CN104721230A - Composite of milk basic protein and milk mineral, preparation method thereof and application - Google Patents
Composite of milk basic protein and milk mineral, preparation method thereof and application Download PDFInfo
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- CN104721230A CN104721230A CN201510171370.6A CN201510171370A CN104721230A CN 104721230 A CN104721230 A CN 104721230A CN 201510171370 A CN201510171370 A CN 201510171370A CN 104721230 A CN104721230 A CN 104721230A
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Abstract
The invention provides a composite of milk basic protein and milk mineral, a preparation method thereof and application. The formulation is an acceptable optional one; the weight ratio of the milk basic protein and milk mineral ranges from 10 : 1 to 50 : 1; the milk basic protein includes milk basic protein or colostrum basic protein. The invention further provides the preparation method of the composite and the application to preparation of medicines preventing osteoporosis, improving bone health, strengthening bone nutrition, protecting bones and reconstructing balance.
Description
Technical field
The present invention relates to a kind of healthy product compositions, and its preparation method and application, the specifically compositions of milk basic protein and newborn mineral salt, with and its preparation method and application.Healthy product compositions of the present invention, includes but not limited to medicine, nutritious health product, medical food, health food or functional food, bread and cheese etc.
Background technology
Milk basic protein take Lac Bovis seu Bubali as raw material, through defat, filtration, concentrated, remove the techniques such as acidic protein, cation chromatography, lyophilization such as casein and make, comprise milk basic protein (Milk Basic Protein, take fresh milk as raw material) and first milk basic protein (Colostrum Basic Protein, cattle colostrums is raw material).Milk basic protein contains the multiple native protein composition that osteogenesis can suppress again bone resorption that can promote, osteocyte can be directly acted in vain, have and promote osteoblast to be formed and regulate the function of osteoclast metabolism, by promoting osteogenesis and suppressing bone resorption, thus raising human bone mineral density, and the balance of bone remoulding can be maintained, to prevention of osteoporosis, improve bone health and there is important function.Ministry of Health of China approved milk basic protein and first milk basic protein are functional new resource food (Ministry of Public Health announces No. 18 files in 2009 and No. 12 file), are natural, safe food or pharmaceutical raw material.
Breast mineral salt, Milk Minerals, usually also referred to as milk calcium, being with the milk surum of milk for raw material, obtaining through removing the composition such as protein, lactose, calcium content 24.0 ~ 28.0%, phosphorus content 10.0 ~ 14.0%, calcium phosphorus ration is reasonable, identical with the ratio 2:1 of calcium phosphorus content in skeleton, be natural, safe calcium source, be conducive to absorption and the utilization of human body.On December 22nd, 2009, health ministry approval milk calcium is functional new resource food (Ministry of Public Health announces No. 18 file in 2009), is natural, safe food or pharmaceutical raw material.
summary of the inventioninventor surprisingly finds; the combination of milk basic protein and newborn mineral salt; especially the combination of special ratios; preventing and treating osteoporosis; improve bone health, improve osteotrophy, protect the aspects such as bone remoulding balance to have good synergistic function; on the other hand, newborn mineral salt significantly can improve milk basic protein stability in the composition.
The object of this invention is to provide a kind of pharmaceutical composition containing milk basic protein and newborn mineral salt, the dosage form of described medicine is any pharmaceutical dosage form of acceptable on pharmaceutics, and described milk basic protein comprises milk basic protein or first milk basic protein.
Another object of the present invention is to provide the preparation method of above-mentioned composition;
The invention still further relates to the application of above-mentioned composition in medicine, medical usage.
Contain a pharmaceutical composition for milk basic protein and newborn mineral salt, its compound mode is existed with the form of compound preparation milk basic protein and newborn mineral salt, and the dosage form of described medicine is any pharmaceutical dosage form of acceptable on pharmaceutics.Use corresponding pharmaceutical carrier or adjuvant, adopt different preparation technologies to can be made into different compound medicinal formulations.Be to be understood that, compound preparation refers to makes independent preparation using milk basic protein and newborn mineral salt as medicament active composition, it can be any pharmaceutical dosage form that pharmaceutics can accept, preferred oral preparation, such as tablet (comprises dispersible tablet, enteric coatel tablets, chewable tablet, oral cavity disintegration tablet, effervescent tablet, Deng), hard capsule (comprising enteric coated capsule), soft capsule, granule, powder, dry suspension, pill, pellet (comprising enteric coated micropill), drop pill, dry syrup, powder, oral solution, oral administration mixed suspension, and oral rapid release or the dosage form such as slow release or controlled release, etc., also can be the dosage form such as rapid release, slow release, controlled release of above various dosage form, such as oral dispersible tablet, slow releasing tablet, slow releasing capsule, enteric coatel tablets, effervescent tablet, oral cavity disintegration tablet, special-shaped tablets, born of the same parents rise granule, etc.Especially, by means known in the art preparation, be preferred for preparing oral solution, tablet (comprising dispersible tablet, slow-release tablet, enteric coatel tablets, effervescent tablet, oral cavity disintegration tablet, special-shaped tablets), capsule (comprising gastric solubleness, enteric, slow releasing capsule) that pharmaceutics uses.Described newborn mineral salt comprises newborn mineral salt or newborn mineral salt.
Preferably give drug regimen of the present invention with single combination preparation form, such as tablet, special in tablet is double-layer tablet, chewable tablet, capsule, granule, powder, dry suspension, oral solution, liquid preparation, spirituosity pharmaceutical solutions, medicinal tea for another example, etc.
