CN106074767A - A kind of Biocal and preparation method thereof - Google Patents
A kind of Biocal and preparation method thereof Download PDFInfo
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- CN106074767A CN106074767A CN201610490725.2A CN201610490725A CN106074767A CN 106074767 A CN106074767 A CN 106074767A CN 201610490725 A CN201610490725 A CN 201610490725A CN 106074767 A CN106074767 A CN 106074767A
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- calcium carbonate
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- vitamin
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- 238000002360 preparation method Methods 0.000 title claims abstract description 31
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims abstract description 138
- 239000000843 powder Substances 0.000 claims abstract description 127
- 229910000019 calcium carbonate Inorganic materials 0.000 claims abstract description 69
- 239000008267 milk Substances 0.000 claims abstract description 58
- 210000004080 milk Anatomy 0.000 claims abstract description 58
- 235000013336 milk Nutrition 0.000 claims abstract description 58
- 239000000463 material Substances 0.000 claims abstract description 57
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 claims abstract description 51
- 239000011647 vitamin D3 Substances 0.000 claims abstract description 49
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 claims abstract description 49
- 235000005282 vitamin D3 Nutrition 0.000 claims abstract description 49
- 229940021056 vitamin d3 Drugs 0.000 claims abstract description 49
- 239000000084 colloidal system Substances 0.000 claims abstract description 36
- 239000002671 adjuvant Substances 0.000 claims abstract description 27
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 17
- 238000007907 direct compression Methods 0.000 claims abstract description 16
- 239000007788 liquid Substances 0.000 claims abstract description 16
- 239000008213 purified water Substances 0.000 claims abstract description 15
- 238000003756 stirring Methods 0.000 claims abstract description 15
- 239000011812 mixed powder Substances 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 14
- 239000002994 raw material Substances 0.000 abstract description 16
- 229960003563 calcium carbonate Drugs 0.000 description 62
- 238000012360 testing method Methods 0.000 description 20
- 239000000203 mixture Substances 0.000 description 18
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 17
- 239000011575 calcium Substances 0.000 description 17
- 229960005069 calcium Drugs 0.000 description 17
- 229910052791 calcium Inorganic materials 0.000 description 17
- 239000003826 tablet Substances 0.000 description 12
- 238000011282 treatment Methods 0.000 description 7
- 230000037182 bone density Effects 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 230000008569 process Effects 0.000 description 6
- 208000001132 Osteoporosis Diseases 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 230000003203 everyday effect Effects 0.000 description 5
- 210000000988 bone and bone Anatomy 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- 230000036541 health Effects 0.000 description 4
- 239000011230 binding agent Substances 0.000 description 3
- 239000008187 granular material Substances 0.000 description 3
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 2
- 208000001164 Osteoporotic Fractures Diseases 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 229910052799 carbon Inorganic materials 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 239000007910 chewable tablet Substances 0.000 description 2
- 229940068682 chewable tablet Drugs 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 235000005911 diet Nutrition 0.000 description 2
- 230000037213 diet Effects 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 229920000159 gelatin Polymers 0.000 description 2
- 235000019322 gelatine Nutrition 0.000 description 2
- 238000011068 loading method Methods 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 230000036651 mood Effects 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- 235000016709 nutrition Nutrition 0.000 description 2
- 230000035764 nutrition Effects 0.000 description 2
- FGRBYDKOBBBPOI-UHFFFAOYSA-N 10,10-dioxo-2-[4-(N-phenylanilino)phenyl]thioxanthen-9-one Chemical compound O=C1c2ccccc2S(=O)(=O)c2ccc(cc12)-c1ccc(cc1)N(c1ccccc1)c1ccccc1 FGRBYDKOBBBPOI-UHFFFAOYSA-N 0.000 description 1
- TVEXGJYMHHTVKP-UHFFFAOYSA-N 6-oxabicyclo[3.2.1]oct-3-en-7-one Chemical compound C1C2C(=O)OC1C=CC2 TVEXGJYMHHTVKP-UHFFFAOYSA-N 0.000 description 1
- 208000010392 Bone Fractures Diseases 0.000 description 1
- 206010006956 Calcium deficiency Diseases 0.000 description 1
- 244000025254 Cannabis sativa Species 0.000 description 1
- 208000019505 Deglutition disease Diseases 0.000 description 1
- 206010017076 Fracture Diseases 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- 239000001828 Gelatine Substances 0.000 description 1
