CN108042595B - Composition with health care function and preparation method and application thereof - Google Patents

Composition with health care function and preparation method and application thereof Download PDF

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CN108042595B
CN108042595B CN201810062994.8A CN201810062994A CN108042595B CN 108042595 B CN108042595 B CN 108042595B CN 201810062994 A CN201810062994 A CN 201810062994A CN 108042595 B CN108042595 B CN 108042595B
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composition
health
solution
water
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CN108042595A (en
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乐智勇
彭晓辉
于珊
黄静
董婧婧
许冬瑾
马兴田
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GUANGDONG KANGMEI PHARMACEUTICAL RESEARCH INSTITUTE CO LTD
Kangmei Beijing Drug Research Institute Co ltd
Kangmei Pharmaceutical Co Ltd
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GUANGDONG KANGMEI PHARMACEUTICAL RESEARCH INSTITUTE CO LTD
Kangmei Beijing Drug Research Institute Co ltd
Kangmei Pharmaceutical Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/26—Iron; Compounds thereof
    • 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
    • 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
    • A61K36/284—Atractylodes
    • 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
    • A61K36/285—Aucklandia
    • 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)
    • A61K36/34—Campanulaceae (Bellflower family)
    • A61K36/344—Codonopsis
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    • 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

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Abstract

The invention relates to the technical field of health-care composition processing, in particular to a composition with a health-care function and a preparation method and application thereof. The composition is mainly prepared from the following raw materials in parts by weight: 20-70 parts of donkey-hide gelatin, 60-90 parts of codonopsis pilosula, 60-90 parts of bighead atractylodes rhizome, 60-90 parts of poria cocos, 10-40 parts of elecampane and 1-5 parts of a nutrition enhancer in terms of iron element. The preparation method comprises the following steps: extracting radix Codonopsis, Atractylodis rhizoma, Poria, and radix aucklandiae with water, filtering to obtain water extractive solution, and concentrating the water extractive solution to obtain concentrated solution; melting colla Corii Asini with water to obtain colla Corii Asini solution; dissolving the nutrition enhancer and the sweetener with proper amount of water to obtain a solution if the sweetener exists in the nutrition enhancer and the raw materials; mixing the concentrated solution, colla Corii Asini solution and the dissolved solution, diluting to desired volume, centrifuging, and filtering. The composition is proved to have safety through toxicological test evaluation and can effectively improve nutritional anemia.

Description

Composition with health care function and preparation method and application thereof
Technical Field
The invention relates to the technical field of health-care composition processing, in particular to a composition with a health-care function and a preparation method and application thereof.
Background
Nutritional anemia is a disease of hypohematopoiesis caused by insufficient hemoglobin formation or insufficient red blood cell formation due to lack of nutrients necessary for hematopoiesis, and is called blood deficiency in traditional Chinese medicine. The "spleen governs blood control" and "kidney governs bone and produces marrow", it is considered that blood comes from spleen, is fundamentally in kidney and involves heart and liver. If the spleen and stomach are weak, food essence cannot be transported and transformed, and the source of qi and blood generation is insufficient, resulting in anemia. The deficiency of spleen and kidney is the root of nutritional anemia, and is the cause of deficiency of qi and blood and dyshematogenesis. Moreover, long-term retention of stagnant blood may cause stagnation of the marrow sea and affect the generation of new blood, so called "the principle of no removal of stagnant blood and no generation of new blood". Therefore, the treatment of blood deficiency should be combined with the qi-moving and blood-activating herbs while tonifying kidney and spleen.
However, in the prior art, most of nutritional anemia is treated by medicines, but the medicines have great side effects and stimulate gastrointestinal mucosa, and serious gastrointestinal reactions can be caused. Moreover, the drug therapy only can temporarily play a role in relieving, the curative effect is not lasting, and the drug dependence is large after long-term use.
In view of the above, the present invention is provided to provide a safe and effective product with health care function and beneficial to improving nutritional anemia symptoms.
Disclosure of Invention
The composition is evaluated by a toxicological test, so that the composition has safety, can effectively improve nutritional anemia, plays a role in health care and improvement, tonifies the kidney and strengthens the spleen, promotes qi and activates blood, fundamentally improves the physique of people, and enables the bodies of the people to be healthy.
The second purpose of the present invention is to provide a preparation method of the composition with health care function, the preparation method of the composition is not exclusive, the preparation method of the present invention can completely retain each effective component in the composition, and the preparation method is simple and convenient to operate, and the conditions are mild.