Especially, the pharmaceutical composition containing milk basic protein and newborn mineral salt provided by the invention, when pharmaceutical dosage form is the solid preparations such as tablet, capsule, granule, powder or dry suspension, wherein milk basic protein or newborn mineral salt are the compositionss made with micronized form, preferred milk basic protein and newborn mineral salt are pulverized by low-temperature airflow crushing technology, its powder size is greater than 800 orders, and preferred powder size is at 800 ~ 1000 orders, and even the granularity of preferred powder is greater than 1000 orders.
The present invention that another aspect of the present invention provides milk basic protein and newborn mineral salt to exist with the ratio of synergistic drug dose combines.
Another aspect of the present invention provides milk basic protein and newborn mineral salt with the combination of arbitrary proportion, preferably with the present invention's combination that the ratio of synergistic dosage exists, breast mineral salt and milk basic protein are (10 ~ 50) with weight ratio: the ratio combination of 1
Preferred newborn mineral salt and milk basic protein are (10 ~ 20) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (12 ~ 45) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (15 ~ 40) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (18 ~ 38) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (20 ~ 35) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (22 ~ 30) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (25 ~ 50) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (25 ~ 45) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (25 ~ 40) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (25 ~ 35) with weight ratio: the ratio combination of 1;
Concrete, such as preferred newborn mineral salt and milk basic protein are that 10:1,11:1,12:1,13:1,14:1,15:1,16:1,17:1,18:1,19:1,20:1,21:1,22:1,23:1,24:1,25:1,26:1,27:1,28:1,29:1,30:1,31:1,32:1,33:1,34:1,35:1,36:1,37:1,38:1,39:1,40:1,41:1,42:1,43:1,44:1,45:1,46:1,47:1,48:1,49:1,50:1 equal proportion combines with weight ratio, and described milk basic protein comprises milk basic protein or first milk basic protein.
Show when in described compositions, milk basic protein generally can adopt it to be used alone with the consumption of newborn mineral salt treat or the amount of preventive effect effect more favourable.
The oral applicable dosage of milk basic protein is generally adult's 0.05 ~ 1g level every day and gives this compound, preferred every day gives 0.1 ~ 0.8g, single or gradation give this compound, such as often meal gives 0.05g, 0.1g, 0.15g, 0.2g, 0.25g, 0.3g, 0.35g, 0.4g, 0.45g, 0.5g, 0.55g, 0.6g, 0.65g, 0.7g, 0.75g, 0.8g, 0.85g, 0.9g, the milk basic protein of 0.95g or 1g, and, give the newborn mineral salt of effective dose, give the newborn mineral salt of 0.5 ~ 5g preferred every day, single or gradation give this compound, such as each or give 0.5g every day, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, the newborn mineral salt of 4.5g or 5g, etc., described milk basic protein comprises milk basic protein or first milk basic protein.
Preferably, the pharmaceutical composition of milk basic protein and newborn mineral salt, wherein contains the milk basic protein of 0.05 ~ 1g and the newborn mineral salt of 0.5 ~ 5g in preferred per unit preparation; Most preferably contain the milk basic protein of 0.1 ~ 0.5g and the newborn mineral salt of 1 ~ 3g in per unit preparation;
Concrete, containing the milk basic protein of 0.05g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.05g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.05g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.05g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.05g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.05g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.05g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.05g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.05g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.05g and the newborn mineral salt of 5g in per unit preparation,
Containing the milk basic protein of 0.08g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.08g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.08g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.08g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.08g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.08g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.08g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.08g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.08g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.08g and the newborn mineral salt of 5g in per unit preparation,
Containing the milk basic protein of 0.1g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.1g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.1g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.1g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.1g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.1g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.1g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.1g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.1g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.1g and the newborn mineral salt of 5g in per unit preparation,
Containing the milk basic protein of 0.15g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.15g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.15g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.15g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.15g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.15g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.15g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.15g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.15g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.15g and the newborn mineral salt of 5g in per unit preparation,
Containing the milk basic protein of 0.2g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.2g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.2g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.2g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.2g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.2g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.2g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.2g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.2g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.2g and the newborn mineral salt of 5g in per unit preparation,
Containing the milk basic protein of 0.25g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.25g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.25g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.25g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.25g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.25g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.25g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.25g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.25g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.25g and the newborn mineral salt of 5g in per unit preparation,
Containing the milk basic protein of 0.3g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.3g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.3g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.3g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.3g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.3g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.3g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.3g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.3g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.3g and the newborn mineral salt of 5g in per unit preparation,
Containing the milk basic protein of 0.35g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.35g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.35g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.35g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.35g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.35g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.35g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.35g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.35g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.35g and the newborn mineral salt of 5g in per unit preparation,
Containing the milk basic protein of 0.4g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.4g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.4g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.4g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.4g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.4g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.4g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.4g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.4g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.4g and the newborn mineral salt of 5g in per unit preparation
Containing the milk basic protein of 0.45g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.45g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.45g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.45g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.45g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.45g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.45g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.45g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.45g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.45g and the newborn mineral salt of 5g in per unit preparation
Containing the milk basic protein of 0.5g and the newborn mineral salt of 0.5g in per unit preparation,
Containing the milk basic protein of 0.5g and the newborn mineral salt of 1g in per unit preparation,
Containing the milk basic protein of 0.5g and the newborn mineral salt of 1.5g in per unit preparation,
Containing the milk basic protein of 0.5g and the newborn mineral salt of 2g in per unit preparation,
Containing the milk basic protein of 0.5g and the newborn mineral salt of 2.5g in per unit preparation,
Containing the milk basic protein of 0.5g and the newborn mineral salt of 3g in per unit preparation,
Containing the milk basic protein of 0.5g and the newborn mineral salt of 3.5g in per unit preparation,
Containing the milk basic protein of 0.5g and the newborn mineral salt of 4g in per unit preparation,
Containing the milk basic protein of 0.5g and the newborn mineral salt of 4.5g in per unit preparation,
Containing the milk basic protein of 0.5g and the newborn mineral salt of 5g in per unit preparation;
Described milk basic protein comprises milk basic protein or first milk basic protein; Described " per unit preparation " refers to the preparation unit of minimum package or minimum form of medication, comprises each bag of granule or powder, each bottle of emulsion formulations, each seed lac wafer, each tablet or pill, etc.
