WO2022062716A1 - 一种具有滋阴补肾功能的组合物及其制备方法和应用 - Google Patents

一种具有滋阴补肾功能的组合物及其制备方法和应用 Download PDF

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WO2022062716A1
WO2022062716A1 PCT/CN2021/110928 CN2021110928W WO2022062716A1 WO 2022062716 A1 WO2022062716 A1 WO 2022062716A1 CN 2021110928 W CN2021110928 W CN 2021110928W WO 2022062716 A1 WO2022062716 A1 WO 2022062716A1
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parts
composition
medicine
spray
ginseng
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PCT/CN2021/110928
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English (en)
French (fr)
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肖伟
许明君
刘世娟
曹苗苗
柏伟荣
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江苏康缘药业股份有限公司
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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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
    • 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
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/287—Chrysanthemum, e.g. daisy
    • 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)
    • A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605—Morus (mulberry)
    • 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)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815—Lycium (desert-thorn)
    • 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)
    • A61K36/894—Dioscoreaceae (Yam family)
    • A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/06—Free radical scavengers or antioxidants
    • 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 medicine, food or health care products, in particular to a composition with the function of nourishing yin and tonifying kidney, and a preparation method and application thereof.
  • the main purpose of the present invention is to provide a medicine, health food or food composition with nourishing yin and kidney and a preparation method thereof.
  • the present invention provides a composition with the function of nourishing yin and invigorating the kidney, the composition comprises 1-10 parts of Poria cocos, 1-5 parts of Polygonatum chinensis, 1-5 parts of mulberry seeds, 1-5 parts of Chinese yam. 9 servings, 1-8 servings of chrysanthemum, 1-7 servings of wolfberry, 1-9 servings of ginseng.
  • the composition and the raw materials used can be directly ground into powder, or can be an extract or other forms prepared by conventional means.
  • composition comprises 2-6 parts of Poria, 1-3 parts of Polygonatum chinensis, 1-3 parts of mulberry, 1-5 parts of yam, 1-6 parts of chrysanthemum, 1-4 parts of wolfberry fruit, 1-6 parts of ginseng share.
  • composition comprises 3-5 parts of Poria, 1-2 parts of Polygonatum chinensis, 1-2 parts of mulberry, 1-2 parts of yam, 1-2 parts of chrysanthemum, 1-2 parts of wolfberry fruit, 1-2 parts of ginseng share.
  • composition includes 4 parts of Poria, 1.5 parts of Polygonatum chinensis, 1.5 parts of mulberry, 1.5 parts of yam, 1.5 parts of chrysanthemum, 1 part of wolfberry fruit, and 1 part of ginseng.
  • composition includes 40 parts of Poria cocos, 15 parts of Polygonatum chinensis, 15 parts of mulberry seeds, 15 parts of yam, 15 parts of chrysanthemum, 10 parts of wolfberry fruit, and 10 parts of ginseng;
  • composition includes 20 parts of Poria cocos, 7.5 parts of Polygonatum chinensis, 7.5 parts of mulberry, 7.5 parts of yam, 7.5 parts of chrysanthemum, 5 parts of wolfberry fruit, and 5 parts of ginseng.
  • the present invention also proposes an application of the composition as described in any preceding one in preparing a medicine, a health product or a food with the function of nourishing yin and tonifying the kidney.
  • the present invention also proposes a medicine, health care product or food containing the composition having the function of nourishing yin and invigorating kidney as described in the preceding one.
  • the medicine, health product or food is selected from oral, injection or external dosage forms.
  • the medicine, food or health care product is prepared from any one of the aforementioned compositions and acceptable auxiliary materials or additives on the medicine, food or health care product.
  • auxiliary materials or additives include vitamin C, mannitol, sorbitol, erythritol, steviol glycosides, citric acid, sodium carboxymethyl cellulose, maltodextrin and the like.
  • the medicine, health product or food is selected from decoction, granule, capsule, tablet, pill, oral liquid, tincture, syrup, suppository, gel, spray and injection.
  • the medicines, health products or foods include but are not limited to oral tablets, buccal tablets, chewable tablets, effervescent tablets, hard capsules, soft capsules, granules, syrups, wines, and oral liquids.
  • the mass percentage of maltodextrin in the tablet is 30% to 10%, and the mass percentage of vitamin C is 0.01% to 0.03%.
  • the present invention also proposes a preparation method of the composition as described above, comprising the following steps:
  • preparation method comprises the following steps:
  • composition comprises the following steps:
  • Flavoring agents such as: stevioside, vitamin C, etc. are mixed evenly and passed through a dry mixing granulator to obtain granules; the composition is obtained.
