CN109381491A - A kind of composition and its preparation method and application for preventing and treating osteoporosis - Google Patents

A kind of composition and its preparation method and application for preventing and treating osteoporosis Download PDF

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CN109381491A
CN109381491A CN201811591004.6A CN201811591004A CN109381491A CN 109381491 A CN109381491 A CN 109381491A CN 201811591004 A CN201811591004 A CN 201811591004A CN 109381491 A CN109381491 A CN 109381491A
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propolis
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朱威
李英华
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Jiuyin Health Management Shanghai Co ltd
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Zhejiang University ZJU
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    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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Abstract

The present invention relates to a kind of composition and its preparation method and application for preventing and treating osteoporosis, the composition is made of the raw material of following weight: 1-20 parts of propolis alcohol extract, 1-20 parts of Bee Pollen water extract, 10-70 parts of modified pectin powder, 1-20 parts of gelatin powder.The propolis alcohol extract be propolis raw material through 70%-75% ethanol solution the refluxing extraction 2-4h under 70-75 DEG C of heating condition, after freeze-drying crush made from;The Bee Pollen water extract extracts 2-4h through distilled water for melissa powder raw material under 80-95 DEG C of heating condition, after freeze-drying made from crushing;The modified pectin powder is the modified pectin that the molecular weight that pectin starting material obtains after alkaline hydrolysis or enzymatic hydrolysis is 5%-35% in 2000-30000, esterification degree.Cell, animal and clinical trial confirm that the present composition prevents and treats osteoporosis effect highly significant.

Description

A kind of composition and its preparation method and application for preventing and treating osteoporosis
Technical field
The present invention relates to medicine, health care product and food technology fields, specifically, being related to a kind of group for preventing and treating osteoporosis Close object and its preparation method and application.
Background technique
Osteoporosis is a kind of silence disease for drastically influencing elderly population quality of life, and the stage is without significant in the early stage Clinical symptoms, it is difficult to be found, majority to fracture is just intervened when occurring.The global annual sclerotin about more than 200,000,000 is dredged Loose patient, wherein about 89,000,000 sufferers of osteoporosis face is fractured.It is calculated according to current osteoporosis incidence 13%, every year The fracture as caused by osteoporosis spends up to 1,000,000,000 U.S. dollars.With the arrival of China's aging society, osteoporotic bone Folding prevention and treatment has become important social public health task.Therefore, the food and drug of exploitation prevention and treatment osteoporosis have extensively Wealthy market prospects can bring good Social benefit and economic benefit.
Balance during the formation of osteoporosis mainly bone remoulding between bone resorption and bon e formation is destroyed, bone resorption Speed is greater than bon e formation speed, and bone loss is caused to be accelerated.At present prevention and treatment osteoporosis mainly from replenish the calcium, replenishing collagen, tune The effects of saving hormonal readiness mechanism is started with.The current natural products in prevention and treatment osteoporosis includes pilose antler, tiger bone, pueraria lobata, Psoralen Rouge, Rehmannia glutinosa, Herba Epimedii, teasel root, Yak Bone, Cortex Eucommiae, ginseng, Rhizoma Chuanxiong etc..Through retrieving, periodical " Xinxiang College of Medical Science's journal " 2005 The paper " influence of propolis flavonoid on bone metabolism in ovariectomized rats " that year publishes discloses propolis flavonoid Bone density can be increased, ovariectomized in rats calcium is reduced and lose, pre- preventing bone rarefaction.Periodical " Hubei University of Chinese Medicine's journal " 2015 It is strong to disclose donkey-hide gelatin kidney tonifying for the paper " influence of the donkey-hide gelatin side of reinforcing the kidney to strengthen the bone to osteoporosis rats of ovaries-removed model " that year publishes Donkey-hide gelatin enters liver kidney channel in bone side, and for the product of " flesh and blood is in love ", energy help essence and blood, hard muscles and bones, hemapodium essence is filled, and essence