WO2021109511A1 - 一种抗疲劳的组合物及其制备方法 - Google Patents

一种抗疲劳的组合物及其制备方法 Download PDF

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WO2021109511A1
WO2021109511A1 PCT/CN2020/094734 CN2020094734W WO2021109511A1 WO 2021109511 A1 WO2021109511 A1 WO 2021109511A1 CN 2020094734 W CN2020094734 W CN 2020094734W WO 2021109511 A1 WO2021109511 A1 WO 2021109511A1
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肖伟
李曼曼
张海弢
范业文
柏伟荣
贾名强
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江苏康仁医药科技开发有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8969—Polygonatum (Solomon's seal)
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L31/00—Edible extracts or preparations of fungi; Preparation or treatment thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/074—Ganoderma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/41—Crassulaceae (Stonecrop family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Definitions

  • the invention relates to the field of medicines, foods or health care products, in particular to a composition for relieving physical fatigue and a preparation method thereof.
  • Physical fatigue is also called physical fatigue. It is due to the fact that a large number of metabolites, such as lactic acid, carbon dioxide, serum urea nitrogen, etc., are produced in the body when people continue to exercise with long-term and high-intensity physical activity. These substances accumulate in the body and stimulate Human tissue cells and nervous system will cause fatigue.
  • metabolites such as lactic acid, carbon dioxide, serum urea nitrogen, etc.
  • the present invention intends to provide a composition, medicine, food or health care product for anti-fatigue and a preparation method thereof.
  • the present invention proposes an anti-fatigue composition, the composition and the raw materials used can be directly ground into powder, or it can be an extract prepared by conventional means or other forms, etc., which is characterized by By weight, the composition includes 3 to 9 parts of Polygonatum, 1 to 6 parts of Ganoderma lucidum, 1 to 6 parts of Phyllanthus emblica and 1 to 4 parts of Rhodiola.
  • composition includes 4 to 8 parts of Polygonatum, 2 to 4 parts of Ganoderma lucidum, 2 to 4 parts of Phyllanthus emblica and 1 to 3 parts of Rhodiola.
  • composition includes 6-9 parts of Polygonatum, 3-6 parts of Ganoderma lucidum, 3-6 parts of Phyllanthus emblica and 2-4 parts of Rhodiola.
  • the composition comprises 6 parts of Polygonatum, 3 parts of Ganoderma lucidum, 3 parts of Phyllanthus emblica, 2 parts of Rhodiola; or, the composition comprises 9 parts of Polygonatum, 6 parts of Ganoderma lucidum, 6 parts of Phyllanthus, Rhodiola 4 parts.
  • the present invention also provides a medicine, food or health care product, characterized in that the medicine, food or health care product is prepared from any one of the foregoing compositions and acceptable excipients or additives on the medicine, food or health care product .
  • the auxiliary material may be microcrystalline cellulose, magnesium stearate, lactose, croscarmellose sodium, corn starch, wheat starch, potato starch, silicon dioxide, and the like.
  • the present invention also provides a method for preparing any of the aforementioned compositions, which is characterized in that it comprises the following steps:
  • the present invention also provides a composition prepared by the above preparation method.
  • the present invention also proposes the application of any of the aforementioned compositions in the preparation of anti-fatigue drugs, foods or health products.
  • the anti-fatigue effect may be, for example, an effect of relieving physical fatigue.
  • the medicines, foods or health products include, but are not limited to, capsules, tablets, granules, pills or oral liquids and the like.
  • the present invention also provides a preparation method of anti-fatigue granules, characterized in that the method comprises: taking 6 parts by weight of Polygonatum, 3 parts by weight of Ganoderma lucidum, 3 parts by weight of Phyllanthus emblica, 2 parts by weight of Rhodiola, and adding 12 parts by weight. Double the amount of water to decoct and extract 3 times, each time for 2.0 hours, filter, combine the three extracts, concentrate under reduced pressure at 70 ⁇ 5°C, and concentrate to a relative density of 1.20, and dry under reduced pressure at 70 ⁇ 5°C to obtain dry leaching Paste, dry extract is sieved after crushing, adding appropriate amount of auxiliary materials, mixing uniformly, granulating, drying, and sizing, ready to be obtained.