Another object of the present invention is to provide a use of the composition with health function, which can effectively improve nutritional anemia.
In order to achieve the above purpose of the present invention, the following technical solutions are adopted:
a composition with a health-care function is mainly prepared from the following raw materials in parts by weight: 20-70 parts of donkey-hide gelatin, 60-90 parts of codonopsis pilosula, 60-90 parts of bighead atractylodes rhizome, 60-90 parts of poria cocos, 10-40 parts of elecampane and 1-5 parts of a nutrition enhancer in terms of iron element.
The invention provides a composition with a health-care function in order to solve the problems of high side effect, strong dependence and unobvious effect of a medicine for treating nutritional anemia in the prior art, wherein the composition is mainly prepared by mutually matching donkey-hide gelatin, codonopsis pilosula, bighead atractylodes rhizome, poria cocos, elecampane, an iron nutrition enhancer and the like, and the composition is evaluated by a toxicological test.
The donkey-hide gelatin has been recorded in Shen nong Ben Cao Jing (Shen nong's herbal), has a long production history of more than 2000 years, and is mostly composed of bone collagen, which can be hydrolyzed to obtain gelatin, protein and various amino acids. The donkey-hide gelatin has protein content of about 60-80% and contains 18 kinds of amino acids (including 7 kinds of essential amino acids). The metal elements contained in the alloy include K, Na, Ca, Mg, Fe, Cu, Al, Mn, Zn, Cr, Pt, Pb, Mo, Sr and the like. It has the physiological activities of enriching blood, enhancing immunity, resisting shock, resisting fatigue, resisting anoxia, balancing calcium, enhancing memory, etc., and is clinically used for hemorrhagic syndromes, such as consumptive disease hemoptysis, hematemesis, hematuria, hematochezia, metrorrhagia, etc. Pharmacological research proves that the donkey-hide gelatin has certain protection effect on bone marrow hematopoietic stem/progenitor cells and hematopoietic precursor cells, and has the effect of increasing Hb, RBC and WBC on a blood loss anemia animal model.
Radix Codonopsis is a tonic drug, and has effects of invigorating spleen and replenishing qi, invigorating spleen and benefiting lung. Radix Codonopsis has effects of enhancing immunity, dilating blood vessel, lowering blood pressure, improving microcirculation, and improving hemopoiesis function. The alcohol and water extract of radix Codonopsis can increase red blood cells of experimental animal when administered orally or subcutaneously.
The Atractylodis rhizoma is dry rhizome of Atractylodes macrocephala Koidz of Compositae, is bitter, sweet and warm, and has effects of invigorating spleen and replenishing qi. The rhizoma atractylodis macrocephalae has the effects of tonifying qi and blood, whitening and moistening skin, and is suitable for rough skin, sallow complexion, chloasma, pigmentation and the like caused by deficiency-cold of qi and blood. The bighead atractylodes rhizome is commonly used in qi tonifying and blood enriching formulas, and modern pharmacological studies prove that the bighead atractylodes rhizome has the effect of promoting proliferation and increasing rate on CFU-E, BFU-E colonies in a bone marrow erythroid progenitor cell colony forming experiment. According to the theory of traditional Chinese medicine, qi is the commander of blood, qi-invigorating and blood-self-generating, and qi-tonifying herbs, rhizoma atractylodis macrocephalae can be used for treating nutritional anemia.
Poria has effects of invigorating spleen and tranquilizing, and has no obvious adverse side effects. The compound product containing Poria has anemia improving effect.
The costustoot is responsible for spleen, stomach, large intestine, triple energizer and gallbladder channel, promoting qi circulation to relieve pain, strengthening spleen and promoting digestion. The traditional Chinese medicine is used in a blood enriching formula, mainly plays a role in regulating spleen and stomach, and is beneficial to qi and blood generation.
More than 90% of nutritional anemia in human bodies is caused by the deficiency of ferrous iron, the iron element mainly acts on a hematopoietic system, and the iron element provides a raw material for hematopoiesis, participates in the synthesis of red blood cells, hemoglobin and the like, and has the advantage of definite curative effect. The daily intake of iron as nutrient should be 5-20mg for adult, and iron nutrition enhancer is added into the composition to achieve health promoting and anemia improving effects by combining with other components. The nutrition enhancer used in the present invention is preferably ferrous gluconate.