is filled, and marrow obtains it It supports, enjoys excellent health;Herba Epimedii tonifying kidney and strengthening yang, strengthening the bones and muscles, kidney yang push essence and blood operation;Semen Cuscutae, psoralea corylifolia, radix achyranthis bidentatae can be mended Kidney is supporing yang, strengthening the bones and muscles, and radix achyranthis bidentatae can be guided drugs to illness station again with priming;Raw oyster is slightly cold, and calcium content is abundant with supplement calcium, can separately prevent Only all medicine sun are warm too;Bush activating microcirculation and removing stasis medicinal, dredging the channel promote QI-blood circulation;All medicines share mend essence and blood must, and muscles and bones obtains It is strong, it mends without staying the stasis of blood;Full side's legislation is thorough, and prescription is rigorous, plays help essence and blood altogether, fills out the effect of marrow strong bone.Donkey-hide gelatin is reinforced the kidney to strengthen the bone Lipid metaboli can be adjusted, osteoporosis rat uterus and double renal indexes are increased, delays bone loss, improves BMD, improves bone tissue Morphosis has the function of preventing and controlling osteoporosis.Chinese medicine or composition of natural products for preventing and treating osteoporosis is special Benefit has: hippocampus, the composition (CN201210162840.9) that petrel is main prescription;Herba Epimedii, teasel root, curcuma zedoary, based on trigone Want the composition (CN200710077729.9) of prescription;Radix achyranthis bidentatae, the composition that Radix Salviae Miltiorrhizae is main prescription (CN201210391169.5), Herba Epimedii, psoralea corylifolia, Chinese yam, the composition that Rhizoma Atractylodis Macrocephalae is main prescription (CN201510829207.4);Herba Epimedii, radix achyranthis bidentatae, the composition (CN201410226893.1) that calcium citrate is main prescription; Herba Epimedii, composition (CN201410037992.5) that the fruit of glossy privet is main prescription etc..
However, the day that research and development preventive and therapeutic effect effect is more significant, raw material sources are wide, material quality is easy to control, highly-safe Right product compositions are still very necessary.It has no at present by propolis alcohol extract, Bee Pollen water extract, modified pectin powder and gelatin powder It is common to the report of osteoporosis prevention and treatment.
Summary of the invention
The purpose of the present invention is aiming at the shortcomings in the prior art, provide a kind of composition and its system for preventing and treating osteoporosis Preparation Method and application.
In a first aspect, the present invention provides it is a kind of prevent and treat osteoporosis composition, it by following weight original Material is made: 1-20 parts of propolis alcohol extract, 1-20 parts of Bee Pollen water extract, 10-70 parts of modified pectin powder, 1-20 parts of gelatin powder;
The propolis alcohol extract the preparation method comprises the following steps: propolis raw material through 70%-75% ethanol solution in 70-75 DEG C of heating condition Lower refluxing extraction 2-4h will be crushed after extract obtained freeze-drying;
The Bee Pollen water extract is the preparation method comprises the following steps: melissa powder raw material extracts under 80-95 DEG C of heating condition through distilled water 2-4h will be crushed after extract obtained freeze-drying;
The modified pectin powder, preparation method thereof are as follows: pectin starting material through alkaline hydrolysis or enzymatic hydrolysis, obtain molecular weight 2000-30000, Esterification degree is the modified pectin of 5%-35%.
As a preference of the invention, it is made of the raw material of following weight: propolis alcohol extract 5-20g, Bee Pollen water extract 3-15g, modified pectin powder 20-65g, gelatin powder 2-15g.
As another preference of the invention, it is made of the raw material of following weight: propolis alcohol extract 5-10g, Bee Pollen water extract 10-15g, modified pectin powder 60-65g, gelatin powder 10-15g.
As another preference of the invention, the composition be further made pulvis, paste, granule, tablet or Capsule.
As another preference of the invention, propolis raw material used in the propolis alcohol extract be Populus in China type propolis or Detection of Brazilian Propolis.
As another preference of the invention, melissa powder raw material used in the Bee Pollen water extract is camellia pollen, lotus Powder or rape pollen.
As another preference of the invention, the modified pectin powder from citrus, apple, carrot, silkworm excrement or to Day certain herbaceous plants with big flowers disk raw material.