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 206010020710 Hyperphagia Diseases 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 229920001617 Vinyon Polymers 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 235000021028 berry Nutrition 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 235000001465 calcium Nutrition 0.000 description 1
- 235000010216 calcium carbonate Nutrition 0.000 description 1
- 239000004227 calcium gluconate Substances 0.000 description 1
- 229960004494 calcium gluconate Drugs 0.000 description 1
- 235000013927 calcium gluconate Nutrition 0.000 description 1
- MKJXYGKVIBWPFZ-UHFFFAOYSA-L calcium lactate Chemical compound [Ca+2].CC(O)C([O-])=O.CC(O)C([O-])=O MKJXYGKVIBWPFZ-UHFFFAOYSA-L 0.000 description 1
- 239000001527 calcium lactate Substances 0.000 description 1
- 229960002401 calcium lactate Drugs 0.000 description 1
- 235000011086 calcium lactate Nutrition 0.000 description 1
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000009547 dual-energy X-ray absorptiometry Methods 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 235000021480 entrance food Nutrition 0.000 description 1
- 210000002436 femur neck Anatomy 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 239000007952 growth promoter Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000003475 lamination Methods 0.000 description 1
- 210000002414 leg Anatomy 0.000 description 1
- 238000005461 lubrication Methods 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 230000018984 mastication Effects 0.000 description 1
- 238000010077 mastication Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000005453 pelletization Methods 0.000 description 1
- 208000022530 polyphagia Diseases 0.000 description 1
- 230000005180 public health Effects 0.000 description 1
- 239000004576 sand Substances 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000001953 sensory effect Effects 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 238000012109 statistical procedure Methods 0.000 description 1
- 230000036561 sun exposure Effects 0.000 description 1
- 230000001502 supplementing effect Effects 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 235000020795 whole food diet Nutrition 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/10—Carbonates; Bicarbonates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/20—Milk; Whey; Colostrum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Zoology (AREA)
- Microbiology (AREA)
- Biomedical Technology (AREA)
- Nutrition Science (AREA)
- Medical Informatics (AREA)
- Physiology (AREA)
- Mycology (AREA)
- Inorganic Chemistry (AREA)
- Alternative & Traditional Medicine (AREA)
- Cell Biology (AREA)
- Developmental Biology & Embryology (AREA)
- Immunology (AREA)
- Virology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Abstract
The invention discloses a kind of Biocal and preparation method thereof, by the raw material components of following weight portion: carbonic acid Ca45～55 parts, defatted milk powder 30～40 parts, Fructus Fragariae Ananssae powder 8～15 parts, vitamin D3 1～3 parts；And use following preparation method to make: (1) takes calcium carbonate, adds the purified water of 4～6 times of weight of calcium carbonate, stirs；(2) while whipping step (1) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；(3) colloid mill is used to grind 3～5 times step (2) gained feed liquid；(4) it is spray-dried；(5) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；(6) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；(7) without any adjuvant, direct compression.
Description
Technical field:
The present invention relates to field of health care food, be specifically related to a kind of Biocal and preparation method thereof.
Background technology:
Osteoporosis is a kind of reduces with bone amount and osseous tissue micro structure is abnormal is characterized, cause skeletal fragility to increase and
Easily there is a kind of generalized metabolic osteopathia of fracture.Along with socio-economic development and aged tendency of population, the trouble of osteoporosis
Sick rate rapidly increases, and the harm that osteoporosis and osteoporotic fracture are brought is the most serious.China's aged tendency of population
Trend is obvious, and the aged of China's over-65s in 2012 has reached " Chinese population and the employment announced in 1.27 hundred million, 2015
Statistical yearbook-2014 years " display, the aged of China's over-65s to 2014 year reaches 137,550,000, accounts for total population
10.1%, the aged also increases in the speed with annual 8000000 people；Relevant expert is it is expected that to the year two thousand fifty, China aged
It is up to the 1/3 of total population.Osteoporosis is a kind of old people's susceptible disease, according to the estimation of WHO, in more than 50 years old women
About 30% suffers from this disease.Therefore, osteoporosis will become the important public health problem that China is faced.