Preferably, the composition with the health-care function is mainly prepared from the following raw materials in parts by weight: 30-60 parts of donkey-hide gelatin, 70-80 parts of codonopsis pilosula, 70-80 parts of bighead atractylodes rhizome, 70-80 parts of poria cocos, 20-30 parts of elecampane and 2-4 parts of a nutrition enhancer in terms of iron element.
Preferably, the composition with the health-care function is mainly prepared from the following raw materials in parts by weight: 50 parts of donkey-hide gelatin, 75 parts of codonopsis pilosula, 75 parts of bighead atractylodes rhizome, 75 parts of poria cocos, 25 parts of elecampane and 3 parts of a nutrition enhancer in terms of iron element.
Preferably, the composition with health care function further comprises a sweetener for seasoning. More preferably, the sweetener comprises one or more of crystal sugar, sucrose, white granulated sugar and xylitol. Further preferably white granulated sugar.
The present invention is one kind of health composition prepared with donkey-hide gelatin, dangshen, white atractylodes rhizome, tuckahoe, aucklandia root, nutritious reinforcing agent (ferrous ion), etc. Donkey-hide gelatin tonifies blood, codonopsis pilosula and bighead atractylodes rhizome tonify middle-jiao and qi, poria cocos calms heart and tranquilizes, and finally elecampane regulates spleen and stomach to neutralize medicine properties. The whole formula has the effects of tonifying qi and blood, strengthening spleen and nourishing heart, and is a good prescription for treating deficiency of both qi and blood. The compatibility of medicines of the formula is characterized in that: firstly, the heart and spleen are treated simultaneously, the emphasis is on the spleen, and the spleen is vigorous, so that qi and blood are generated and generated actively; secondly, qi and blood tonify, but the emphasis is on tonifying qi, meaning that qi is the commander of blood, qi is vigorous and blood is self-generated, and blood is sufficient to nourish heart; thirdly, the costus root is used for regulating qi and activating spleen in the qi and blood nourishing medicine, and the tonifying is not stagnated. Meanwhile, the nutrition enhancer is added into the formula and participates in the synthesis of red blood cells, hemoglobin and the like, so that the effect of improving nutritional anemia is more remarkable. The whole formula is safe and reasonable in compatibility, treats both principal and secondary aspects of diseases and can effectively improve nutritional anemia.
Preferably, the composition with health care function is prepared into a liquid preparation of an oral dosage form. The liquid preparation is preferably an oral liquid. The composition with the health care function can be prepared into an oral liquid preparation by being matched with conventional auxiliary materials and adopting a conventional oral liquid preparation process, is convenient to take and carry, and is suitable for people with wide needs.
The invention also provides a preparation method of the composition with the health care function, which comprises the following steps:
(A) extracting radix Codonopsis, Atractylodis rhizoma, Poria and radix aucklandiae with 7-15 times of water, filtering to obtain water extractive solution, and concentrating the water extractive solution to obtain concentrated solution;
(B) adding 4-8 times of water into colla Corii Asini, and melting to obtain colla Corii Asini solution;
(C) dissolving the nutrition enhancer and the sweetener with proper amount of water to obtain a solution if the sweetener exists in the nutrition enhancer and the raw materials;
(D) and uniformly mixing the concentrated solution, the colla corii asini solution and the dissolved solution, fixing the volume, centrifuging and filtering to obtain the propolis liquid.
The preparation method of the composition with the health care function is simple to operate, mild in operation condition and capable of completely retaining the effective components of the components.
Preferably, the water extraction in the step (a) comprises: adding 7-15 times of water, and extracting for 1-3 hr each time. The effective components can be extracted more thoroughly after extraction for many times, and the maximum effective components can be extracted after about 3 times.
Preferably, the water extracted in step (a) is filtered through a 120-mesh filter to obtain a water extract.
Preferably, the concentration in step (a) is concentration under reduced pressure. More preferably, the conditions for the concentration under reduced pressure are: concentrating under reduced pressure at 75 + -5 deg.C. Avoid the damage to the effective components caused by overhigh concentration temperature.
Preferably, the concentrated solution in the step (A) has a relative density of 1.04-1.13 measured at 60 ℃.
Preferably, the rotation speed of the centrifugation in the step (D) is 12000-16000rpm/min, preferably 14000 rpm/min.
Preferably, in the step (D), the filtration is carried out by plate-and-frame filtration with the filtration pore diameter less than or equal to 0.45 mu m.
Preferably, the step (D) further comprises packaging, sealing and sterilizing after filtering.