Usually can give the active component of drug regimen with chemical raw material form, but preferably give with Pharmaceutical composition form.Pharmaceutical composition of the present invention comprises milk basic protein and newborn mineral salt, and the drug regimen of the present invention of one or more pharmaceutically acceptable carriers or excipient.These carriers must be acceptable, can with other component compatibility of formula, and nontoxic to its receiver.When giving separately each component of said composition, they are each form of Pharmaceutical composition naturally generally.Unless otherwise indicated, the compositions of indication of the present invention refers to the drug regimen containing milk basic protein and newborn mineral salt, or the compositions of the wherein drug regimen of each component of milk basic protein and newborn mineral salt.
Preferably, the combination of milk basic protein and newborn mineral salt is generally the Pharmaceutical composition with one or more pharmaceutically acceptable carriers of unit dosage form, and the dosage of the milk basic protein contained in conventional unit formulation and newborn mineral salt is clear and definite in the foregoing.
Use corresponding, different pharmaceutical carriers and preparation technology, pharmaceutical composition of the present invention can be made different pharmaceutical dosage forms.What those skilled in the art were appreciated that is, these pharmaceutical carriers be become various dosage form for the ease of production and processing, guarantee medicine safe, effectively with the factor such as to stablize, and to select according to the physicochemical property of different pharmaceutical dosage forms and medicine self.The choice for use of pharmaceutical carrier is that those of skill in the art of the present invention know with apparent.
Be to be understood that, for oral agents, according to method well known in the art, usually according to the pharmaceutical carrier that different medicaments is selected or combinationally used, optionally comprise excipient or diluent, such as microcrystalline Cellulose, mannitol, non-dairy creamer, lactose, pregelatinized Starch, starch, dextrin, cyclodextrin, calcium phosphate, calcium hydrogen phosphate, hydroxypropyl emthylcellulose, sucrose, dextran, poloxamer, sodium chloride, sorbitol, glucose, polydextrose, oligofructose, Oligomeric manna sugar, resistant dextrin, fructose, water, Polyethylene Glycol, propylene glycol, glycerol, cyclodextrin and derivant thereof, etc., for oral solid formulation, optionally can also comprise binding agent, such as polyvidone (polyvinylpyrrolidone), methylcellulose, hydroxy methocel, hydroxypropyl methylcellulose, pregelatinized Starch, carboxymethyl starch sodium, hydroxypropyl cellulose, hydroxyethyl-cellulose, gelatin, guar gum, xanthan gum, etc., also comprise lubricant, such as magnesium stearate, stearic acid, Pulvis Talci, stearyl fumarate, sodium lauryl sulphate, etc., also optionally comprise disintegrating agent, such as carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, pregelatinized Starch, etc., also optionally comprise surfactant or cosolvent, such as sodium lauryl sulphate, Tween-80, etc., also can comprise pH value regulator or buffer agent or cosolvent, such as phosphate buffer, citric acid, sodium citrate, acetate buffer, dilute hydrochloric acid, lactic acid, sodium carbonate, sodium hydroxide, alkaline organic compound, as arginine, lysine, meglumine, trometamol, etc., also optionally comprise antiseptic, such as sodium benzoate, potassium sorbate, methyl parahydroxybenzoate, propyl p-hydroxybenzoate, etc., also optionally comprise stabilizing agent and antioxidant, such as metal chelating agent selects ethylenediaminetetraacetic acid and salt (calcium disodium edetate, disodium edetate) etc. thereof, sodium sulfite, sodium pyrosulfite, vitamin C, vitamin E, etc., also optionally comprise taste regulator, such as maltose alcohol, fructose, sucrose, saccharin sodium, flavoring orange essence, strawberry essence, etc., that also can comprise other routine in addition, appropriate additive.It is also understood that agent type be tablet or capsule time, can be film coating.For the material of film coating, comprise applicable coating materials, such as hydroxypropyl methylcellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose phthalate (enteric-coating material), etc.; Also can comprise plasticizer, such as Polyethylene Glycol, triethyl citrate, etc.; Also optionally comprise suitable solubilizing agent, as Polyoxyethylene Sorbitan Monooleate; Also can comprise suitable pigment, as titanium dioxide, various ferrum oxide, pink pigment, etc.Should be appreciated that above-mentioned " optionally comprising " refers to namely can optionally choice for use, also can not use.
Especially, the pharmaceutical composition of milk basic protein of the present invention and newborn mineral salt, milk basic protein can be different on medicament releasing pattern from the chemical composition of newborn mineral salt, such as milk basic protein can the form of slow release or controlled release occur, and newborn mineral salt also can the form of slow release or controlled release occur, to improve the not synergism of the blood drug level that milk basic protein and the time difference of newborn mineral salt in onset or metabolism cause.