  • the present invention also proposes a preparation method of a medicine, health product or food with the function of nourishing yin and kidney as mentioned above, characterized in that, when the medicine, health product or food is selected from oral preparations, the preparation method comprises the following steps: The following steps:
  • the tablet steps are as follows:
  • Drying add conventional auxiliary materials (such as maltodextrin, xylitol, etc.) according to the quality of the concentrate. Mix well, filter, spray dry in a spray dryer, and spray (drying temperature: 165-180°C, rotating speed 60-80rpm) to obtain dry powder;
  • conventional auxiliary materials such as maltodextrin, xylitol, etc.
  • Granulation The spray-dried powder is mixed with conventional excipients (such as maltodextrin, xylitol, etc.) in proportion, and flavoring agents (such as steviol glycosides, vitamin C, etc.) are added. granulator to obtain granules;
  • excipients such as maltodextrin, xylitol, etc.
  • flavoring agents such as steviol glycosides, vitamin C, etc.
  • the preparation method comprises the following steps:
  • Drying add conventional excipients (maltodextrin) according to the quality of the concentrate. Mix well, filter, spray dry in a spray dryer, and spray (drying temperature: 170°C, rotating speed 70rpm) to obtain dry powder;
  • the composition provided by the invention has the functions of maintaining the balance of body functions, strengthening the body and strengthening the body, nourishing the yin and tonifying the kidney, protecting the body, preventing the invasion of external pathogens, and reducing the probability of people contracting diseases. , to promote the improvement of the body's immune function, delay aging.
  • the present invention has the following beneficial effects:
  • compositions and preparations of the present invention collect the essence of mushrooms with high nutritional value and immunomodulatory polysaccharides and the homologous products of medicine and food, and are scientifically and reasonably compatible with Poria cocos, Polygonatum chinensis, mulberry, yam, chrysanthemum, wolfberry and ginseng with high safety: Among them, Poria is invigorating the spleen and stomach. Ginseng nourishes the spleen and the lungs, nourishes the blood, and replenishes the vitality.
  • Huang Jing nourishes the kidney and produces body fluid, enriches the yin essence of the kidney, nourishes the qi, nourishes the yin, and invigorates the kidney.
  • Mulberry nourishes yin and blood, nourishes body fluid and moistens dryness.
  • Lycium barbarum invigorating the kidney and nourishing the liver, invigorating the essence and nourishing qi, nourishing the yin of the kidney.
  • Chrysanthemum disperses wind and clears heat, calms liver and improves eyesight, clears heat and detoxifies.
  • Poria, ginseng and Chinese yam can strengthen the spleen and stomach;
  • Huang Jing, mulberry and wolfberry can nourish yin, nourish the kidney and fill the essence, and can supplement the foundation of the day after tomorrow; if the spleen and stomach are strong, water and grains are transported and transformed, and Huang Jing, mulberry and wolfberry are strengthened.
  • the above raw materials complement each other, maintain the balance of internal functions by regulating the endocrine of the body, strengthen the body and strengthen the root, combine treatment and nourishment, synergistically synergize, and regulate body functions.
  • the range of extraction times (factor C) of medicinal materials is the largest, and the C factor in each index component is significant, and the optimal value is C 2 , so it is determined that the extraction times in the optimal process is 2 times.
  • the extreme difference of the amount of water added (factor A) is second, and the A factor in each index component is not significant, and the optimal value is A 2 , so it is determined that the amount of water added (factor A) in the optimal process is A 2 , that is Add 10 times the amount of water each time.
  • the range of extraction time (factor B) has the smallest effect, and the B factor in the single index component is not significant.
  • the intuitive analysis under each index shows that B 3 , since the B factor in the single index component is not significant, considering the principle of energy saving, it is determined that the most The extraction time (factor B) in the optimal process is B 1 , that is, 1.0 hours each time.
  • the optimal extraction process is as follows: adding 10 times the amount of water each time, and refluxing extraction twice for 1.0 hours each time.
  • a composition for nourishing yin and tonifying kidney function is prepared according to the following raw materials in parts by weight: 40 parts of Poria, 15 parts of Polygonatum chinensis, 15 parts of mulberry, 15 parts of yam, 15 parts of chrysanthemum, 10 parts of wolfberry and 10 parts of ginseng.
  • the preparation method is as follows: take each medicinal material according to the above weight portion, remove impurities, wash it, add water 10 times the total weight of the medicinal material, boil and extract twice, each time for boiling and extraction is 1 hour, filter through 100 meshes, and combine twice The filtrate was concentrated under reduced pressure at 65°C to a relative density of 1.07 to obtain a water-extracted concentrate, and conventional auxiliary materials (maltodextrin) were added according to the quality of the concentrate.