Preferably, the sterilization method comprises: 105-121 ℃ high-temperature high-pressure moist heat sterilization of 15-40 min.
The water is preferably purified water, and has little influence on the efficacy of the health food itself.
Compared with the prior art, the invention has the beneficial effects that:
(1) the composition with the health care function is mainly prepared by matching donkey-hide gelatin, codonopsis pilosula, bighead atractylodes rhizome, poria cocos, elecampane and an iron nutrition enhancer, has high safety and can effectively improve nutritional anemia;
(2) the composition with the health care function of the invention has the functions of tonifying kidney and spleen, promoting qi and activating blood circulation, fundamentally improving the constitution of people, and treating both principal and secondary aspect of disease, thereby improving nutritional anemia;
(3) the preparation method of the composition with the health care function can completely reserve the effective components of the components, and has simple operation process and mild conditions.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the following detailed description, but those skilled in the art will understand that the following described examples are some, not all, of the examples of the present invention, and are only used for illustrating the present invention, and should not be construed as limiting the scope of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
Example 1
The embodiment provides a composition with a health-care function, which is prepared from the following raw materials in parts by weight: 50 parts of donkey-hide gelatin, 75 parts of codonopsis pilosula, 75 parts of bighead atractylodes rhizome, 75 parts of poria cocos, 25 parts of elecampane, 3 parts of ferrous gluconate, 20 parts of white granulated sugar and a proper amount of purified water.
The preparation method of the composition with health care function in the embodiment comprises the following steps:
placing radix Codonopsis, Atractylodis rhizoma, Poria and radix aucklandiae in extraction tank, adding 8 times of water, decocting for 2 times, each time for 1.5 hr, filtering with 120 mesh sieve, mixing filtrates to obtain water extractive solution, and concentrating at 75 deg.C under reduced pressure to obtain concentrated solution with relative density of 1.04(60 deg.C).
Dissolving white granulated sugar and ferrous gluconate in warm water to obtain a solution for later use.
Adding 5 times of hot water into colla Corii Asini, and boiling in jacketed pan to melt to obtain colla Corii Asini solution.
Mixing the above concentrated solution, dissolved solution and colla Corii Asini solution, placing in a preparation tank, adding purified water to desired volume, and stirring for 30min to obtain a preparation solution.
Centrifuging in a liquid tube centrifuge at 14000rpm/min, collecting the centrifugate, and filtering with plate-frame filter (0.45 μm) to obtain filtrate. Packaging the filtrate into clean oral liquid bottles, sealing, sterilizing at 105 deg.C under high temperature and high pressure for 30min, cooling, and packaging.
Wherein, the concentrated solution, the colla corii asini solution and the dissolved solution are prepared in sequence.
Example 2
The embodiment provides a composition with a health-care function, which is prepared from the following raw materials in parts by weight: 20 parts of donkey-hide gelatin, 90 parts of codonopsis pilosula, 90 parts of bighead atractylodes rhizome, 90 parts of poria cocos, 40 parts of elecampane, 3 parts of ferrous gluconate, 20 parts of white granulated sugar and a proper amount of purified water.
The preparation method of the composition with health care function in the embodiment comprises the following steps:
placing radix Codonopsis, Atractylodis rhizoma, Poria and radix aucklandiae in extraction tank, adding 10 times of water, decocting and extracting for 3 times, each time for 1 hr, filtering with 120 mesh sieve, mixing filtrates to obtain water extractive solution, and concentrating the water extractive solution at 75 deg.C under reduced pressure to obtain concentrated solution with relative density of 1.09(60 deg.C) for use.
Dissolving white granulated sugar and ferrous gluconate in warm water to obtain a solution for later use.
Adding 6 times of hot water into colla Corii Asini, and boiling in jacketed pan to melt to obtain colla Corii Asini solution.
Mixing the above concentrated solution, dissolved solution and colla Corii Asini solution, placing in a preparation tank, adding purified water to desired volume, and stirring for 30min to obtain a preparation solution.
Centrifuging in a liquid tube centrifuge at 14000rpm/min, collecting the centrifugate, and filtering with plate-frame filter (0.45 μm) to obtain filtrate. Packaging the filtrate into clean oral liquid bottles, sealing, sterilizing at 116 deg.C under high temperature and high pressure for 40min, cooling, and packaging.
Example 3
The embodiment provides a composition with a health-care function, which is prepared from the following raw materials in parts by weight: 70 parts of donkey-hide gelatin, 60 parts of codonopsis pilosula, 60 parts of bighead atractylodes rhizome, 60 parts of poria cocos, 10 parts of elecampane, 3 parts of ferrous gluconate, 20 parts of white granulated sugar and a proper amount of purified water.