As another preference of the invention, the gelatin powder is to crush after moisture content is chilled lower than 12% donkey-hide gelatin It crosses made from 60 meshes.
Second aspect, the present invention provides the preparation methods of the composition, comprising the following steps:
The preparation of propolis alcohol extract: propolis raw material flows back under 70-75 DEG C of heating condition through 70%-75% ethanol solution and mentions 2-4h is taken, will be crushed after extract obtained freeze-drying;
The preparation of Bee Pollen water extract: melissa powder raw material extracts 2-4h under 80-95 DEG C of heating condition through distilled water, by institute It is crushed after obtaining extract freeze-drying;
The preparation of modified pectin powder: through alkaline hydrolysis or enzymatic hydrolysis, obtain molecular weight in 2000-30000, esterification degree is pectin starting material The modified pectin of 5%-35%;
The preparation of gelatin powder: it is crushed after moisture content is chilled lower than 12% donkey-hide gelatin;
According still further to the weight by the propolis alcohol extract, Bee Pollen water extract, modified pectin powder and gelatin powder Mixing.
The third aspect, the present invention provides the compositions in drug, health care product or the food for preparing prevention and treatment osteoporosis In application.
A effective amount of composition of the invention can be mixed with other materials to obtain composition, the other materials can be Carrier, excipient, bottom material, food, drug, active constituent etc., those of ordinary skill in the art can be as needed to other materials It is selected.Term " effective quantity " refer to by mode of the invention using when be enough to obtain the effect of needs and without excessive ill-effect (such as toxicity, stimulation and allergy) has the amount of the ingredient of reasonable benefit/risk ratio.Obviously, specific " effective quantity " because Various factors and different, such as the food of required addition, drug or health care product type, processing method and degree.Combination of the invention Object can exist with a variety of dosage forms.Its generally with pharmaceutically, on health care product or on food acceptable carrier mixes.The medicine Acceptable carrier can be solid or liquid on, on health care product or on food, generally give mode according to used And Selective type.The example of solid-state carrier includes (but being not limited to): lactose, sucrose, gelatin and agar.Capsule or tablet can be with It easily prepares, and convenient for swallowing or chewing;Other solid forms include particle.Tablet can containing adhesive appropriate, Lubricant, diluent, disintegrating agent, colorant, flavoring agent etc..The example of liquid dosage form includes: in water, pharmaceutically acceptable rouge Fat or oil, alcohol or solution in other organic solvents (including ester) or suspension, emulsion, syrup, elixir, with non-effervescence granular again Raw solution and/or suspension and with the regenerated effervescent formulation of effervescence granular.Such liquid dosage form can contain, for example, suitable When solvent, preservative, emulsifier, suspending agent, diluent, sweetener, thickener and cosolvent.Peroral dosage form can contain flavoring agent And colorant.The dosage form of parenteral and intravenous administration can also containing minerals and other substances, so as to make they and injection or Selected type of release system is compatible.
The invention has the advantages that:
1, using propolis alcohol extract as main component, propolis flavone, which has, inhibits osteoclast proliferation, anti-inflammatory analgesic etc. to make With inflammatory factor can be prevented to the further excitation of osteoclast activity.It is aided with the adjusting climacteric of Bee Pollen water extract The effect of phase female estrogen sample, the promotion chondroblast effect of donkey-hide gelatin, the adjusting alcium and phosphor metabolization effect of modified pectin, each ingredient It complements each other, acts synergistically, suitable for preventing and treating primary and secondary osteoporosis, significant effect.Test cell line result is aobvious Show, can effectively inhibit the differentiation of osteoclast, promotes the proliferation of mesenchymal stem cell and osteoblast;Animal test results It has been shown that, can effectively prevent bone loss;Clinical test results are shown, the osteoporosis generation that bone amount reduces crowd can be effectively reduced Rate.
2, raw material sources are easy to get extensively, and raw material standardization is easy to control, highly-safe, eat medicinal.
3, wide using range, it can be used for being added to milk powder, candy, in instant food, also can be made tablet, capsule Agent or paste are taken.