In the present patent application, " compositions " refer on one or more described compounds or its physiology/pharmaceutically acceptable salt or prodrug, with other chemical composition, such as, on physiology/and the mixture that formed of pharmaceutically acceptable carrier or excipient, the object of pharmaceutical composition is conducive to the using of medicine, carries, preserves; " administration " mentioned here refer in order to prevent or disease therapy and to organism (comprising patient or healthy population) deliver described in compound, its pharmaceutically useful salt or its solvate; Described " per unit preparation " refers to the preparation unit of minimum package or minimum form of medication, comprises each bag of granule or powder, each bottleneck takes emulsion agent, each seed lac wafer, each tablet or pill, each pipe ointment, etc.
On the other hand, have now found that, when milk basic protein and newborn mineral salt combinationally use, it demonstrates unexpected advantage, especially this drug regimen demonstrates outstanding, beyond thoughtly preventing and treating osteoporosis, improve bone health, strengthening osteotrophy, the aspects such as protection bone remoulding balance have good synergistic function, preferably, the pharmaceutical composition of milk basic protein of the present invention and newborn mineral salt, for the preparation of the application in the osteoporotic medicine of control, preparing the application improved in the medicine of bone health, application in the medicine of preparation strengthening osteotrophy, application in the medicine of preparation protection bone remoulding balance, etc..
Therefore, on the other hand, the invention provides a kind of pharmaceutical composition prevented and treated osteoporosis, improve bone health, strengthen osteotrophy, protect bone remoulding balance, it contains milk basic protein and newborn mineral salt.It will be appreciated by those skilled in the art that, in its pharmaceutical composition, dosage ratio in the compound mode of milk basic protein and newborn mineral salt, per unit preparation and content, just the same with the aforesaid content of the present invention, described milk basic protein comprises milk basic protein or first milk basic protein.
Further, present invention also offers the preparation method of the pharmaceutical composition of milk basic protein and newborn mineral salt, it comprises and milk basic protein and newborn mineral salt is mixed with pharmaceutically acceptable pharmaceutical carrier and make acceptable any pharmaceutical preparation on pharmaceutics, such as milk basic protein and newborn mineral salt and pharmaceutical carrier dry powder blend, dry granulation mixing (dry granulating machine process), wet granulation mixing (with water or alcoholic solution wet granulation), liquid or semisolid mixes (as the content of soft capsule, drop pill dropping liquid mixes) etc., preferred pharmaceutical dosage form is granule, dry suspension, tablet (comprises dispersible tablet, enteric coatel tablets, chewable tablet, oral cavity disintegration tablet, effervescent tablet etc.), hard capsule (comprising enteric coated capsule), oral solution, dry syrup, powder, oral administration mixed suspension, soft capsule, pill, pellet (comprising enteric coated micropill), drop pill, and oral rapid release or the dosage form such as slow release or controlled release, also can be the rapid release of above various dosage form, slow release, the dosage forms such as controlled release, such as oral dispersible tablet, slow releasing tablet, slow releasing capsule, enteric coatel tablets, effervescent tablet, oral cavity disintegration tablet, special-shaped tablets, born of the same parents rise granule, etc.Especially, by means known in the art preparation, be preferred for preparing tablet (comprising dispersible tablet, slow-release tablet, enteric coatel tablets, effervescent tablet, oral cavity disintegration tablet, special-shaped tablets), capsule (comprising gastric solubleness, enteric, slow releasing capsule), oral solution etc. that pharmaceutics uses.
Preferably, the invention provides a kind of granule containing milk basic protein and newborn mineral salt, described newborn mineral salt and milk basic protein are (10 ~ 50) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (10 ~ 20) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (12 ~ 45) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (15 ~ 40) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (18 ~ 38) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (20 ~ 35) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (22 ~ 30) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (25 ~ 50) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (25 ~ 45) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (25 ~ 40) with weight ratio: the ratio combination of 1,
Preferred newborn mineral salt and milk basic protein are (25 ~ 35) with weight ratio: the ratio combination of 1; Described milk basic protein comprises milk basic protein or first milk basic protein; Concrete, such as preferred newborn mineral salt and milk basic protein are that 10:1,11:1,12:1,13:1,14:1,15:1,16:1,17:1,18:1,19:1,20:1,21:1,22:1,23:1,24:1,25:1,26:1,27:1,28:1,29:1,30:1,31:1,32:1,33:1,34:1,35:1,36:1,37:1,38:1,39:1,40:1,41:1,42:1,43:1,44:1,45:1,46:1,47:1,48:1,49:1,50:1 equal proportion combines with weight ratio, and described milk basic protein comprises milk basic protein or first milk basic protein; Described compositions is optionally also containing granule adjuvant, and described granule adjuvant is selected from least one in fructose, xylitol, steviol glycosides, starch, microcrystalline Cellulose, dextrin, cyclodextrin, resistant dextrin, carboxymethyl cellulose, hydroxypropyl methylcellulose, pregelatinized Starch, carboxymethyl starch sodium, sucralose, Sorbitol, protein sugar, aspartame, acesulfame potassium, stachyose, neotame, Mel, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, non-dairy creamer, milk powder, vegetable protein powder, coffee.