It addition, child is in growth and development process, owing to calcium amount deficiency taken in by diet, lacks again outdoor activities, cause
The symptom of more existing calcium deficiency, as slow in growth promoter, sleep in evening frequent cramp in the leg, fatigue and weakness etc., this is also to need to replenish the calcium
A big crowd.
Calcium supplementing product is a feast for the eyes in the market, and kind is numerous and diverse, and dividing by dosage form has powder, granule, tablet, oral liquid
Deng, divide by calcium source have animal bone to extract amino acid calcium, calcium carbonate, calcium lactate, calcium gluconate etc., the wherein benefit of tablet class
Calcium product carries and takes the most more convenient, and in the majority with calcium carbonate for the product in calcium source, the bulk density of ordinary calcium carbonate is smaller,
Poor compressibility, is required to add some tableting aid such as binding agent, fluidizer during preparing tablet, according to China's nutrition
The amount of replenishing the calcium every day that association is recommended is 600mg, so the calcium tablet volume on market is bigger than normal, though or volume is little but medicine carrying
Amount (calcium carbonate) can be only achieved the amount of replenishing the calcium needed for every day if must once take dry tablet less, causes dysphagia；Also having some is nozzle
Chewable tablet, in addition to above swallowing the drawback that tablet is mentioned, there is also sensory issues, the Chalk taste of calcium carbonate in mastication processes
People's mood can be allowed unhappy, and a lot of children refusal re-uses this type of calcium preparation product；Furthermore along with the pursuit of quality of the life is got over by people
Coming the highest, health care consciousness is also further enhancing, and advocates healthy green life idea and makes them to the nutrition of entrance food, peace
Full property requires more and more higher, and a lot of people, while taking in the raw material useful to human body, are unwilling to eat more adjuvant, but with
Ordinary calcium carbonate is that the health product of primary raw material prescription are without some tableting aid such as binding agent, filler, fluidizer
In the case of can not make tablet.Based on the strongest market demand, need that a kind of drug loading is high, tablet format is little, mouth badly
Sense is more preferably without the Biocal of adjuvant.
Summary of the invention:
The deficiency existed for prior art, it is an object of the invention to provide a kind of Biocal without adjuvant.
Second object of the present invention is to provide the preparation method of a kind of Biocal without adjuvant.
Technical scheme is as follows:
The preparation method of a kind of Biocal without adjuvant, comprises the following steps:
(1) weight share weighs: carbonic acid Ca45～55 parts, defatted milk powder 30～40 parts, Fructus Fragariae Ananssae powder 8～15 parts, dimension life
Element D3 1～3 parts；
(2) take calcium carbonate, add the purified water of 4～6 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) colloid mill is used to grind 3～5 times step (3) gained feed liquid；
(5) it is spray-dried；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
Preferably, the present composition is made up of the raw material components of following weight portion:
Calcium carbonate 48～52 parts, defatted milk powder 32～38 parts, Fructus Fragariae Ananssae powder 10～14 parts, vitamin D3 1.5～3 parts.
It is furthermore preferred that the present composition is made up of the raw material components of following weight portion:
Calcium carbonate 49～51 parts, defatted milk powder 34～36 parts, Fructus Fragariae Ananssae powder 11～13 parts, vitamin D3 2～3 parts.
It is further preferred that the present composition is made up of the raw material components of following weight portion:
Calcium carbonate 50 parts, defatted milk powder 35 parts, Fructus Fragariae Ananssae powder 12 parts, vitamin D3 3 parts.
Preferably, step (4) arranges colloid bistrique rotating speed 3300-3600r/min in colloid mill process of lapping.
It is further preferred that step (4) arranges in colloid mill process of lapping colloid bistrique rotating speed 3400-3500r/min.