  • the present invention also provides a method for preparing anti-fatigue tablets, which is characterized in that the method comprises: 6 parts by weight of Polygonatum, 3 parts by weight of Ganoderma lucidum, 3 parts by weight of Phyllanthus emblica, 2 parts by weight of Rhodiola, and 12 parts by weight.
  • the ointment and dry extract are crushed with a universal pulverizer and sieved, add appropriate amount of auxiliary materials, mix evenly, granulate, compress, and coat, and get ready.
  • qi and blood are the basic substances of the human body, and the two are closely related and affect each other. Blood has the effect of nourishing the limbs and bones, while qi has the effect of pushing and warming. The movement of blood depends on the promotion of qi, and the generation of qi depends on the nourishment of blood. Insufficient blood will cause qi deficiency, and insufficient qi will lead to blood stasis. Block the meridians.
  • Traditional Chinese medicine emphasizes that there is no pain if it is normal, and no pain if it is painful. Unsmooth qi and blood will cause muscle soreness and weakness in limbs. When sports fatigue occurs, both are often damaged, resulting in deficiency of both qi and blood.
  • Polygonatum plays a major role as a monarch drug
  • Ganoderma lucidum plays a role as a minister drug and assists the monarch drug
  • Phyllanthus emblica and Rhodiola are used as adjuvants and agents to coordinate and assist Polygonatum and Ganoderma lucidum play a role in relieving physical fatigue.
  • Polygonatum replenishes qi and nourishes yin, invigorates the spleen, nourishes the lungs, and nourishes the kidneys; Ganoderma lucidum, nourishes qi and soothes the nerves; Rhodiola, nourishes the kidney, regulates qi and nourishes blood; Rhodiola and Ganoderma lucidum combine to play the power of nourishing qi; Phyllanthus emblica nourishes liver and kidney ;
  • the prescription is compatible with replenishing qi to soothe the nerves, nourishing yin and cooling blood, insisting on using qi and blood to fill, the righteousness is sufficient, and fatigue is obviously eliminated. Therefore, the composition of the present invention combines the occurrence mechanism of physical fatigue, uses the theory of traditional Chinese medicine, and the synergistic effect of various raw materials has a relieving effect on physical fatigue.
  • composition can significantly extend the weight-bearing swimming time of mice, reduce the area under the blood lactic acid curve and the serum urea nitrogen content at three time points before and after exercise, and have the function of relieving physical fatigue.
  • the preparation method of the composition of the present invention is the combined extraction of Polygonatum, Ganoderma lucidum, Phyllanthus emblica and Rhodiola rosea, and the extraction process is simple, and the extraction process is more complicated compared to the separate extraction of raw materials. And compared to the direct purchase of commercially available extracts, the cost is also greatly reduced.
  • the components used in the present invention such as Polygonatum, Ganoderma lucidum, Phyllanthus emblica and Rhodiola rosea are all commercially available Chinese medicinal materials. It should be noted that if the specific conditions are not specified, they will be carried out in accordance with the conventional conditions or the conditions recommended by the manufacturer. The raw materials or auxiliary materials used, and the reagents or instruments used without the manufacturer’s instructions are all commercially available. Regular products. Unless otherwise stated, all percentages, ratios, ratios or parts are by weight.
  • compositions prepared in Examples 1 to 3 and Comparative Examples 1 to 5 were prepared into an aqueous solution with a concentration of 0.021 g/mL according to the standard of 0.42 g of the composition per 1 kg body weight of the mouse. 20mL/Kg body weight was given to mice by gavage.
  • mice Ninety ICR mice were randomly divided into 9 groups, 10 in each group.
  • the control group was given purified water, and the experimental group was given each composition solution, which was given by oral gavage for 30 days.
  • Weight-bearing swimming experiment 30 minutes after the last oral administration of the test substance, the mice bearing 5% body weight lead skin at the root of their tails are placed in a swimming box, the water depth is greater than 30cm, and the water temperature is 25°C ⁇ 1.0°C. The time from the beginning of swimming to death was used as the time for the mice to swim with weight.