The preparation method of the composition with health care function in the embodiment comprises the following steps:
placing radix Codonopsis, Atractylodis rhizoma, Poria and radix aucklandiae in extraction tank, adding 15 times of water, decocting for 1 time, extracting for 3 hr, filtering with 120 mesh to obtain water extractive solution, and concentrating the water extractive solution at 75 deg.C under reduced pressure to obtain concentrated solution with relative density of 1.14(60 deg.C).
Dissolving white granulated sugar and ferrous gluconate in warm water to obtain a solution for later use.
Adding 8 times of hot water into colla Corii Asini, and boiling in jacketed pan to melt to obtain colla Corii Asini solution.
Mixing the above concentrated solution, dissolved solution and colla Corii Asini solution, placing in a preparation tank, adding purified water to desired volume, and stirring for 40min to obtain a preparation solution.
Centrifuging in a liquid tube centrifuge at 14000rpm/min, collecting the centrifugate, and filtering with plate-frame filter (0.45 μm) to obtain filtrate. Packaging the filtrate into clean oral liquid bottles, sealing, sterilizing at 121 deg.C under high temperature and high pressure for 15min, cooling, and packaging.
Example 4
The embodiment provides a composition with a health-care function, which is prepared from the following raw materials in parts by weight: 50 parts of donkey-hide gelatin, 70 parts of codonopsis pilosula, 70 parts of bighead atractylodes rhizome, 70 parts of poria cocos, 25 parts of elecampane, 3 parts of ferrous gluconate, 20 parts of white granulated sugar and a proper amount of purified water.
The preparation method of the composition with health care function in the embodiment comprises the following steps:
placing radix Codonopsis, Atractylodis rhizoma, Poria, and radix aucklandiae in extraction tank, adding 7 times of water, decocting for 3 times, each time for 1 hr, filtering with 120 mesh sieve, mixing filtrates to obtain water extractive solution, and concentrating at 75 deg.C under reduced pressure to obtain concentrated solution with relative density of 1.05(60 deg.C).
Dissolving white granulated sugar and ferrous gluconate in warm water to obtain a solution for later use.
Adding 4 times of hot water into colla Corii Asini, and boiling in jacketed pan to melt to obtain colla Corii Asini solution.
Mixing the above concentrated solution, dissolved solution and colla Corii Asini solution, placing in a preparation tank, adding purified water to desired volume, and stirring for 100min to obtain a preparation solution.
Centrifuging in a liquid tube centrifuge at 14000rpm/min, collecting the centrifugate, and filtering with plate-frame filter (0.45 μm) to obtain filtrate. Packaging the filtrate into clean oral liquid bottles, sealing, sterilizing at 105 deg.C under high temperature and high pressure for 30min, cooling, and packaging.
Example 5
The composition with health care function in this example is prepared from the following raw materials in parts by weight, with the difference that the raw material ratio is different with reference to the preparation method in example 1: 50 parts of donkey-hide gelatin, 75 parts of codonopsis pilosula, 75 parts of bighead atractylodes rhizome, 75 parts of poria cocos, 25 parts of elecampane, 1 part of ferrous gluconate, 20 parts of white granulated sugar and a proper amount of purified water.
Example 6
The composition with health care function in this example is prepared from the following raw materials in parts by weight, with the difference that the raw material ratio is different with reference to the preparation method in example 1: 50 parts of donkey-hide gelatin, 75 parts of codonopsis pilosula, 75 parts of bighead atractylodes rhizome, 75 parts of poria cocos, 25 parts of elecampane, 5 parts of ferrous gluconate, 20 parts of white granulated sugar and a proper amount of purified water.
Experimental example 1
According to safety tests in "test and evaluation of health food" technical specifications (2003 edition) and "national food and drug accreditation [2012] 107: procedure and method for functional evaluation of iron deficiency anemia improvement method the health foods prepared in examples 1 to 6 of the present invention were subjected to toxicological and functional (iron deficiency anemia improvement) tests. The experimental methods are as follows, and the experimental results are detailed in tables 1 to 13.
1 toxicology test
1.1 acute toxicity test
Experimental animals: 20 Kunming mice, each half male and female, with the animal weight of 18-22 g.