Further, the invention provides a kind of preparation method containing the granule of milk basic protein and newborn mineral salt, it comprises: milk basic protein, newborn mineral salt are mixed homogeneously with granule adjuvant respectively, then use ethanol water wet granulation, dry, granulate; Especially, the invention provides a kind of preparation method containing the granule of milk basic protein and newborn mineral salt, it comprises:
(1) prepare burden: take milk basic protein, newborn mineral salt by formula, mix homogeneously;
(2) granulate: by the material 75% alcoholic solution wet granulation prepared in (1), 45 ~ 70 DEG C of dryings, granulate;
(3) pack, check, obtain the granule that the present invention contains milk basic protein and newborn mineral salt;
Or, a kind of preparation method containing the granule of milk basic protein and newborn mineral salt, it comprises:
(1) prepare burden: take milk basic protein, newborn mineral salt by formula, first milk basic protein is mixed homogeneously with newborn mineral salt, then add granule adjuvant mix homogeneously;
(2) granulate: by the material 75% alcoholic solution wet granulation prepared in (1), 45 ~ 70 DEG C of dryings, granulate;
(3) pack, check, obtain the granule that the present invention contains milk basic protein and newborn mineral salt;
Described granule adjuvant comprises one or more compositions following: fructose, xylitol, steviol glycosides, starch, microcrystalline Cellulose, dextrin, cyclodextrin, resistant dextrin, carboxymethyl cellulose, hydroxypropyl methylcellulose, pregelatinized Starch, carboxymethyl starch sodium, sucralose, Sorbitol, protein sugar, aspartame, acesulfame potassium, stachyose, neotame, Mel, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, non-dairy creamer, milk powder, vegetable protein powder, coffee, described milk basic protein comprises milk basic protein or first milk basic protein.
Further, the compositions of milk basic protein of the present invention and newborn mineral salt, preferably milk basic protein and newborn mineral salt are combined with the form of solid dispersion, be beneficial to obtain the higher compositions of mixing homogeneity, its preparation method comprises and is dissolved or dispersed in solvent by milk basic protein and newborn mineral salt, from this mixture, desolventizing is removed after mix homogeneously, and it is dry and pulverize and obtain solid dispersion, wherein said solvent is selected from purified water or ethanol-water solution, the ethanol water etc. of such as 75%, Rotary Evaporators can be taked to steam except desolventizing and dry method to remove, remove under reduced pressure, drying under reduced pressure, vacuum drying, lyophilization, spraying dry, fluid bed drying, one or more in heating, drying.
Further, the present invention also provides the compositions of milk basic protein and newborn mineral salt preparing the application prevented and treated in osteoporotic medicine;
Preparing the application improved in the medicine of bone health;
Application in the medicine of preparation strengthening osteotrophy;
Application in the medicine of preparation protection bone remoulding balance, etc.;
Described milk basic protein comprises milk basic protein or first milk basic protein.
The combination of milk basic protein of the present invention and newborn mineral salt; preventing and treating osteoporosis; improve bone health, improve osteotrophy, protect the aspects such as bone remoulding balance to have good synergistic function, on the other hand, newborn mineral salt significantly can improve milk basic protein stability in the composition.
detailed description of the inventionin implementation process of the present invention, those of ordinary skill in the art are not departing from the scope of the present invention various embodiment that the basis with spirit produces and are modifying apparent and be easily carry out.By the following examples application of the present invention etc. done and illustrate further, but do not represent embodiment limitation of the present invention.
The compound granule of embodiment 1, milk basic protein and newborn mineral salt and preparation thereof
Recipe quantity by weight percentage, contains:
Milk basic protein 1.8% ~ 10%, is preferably 3.85%,
Breast mineral salt 90% ~ 98.2%, is preferably 96.15%;
Its preparation method comprises: milk basic protein, newborn mineral salt are crossed 80 mesh sieves respectively, preferred mistake 100 order, after taking by recipe quantity, and mix homogeneously, with 75% alcoholic solution wet granulation, 45 ~ 70 DEG C of dryings, granulate, pack, sealing, to obtain final product; Wherein said milk basic protein comprises milk basic protein or first milk basic protein.
Steady quality Journal of Sex Research shows, the compound granule of above-mentioned milk basic protein and newborn mineral salt has good quality stability.
The compound granule of embodiment 2, milk basic protein and newborn mineral salt and preparation thereof
Recipe quantity by weight percentage, contains:
Milk basic protein 1.5% ~ 8%, is preferably 3%,
Breast mineral salt 15% ~ 55%, is preferably 35%,
Granule adjuvant 30% ~ 65%, is preferably 62%;
Its preparation method comprises: milk basic protein, newborn mineral salt, granule adjuvant are crossed 80 mesh sieves respectively, preferred mistake 100 order, after taking by recipe quantity, first milk basic protein is mixed homogeneously with newborn mineral salt, then after adding granule adjuvant mix homogeneously, with 75% alcoholic solution wet granulation, 45 ~ 70 DEG C of dryings, granulate packaging, inspection, to obtain final product;
Wherein said milk basic protein comprises milk basic protein or first milk basic protein, described granule adjuvant comprises one or more compositions following: fructose, xylitol, Sorbitol, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, starch, microcrystalline Cellulose, dextrin, cyclodextrin, resistant dextrin, carboxymethyl cellulose, hydroxypropyl methylcellulose, pregelatinized Starch, carboxymethyl starch sodium, sucralose, steviol glycosides, protein sugar, aspartame, acesulfame potassium, stachyose, neotame, Mel, non-dairy creamer, milk powder, vegetable protein powder, coffee, be preferably fructose, xylitol, Sorbitol, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, most preferably be fructose or/and oligofructose.
Steady quality Journal of Sex Research shows, the compound granule of above-mentioned milk basic protein and newborn mineral salt has good quality stability.