Preferably, the moisture being spray-dried gained mixed powder in step (5) is 1.8～2.5%.
Preferably, step (5) is spray-dried inlet temperature 170～190 DEG C are set, feed liquor speed 30～45ml/min,
Atomizing pressure 0.30～0.50MPa.
It is further preferred that step (5) is spray-dried, inlet temperature 170～178 DEG C are set, feed liquor speed 35～
40ml/min, atomizing pressure 0.30～0.40MPa.
Add up through abundant experimental results, from step (2) to step (6) calcium carbonate and defatted milk powder in technical solution of the present invention
Powder delivery yield be about 97.2～97.8%.
Calcium carbonate of the present invention is biological calcium carbonate, calcium carbonate content >=97.6%；Vitamin D3, content with
C27H44O meter >=80000IU/g.
Raw material used in the present invention is poor compressibility or the extremely strong raw material of hygroscopicity, and those skilled in the art are selecting
When Tabules made by this type of raw material, all consider to add the adjuvant that some tablets are conventional, such as binding agent, fluidizer, make slice, thin piece energy
Enough smooth molding, and the difficult point of the present invention is that the characteristic of raw material itself is not suitable for direct compression, but to reach without auxiliary
Expect and make the smooth molding of tablet and meet the relevant criterion requirement of industry.For this difficulties, inventor have studied every kind
The physical characteristic of raw material, devises a series of testing program, investigates whether different process conditions can cause raw material physics special
Property occurs some to change.After substantial amounts of test, inventor is found that the technical scheme used in present invention, according to
The mouthfeel of defatted milk powder lubrication sweet-smelling and the good fluidity of spray drying, it is achieved that above goal of the invention.Making of colloid mill
With calcium carbonate can be made to become finer and smoother, the Chalk taste of calcium carbonate can be obviously improved after combining closely with defatted milk powder, and carry
High carbon acid calcium obtains compressibility and mobility, reduces drawing of defatted milk powder moist so that it is can tabletting smoothly, additional Fructus Fragariae Ananssae powder enters one
Step joint mouthfeel, makes element sheet outward appearance be improved, optimizes the organoleptic quality of this product.
Test example:
Below by test data, further illustrate design and the effect of the present invention:
One, efficacy test
1 data and method
1.1 physical data:
Total cases is 80 examples, male 35 example, women 45 example, and age 38～50 years old, the product for our unit takes aspiration
Person, all cases use the Dual-energy X-rays absorptionmetry of Lunar company of the U.S. to measure bone density and are below normal value, run off for bone
Or osteoporosis.Being randomly divided into test A group, test B group, test C group and matched group, test A group 20 example, male 8 example, women 12
Example, the age, the mean age was 45.2 years old 38～49 years old, tested B group 20 example, and male 9 example, women 11 example, the age is 39～50
In year, the mean age be that (45.6 years old, test C group 20 example, male 9 example, women 11 example, the age, the mean age was 38～50 years old
44.9 years old, matched group 20 example, male 9 example, women 11 example, the age, the mean age was 45.0 years old 40～48 years old.Four groups of volunteers
The physical data such as age, the state of an illness does not exist significant difference (P ＞ 0.05), there is comparability.
1.2 administrated method
Test A group gives the medicine of the embodiment of the present invention 1, each 1, every day 2 times；Test B group gives the present invention and implements
The medicine of example 2, each 1, every day 2 times；Test C group gives the medicine of the embodiment of the present invention 3, each 1, every day 2 times；Comparison
Group does not takes any calcium preparation, only advises its polyphagia containing calcium diet, suitably increase quantity of motion and sun exposure.All cases all take 3
Moon treatment, checks bone density after terminating the course for the treatment of.
1.3 observation items and measuring method
Bone density (BMD): (Midlink company of France is raw to use dual energy X-ray absorptiometry measuring instrument before and after treatment
Produce) measure lumbar vertebra normotopia (L1～L4) and femoral neck BMD value, unit uses g/cm2。
1.4 statistical procedures
Measurement data mean ± standard deviationRepresent, use t inspection to carry out statistical analysis.