Detailed description of the invention
Attached drawing 1: the preparation technology flow chart of the present composition.
Attached drawing 2: composition inhibits osteoclast TRAP expression.
Attached drawing 3: composition inhibits TRAP enzymatic activity in Osteoclast culture supernatant.
Attached drawing 4: composition promotes MC3T3E1 cell Proliferation.
Attached drawing 5: composition promotes hFOB1.19 osteoblastic proliferation.
Specific embodiment
It elaborates with reference to the accompanying drawing to specific embodiment provided by the invention.
Populus in China type propolis, Detection of Brazilian Propolis, camellia pollen, lotus powder, rape pollen are bought to be had in Hangzhou East Sea apiculture Limit company, the pectin of citrus origin, the pectin in carrot source, the pectin in silkworm excrement source, sunflower plate source pectin purchase It buys in Zhejiang Guo Yuankang product Science and Technology Ltd., donkey-hide gelatin is bought in Neptune occasion pharmacy.
The preparation (one) of 1 present composition pulvis of embodiment
Each natural products weight are as follows: propolis alcohol extract 10g, Bee Pollen water extract 10g, modified pectin powder 70g, Ah Rubber powder 10g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 70% ethanol solution Refluxing extraction 2h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 90 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate is through alkaline hydrolysis (1% NaOH Aqueous solution hydrolyzes 60min at room temperature, the control of pectin solution concentration 5%) or enzymatic hydrolysis (defatting enzyme additional amount is jelly powder dry weight 20 times, pectase additional amount is 0.1%, and 120min is hydrolyzed at 30 DEG C, and pectin solution concentration controls after 5%), obtains molecular weight 20000, esterification degree 25%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after the donkey-hide gelatin freezing of moisture content 10%, crosses 60 meshes.
(5) it is mixed into the preparation of requirement: mixing above-mentioned pulvis up to required product according to weight.
The preparation (two) of 2 present composition pulvis of embodiment
Each natural products weight are as follows: propolis alcohol extract 5g, Bee Pollen water extract 15g, modified pectin powder 65g, Ah Rubber powder 15g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 75% ethanol solution Refluxing extraction 3h under 70 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 95 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 10000, esterification degree 18%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) it is mixed into the preparation of requirement: mixing above-mentioned pulvis up to required product according to weight.
The preparation (three) of 3 present composition pulvis of embodiment
Each natural products part weight are as follows: propolis alcohol extract 1g, Bee Pollen water extract 1g, modified pectin powder 10g, Ah Rubber powder 1g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 75% ethanol solution Refluxing extraction 4h under 70 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 80 DEG C of hot dippings of distilled water 4h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 2000, esterification degree 30%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) it is mixed into the preparation of requirement: mixing above-mentioned pulvis up to required product according to weight.
The preparation (four) of 4 present composition pulvis of embodiment
Each natural products part weight are as follows: propolis alcohol extract 10g, Bee Pollen water extract 1g, modified pectin powder 10g, Gelatin powder 1g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 70% ethanol solution Refluxing extraction 3h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 90 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 25000, esterification degree 15%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) it is mixed into the preparation of requirement: mixing above-mentioned pulvis up to required product according to weight.
The preparation (one) of 5 present composition tablet of embodiment
Each natural products weight are as follows: propolis alcohol extract 10g, Bee Pollen water extract 15g, modified pectin powder 60g, Ah Rubber powder 15g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 70% ethanol solution Refluxing extraction 3h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 90 DEG C of hot dippings of distilled water 2h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 8000, esterification degree 18%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) press sheet formulation: tabletting is after mixing above-mentioned pulvis according to weight up to required product.
The preparation (two) of 6 present composition tablet of embodiment
Each natural products weight are as follows: propolis alcohol extract 20g, Bee Pollen water extract 10g, modified pectin powder 60g, Ah Rubber powder 10g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 70% ethanol solution Refluxing extraction 3h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 90 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 12000, esterification degree 13%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) press sheet formulation: tabletting is after mixing above-mentioned pulvis according to weight up to required product.
