect, wherein the pharmaceutical preparation has a hydrogen content of 72 to 720 mL per dose.
  5. 如权利要求1所述的补镁兼具抗氧化作用的保健药品制剂,其特征在于,所述药品制剂为片剂、丸剂或胶囊形式。The health care pharmaceutical preparation according to claim 1, which has both an antioxidant effect and an antioxidant composition, wherein the pharmaceutical preparation is in the form of a tablet, a pill or a capsule.
  6. 一种如权利要求1~5任一项所述的补镁兼具抗氧化作用的保健药品制剂的制备方法,其特征在于,所述制备方法为:将MgH2微纳米粉与常用药用辅料进行均匀混合,经称量分料、压实、灭菌处理和包装加工后制得。 A method for preparing a health care pharmaceutical preparation containing magnesium supplementation and antioxidant activity according to any one of claims 1 to 5, wherein the preparation method comprises the following steps: using MgH 2 micro-nano powder and common pharmaceutical excipients It is uniformly mixed and prepared by weighing, compacting, sterilizing and packaging.
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