The experimental method and the steps are as follows: the mouse acute toxicity test was performed by the maximum tolerated dose method, at a design dose of 25.00g/kg BW (equivalent to 240 times the recommended daily intake by humans). Animal quarantine for 3d, and animal fasting for 16h before test and free drinking water. The sample is prepared by sterile water, the preparation concentration is 0.75g/mL, the sample is taken once according to the maximum gavage amount (20mL/kg BW), and the administration dose of the test object is 25.00g/kg BW. After the administration, the specimens were observed continuously for 14d, and the manifestation of poisoning and death were recorded.
1.2 three genotoxicity tests
1.2.1Ames test
Experimental strains: salmonella typhimurium histidine-deficient strain TA97, TA98, TA100 and TA 102.
Selecting the dosage: the highest dosage of the test object is 5000 mug/dish, 5 dosage groups are set at 5 times of intervals, the dosage groups are 5000, 1000, 200, 40 and 8 mug/dish respectively, and meanwhile, an untreated control group, a solvent control group and a positive control group are set.
The experimental method and the steps are as follows: plate doping method: 0.10mL of the test strain enrichment broth, 0.1mL of the test solution and 0.50mL of the S9 mixture (added during metabolic activation) were added to the top layer medium, mixed and poured onto the bottom layer medium plate, and each dose group was three dishes. After incubation at 37 ℃ for 48h, the number of colonies per dish for each dose was recorded.
1.2.2 sperm malformation test
Experimental animals: 25 mature male mice weighing 25-35 g.
The experimental method and the steps are as follows: the high, medium and low dose groups were designed to be 10.0g/kg BW, 5.0g/kg BW, 2.5g/kg BW, respectively. The gavage volume of the mice is 20mL/kg BW, the positive control group is given 40mg/kg BW cyclophosphamide, and the negative control group is given equal volume of distilled water. The test substance is administered by oral gavage for 1 time every day and continuously gavage for 5 days. The mice were sacrificed at the 35d cervical dislocation where the test article was first given, and the bilateral epididymis were taken out, and subjected to flaking and staining according to a conventional method. Reading the film by double blind method.
1.2.3 bone marrow cell micronucleus assay
Experimental animals: 50 mice weighing 25-30 g.
The experimental method and the steps are as follows: the high, medium and low dose groups were designed to be 10.0g/kg BW, 5.0g/kg BW, 2.5g/kg BW, respectively. The gavage volume of the mice is 20mL/kg BW, the positive control group is given 40mg/kg BW cyclophosphamide, and the negative control group is given equal volume of distilled water. The test substance is administered for 30 h: the test objects are fed twice at an interval of 24 hours, the mice are killed by dislocation of cervical vertebrae 6 hours after the test objects are fed twice, sternum bone marrow materials are taken for flaking and staining, and the flaking is read by a double-blind method.
1.330 day feeding trial
Experimental animals: healthy weaning rats 80 in half female and half male.
The experimental method and the steps are as follows: the health food prepared by the invention is given to a control group, a high, medium and low dose group for 25 times, 50 times and 100 times of the recommended dose of a human body, and is perfused for 30 days. During the experiment, animals have food and water for themselves, the test substances are given by a gastric lavage method for 1 time per day, the gastric lavage volume is 10mL/kg BW, the animals are raised in a single cage, the animals are called fasting body weight after being fasted for 16 hours at 30 days, and various indexes are measured.
The result of the overall toxicological experiment shows that the maximum tolerance of the health care composition to the test animal is more than 25g/kg BW, and the health care composition belongs to non-toxic grade. The Ames test, mouse marrow pleochromocyte micronucleus test and mouse sperm malformation test result are all negative. The result of the 30-day feeding test shows that no obvious toxic or side effect is seen on rats.
TABLE 1 weight change in animals tested for acute toxicity
Figure BDA0001555880480000111
Figure BDA0001555880480000112
Table 2 units of first Ames test results: one/one dish
Figure BDA0001555880480000121
Note: the above results are mean ± sd of three dishes.
Table 3 units of second Ames test results: one/one dish
Figure BDA0001555880480000122
Note: the above results are mean ± sd of three dishes.
TABLE 4 mouse teratospermia test results
Figure BDA0001555880480000131
*: compared with the solvent control group, the positive control group has very significant difference (P is less than 0.01).
TABLE 5 Effect of bone marrow micronucleus incidence in mice
Figure BDA0001555880480000132
*: compared with the solvent control group, the positive control group has very significant difference (P is less than 0.01).