  • BUN serum urea nitrogen
  • liver glycogen content 30 minutes after the last administration of the test substance, the animals were sacrificed, and 100 mg of liver was accurately weighed, homogenized according to the procedure, centrifuged, and 95% ethanol was used to precipitate glycogen. The anthrone method was used to determine liver glycogen content.
  • lactic acid 30 minutes after the last administration of the test substance, first blood was taken from the intraocular canthus to determine the baseline blood lactic acid value in a resting state; swimming in 30°C water for 10 minutes, picked up and wiped dry, immediately took the second blood from the intraocular canthus, and The blood was collected from the intraocular canthus for the third time after resting for 20 minutes, and the lactic acid content was measured with a glucose-lactic acid analyzer.
  • Example 1 P ⁇ 0.01
  • Example 3 P ⁇ 0.01
  • Example 2 P ⁇ 0.05
  • the liver glycogen of mice in each comparative group also has a certain decrease, but compared with the control group, there is no significant difference (P>0.05).
  • composition of the present invention has the effect of relieving physical fatigue, and compared with the comparative example, the function of relieving physical fatigue is better.

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Abstract

一种缓解体力疲劳的组合物，其特征在于，以重量计，该组合物包括黄精3～9份、灵芝1～6份、余甘子1～6份、红景天1～4份。实验表明，组合物提取物的提取工艺简单。此外，组合物的配方中所用原料配伍合理、制剂工艺简单，同时组合物能够显著延长小鼠负重游泳时间，减少小鼠运动前后三个时间点血乳酸曲线下面积及血清尿素氮含量，具有缓解体力疲劳的功能。

Description

一种抗疲劳的组合物及其制备方法 技术领域
本发明涉及药品、食品或保健品领域，特别涉及一种缓解体力疲劳的组合物、其制备方法。
背景技术
体力疲劳又叫躯体性疲劳，是由于当人持续长时间、大强度的体力活动运动时，体内产生了大量的代谢物，如乳酸、二氧化碳、血清尿素氮等，这类物质在体内积聚，刺激人体组织细胞和神经系统，就会使人产生疲劳感。
对于当今高速率的发展时代，人们的身心更容易感到疲劳。不管是体力疲劳或者是心理疲劳，均会有不同的表现，如脾气的烦躁、身体免疫力下降等，严重的则影响正常生活及工作。所以具有缓解体力疲劳功能的产品的研制与开发已成为当今社会的一个重要课题。
发明内容
本发明意在提供一种用于抗疲劳的组合物、药品、食品或保健品及其制备方法。具体来说，本发明提出了一种抗疲劳的组合物，该组合物以及所用的原料可以直接研磨成粉，也可以是经过常规手段制得的提取物或其它形态等，其特征在于，以重量计，该组合物包括黄精3～9份、灵芝1～6份、余甘子1～6份、红景天1～4份。
进一步地，所述组合物包括黄精4～8份、灵芝2～4份、余甘子2～4 份、红景天1～3份。