  • a composition for nourishing yin and tonifying kidney function is prepared according to the following raw materials in parts by weight: 20 parts of Poria, 7.5 parts of Polygonatum chinensis, 7.5 parts of mulberry, 7.5 parts of yam, 7.5 parts of chrysanthemum, 5 parts of wolfberry fruit and 5 parts of ginseng.
  • the preparation method is as follows: take each medicinal material according to the above weight portion, remove impurities, wash it, add water 10 times the total weight of the medicinal material, boil and extract twice, each time for boiling and extracting for 1 hour, filter through 120 mesh, and combine twice
  • the filtrate was concentrated under reduced pressure at 65°C to a relative density of 1.07 to obtain a water-extracted concentrate, and conventional auxiliary materials (maltodextrin) were added according to the quality of the concentrate.
  • a composition for nourishing yin and tonifying kidney function is prepared according to the following raw materials in parts by weight: 20 parts of Poria, 7.5 parts of Polygonatum chinensis, 7.5 parts of mulberry, 7.5 parts of yam, 7.5 parts of chrysanthemum, 5 parts of wolfberry fruit and 5 parts of ginseng.
  • the preparation method is as follows: take each medicinal material according to the above weight portion, remove impurities, wash it, add water 12 times the total weight of the medicinal material, boil and extract once, each time for boiling and extraction is 1.5h, filter through 120 mesh, and combine the two.
  • the second filtrate was concentrated under reduced pressure at 70° C.
  • auxiliary materials maltodextrin
  • a composition for nourishing yin and tonifying kidney function is prepared according to the following raw materials in parts by weight: 20 parts of Poria, 7.5 parts of Polygonatum chinensis, 7.5 parts of mulberry, 7.5 parts of yam, 7.5 parts of chrysanthemum, 5 parts of wolfberry fruit and 5 parts of ginseng.
  • the preparation method is as follows: take each medicinal material according to the above weight portion, remove impurities, wash it, add water 8 times the total weight of the medicinal material, boil and extract for 3 times, each time for boiling and extraction is 2 hours, filter through 120 mesh, and combine twice The filtrate was concentrated under reduced pressure at 75°C to a relative density of 1.07 to obtain a water-extracted concentrate, and conventional auxiliary materials (maltodextrin) were added according to the quality of the concentrate.
  • a tablet for nourishing yin and kidney function is prepared according to the following raw materials in parts by weight: 20 parts of Poria, 7.5 parts of Polygonatum chinensis, 7.5 parts of mulberry, 7.5 parts of yam, 7.5 parts of chrysanthemum, 5 parts of wolfberry and 5 parts of ginseng.
  • the preparation method is as follows: (1) Extraction: take Poria, Polygonatum chinensis, mulberry, yam, chrysanthemum, wolfberry, and ginseng, add 10 times the total weight of the medicinal materials, boil and extract twice, and the time for each boiling and extraction is 1h, After 100 mesh filtration, the filtrate was combined twice, and the filtrate was concentrated under reduced pressure at 65 ° C to a relative density of 1.07 to obtain a water-extracted concentrate; (2) Drying: add conventional auxiliary materials (such as: maltodextrin, wood, etc.) according to the quality of the concentrate. sugar alcohols, etc.).
  • the evaluation of the curative effect of nourishing yin and invigorating kidney of the present invention is as follows.
  • Example Group 1 take the Yin-nourishing and Kidney-invigorating composition prepared in Example 1, 10 grams each time, 3 times a day;
  • Example 3 Take the Yin-nourishing and Kidney-invigorating composition prepared in Example 3, 10 grams each time, 3 times a day;
  • Group 5-Example 5 Group take the tablet of the composition for nourishing yin and invigorating kidney prepared in Example 5, 10 grams each time, 3 times a day;
  • Group 6-Example Blank group blank sample prepared by taking corn starch, 10 grams each time, 3 times a day.
  • composition and preparation of the present invention have the effect of nourishing yin and tonifying kidney.