The compound granule of embodiment 3, milk basic protein and newborn mineral salt and preparation thereof
Recipe quantity by weight percentage, contains:
Milk basic protein 1% ~ 10%, is preferably 2%,
Breast mineral salt 10% ~ 60%, is preferably 50%,
Granule adjuvant 40% ~ 65%, is preferably 48%;
Its preparation method comprises: milk basic protein, newborn mineral salt, granule adjuvant are crossed 80 mesh sieves respectively, preferred mistake 100 order, after taking by recipe quantity, first milk basic protein is mixed homogeneously with newborn mineral salt, then after adding granule adjuvant mix homogeneously, with 75% alcoholic solution wet granulation, 45 ~ 70 DEG C of dryings, granulate packaging, inspection, to obtain final product;
Wherein said milk basic protein comprises milk basic protein or first milk basic protein, described granule adjuvant comprises one or more compositions following: fructose, xylitol, Sorbitol, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, starch, microcrystalline Cellulose, dextrin, cyclodextrin, resistant dextrin, carboxymethyl cellulose, hydroxypropyl methylcellulose, pregelatinized Starch, carboxymethyl starch sodium, sucralose, steviol glycosides, protein sugar, aspartame, acesulfame potassium, stachyose, neotame, Mel, non-dairy creamer, milk powder, vegetable protein powder, coffee, be preferably fructose, xylitol, Sorbitol, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, most preferably be fructose or/and oligofructose.
Steady quality Journal of Sex Research shows, the compound granule of above-mentioned milk basic protein and newborn mineral salt has good quality stability.
The compound tablet of embodiment 4, milk basic protein and newborn mineral salt and preparation thereof
Recipe quantity by weight percentage, contains:
Milk basic protein 3% ~ 5%, is preferably 3.5%,
Breast mineral salt 30% ~ 50%, is preferably 45%,
Mannitol 15% ~ 45%, is preferably 35%,
Pregelatinized Starch 8% ~ 25%, is preferably 12%,
Carboxymethyl starch sodium 1% ~ 10%, is preferably 3.5%,
75% alcoholic solution is appropriate,
Magnesium stearate 0.5% ~ 2%, is preferably 1%;
Its preparation method comprises: milk basic protein, newborn mineral salt, mannitol, pregelatinized Starch, carboxymethyl starch sodium are crossed 80 mesh sieves respectively, preferred mistake 100 mesh sieve, after taking by recipe quantity, first by milk basic protein and newborn mineral salt mix homogeneously, obtain A mixed-powder, stand-by; Another by mannitol, pregelatinized Starch, carboxymethyl starch sodium mix homogeneously, obtain B mixed-powder, then A mixed-powder is fully mixed homogeneously with B mixed-powder, add 75% alcoholic solution and make soft material, cross 20 mesh sieves to granulate, 45 ~ 70 DEG C of oven dry, granulate, add tabletting after magnesium stearate mix homogeneously, to obtain final product.
Steady quality Journal of Sex Research shows, the compound tablet of above-mentioned milk basic protein and newborn mineral salt has good quality stability.
The compositions of embodiment 5, milk basic protein and newborn mineral salt strengthening osteotrophy, strengthen significance effect in bone density and significance
Laboratory animal: SPF level SD rat in healthy 4 week age, female, body weight 60 ~ 75g.
Experiment grouping:
(1) blank group: normal care and diet;
(2) milk basic protein group: on the basis of normal care and diet, feed milk basic protein, dosage is 10mg/kg weighing machine every day;
(3) newborn mineral salt group: on the basis of normal care and diet, feed breast mineral salt, dosage is 150mg/kg weighing machine every day;
(4) milk basic protein breast mineral salt group: on the basis of normal care and diet, feed milk basic protein and newborn mineral salt, wherein milk basic protein dosage is 10mg/kg weighing machine every day, the proportioning feed that breast mineral salt dosage is 10:1,12:1,14:1,16:1,18:1,20:1 with the weight ratio with milk basic protein, namely newborn mineral salt dosage is for pressing 100mg/kg body weight every day, 120mg/kg body weight, 140mg/kg body weight, 160mg/kg body weight, 180mg/kg body weight, 200mg/kg weighing machine;
Above-mentioned each group of Continuous Nursing feed 90 days, fasting 12 hours, after putting to death rat, wins rats with bilateral femur and tibia, picks clean attachment, measures bone density, bone calcium mass fraction.
Statistical procedures: application SPSS13.0 software carries out analytic statistics; Wherein measurement data adopt mean ± standard deviation (
) represent, represent that difference has statistical significance with P<0.05.
Result is as following table 1.
Table 1 respectively organize bone density, bone calcium data (
, n=15)
In upper table, compare with milk basic protein group, newborn mineral salt group with each group in string, * is that group difference has significance, P < 0.05; # is that group difference has very significant, P < 0.01;
Conclusion: from table 1, each group of femur distal end bone density, femur mid point bone density, bone calcium mass fraction compare, the weight proportion (10 ~ 20) of breast mineral salt and milk basic protein: the compositions of 1, its femur distal end bone density, femur mid point bone density, bone calcium mass fraction compare with milk basic protein group, newborn mineral salt group, all have significant difference statistically or significant differences; This is significant for preventing and treating osteoporosis, strengthening osteotrophy and improving the aspects such as bone health, demonstrates creativeness of the present invention.