2 results
Bone density value contrast before and after 2.1 4 groups of patient treatments
Before and after the treatment of 1 four groups of table, BMD value compares (g/cm2,)
Note: * compares before treatment, P ＜ 0.05；* compares before treatment, P ＜ 0.01
△ compares with matched group, P ＜ 0.05；△ △ compares with matched group, P ＜ 0.01
3 conclusions
Embodiments of the invention test A group, test B group, test C group have significant effect, P in terms of increasing bone density
＜ 0.01.The all of embodiment that the present invention is write by inventor is all tested according to above-mentioned test method, and obtains
Similar result of the test, it was demonstrated that the present composition has the effect significantly increasing bone density.
Two, preparation technology test
The physical index of 1 several raw materials:
1.1 calcium carbonate: purchased from Penglai, shandong Province Marine Bio Co., Ltd., granularity 98% is above by 100 mesh standard sieves
1.2 defatted milk powder: purchased from perseverance wholefood company limited of New Zealand
1.3 Fructus Fragariae Ananssae powder: purchased from Beijing Sheng Lun company limited, granularity 85% is above by 80 mesh standard sieves
1.4 vitamin D3: purchased from Di Siman (Switzerland), granularity 90% is above by 40 mesh standard sieves
Note: hygroscopicity contrast test: test material is sealed in vinyon bottle, in climatic chamber (temperature
Spend 38 ± 2 DEG C, humidity 75%) in deposit 3 months, after contrasting 3 months, the moisture data of material increase compared with initial water divided data
Ratio.The contrast of following hygroscopicity all uses the method.
The physical index of above-mentioned several raw material mixed powders of 2 Different Weight share ratios:
Powder after mixed powder A: carbonic acid Ca45 part, defatted milk powder 30 parts, Fructus Fragariae Ananssae powder 8 parts, 1 part of mix homogeneously of vitamin D3
Material
Powder after mixed powder B: calcium carbonate 55 parts, defatted milk powder 40 parts, Fructus Fragariae Ananssae powder 15 parts, 3 parts of mix homogeneously of vitamin D3
Material
Mixed powder C: after calcium carbonate 48 parts, defatted milk powder 32 parts, Fructus Fragariae Ananssae powder 10 parts, 1.5 parts of mix homogeneously of vitamin D3
Powder
Powder after mixed powder D: calcium carbonate 52 parts, defatted milk powder 38 parts, Fructus Fragariae Ananssae powder 14 parts, 3 parts of mix homogeneously of vitamin D3
Material
Powder after mixed powder E: calcium carbonate 49 parts, defatted milk powder 34 parts, Fructus Fragariae Ananssae powder 11 parts, 2 parts of mix homogeneously of vitamin D3
Material
Powder after mixed powder F: calcium carbonate 51 parts, defatted milk powder 36 parts, Fructus Fragariae Ananssae powder 13 parts, 3 parts of mix homogeneously of vitamin D3
Material
Powder after mixed powder G: calcium carbonate 50 parts, defatted milk powder 35 parts, Fructus Fragariae Ananssae powder 12 parts, 3 parts of mix homogeneously of vitamin D3
Material
Powder after mixed powder H: carbonic acid Ca45 part, defatted milk powder 40 parts, Fructus Fragariae Ananssae powder 8 parts, 3 parts of mix homogeneously of vitamin D3
Material
Powder after mixed powder I: calcium carbonate 55 parts, defatted milk powder 30 parts, Fructus Fragariae Ananssae powder 15 parts, 1 part of mix homogeneously of vitamin D3
Material
Powder after mixed powder J: calcium carbonate 48 parts, defatted milk powder 38 parts, Fructus Fragariae Ananssae powder 10 parts, 3 parts of mix homogeneously of vitamin D3
Material
After mixed powder K: calcium carbonate 52 parts, defatted milk powder 32 parts, Fructus Fragariae Ananssae powder 14 parts, 1.5 parts of mix homogeneously of vitamin D3
Powder
Powder after mixed powder L: carbonic acid Ca45 part, defatted milk powder 40 parts, Fructus Fragariae Ananssae powder 15 parts, 3 parts of mix homogeneously of vitamin D3
Material
3 powder mixed above, according to the characteristic of raw material, those of ordinary skill in the art use the tabletting technology of routine, add
Adjuvant commonly used by tablet, can tabletted.As a example by mixed powder A: weigh carbonic acid Ca45 part, defatted milk powder 30 parts, grass by weight
8 parts of certain kind of berries powder, vitamin D3 1 part and 15 parts of hydroxypropyl celluloses, 7 parts of microcrystalline Cellulose, mix homogeneously, put into boiling type and be dried