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Abstract

一种具有滋阴补肾功能的组合物及其制备方法和应用，所述组合物以重量计包括茯苓1～10份、黄精1～5份、桑椹子1～5份、山药1～9份、菊花1～8份、枸杞子1～7份、人参1～9份。

Description

一种具有滋阴补肾功能的组合物及其制备方法和应用 技术领域
本发明涉及药品、食品或保健品领域，特别涉及一种具有滋阴补肾功能的组合物及其制备方法和应用。
背景技术
随着经济的快速发展，社会竞争日益激烈，现代人生活节奏快，生活压力大，不少人忙于应酬，熬夜工作，以透支健康为代价，超负荷工作，饮食时间不规律，又缺乏锻炼等造成普遍身体素质下降，一部分人持续过度疲劳，产生肾虚的症状，最终损害人体健康。医学专家指出，目前中国“亚健康”人群比例达70％。据世界卫生组织调查，全球约有35％以上的人处于疲劳状态。因此，开发一种提高滋阴补肾功能的组合物具有重要意义
国内外专家指出，消除“亚健康”、预防疾病最有效的办法是增强人体对疾病的免疫力。而滋阴补肾填精，可补后天之本，滋阴补肾的关键在于自我调适、膳食或中药调节。现代医学研究表明，研制开发具有滋阴补肾功能的药品、保健食品或食品，在机体处于肾虚低下的“亚健康”状态时进行干预，提高机体免疫力，降低各种疾病发生的概率，保证人们的生活质量和提高身体素质显得尤其迫切。
发明内容
有鉴于此，本发明的主要目的在于提供一种具有滋阴补肾的药物、保健食品或食品组合物及其制备方法。
具体来说，本发明提供了一种具有滋阴补肾功能的组合物，以重量计，所述组合物包括茯苓1～10份、黄精1～5份、桑椹子1～5份、山药1～9份、菊花1～8份、枸杞子1～7份、人参1～9份。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。
进一步地，所述组合物包括茯苓2～6份、黄精1～3份、桑椹子1～3份、山药1～5份、菊花1～6份、枸杞子1～4份、人参1～6份。
进一步地，所述组合物包括茯苓3～5份、黄精1～2份、桑椹子1～2份、山药1～2份、菊花1～2份、枸杞子1～2份、人参1～2份。
进一步地，所述组合物包括茯苓4份、黄精1.5份、桑椹子1.5份、山药1.5份、菊花1.5份、枸杞子1份、人参1份。
进一步地，所述组合物包括茯苓40份、黄精15份、桑椹子15份、山药15份、菊花15份、枸杞子10份、人参10份；
进一步地，所述组合物包括茯苓20份、黄精7.5份、桑椹子7.5份、山药7.5份、菊花7.5份、枸杞子5份、人参5份。
本发明还提出了如前任一所述的组合物在制备具有滋阴补肾功能的药物、保健品或食品中的应用。
本发明还提出了一种含有如前任一所述具有滋阴补肾功能的组合物的药物、保健品或食品。
具体地，该药物、保健品或食品选自口服、注射或外用剂型。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。
进一步地，可接受的辅料或添加剂包括维生素C、甘露糖醇、山梨糖醇、赤鲜糖醇、甜菊糖苷、柠檬酸、羧甲基纤维素钠、麦芽糊精等。
进一步地，该药物、保健品或食品选自汤剂、颗粒剂、胶囊剂、片剂、丸剂、口服液、酊剂、糖浆剂、栓剂、凝胶剂、喷雾剂、注射剂。
具体地，该药物、保健品或食品包括但不限于口服片、含片、咀嚼片、泡腾片、硬胶囊、软胶囊剂、颗粒剂、糖浆、酒剂、口服液。
优选的，所述的片剂中麦芽糊精的质量百分比为30％～10％，维生素C的质量百分比为0.01％～0.03％。
本发明还提出了一种如前任一所述的组合物的制备方法，包括以下步骤：
取茯苓、黄精、桑椹子、山药、菊花、枸杞子、人参，加入药材总重量8～12倍的水煮沸提取1～3次，每次提取的时间为0.5～1.5h，过滤，于60～70℃减压浓缩至相对密度为1.05～1.09，喷干，得干粉，与辅料混匀。
进一步地，所述制备方法包括以下步骤：
取茯苓、黄精、桑椹子、山药、菊花、枸杞子、人参，加入药材总重量8～12倍的水煮沸提 取1～3次，每次提取的时间为1.0～2.0h，过滤，合并滤液，滤液于60～70℃减压浓缩至相对密度为1.05～1.09，得水提浓缩液，按浓缩液质量加入常规辅料(如：麦芽糊精、木糖醇等)。拌匀，过滤，于喷干机喷干，喷雾(干燥温度：165-180℃、转速60-80rpm)，得干粉，喷干粉与常规辅料(如：麦芽糊精、木糖醇等)按比例混匀，加入调味剂(如：甜菊糖苷、维生素C等)，混匀后经干法混合制粒机，调整合适的制粒参数，制得颗粒。