进一步地，所述组合物包括黄精6～9份、灵芝3～6份、余甘子3～6份、红景天2～4份。
优选地，所述组合物包括黄精6份、灵芝3份、余甘子3份、红景天2份；或者，所述组合物包括黄精9份、灵芝6份、余甘子6份、红景天4份。
本发明还提出了一种药品、食品或保健品，其特征在于，该药品、食品或保健品由前述任一所述的组合物与药品、食品或保健品上可接受的辅料或添加剂制得。
具体地，所述辅料可以是微晶纤维素、硬脂酸镁、乳糖、交联羧甲基纤维素钠、玉米淀粉、小麦淀粉、马铃薯淀粉、二氧化硅等等。
本发明还提出了一种前述任一所述组合物的制备方法，其特征在于，包括以下步骤：
(A)取药材加入8～14倍量水煎煮提取1～3次，每次0.5～2.0小时，滤过，合并提取液，得到滤液；
(B)将所得滤液在60±5℃～80±5℃条件下减压浓缩，并浓缩至相对密度1.10～1.30的浓缩液，60±5℃～80±5℃减压干燥得干浸膏，干浸膏粉碎后过筛，即得。
本发明还提出了上述制备方法制得的组合物。
本发明还提出了前述任一所述组合物在制备抗疲劳的药品、食品或保健品中的应用。该抗疲劳作用例如可以是对体力疲劳具有缓解作用。
具体地，所述药品、食品或保健品包括但不限于胶囊剂、片剂、颗粒剂、丸剂或口服液等等。
本发明还提出了一种抗疲劳的颗粒剂的制备方法，其特征在于，该方法 包括：取黄精6重量份、灵芝3重量份、余甘子3重量份、红景天2重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并三次提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏粉碎后过筛，加入辅料适量，混合均匀，制粒、干燥、整粒、即得。
本发明还提出了一种具有抗疲劳的片剂的制备方法，其特征在于，该方法包括：黄精6重量份、灵芝3重量份、余甘子3重量份、红景天2重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并三次提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，加入辅料适量，混合均匀，制粒、压片、包衣，即得。
中医上讲气血是人体的基础物质，两者关系密切，相互影响。血具有滋养四肢百骸之功效，气则具有推动、温煦的作用，血的运行要靠气的推动，气的生成又靠血的滋养，血不足会使得气虚，气不足则会导致血瘀，阻塞经络。中医强调通则不痛，痛则不通，气血不畅就会出现肌肉酸痛、四肢乏力等现象，在产生运动性疲劳的时候，两者往往一损俱损，造成气血两虚。气血充盈，正气充足，可减轻或消除疲劳感。按照中医君臣佐使的配伍原则，本发明的组合物中，黄精作为君药，发挥主要作用，灵芝作为臣药，辅助君药发挥作用，余甘子和红景天作为佐药和使药，协调和辅助黄精和灵芝发挥缓解体力疲劳的作用。黄精补气养阴，健脾，润肺，益肾；灵芝，补气安神；红景天补肾，理气养血；红景天、灵芝二者合用共奏补气之功；余甘子滋补肝肾；处方配伍益气安神、滋阴凉血，坚持使用气血充盈，正气充足，疲劳感明显消除。因此本发明的组合物是结合体力疲劳的发生机理，运用中医学理论，各原料协同作用，对体力疲劳具有缓解作用。
实验表明，本组合物能够显著延长小鼠负重游泳时间，减少小鼠运动前后三个时间点血乳酸曲线下面积及血清尿素氮含量，具有缓解体力疲劳的功 能。
本发明组合物的制备方法为将黄精、灵芝、余甘子和红景天合并提取，提取工艺简单，相比于原料分别提取，提取工艺较复杂。而且相对于直接购买市售提取物也大大降低了成本。
具体实施方式
为了进一步理解本发明，下面结合实施例对本发明提供的组合物、制剂，其制备方法进行详细说明，本发明的保护范围不受以下实施例的限制。
药效实验部分，采用卫生部发布的《保健食品检验与评价技术规范》(2003版)中“缓解体力疲劳功能”进行研究。
本发明所用的组分如黄精、灵芝、余甘子和红景天均为市售中药材。需要注意的是，如未注明具体条件者，均按照常规条件或制造商建议的条件进行，所用原料或辅料，以及所用试剂或仪器未注明生产厂商者，均为可以通过市购获得的常规产品。除非另外说明，否则所有的百分数、比率、比例或份数按重量计。
除非另行定义，文中所使用的所有专业与科学用语与本领域熟练人员所熟悉的意义相同。此外，任何与所记载内容相似或均等的方法及材料皆可应用与本发明。
实施例1组合物的制备
取黄精6重量份、灵芝3重量份、余甘子3重量份、红景天2重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干 浸膏用万能粉碎机粉碎后过筛，得到具有缓解体力疲劳功能的组合物。
实施例2组合物的制备