Granulator, takes 7 parts of gelatin and makes the gelatine size that mass concentration is 8.0%, and whitewashing carries out pelletizing and be dried, 20 mesh sieve granulate；Whole
Tabletting after granule after Li and 1 part of magnesium stearate mix homogeneously.The slice, thin piece made meets standards of pharmacopoeia and inner controlling standard of enterprise, tool
It is as follows that data are surveyed in health check-up:
The physical index of step (5) gained dry powder in 4 embodiment of the present invention:
The physical index of powder and tabletting effect data before tabletting in 5 embodiment of the present invention:
6 embodiment of the present invention make the detection data of slice, thin piece:
Calcium carbonate, defatted milk powder, Fructus Fragariae Ananssae powder raw material each tabletting poor compressibility, and defatted milk powder and Fructus Fragariae Ananssae powder are easily inhaled
Wet, the present invention, in the case of design is without adjuvant, by screening technology condition, draws technical scheme.By carbon
After acid calcium is spray-dried together with defatted milk powder, improves mobility and the mouthfeel of calcium carbonate, add its compressibility, by seeing
Examining high temperature and humidity test data, the hygroscopicity of defatted milk powder improves, after mixing with Fructus Fragariae Ananssae powder, vitamin D3, and tableting processes sheet
The method of double differences is different stable, sticking, lamination does not occurs, it is possible to has prepared in the case of without adjuvant and has added adjuvant with by routine
The slice, thin piece of obtained chewable tablet equal quality, and add adjuvant technique than routine and possessed more excellent mouthfeel, it is finer and smoother,
Sand type and Chalk taste have had great improvement, so chew patient and are easier to acceptance, and the mood of the joyful patient of energy；
The technique of slice, thin piece made by the more conventional adjuvant that adds, and the drug loading of every flake products there has also been the biggest lifting, at identical tablet weight (1.2g/
Sheet) in the case of, every calcium content averagely adds 58.08mg, about increases by the calcium content of 30%.
Detailed description of the invention
The preparation method of 1 one kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: carbonic acid Ca45 part, defatted milk powder 30 parts, Fructus Fragariae Ananssae powder 8 parts, vitamin D3 1 part；
(2) take calcium carbonate, add the purified water of 4 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 3 times step (3) gained feed liquid, colloid bistrique rotating speed 3300r/min is set；
(5) it is spray-dried, inlet temperature 170 DEG C, feed liquor speed 30ml/min, atomizing pressure 0.30MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 2 one kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: calcium carbonate 55 parts, defatted milk powder 40 parts, Fructus Fragariae Ananssae powder 15 parts, vitamin D3 3 parts；
(2) take calcium carbonate, add the purified water of 6 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 5 times step (3) gained feed liquid, colloid bistrique rotating speed 3600r/min is set；
(5) it is spray-dried, inlet temperature 190 DEG C, feed liquor speed 45ml/min, atomizing pressure 0.50MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 3 one kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: calcium carbonate 48 parts, defatted milk powder 32 parts, Fructus Fragariae Ananssae powder 10 parts, vitamin D3 1.5 parts；
(2) take calcium carbonate, add the purified water of 5 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 4 times step (3) gained feed liquid, colloid bistrique rotating speed 3500r/min is set；
(5) it is spray-dried, inlet temperature 180 DEG C, feed liquor speed 40ml/min, atomizing pressure 0.40MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 4 one kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: calcium carbonate 52 parts, defatted milk powder 38 parts, Fructus Fragariae Ananssae powder 14 parts, vitamin D3 3 parts；
(2) take calcium carbonate, add the purified water of 4 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 3 times step (3) gained feed liquid, colloid bistrique rotating speed 3400r/min is set；
(5) it is spray-dried, inlet temperature 172 DEG C, feed liquor speed 30ml/min, atomizing pressure 0.40MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 5 one kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: calcium carbonate 49 parts, defatted milk powder 34 parts, Fructus Fragariae Ananssae powder 11 parts, vitamin D3 2 parts；