TABLE 630 days feeding test rats (females) weight gain, food intake, food availability
Figure BDA0001555880480000133
Figure BDA0001555880480000134
Figure BDA0001555880480000141
TABLE 630 days of feeding test rats (male) for weight gain, food intake, food availability
Figure BDA0001555880480000142
Figure BDA0001555880480000143
Figure BDA0001555880480000151
TABLE 7 examination results of organ coefficients of rats
Figure BDA0001555880480000152
Figure BDA0001555880480000161
TABLE 7 examination of organ coefficients of rats
Figure BDA0001555880480000162
TABLE 8 Biochemical examination of rats
Figure BDA0001555880480000163
Figure BDA0001555880480000171
TABLE 8 Biochemical examination of rats
Figure BDA0001555880480000172
TABLE 8 Biochemical examination of rats
Figure BDA0001555880480000173
TABLE 9 results of hematological examination of rats
Figure BDA0001555880480000174
Figure BDA0001555880480000181
TABLE 9 results of hematological examination of rats
Figure BDA0001555880480000182
2 functional test
Improving iron deficiency anemia
The effect of the test substance on ameliorating iron deficiency anemia is evaluated in an experimental iron deficiency anemia rat model. After a rat model of iron deficiency anemia is established by feeding low-iron feed and deionized water, the test substances are continuously perfused for one month at the doses of 1.7mL/kg BW/d, 3.3mL/kg BW/d and 10.0mL/kg BW/d (which are respectively equal to 2.5 times, 5 times and 15 times of the recommended intake of a human body). The results show that the 1.7mL/kg BW/d group can increase the hemoglobin content of rats (P <0.001), and compared with the test object, the hemoglobin content is increased by 55.4g/L on average and is more than 10g/L, and the specific volume of the red blood cells of the rats is increased (P < 0.001); the 3.3mL/kg BW/d group can increase the hemoglobin content of rats (P <0.001), and compared with the group before the test object, the hemoglobin content is increased by 58.9g/L on average and is more than 10g/L, and the specific volume of red blood cells of the rats is increased (P < 0.001); the 10.0mL/kg BW/d group can increase the hemoglobin content of rats (P <0.001), and compared with the test object, the hemoglobin content is increased by 74.6g/L on average and is more than 10g/L, the free protoporphyrin content in rat erythrocytes (P <0.01) can be reduced, and the specific volume of the rat erythrocytes (P <0.001) can be increased. The human body test diet test adopts two control designs of self and group, and subjects are randomly divided into a control group and a test diet group according to the hemoglobin level. The test sample is taken directly and orally 2 times a day, 1 bottle each time. Adverse reactions are not seen in the process of eating the test food, and a plurality of detection indexes show that the test substance has the effect of improving iron-deficiency anemia.
According to the results of the functional test for improving iron deficiency anemia in national food and drug administration No. 2012/107, the test substance has the function of improving iron deficiency anemia under the test conditions.
TABLE 10 Effect on rat body weight
Figure BDA0001555880480000191
Figure BDA0001555880480000192
TABLE 11 Effect on hemoglobin content in rats
Figure BDA0001555880480000193
Figure BDA0001555880480000194
*: compared with a low-iron control group (0mL/kg BW), the composition has significant difference.
TABLE 12 Effect of test substances on the content of free protoporphyrin in Red blood cells of rats
Figure BDA0001555880480000201
Figure BDA0001555880480000202
*: compared with a low-iron control group (0mL/kg BW), the composition has significant difference.
TABLE 13 Effect of test substances on the hematocrit of rats in a model of iron deficiency anemia
Figure BDA0001555880480000203
Figure BDA0001555880480000204
*: compared with a low-iron control group (0mL/kg BW), the composition has significant difference.
From the results in the tables, it can be seen that the composition with health care function in the embodiments of the present invention has safety confirmed by toxicological test evaluation, and can effectively improve nutritional anemia, fundamentally improve human body constitution, address both symptoms and root causes, and thereby improve nutritional anemia.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims (18)

1. The composition with the health-care function is characterized by being prepared from the following raw materials in parts by weight: 20-70 parts of donkey-hide gelatin, 60-90 parts of codonopsis pilosula, 60-90 parts of bighead atractylodes rhizome, 60-90 parts of poria cocos, 10-40 parts of elecampane, 1-5 parts of a nutrition enhancer calculated by iron element and a sweetener;
the nutrition enhancer is ferrous gluconate.