取黄精2重量份、灵芝1重量份、余甘子1重量份、红景天1重量份，加8倍量水煎煮提取1次，提取0.5小时，滤过，提取液在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，得到具有缓解体力疲劳功能的组合物。
实施例3组合物的制备
取黄精9重量份、灵芝6重量份、余甘子6重量份、红景天4重量份，加10倍量水煎煮提取2次，每次2小时，滤过，合并提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，得到具有缓解体力疲劳功能的组合物。
实施例4片剂的制备
取黄精6重量份、灵芝3重量份、余甘子3重量份、红景天2重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，加入辅料适量，混合均匀，制粒、压片、包衣、包装，得到具有缓解体力疲劳功能的组合物片剂。
实施例5胶囊剂的制备
取黄精6重量份、灵芝3重量份、余甘子3重量份、红景天2重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，加入辅料适量，混合均匀，制粒、干燥、整粒、灌装、包装，得到具有缓解体力疲劳功能的组合物胶囊剂。
实施例6颗粒剂的制备
取黄精6重量份、灵芝3重量份、余甘子3重量份、红景天2重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，加入辅料适量，混合均匀，制粒、干燥、整粒、包装，得到具有缓解体力疲劳功能的组合物片剂。
对比例1组合物的制备
取余甘子5重量份，绞股蓝3重量份，灵芝2重量份，按照专利CN1269493C中实施例1相应的制备方法制备，得组合物。
对比例2组合物的制备
取黄精6重量份、灵芝3重量份、余甘子3重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，得组合物。
对比例3组合物的制备
取黄精6重量份、灵芝3重量份、红景天2重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，得组合物。
对比例4组合物的制备
取黄精6重量份、余甘子3重量份、红景天2重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，得组合物。
对比例5组合物的制备
取灵芝3重量份、余甘子3重量份、红景天2重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，得组合物。
抗疲劳作用药效试验
空白组：给予纯净水，按照20mL/Kg体重给小鼠灌胃。
实验组：将实施例1～3及比较例1～5制备的组合物，按照小鼠每1千克体重给予组合物0.42克的标准，将组合物制备成水溶液，浓度为0.021g/mL，按照20mL/Kg体重给小鼠灌胃。
90只ICR小鼠随机分为9组，每组10只。对照组给予纯净水，实验组给予各组合物溶液，经口灌胃30d。
实验方法：
1、负重游泳实验：末次经口灌胃给予受试物30min后，置尾根部负荷5％体重铅皮的小鼠于游泳箱中，水深大于30cm，水温25℃±1.0℃，记录小鼠从游泳开始至死亡的时间，作为小鼠负重游泳时间。
2、血清尿素氮(BUN)含量测定：末次经口灌胃给予受试物30min后，小鼠在温度为30℃的水中游泳90min，休息60min后采血，分离血清按有关试剂盒要求检测。
3、肝糖原含量测定：末次给予受试物30min后处死动物，精确称取肝脏100mg，按程序匀浆，离心，95％乙醇沉淀糖原，蒽酮法测定肝糖原含量。
4、乳酸测定：末次给予受试物30min后，首先眼内眦采血测定安静状态下的血乳酸基础值；在30℃水中游泳10min，捞起擦干，立即第二次眼内眦采血，并于休息20min后第三次眼内眦采血，均用葡萄糖乳酸分析仪测定乳酸含量。
统计方法：实验数据用SPSS软件进行统计分析。
实验结果见表1-表4。
表1各组合物对小鼠体重的影响
Figure PCTCN2020094734-appb-000001
游泳组
Figure PCTCN2020094734-appb-000002
Figure PCTCN2020094734-appb-000003
乳酸组
Figure PCTCN2020094734-appb-000004
肝糖原组
Figure PCTCN2020094734-appb-000005
Figure PCTCN2020094734-appb-000006
尿素氮组
Figure PCTCN2020094734-appb-000007
由表1可见，小鼠的初始体重各实验组与溶剂对照组间比较，差异均无显著性(P＞0.05)，即小鼠的初始体重在各组间较为均衡。经口给予小鼠不同剂量的受试物30d后，各组终末体重满足方差齐的要求，各剂量组与对照组比较，差异均无显著性(P＞0.05)，即实施例以及对比例中各组合物均对小鼠体重增长无明显影响。