The preparation (three) of 7 present composition tablet of embodiment
Each natural products weight are as follows: propolis alcohol extract 20g, Bee Pollen water extract 15g, modified pectin powder 10g, Ah Rubber powder 1g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 70% ethanol solution Refluxing extraction 4h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 85 DEG C of hot dippings of distilled water 4h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 30000, esterification degree 5%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) press sheet formulation: tabletting is after mixing above-mentioned pulvis according to weight up to required product.
The preparation (four) of 8 present composition tablet of embodiment
Each natural products weight are as follows: propolis alcohol extract 1g, Bee Pollen water extract 5g, modified pectin powder 20g, donkey-hide gelatin Powder 5g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 70% ethanol solution Refluxing extraction 3h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 90 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 12000, esterification degree 13%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) press sheet formulation: tabletting is after mixing above-mentioned pulvis according to weight up to required product.
The preparation (one) of 9 present composition capsule of embodiment
Each natural products weight are as follows: propolis alcohol extract 5g, Bee Pollen water extract 20g, modified pectin powder 70g, Ah Rubber powder 5g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 75% ethanol solution Refluxing extraction 3h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 95 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 12000, esterification degree 13%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) capsule preparations: encapsulating capsule is after mixing above-mentioned pulvis according to weight up to required product.
The preparation (two) of 10 present composition capsule of embodiment
Each natural products weight are as follows: propolis alcohol extract 10g, Bee Pollen water extract 10g, modified pectin powder 70g, Ah Rubber powder 10g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 75% ethanol solution Refluxing extraction 3h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 95 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 12000, esterification degree 13%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) capsule preparations: encapsulating capsule is after mixing above-mentioned pulvis according to weight up to required product.
The preparation (three) of 11 present composition capsule of embodiment
Each natural products weight are as follows: propolis alcohol extract 1g, Bee Pollen water extract 2g, modified pectin powder 30g, donkey-hide gelatin Powder 1g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 75% ethanol solution Refluxing extraction 3h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 85 DEG C of hot dippings of distilled water 2h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 5000, esterification degree 20%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) capsule preparations: encapsulating capsule is after mixing above-mentioned pulvis according to weight up to required product.
The preparation (four) of 12 present composition capsule of embodiment
Each natural products weight are as follows: propolis alcohol extract 20g, Bee Pollen water extract 5g, modified pectin powder 15g, Ah Rubber powder 2g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 75% ethanol solution Refluxing extraction 2h under 70 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 90 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 20000, esterification degree 25%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) capsule preparations: encapsulating capsule is after mixing above-mentioned pulvis according to weight up to required product.
The preparation (one) of 13 present composition granule of embodiment
Each natural products weight are as follows: propolis alcohol extract 10g, Bee Pollen water extract 20g, modified pectin powder 60g, Ah Rubber powder 10g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 75% ethanol solution Refluxing extraction 3h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 90 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 28000, esterification degree 20%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) it granular preparation: is made pellet after mixing above-mentioned pulvis according to weight up to required product.
The preparation (two) of 14 present composition granule of embodiment
Each natural products weight are as follows: propolis alcohol extract 15g, Bee Pollen water extract 10g, modified pectin powder 60g, Ah Rubber powder 15g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 75% ethanol solution Refluxing extraction 3h under 70 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 90 DEG C of hot dippings of distilled water 2h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 18000, esterification degree 13%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) it granular preparation: is made pellet after mixing above-mentioned pulvis according to weight up to required product.
The preparation (one) of 15 present composition paste of embodiment
Each natural products weight are as follows: propolis alcohol extract 20g, Bee Pollen water extract 10g, modified pectin powder 50g, Ah Rubber powder 20g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 75% ethanol solution Refluxing extraction 3h under 70 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 90 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 20000, esterification degree 28%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) paste preparation: every 10g composition 100ml water boiling water boils after mixing above-mentioned pulvis according to weight 120min is up to required product.
The preparation (two) of 16 present composition paste of embodiment
Each natural products weight are as follows: propolis alcohol extract 15g, Bee Pollen water extract 10g, modified pectin powder 60g, Ah Rubber powder 15g.