进一步地，所述的组合物的制备包括以下步骤：
取茯苓、黄精、桑椹子、山药、菊花、枸杞子、人参，加入药材总重量10倍量的水煮沸提取2次，每次煮沸提取的时间均为1h，经100目过滤，合并两次滤液，滤液于65℃减压浓缩至相对密度为1.06，制得水提浓缩液；按浓缩液质量加入常规辅料(如：麦芽糊精、木糖醇等)。拌匀，过滤，于喷干机喷干，喷雾(干燥温度：170℃、转速70rpm)，得干粉；喷干粉与常规辅料(如：麦芽糊精、木糖醇等)按比例混匀，加入调味剂(如：甜菊糖苷、维生素C等)，混匀后经干法混合制粒机，制得颗粒；得到组合物。
本发明还提出了一种如前所述具有滋阴补肾功能的药物、保健品或食品的制备方法，其特征在于，所述药物、保健品或食品选自口服剂时，所述制备方法包括以下步骤：
取茯苓、黄精、桑椹子、山药、菊花、枸杞子、人参，加入药材总重量8～12倍的水煮沸提取1～3次，每次提取的时间为1.0～2.0h，过滤，合并滤液，滤液于60～70℃减压浓缩至相对密度为1.05～1.09，得水提浓缩液，按浓缩液质量加入常规辅料(如：麦芽糊精、木糖醇等)。拌匀，过滤，于喷干机喷干，喷雾(干燥温度：165-180℃、转速60-80rpm)，得干粉，喷干粉与常规辅料(如：麦芽糊精、木糖醇等)按比例混匀，加入调味剂(如：甜菊糖苷、维生素C等)，混匀后经干法混合制粒机，调整合适的制粒参数，制得颗粒。
具体地，所述片剂步骤如下：
(1)提取：取茯苓、黄精、桑椹子、山药、菊花、枸杞子、人参，加入药材总重量8-12倍量的水煮沸提取1～3次，每次煮沸提取的时间均为1.0～2.0h，经100目过滤，合并两次滤液，滤液于60～70℃减压浓缩至相对密度为1.05～1.09，制得水提浓缩液；
(2)干燥：按浓缩液质量加入常规辅料(如：麦芽糊精、木糖醇等)。拌匀，过滤，于喷干机喷干，喷雾(干燥温度：165～180℃、转速60～80rpm)，得干粉；
(3)制粒：喷干粉与常规辅料(如：麦芽糊精、木糖醇等)按比例混匀，加入调味剂(如：甜菊糖苷、维生素C等)，混匀后经干法混合制粒机，制得颗粒；
(4)压片：取(3)中的颗粒，经过压制得到所述片剂；
优选地，所述药物、保健品或食品选自片剂时，所述制备方法包括以下步骤：
(1)提取：取茯苓、黄精、桑椹子、山药、菊花、枸杞子、人参，加入药材总重量10倍量的水煮沸提取2次，每次煮沸提取的时间均为1h，经100目过滤，合并两次滤液，滤液于65℃减压浓缩至相对密度为1.06，制得水提浓缩液；
(2)干燥：按浓缩液质量加入常规辅料(麦芽糊精)。拌匀，过滤，于喷干机喷干，喷雾(干燥温度：170℃、转速70rpm)，得干粉；
(3)制粒：喷干粉与常规辅料(木糖醇)按比例20％混匀，加入调味剂(维生素C)，混匀后经干法混合制粒机，制得颗粒；
(4)压片：取(3)中的颗粒，经过压制得到所述片剂
本发明提供的组合物具有维持体内机能平衡，扶正固本、滋阴补肾、保护身体健康，防止外邪入侵，减少人们感染疾病机率的功能，各组分配伍合理，能有效的提高亚健康患者，促进机体免疫机能的提高，延缓衰老。
与现有技术相比，本发明有如下有益效果：
本发明组合物及制剂集高营养价值和免疫调节多糖的菌菇和药食同源品之精华，由安全性高的茯苓、黄精、桑椹子、山药、菊花、枸杞子、人参科学合理配伍：其中茯苓渗湿利水，健脾和胃。人参补脾益肺，生津养血，大补元气。山药健脾补虚，滋精固肾，治诸虚百损，疗五劳七伤。黄精滋肾生津、以充实肾之阴精，补气养阴、益肾。桑椹子滋阴补血，生津润燥。枸杞：补肾养肝，生精益气，滋肾阴。菊花散风清热，平肝明目，清热解毒。本方经合理配伍后，茯苓、人参和山药健脾胃；黄精、桑椹子和枸杞子，滋阴补肾填精，可补后天之本；脾胃强健则水谷运化，加强黄精、桑椹子和枸杞子滋阴补肾的效果。以上诸原料相辅相成，通过调节机体内分泌维持体内机能平衡，扶正固本，治养结合，协同增效，调理身体机能。
具体实施方式
下面将结合本发明实施例的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
1.提取工艺的考察
1.1药材水提取单因素实验
1.1.1药材水提取时间单因素考察
取茯苓20份、黄精7.5份、桑椹子7.5份、山药7.5份、菊花7.5份、枸杞子5份、人参5份，平行4份，加入10倍量水，提取2次，提取时间分别设为1.0h、1.5h、2.0h、2.5h，以水提液中粗多糖总量、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1转移率为指标，采用单因素试验方案进行考察。试验结果见表1。