表2各组合物对小鼠负重游泳时间的影响
Figure PCTCN2020094734-appb-000008
Figure PCTCN2020094734-appb-000009
由表2可见，与溶剂对照组比，实施例以及对比例组的小鼠游泳时间均延长，其中，实施例组均优于对比例组，实施例1和实施例3与对照组比较最为明显，有显著差异(P＜0.01)；对比例1～5与对照组比较也有一定的提高。
表3各组合物对小鼠运动后血清尿素水平和肝糖原储备量的影响
Figure PCTCN2020094734-appb-000010
Figure PCTCN2020094734-appb-000011
由表3可见，游泳90min后，各实施例以及对比例组的小鼠血清尿素氮含量均低于对照组，实施例1(P＜0.01)、实施例3(P＜0.01)、实施例2(P＜0.05)均有显著性差异；各对比例组小鼠肝糖原也有一定的降低，但与对照组比较，无显著差异(P＞0.05)。
表4各组合物对小鼠运动后血乳酸含量影响
Figure PCTCN2020094734-appb-000012
Figure PCTCN2020094734-appb-000013
Figure PCTCN2020094734-appb-000014
由表4可见，各实施例以及对比例组小鼠运动后三个时间点血乳酸曲线下面积均小于对照组，其中，实施例组均优于对比例组，实施例1(P＜0.01)、实施例3(P＜0.01)最为明显，有显著性差异。
由以上数据可见，本发明组合物具有缓解体力疲劳的作用，与对比例相比，缓解体力疲劳的功能更优。
以上实施例说明只是用于帮助理解本发明的方法及其核心思想。应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以对本发明进场若干修改和修饰，这些改进和修饰也落入本发明权利要求的保护范围内。

Claims (10)

  1. 一种抗疲劳的组合物，其特征在于，以重量计，该组合物包括黄精3～9份、灵芝1～6份、余甘子1～6份、红景天1～4份。
  2. 根据权利要求1所述的组合物，其特征在于，所述组合物包括黄精6～9份、灵芝3～6份、余甘子3～6份、红景天2～4份。
  3. 根据权利要求1所述的组合物，其特征在于，所述组合物包括黄精6份、灵芝3份、余甘子3份、红景天2份。
  4. 根据权利要求1所述的组合物，其特征在于，所述组合物包括黄精9份、灵芝6份、余甘子6份、红景天4份。
  5. 一种如权利要求1-4任一所述的组合物的制备方法，其特征在于，包括以下步骤：
    (A)取药材加入8～14倍量水煎煮提取1～3次，每次0.5～2.0小时，滤过，合并提取液，得到滤液；
    (B)将所得滤液在60±5℃～80±5℃条件下减压浓缩，并浓缩至相对密度1.10～1.30的浓缩液，60±5℃～80±5℃减压干燥得干浸膏，干浸膏粉碎后过筛。
  6. 根据权利要求5所述的组合物的制备方法，其特征在于，包括以下步骤：
    (A)取药材加入10倍量水煎煮提取2次，每次2.0小时，滤过，合并提取液，得到滤液；
    (B)将所得滤液在70±5℃条件下减压浓缩，并浓缩至相对密度1.20的浓缩液，70±5℃减压干燥得干浸膏，干浸膏粉碎后过筛。
  7. 权利要求1-4任一项所述的组合物在制备抗疲劳的药品、食品或保健品中的应用。
  8. 一种药品、食品或保健品，其特征在于，该药品、食品或保健品由权利要求1-4任一所述的组合物与药学、食品或保健品上可接受的辅料或添加剂制得。
  9. 如权利要求8所述的药品、食品或保健品，其特征在于，该药品、食品或保健品包括胶囊剂、片剂、颗粒剂、丸剂或口服液。
  10. 一种抗疲劳的片剂的制备方法，其特征在于，该方法包括：取黄精6重量份、灵芝3重量份、余甘子3重量份、红景天2重量份，加12倍量水煎煮提取3次，每次2.0小时，滤过，合并提取液，在70±5℃条件下减压浓缩，并浓缩至相对密度1.20，70±5℃减压干燥得干浸膏，干浸膏用万能粉碎机粉碎后过筛，加入辅料适量，混合均匀，制粒、压片。
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CN105053190A (zh) * 2015-07-13 2015-11-18 王学香 一种女士保健驴奶饮品及其制备方法
CN110960624A (zh) * 2019-12-02 2020-04-07 江苏康缘药业股份有限公司 一种抗疲劳的组合物及其制备方法

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