(1) prepared by propolis alcohol extract: Populus in China type propolis or Detection of Brazilian Propolis raw material Freezing smashing, through 70% ethanol solution Refluxing extraction 3h under 75 DEG C of heating conditions crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen, lotus powder or rape pollen pulverize, through 95 DEG C of hot dippings of distilled water 3h is mentioned, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (NaOH is water-soluble through alkaline hydrolysis for the pectin in the sources such as citrus, carrot, silkworm excrement, sunflower plate 5%) or enzymatic hydrolysis (hydrolyzes, pectin solution is dense at defatting enzyme and 30 DEG C of pectase it is hydrolyzed under liquid chamber temperature, the control of pectin solution concentration is Degree control is after 5%), molecular weight 13000, esterification degree 18%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) paste preparation: every 10g composition 100ml water boiling water boils after mixing above-mentioned pulvis according to weight 120min is up to required product.
The cell experiment of 17 present composition of embodiment prevention and treatment osteoporosis
RAW264.7 cell, mesenchymal stem cell MC3T3-E1, osteoblast hFOB1.19 are purchased from the Chinese Academy of Sciences Cell bank;RANKL is purchased from sigma company.
(wherein propolis alcohol extracting raw material is Populus in China type propolis, Bee Pollen water to composition prepared by above-described embodiment 1 Extract raw material is camellia pollen, and modified pectin raw material is citrus origin pectin, is prepared using alkaline hydrolysis method) it is configured to various concentration Composition solution.Then the composition solution of various concentration is added in culture medium, as a result, it has been found that composition is water-soluble Liquid can be presented concentrationdependent manner in 2mg/ml or less and RANKL is effectively inhibited to induce point of the RAW264.7 cell to osteoclast Change, and TRAP enzymatic activity in cells and supernatant can be reduced.Fig. 2, Fig. 3 are shown in influence to osteoclast.And composition is water-soluble Liquid can be presented concentrationdependent manner in 2mg/ml or less and effectively facilitate mesenchymal stem cell MC3T3-E1 and osteoblast The proliferation of hFOB1.19.Fig. 4, Fig. 5 are shown on osteoblast and mesenchymal stem cell influence.The sheet prepared using other raw materials Inventive composition also shows to reduce TRAP enzymatic activity and promotes mesenchymal stem cell MC3T3-E1 and osteoblast The effect of hFOB1.19 proliferation.
The zoopery of 18 present composition of embodiment prevention and treatment osteoporosis
(wherein propolis alcohol extracting raw material is Populus in China type propolis, Bee Pollen water to composition prepared by above-described embodiment 2 Extract raw material is camellia pollen, and modified pectin raw material is citrus origin pectin, is hydrolyzed at room temperature using 3% NaOH aqueous solution 60min, the control of pectin solution concentration prepare modified pectin 5%) it is configured to the composition solution of various concentration.Then will The SD rat (200 ± 20g) of the preventative gastric infusion ovariectomy of the composition solution of various concentration 12 weeks is administered 12 weeks After take hematometry serum skeleton metabolism alkaline phosphatase, OPG, PINP etc., taken after execution bilateral femur measure bone density.Analysis Skeleton metabolism level, the bone for comparing sham-operation group, blank group, model group, operation plus various concentration composition solution group are close Angle value difference.As a result, it has been found that composition solution dose-dependently can effectively prevent the bone density of Ovariectomized Rats from dropping It is low, reduce the incidence (table 1) of osteoporosis.
The bone density and skeleton metabolism situation of change of rat after 1 composition of table is intervened
Note: compared with sham-operation group, P < 0.01 * P < 0.05, * *.Compared with model group, #P < 0.05.
Compare prevention and treatment of the different components to SD rat (200 ± 20g) osteoporosis of ovariectomy by zoopery Effect.Grouping includes: that (wherein propolis alcohol extracting raw material is for sham-operation group, blank group, model group, operation plus 2 composition of embodiment Populus in China type propolis, Bee Pollen water extract raw material are camellia pollen, and modified pectin raw material is citrus origin pectin, using 3% NaOH aqueous solution hydrolyzes 60min at room temperature, and pectin solution concentration control prepares modified pectin 5%) aqueous solution group, operation plus One aqueous solution group of reference composition, operation plus reference composition two aqueous solution group, operation plus three aqueous solution group of reference composition.It is real Apply the composition that 2 composition of example is prepared according to above-described embodiment 2.