表1 提取时间单因素试验
Figure PCTCN2021110928-appb-000001
由表1可知，粗多糖总量在提取2.5h时，总量最高，1.5h后逐渐趋于平稳。人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1转移率则是随着时间的增加升高后趋于平稳。因此选择提取时间范围为1.0～2.0h。
1.1.2药材水提取加水倍量考察
取茯苓20份、黄精7.5份、桑椹子7.5份、山药7.5份、菊花7.5份、枸杞子5份、人参5份，平行4份，提取时间设为1.5h，提取2次，加水倍量分别为8、10、12、14倍，以水提液中粗多糖总量、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1转移率为指标，采用单因素试验方案进行考察。试验结果见表2。
表2 加水倍量单因素试验
Figure PCTCN2021110928-appb-000002
由表2可知，随着加水倍量的增加，粗多糖总量先升高后平稳；人参皂苷Rg1、人参皂苷 Re、人参皂苷Rb1转移率增加，10～14倍平缓；因此选择加水倍量范围为8～12倍。
1.2提取正交试验
选取加水量(A)、提取时间(B)、提取次数(C)、液料比(D)作为四个因素，每个因素各选三个水平，以提取液中粗多糖总量、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1转移率为指标，选用采用L9(3 4)正交试验进行考察，因素水平见表3。
表3 因素水平表
Figure PCTCN2021110928-appb-000003
取茯苓20份、黄精7.5份、桑椹子7.5份、山药7.5份、菊花7.5份、枸杞子5份、人参5份，平行9份，按正交表相关参数要求进行提取，测定提取液中粗多糖、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1，实验结果见表4～表7。
表4 L9(3 4)正交试验表(粗多糖)
Figure PCTCN2021110928-appb-000004
表5 方差分析表(粗多糖)
Figure PCTCN2021110928-appb-000005
表6 L 9(3 4)正交表(人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1)
Figure PCTCN2021110928-appb-000006
表7 方差分析表(人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1)
Figure PCTCN2021110928-appb-000007
从表4～表5可知，以提取液中粗多糖量为指标进行考察，各因素对提取工艺的影响极差R值 为C>B>A，药材提取次数(因素C)的极差最大，各因素中C 3>C 2>C 1、A 2>A 3>A 1、B 3>B 2>B 1，故直观分析最佳提取工艺为A 2B 3C 3。方差分析显示，B、C因素显著，但是B 3、B 2相差较小，C 3、C 2相差较小，考虑节能原则，故最佳提取工艺为A 2B 2C 2，即每次加10倍量水，回流提取2次，每次1.5小时。
从表6～表7可知，以提取液中人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1转移率为指标进行考察，各因素对提取工艺的影响极差R值为C>A>B，药材提取次数(因素C)的极差最大，各因素中C 2>C 3>C 1、A 2>A 3>A 1、B 3>B 2>B 1，故直观分析最佳提取工艺为A 2B 3C 2。方差分析显示，C因素显著，考虑节能原则，故最佳提取工艺为A 2B 2C 2，即每次加10倍量水，回流提取2次，每次1.5小时。
综合考虑，药材提取次数(因素C)的极差最大，且各指标成分中C因素显著，且最优值均为C 2，因此确定最佳工艺中提取次数为2次。加水倍量(因素A)的极差其次，且各指标成分中A因素均不显著，且最优值均为A 2，因此确定最佳工艺中加水倍量(因素A)为A 2，即每次加10倍量水。提取时间(因素B)的极差影响最小，且单指标成分中B因素不显著，各指标下的直观分析显示B 3，由于单指标成分中B因素均不显著，考虑节能原则，因此确定最佳工艺中提取时间(因素B)为B 1，即每次1.0小时。综上所述，最佳提取工艺为：每次加10倍量水，回流提取2次，每次1.0小时。