Embodiment 6, newborn mineral salt and milk basic protein are with the stability study of the compositions of Different Weight ratio
Basic research shows, the stability of breast mineral salt is better, but the less stable of newborn alkaline egg, especially to thermo-responsive, by newborn mineral salt and milk basic protein with the compositions of Different Weight proportioning, find that the heat stability of newborn mineral salt to milk basic protein has facilitation.
Test method: according to the preparation method of embodiment 1, prepare newborn mineral salt respectively and milk basic protein weight proportion is the granule composite of 2:1,4:1,6:1,8:1,10:1,12:1, granule composite is placed in 45 DEG C and carries out acceleration heat stability investigation 30d, check the purity of each granule composite at the milk basic protein of 0 day and 30 days, calculate the denaturation rate (degradation rate) of milk basic protein.
Detection method: adopt cellulose acetate electrophoresis method.
Result is as following table 2.
Table 2
As can be seen from Table 2, in the compositions of the different ratio of breast mineral salt and milk basic protein, along with the amount of newborn mineral salt increases, the denaturation rate of milk basic protein reduces, especially when the weight proportion of newborn mineral salt and milk basic protein is greater than 10:1, the denaturation rate of milk basic protein is minimum, reach the requirement of quality control standard, analyze its reason, may be the degeneration of the mineral composition in newborn mineral salt to milk basic protein on the one hand, degrade inhibited, the increase along with newborn mineral salt ratio on the other hand, mineral composition in breast mineral salt forms parcel effect to milk basic protein, absorb and disperseed heat, reduce the heat effect to milk basic protein, the effect that two aspects are common, the stability of compositions is significantly improved, and can find out, when the weight proportion of newborn mineral salt and milk basic protein is greater than 10:1, compared with the compositions of other proportioning, in the stability improving compositions, to there is significant difference, embody creativeness of the present invention further.
The application in following of the compositions of embodiment 7, milk basic protein described in embodiment 1 to embodiment 4 and newborn mineral salt:
Application in the osteoporotic medicine of preparation control;
Preparing the application improved in the medicine of bone health;
Application in the medicine of preparation strengthening osteotrophy;
Application in the medicine of preparation protection bone remoulding balance.
Claims (10)
1. contain the pharmaceutical composition of milk basic protein and newborn mineral salt, the dosage form of described medicine is any pharmaceutical dosage form of acceptable on pharmaceutics, wherein newborn mineral salt and milk basic protein are (10 ~ 50) with weight ratio: the ratio combination of 1, and described milk basic protein comprises milk basic protein or first milk basic protein.
2. contain the pharmaceutical composition of milk basic protein and newborn mineral salt, the dosage form of described medicine is any pharmaceutical dosage form of acceptable on pharmaceutics, wherein newborn mineral salt and milk basic protein are (10 ~ 20) with weight ratio: the ratio combination of 1, and described milk basic protein comprises milk basic protein or first milk basic protein.
3. the pharmaceutical composition of milk basic protein and newborn mineral salt, wherein contains the milk basic protein of 0.05 ~ 1g and the newborn mineral salt of 0.5 ~ 5g in per unit preparation; Most preferably contain the milk basic protein of 0.1 ~ 0.5g and the newborn mineral salt of 1 ~ 3g in per unit preparation; Described milk basic protein comprises milk basic protein or first milk basic protein, described " per unit preparation " refers to the preparation unit of minimum package or minimum form of medication, comprises each bag of granule or powder, each bottle of emulsion formulations, each seed lac wafer, each tablet or pill.
4. described in claim 1 to claim 3, any one contains the preparation method of the pharmaceutical composition of milk basic protein and newborn mineral salt, and it comprises and milk basic protein and newborn mineral salt is mixed with pharmaceutically acceptable pharmaceutical carrier and make acceptable any pharmaceutical preparation on pharmaceutics.
5. one kind contains the granule of milk basic protein and newborn mineral salt, described newborn mineral salt and milk basic protein are (10 ~ 50) with weight ratio: the ratio combination of 1, preferred newborn mineral salt and milk basic protein are (10 ~ 20) with weight ratio: the ratio combination of 1, described compositions is optionally containing granule adjuvant, wherein granule adjuvant is selected from fructose, xylitol, steviol glycosides, starch, microcrystalline Cellulose, dextrin, cyclodextrin, resistant dextrin, carboxymethyl cellulose, hydroxypropyl methylcellulose, pregelatinized Starch, carboxymethyl starch sodium, sucralose, Sorbitol, protein sugar, aspartame, acesulfame potassium, stachyose, neotame, Mel, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, non-dairy creamer, milk powder, vegetable protein powder, at least one in coffee, the preparation method of described granule comprises:
(1) prepare burden: take milk basic protein, newborn mineral salt by formula, mix homogeneously;
(2) granulate: by the material 75% alcoholic solution wet granulation prepared in (1), 45 ~ 70 DEG C of dryings, granulate;
(3) pack, check, obtain the granule that the present invention contains milk basic protein and newborn mineral salt;
Or, a kind of preparation method containing the granule of milk basic protein and newborn mineral salt, it comprises:
(1) prepare burden: take milk basic protein, newborn mineral salt by formula, first milk basic protein is mixed homogeneously with newborn mineral salt, then add granule adjuvant mix homogeneously;
(2) granulate: by the material 75% alcoholic solution wet granulation prepared in (1), 45 ~ 70 DEG C of dryings, granulate;
(3) pack, check, obtain the granule that the present invention contains milk basic protein and newborn mineral salt;
Described milk basic protein comprises milk basic protein or first milk basic protein.