Reference composition one are as follows: propolis alcohol extract 5g, Bee Pollen water extract 15g, gelatin powder 15g.
(1) prepared by propolis alcohol extract: Populus in China type propolis raw material Freezing smashing, through 75% ethanol solution, 70 DEG C of fire-bars Refluxing extraction 3h under part crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen water extract: camellia pollen pulverizes, and 3h is mentioned through 95 DEG C of hot dippings of distilled water, after extracting solution freeze-drying It crushed 60 meshes.
(3) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(4) it is mixed into the preparation of requirement: mixing above-mentioned pulvis up to required product according to weight.
Reference composition two are as follows:
Propolis alcohol extract 5g, modified pectin powder 65g, gelatin powder 15g.
(1) prepared by propolis alcohol extract: Populus in China type propolis raw material Freezing smashing, through 75% ethanol solution, 70 DEG C of fire-bars Refluxing extraction 3h under part crushed 60 meshes after extracting solution freeze-drying.
(2) modified pectin prepare: the pectin of citrus origin through alkaline hydrolysis (3% NaOH aqueous solution hydrolyzes 60min at room temperature, Pectin solution concentration controls after 5%), molecular weight 10000, esterification degree 18%.Products obtained therefrom crosses 60 meshes.
(3) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(4) it is mixed into the preparation of requirement: mixing above-mentioned pulvis up to required product according to weight.
Reference composition three are as follows:
Propolis alcohol extract 5g, Bee Pollen alcohol extract 15g, modified pectin powder 65g, gelatin powder 15g.
(1) prepared by propolis alcohol extract: Populus in China type propolis raw material Freezing smashing, through 75% ethanol solution, 70 DEG C of fire-bars Refluxing extraction 3h under part crushed 60 meshes after extracting solution freeze-drying.
(2) prepared by Bee Pollen alcohol extract: camellia pollen pulverizes, and mentions through flowing back under 75% ethanol solution, 70 DEG C of heating conditions 3h is taken, crushed 60 meshes after extracting solution freeze-drying.
(3) prepared by modified pectin: (pectin of citrus origin hydrolyzes 60min through the NaOH aqueous solution of alkaline hydrolysis 3% at room temperature, Pectin solution concentration controls after 5%), molecular weight 10000, esterification degree 18%.Products obtained therefrom crosses 60 meshes.
(4) it the preparation of gelatin powder: is crushed after donkey-hide gelatin freezing, crosses 60 meshes.
(5) it is mixed into the preparation of requirement: mixing above-mentioned pulvis up to required product according to weight.
Dosage is 2mg/kg, administration 12 weeks after take hematometry serum skeleton metabolism alkaline phosphatase, OPG, PINP etc. takes bilateral femur to measure bone density after execution.Skeleton metabolism level, bone density value difference are compared in analysis.As a result it sends out Existing, compared with model group, each group rat bone density increases, and skeleton metabolism improves;Compared with sham-operation group, embodiment 2 groups of rat bone density and skeleton metabolism no significant difference (P > 0.05), and control group one, control group two, control Difference between group three and sham-operation group is still statistically significant (P < 0.05);Compared with 2 groups of embodiment, control group one, control Group two, the rat bone density of control group three and skeleton metabolism difference statistically significant (P < 0.05) (table 2).
The bone density and skeleton metabolism situation of change of rat after 2 composition of table is intervened
Note: compared with sham-operation group, P < 0.01 * P < 0.05, * *;Compared with 2 groups of embodiment, #P < 0.05.