实施例1
一种滋阴补肾功能的组合物，按下列重量份的原料制备而成：茯苓40份、黄精15份、桑椹子15份、山药15份、菊花15份、枸杞子10份、人参10份。制备方法如下：按上述重量份取各药材，去除杂质、洗净，加入药材总重量10倍量的水煮沸提取2次，每次煮沸提取的时间均为1h，经100目过滤，合并两次滤液，滤液于65℃减压浓缩至相对密度为1.07，制得水提浓缩液，按浓缩液质量加入常规辅料(麦芽糊精)。拌匀，过滤，于喷干机喷干，喷雾(干燥温度：170℃、转速70rpm)，得干粉，喷干粉与常规辅料(木糖醇)按比例20％混匀，加入调味剂(维生素C)，混匀后经干法混合制粒机，调整合适的制粒参数，制得颗粒，得到组合物(1g相当于0.64g生药)。
实施例2
一种滋阴补肾功能的组合物，按下列重量份的原料制备而成：茯苓20份、黄精7.5份、桑椹子7.5份、山药7.5份、菊花7.5份、枸杞子5份、人参5份。制备方法如下：按上述重量份取各药材，去除杂质、洗净，加入药材总重量10倍量的水煮沸提取2次，每次煮沸提取的时间 均为1h，经120目过滤，合并两次滤液，滤液于65℃减压浓缩至相对密度为1.07，制得水提浓缩液，按浓缩液质量加入常规辅料(麦芽糊精)。拌匀，过滤，于喷干机喷干，喷雾(干燥温度：170℃、转速70rpm)，得干粉，喷干粉与常规辅料(木糖醇)按比例20％混匀，加入调味剂(维生素C)，混匀后经干法混合制粒机，调整合适的制粒参数，制得颗粒，得到组合物(1g相当于0.32g生药)。
实施例3
一种滋阴补肾功能的组合物，按下列重量份的原料制备而成：茯苓20份、黄精7.5份、桑椹子7.5份、山药7.5份、菊花7.5份、枸杞子5份、人参5份。制备方法如下：按上述重量份取各药材，去除杂质、洗净，加入药材总重量12倍量的水煮沸提取1次，每次煮沸提取的时间均为1.5h，经120目过滤，合并两次滤液，滤液于70℃减压浓缩至相对密度为1.09，制得水提浓缩液，按浓缩液质量加入常规辅料(麦芽糊精)。拌匀，过滤，于喷干机喷干，喷雾(干燥温度：175℃、转速65rpm)，得干粉，喷干粉与常规辅料(木糖醇)按比例20％混匀，加入调味剂(维生素C)，混匀后经干法混合制粒机，调整合适的制粒参数，制得颗粒，得到组合物(1g相当于0.32g生药)。
实施例4
一种滋阴补肾功能的组合物，按下列重量份的原料制备而成：茯苓20份、黄精7.5份、桑椹子7.5份、山药7.5份、菊花7.5份、枸杞子5份、人参5份。制备方法如下：按上述重量份取各药材，去除杂质、洗净，加入药材总重量8倍量的水煮沸提取3次，每次煮沸提取的时间均为2h，经120目过滤，合并两次滤液，滤液于75℃减压浓缩至相对密度为1.07，制得水提浓缩液，按浓缩液质量加入常规辅料(麦芽糊精)。拌匀，过滤，于喷干机喷干，喷雾(干燥温度：165℃、转速70rpm)，得干粉，喷干粉与常规辅料(木糖醇)按比例20％混匀，加入调味剂(维生素C)，混匀后经干法混合制粒机，调整合适的制粒参数，制得颗粒，得到组合物(1g相当于0.32g生药)。
实施例5
一种滋阴补肾功能的片剂，按下列重量份的原料制备而成：茯苓20份、黄精7.5份、桑椹子7.5份、山药7.5份、菊花7.5份、枸杞子5份、人参5份。制备方法如下：(1)提取：取茯苓、黄精、桑椹子、山药、菊花、枸杞子、人参，加入药材总重量10倍量的水煮沸提取2次，每次煮沸提取的时间均为1h，经100目过滤，合并两次滤液，滤液于65℃减压浓缩至相对密度为1.07，制得水提浓缩液；(2)干燥：按浓缩液质量加入常规辅料(如：麦芽糊精、木糖醇等)。 拌匀，过滤，喷干机喷干，喷雾(干燥温度：170℃、转速70rpm)，得干粉；(3)制粒：喷干粉与常规辅料(如：麦芽糊精、木糖醇等)按比例20％混匀，加入调味剂(如：甜菊糖苷、维生素C等)，混匀后经干法混合制粒机，制得颗粒；(4)压片：取(3)中的颗粒，经过压制得到片剂(1g相当于0.32g生药)；
实施例4
实验目的
本发明物的滋阴补肾的疗效评估如下所述。
二、实验方法
1、实验对象：选取超负荷工作，饮食时间不规律，又缺乏锻炼，易疲劳并出现头痛，腰膝酸软症状的志愿者180例，分为1、2、3、4、5、6组，每组30人
2、实验方法
1组-实施例1组：服用实施例1制备的所述滋阴补肾组合物，每次服用10克，每天服用3次；
2组-实施例2组：服用实施例2制备的所述的滋阴补肾组合物，每次服用10克，每天服用3次；
3组-实施例3组：服用实施例3制备的所述的滋阴补肾组合物，每次服用10克，每天服用3次；