2. The composition with health function according to claim 1, wherein the composition with health function is prepared from the following raw materials in parts by weight: 30-60 parts of donkey-hide gelatin, 70-80 parts of codonopsis pilosula, 70-80 parts of bighead atractylodes rhizome, 70-80 parts of poria cocos, 20-30 parts of elecampane, 2-4 parts of a nutrition enhancer calculated by iron element and a sweetener.
3. The composition with health function according to claim 1, wherein the composition with health function is prepared from the following raw materials in parts by weight: 50 parts of donkey-hide gelatin, 75 parts of codonopsis pilosula, 75 parts of bighead atractylodes rhizome, 75 parts of poria cocos, 25 parts of elecampane, 3 parts of a nutrition enhancer calculated by iron element and a sweetener.
4. A composition with health promoting effect according to any one of claims 1-3, wherein the raw material comprises 10-50 parts of sweetener.
5. A composition with health-care function as claimed in claim 4, wherein the sweetener comprises one or more of crystal sugar, sucrose, white granulated sugar and xylitol.
6. The composition with health-care function according to claim 5, wherein the sweetener is white granulated sugar.
7. A health-promoting composition according to any one of claims 1 to 3, wherein the health-promoting composition is formulated as a liquid preparation in an oral dosage form.
8. A method for preparing a composition with health-care function according to any one of claims 1 to 7, which comprises the following steps:
(A) extracting radix Codonopsis, Atractylodis rhizoma, Poria and radix aucklandiae with 7-15 times of water, filtering to obtain water extractive solution, and concentrating the water extractive solution to obtain concentrated solution;
(B) adding 4-8 times of water into colla Corii Asini, and melting to obtain colla Corii Asini solution;
(C) dissolving the nutrition enhancer and the sweetener with proper amount of water to obtain a solution;
(D) and uniformly mixing the concentrated solution, the colla corii asini solution and the dissolved solution, fixing the volume, centrifuging and filtering to obtain the propolis liquid.
9. The method for preparing a health-promoting composition according to claim 8, wherein the water extraction in the step (a) comprises: adding 7-15 times of water, and extracting for 1-3 hr each time.
10. The method for preparing a composition with health promoting effect according to claim 9, wherein the water extract is obtained by filtering with 120 mesh or more after extracting with water.
11. The method for preparing a health-care composition according to claim 8, wherein the relative density of the concentrated solution obtained in the step (A) is 1.04-1.13 measured at 60 ℃.
12. The method for preparing a composition with health function according to claim 8, wherein the concentration in the step (A) is concentration under reduced pressure.
13. A method for preparing a composition with health promoting effect according to claim 12, wherein the concentration is performed under reduced pressure at a temperature of 75 ± 5 ℃.
14. The method for preparing a composition with health function as claimed in claim 8, wherein the rotation speed of the centrifugation in step (D) is 12000-16000 rpm/min.
15. The method for preparing a health composition according to claim 8, wherein the step (D) is performed by plate-and-frame filtration with a filter pore size of 0.45 μm or less.
16. The method for preparing a composition with health promoting effect according to claim 8, wherein the step (D) further comprises packaging, sealing and sterilizing after filtering.
17. A method for preparing a composition with health-care function according to claim 16, wherein the sterilization method comprises: 105-121 ℃ high-temperature high-pressure moist heat sterilization for 15-40 min.
18. Use of the composition with health function of any one of claims 1-7 for preparing a medicine or food for improving nutritional anemia.
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Citations (3)

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Publication number Priority date Publication date Assignee Title
CN1287836A (en) * 2000-07-10 2001-03-21 山东东阿阿胶股份有限公司 Doukey-hide gelatin capsule
CN1965951A (en) * 2005-11-17 2007-05-23 大连天山药业有限公司 Blood tonic capsule having ass hide and method for preparing same
JP4722492B2 (en) * 2005-01-11 2011-07-13 日本メナード化粧品株式会社 An agent for preventing or ameliorating indefinite complaints associated with iron deficiency anemia.

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Publication number Priority date Publication date Assignee Title
CN1287836A (en) * 2000-07-10 2001-03-21 山东东阿阿胶股份有限公司 Doukey-hide gelatin capsule
JP4722492B2 (en) * 2005-01-11 2011-07-13 日本メナード化粧品株式会社 An agent for preventing or ameliorating indefinite complaints associated with iron deficiency anemia.
CN1965951A (en) * 2005-11-17 2007-05-23 大连天山药业有限公司 Blood tonic capsule having ass hide and method for preparing same

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