The clinical trial of 19 present composition of embodiment prevention and treatment osteoporosis
Case source is the osteoporosis sample database volunteer of Zhejiang Hospital, is tested in December, -2017 in December, 2015 It carries out.Bone amount is reduced into (DXA measures bone density T value between -1.0S to -2.5S) crowd and is divided into two groups, two groups of population of weight Index, age, sex ratio are close, and every group is 40 people.One group is to be willing to participate in the Subject Population that nutritional intervention is carried out according to guidance, One group is the Subject Population for being unwilling to receive nutritional intervention.It the results are shown in Table 3 with after composition intervention 2 years.In composition intervention Group, incidence of osteoporosis 40%, and control group incidence is 60%.Control group either neck of femur, lumbar vertebrae or full hip Bone density is compared with intervention group, there is significant decrease.
Influence of 3 composition of table to elderly population bone density and incidence of osteoporosis
Note: compared with composition intervention group, P < 0.05 *.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art Member, under the premise of not departing from the method for the present invention, can also make several improvement and supplement, these are improved and supplement also should be regarded as Protection scope of the present invention.

Claims (10)

1. a kind of composition for preventing and treating osteoporosis, which is characterized in that it is made of the raw material of following weight: propolis alcohol 1-20 parts of extract, 1-20 parts of Bee Pollen water extract, 10-70 parts of modified pectin powder, 1-20 parts of gelatin powder;
The propolis alcohol extract the preparation method comprises the following steps: propolis raw material through 70%-75% ethanol solution 70-75 DEG C of heating condition next time Stream extracts 2-4h, will crush after extract obtained freeze-drying;
The Bee Pollen water extract the preparation method comprises the following steps: melissa powder raw material extracts 2-4h under 80-95 DEG C of heating condition through distilled water, It will be crushed after extract obtained freeze-drying;
The modified pectin powder, preparation method thereof are as follows: pectin starting material obtains molecular weight in 2000-30000, esterification through alkaline hydrolysis or enzymatic hydrolysis Degree is the modified pectin of 5%-35%.
2. composition according to claim 1, which is characterized in that it is made of the raw material of following weight: propolis Alcohol extract 5-20g, Bee Pollen water extract 3-15g, modified pectin powder 20-65g, gelatin powder 2-15g.
3. composition according to claim 2, which is characterized in that it is made of the raw material of following weight: propolis Alcohol extract 5-10g, Bee Pollen water extract 10-15g, modified pectin powder 60-65g, gelatin powder 10-15g.
4. composition according to claim 1, which is characterized in that the composition be further made pulvis, paste, Granula, tablet or capsule.
5. composition according to claim 1, which is characterized in that propolis raw material used in the propolis alcohol extract is China Poplar type propolis or Detection of Brazilian Propolis.
6. composition according to claim 1, which is characterized in that melissa powder raw material used in the Bee Pollen water extract is Camellia pollen, lotus powder or rape pollen.
7. composition according to claim 1, which is characterized in that the modified pectin powder derives from citrus, apple, Hu Luo Fore-telling, silkworm excrement or sunflower plate raw material.
8. composition according to claim 1, which is characterized in that the gelatin powder is the donkey-hide gelatin that moisture content is lower than 12% It crushed after chilled made from 60 meshes.
9. the preparation method of composition described in claim 1, which comprises the following steps:
The preparation of propolis alcohol extract: propolis raw material refluxing extraction 2- under 70-75 DEG C of heating condition through 70%-75% ethanol solution 4h will be crushed after extract obtained freeze-drying;
The preparation of Bee Pollen water extract: melissa powder raw material extracts 2-4h under 80-95 DEG C of heating condition through distilled water, and gained is mentioned It is crushed after taking object to be lyophilized;
The preparation of modified pectin powder: pectin starting material obtains molecular weight in 2000-30000, esterification degree 5%- through alkaline hydrolysis or enzymatic hydrolysis 35% modified pectin;
The preparation of gelatin powder: it is crushed after moisture content is chilled lower than 12% donkey-hide gelatin;
According still further to weight described in claim 1 by the propolis alcohol extract, Bee Pollen water extract, modified pectin powder and Ah Rubber powder mixing.
10. application of the composition described in claim 1 in the drug, health care product or food of preparation prevention and treatment osteoporosis.
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