4组-实施例4组：服用实施例4制备的所述的滋阴补肾组合物，每次服用10克，每天服用3次；
5组-实施例5组：服用实施例5制备的所述的滋阴补肾组合物的片剂，每次服用10克，每天服用3次；
6组-实施例空白组：服用玉米淀粉制备的空白样品，每次服用10克，每天服用3次。
三、实验结果
第1组服用10天后，19人表示头晕，头痛，腰膝酸软症状减轻，11人表示效果不明显；连续服用20天后，27人表示头晕，腰膝酸软症状明显减轻，2人表示疲劳见好转，1人表示效果不明显；
第2组服用10天后，8人表示头晕，腰膝酸软症状减轻，22人表示效果不明显；连续服用20天后，22人表示头晕，腰膝酸软症状减轻，5人表示疲劳见好转，3人表示效果不明显；
第3组服用10天后，9人表示头晕，腰膝酸软症状减轻，21人表示效果不明显；连续服用 20天后，23人表示头晕，腰膝酸软症状减轻，4人表示疲劳见好转，3人表示效果不明显；
第4组服用10天后，10人表示头晕，腰膝酸软症状减轻，20人表示效果不明显；连续服用20天后，22人表示头晕，腰膝酸软症状减轻，5人表示疲劳见好转，3人表示效果不明显；
第5组服用10天后，9人表示头晕，腰膝酸软症状减轻，21人表示效果不明显；连续服用20天后，24人表示头晕，腰膝酸软症状减轻，4人表示疲劳见好转，2人表示效果不明显；
第6组服用10天后，1人表示头晕，腰膝酸软症状减轻，29人表示效果不明显；连续服用20天后，1人表示头晕，腰膝酸软症状明显减轻，2人表示症状减轻，27人表示效果不明显。
从实验结果看，本发明的组合物及制剂具有滋阴补肾的作用。
以上实施例的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，还可以对本发明进行若干改进和修饰，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. 一种具有滋阴补肾功能的组合物，其特征在于，以重量计，所述组合物包括茯苓1～10份、黄精1～5份、桑椹子1～5份、山药1～9份、菊花1～8份、枸杞子1～7份、人参1～9份。
  2. 根据权利要求1所述的组合物，其特征在于，所述组合物包括茯苓2～6份、黄精1～3份、桑椹子1～3份、山药1～5份、菊花1～6份、枸杞子1～4份、人参1～6份。
  3. 根据权利要求1所述的组合物，其特征在于，所述组合物包括茯苓3-～5份、黄精1～2份、桑椹子1～2份、山药1～2份、菊花1～2份、枸杞子1-～2份、人参1～2份。
  4. 根据权利要求1所述的组合物，其特征在于，所述组合物包括茯苓4份、黄精1.5份、桑椹子1.5份、山药1.5份、菊花1.5份、枸杞子1份、人参1份。
  5. 权利要求1～4任一所述的组合物在制备具有滋阴补肾功能的药物、保健品或食品中的应用。
  6. 一种含有权利要求1～4任一所述具有滋阴补肾功能的组合物的药物、保健品或食品。
  7. 根据权利要求6所述的药物、保健品或食品，其特征在于，该药物、保健品或食品选自口服、注射或外用剂型。
  8. 根据权利要求7所述的药物、保健品或食品，其特征在于，该药物、保健品或食品选自汤剂、颗粒剂、胶囊剂、片剂、丸剂、口服液、酊剂、糖浆剂、栓剂、凝胶剂、喷雾剂、注射剂。
  9. 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：
    取药材，加入药材总重量8～12倍的水煮沸提取1～3次，每次提取的时间为1.0～2.0h， 过滤，于60～70℃减压浓缩至相对密度为1.05～1.09，喷干，得干粉，与辅料混匀。
  10. 一种如权利要求6～8任一所述的药物、保健品或食品的制备方法，其特征在于，所述药物、保健品或食品选自片剂时，所述制备方法包括以下步骤：
    (1)提取：取茯苓、黄精、桑椹子、山药、菊花、枸杞子、人参，加入药材总重量8～12倍量的水煮沸提取1～3次，每次煮沸提取的时间均为1.0～2.0h，经100～120目过滤，合并两次滤液，滤液于60～70℃减压浓缩至相对密度为1.05～1.09，制得水提浓缩液；
    (2)干燥：按浓缩液质量加入常规辅料。拌匀，过滤，于喷干机喷干，喷雾，得干粉；
    (3)制粒：喷干粉与常规辅料按比例20％混匀，加入调味剂，混匀后经干法混合制粒机，制得颗粒；
    (4)压片：取(3)中的颗粒，经过压制得到所述片剂。
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