6. a compound granule for milk basic protein and newborn mineral salt, its recipe quantity by weight percentage, contains:
Milk basic protein 1.8% ~ 10%, is preferably 3.85%,
Breast mineral salt 90% ~ 98.2%, is preferably 96.15%;
Its preparation method comprises: milk basic protein, newborn mineral salt are crossed 80 mesh sieves respectively, preferred mistake 100 order, after taking by recipe quantity, and mix homogeneously, with 75% alcoholic solution wet granulation, 45 ~ 70 DEG C of dryings, granulate, pack, sealing, to obtain final product; Wherein said milk basic protein comprises milk basic protein or first milk basic protein.
7. a compound granule for milk basic protein and newborn mineral salt, its recipe quantity by weight percentage, contains:
Milk basic protein 1.5% ~ 8%, is preferably 3%,
Breast mineral salt 15% ~ 55%, is preferably 35%,
Granule adjuvant 30% ~ 65%, is preferably 62%;
Its preparation method comprises: milk basic protein, newborn mineral salt, granule adjuvant are crossed 80 mesh sieves respectively, preferred mistake 100 order, after taking by recipe quantity, first milk basic protein is mixed homogeneously with newborn mineral salt, then after adding granule adjuvant mix homogeneously, with 75% alcoholic solution wet granulation, 45 ~ 70 DEG C of dryings, granulate packaging, inspection, to obtain final product;
Wherein said milk basic protein comprises milk basic protein or first milk basic protein, described granule adjuvant comprises one or more compositions following: fructose, xylitol, Sorbitol, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, starch, microcrystalline Cellulose, dextrin, cyclodextrin, resistant dextrin, carboxymethyl cellulose, hydroxypropyl methylcellulose, pregelatinized Starch, carboxymethyl starch sodium, sucralose, steviol glycosides, protein sugar, aspartame, acesulfame potassium, stachyose, neotame, Mel, non-dairy creamer, milk powder, vegetable protein powder, coffee, be preferably fructose, xylitol, Sorbitol, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, most preferably be fructose or/and oligofructose.
8. a compound granule for milk basic protein and newborn mineral salt, its recipe quantity by weight percentage, contains:
Milk basic protein 1% ~ 10%, is preferably 2%,
Breast mineral salt 10% ~ 60%, is preferably 50%,
Granule adjuvant 40% ~ 65%, is preferably 48%;
Its preparation method comprises: milk basic protein, newborn mineral salt, granule adjuvant are crossed 80 mesh sieves respectively, preferred mistake 100 order, after taking by recipe quantity, first milk basic protein is mixed homogeneously with newborn mineral salt, then after adding granule adjuvant mix homogeneously, with 75% alcoholic solution wet granulation, 45 ~ 70 DEG C of dryings, granulate packaging, inspection, to obtain final product;
Wherein said milk basic protein comprises milk basic protein or first milk basic protein, described granule adjuvant comprises one or more compositions following: fructose, xylitol, Sorbitol, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, starch, microcrystalline Cellulose, dextrin, cyclodextrin, resistant dextrin, carboxymethyl cellulose, hydroxypropyl methylcellulose, pregelatinized Starch, carboxymethyl starch sodium, sucralose, steviol glycosides, protein sugar, aspartame, acesulfame potassium, stachyose, neotame, Mel, non-dairy creamer, milk powder, vegetable protein powder, coffee, be preferably fructose, xylitol, Sorbitol, polydextrose, hydroxyl isomaltulose, oligofructose, Oligomeric manna sugar, most preferably be fructose or/and oligofructose.
9. a compound tablet for milk basic protein and newborn mineral salt, its recipe quantity by weight percentage, contains:
Milk basic protein 3% ~ 5%, is preferably 3.5%,
Breast mineral salt 30% ~ 50%, is preferably 45%,
Mannitol 15% ~ 45%, is preferably 35%,
Pregelatinized Starch 8% ~ 25%, is preferably 12%,
Carboxymethyl starch sodium 1% ~ 10%, is preferably 3.5%,
75% alcoholic solution is appropriate,
Magnesium stearate 0.5% ~ 2%, is preferably 1%;
Its preparation method comprises: milk basic protein, newborn mineral salt, mannitol, pregelatinized Starch, carboxymethyl starch sodium are crossed 80 mesh sieves respectively, preferred mistake 100 mesh sieve, after taking by recipe quantity, first by milk basic protein and newborn mineral salt mix homogeneously, obtain A mixed-powder, stand-by; Another by mannitol, pregelatinized Starch, carboxymethyl starch sodium mix homogeneously, obtain B mixed-powder, then A mixed-powder is fully mixed homogeneously with B mixed-powder, add 75% alcoholic solution and make soft material, cross 20 mesh sieves to granulate, 45 ~ 70 DEG C of oven dry, granulate, add tabletting after magnesium stearate mix homogeneously, to obtain final product.
10. the application of the pharmaceutical composition that contains milk basic protein and newborn mineral salt of any one described in claim 1 to claim 3, claim 5 to claim 9 in following:
Application in the osteoporotic medicine of preparation control;
Preparing the application improved in the medicine of bone health;
Application in the medicine of preparation strengthening osteotrophy;
Application in the medicine of preparation protection bone remoulding balance.
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| CN113558247A (en) * | 2021-08-03 | 2021-10-29 | 汤臣倍健股份有限公司 | A method for preparing tablet containing high content of milk mineral salt |
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| CN113558247A (en) * | 2021-08-03 | 2021-10-29 | 汤臣倍健股份有限公司 | A method for preparing tablet containing high content of milk mineral salt |
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