(2) take calcium carbonate, add the purified water of 6 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 5 times step (3) gained feed liquid, colloid bistrique rotating speed 3500r/min is set；
(5) it is spray-dried, inlet temperature 178 DEG C, feed liquor speed 35ml/min, atomizing pressure 0.30MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 6 one kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: calcium carbonate 51 parts, defatted milk powder 36 parts, Fructus Fragariae Ananssae powder 13 parts, vitamin D3 3 parts；
(2) take calcium carbonate, add the purified water of 5 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 4 times step (3) gained feed liquid, colloid bistrique rotating speed 3450r/min is set；
(5) it is spray-dried, inlet temperature 184 DEG C, feed liquor speed 40ml/min, atomizing pressure 0.35MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 7 one kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: calcium carbonate 50 parts, defatted milk powder 35 parts, Fructus Fragariae Ananssae powder 12 parts, vitamin D3 3 parts；
(2) take calcium carbonate, add the purified water of 4 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 3 times step (3) gained feed liquid, colloid bistrique rotating speed 3550r/min is set；
(5) it is spray-dried, inlet temperature 185 DEG C, feed liquor speed 45ml/min, atomizing pressure 0.50MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 8 one kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: carbonic acid Ca45 part, defatted milk powder 40 parts, Fructus Fragariae Ananssae powder 8 parts, vitamin D3 3 parts；
(2) take calcium carbonate, add the purified water of 6 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 5 times step (3) gained feed liquid, colloid bistrique rotating speed 3350r/min is set；
(5) it is spray-dried, inlet temperature 175 DEG C, feed liquor speed 35ml/min, atomizing pressure 0.40MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 9 one kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: calcium carbonate 55 parts, defatted milk powder 30 parts, Fructus Fragariae Ananssae powder 15 parts, vitamin D3 1 part；
(2) take calcium carbonate, add the purified water of 5 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 4 times step (3) gained feed liquid, colloid bistrique rotating speed 3400r/min is set；
(5) it is spray-dried, inlet temperature 190 DEG C, feed liquor speed 40ml/min, atomizing pressure 0.3MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 10 1 kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: calcium carbonate 48 parts, defatted milk powder 38 parts, Fructus Fragariae Ananssae powder 10 parts, vitamin D3 3 parts；
(2) take calcium carbonate, add the purified water of 4 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 3 times step (3) gained feed liquid, colloid bistrique rotating speed 3550r/min is set；
(5) it is spray-dried, inlet temperature 178 DEG C, feed liquor speed 35ml/min, atomizing pressure 0.30MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 11 1 kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: calcium carbonate 52 parts, defatted milk powder 32 parts, Fructus Fragariae Ananssae powder 14 parts, vitamin D3 1.5 parts；
(2) take calcium carbonate, add the purified water of 6 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 5 times step (3) gained feed liquid, colloid bistrique rotating speed 3350r/min is set；
(5) it is spray-dried, inlet temperature 188 DEG C, feed liquor speed 45ml/min, atomizing pressure 0.50MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
The preparation method of 12 1 kinds of Biocals of embodiment, comprises the steps:
(1) weight share weighs: carbonic acid Ca45 part, defatted milk powder 40 parts, Fructus Fragariae Ananssae powder 15 parts, vitamin D3 3 parts；
(2) take calcium carbonate, add the purified water of 5 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) use colloid mill to grind 4 times step (3) gained feed liquid, colloid bistrique rotating speed 3450r/min is set；
(5) it is spray-dried, inlet temperature 183 DEG C, feed liquor speed 40ml/min, atomizing pressure 0.40MPa are set；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
Embodiments of the invention are only the specific descriptions to technical scheme, are not the restrictions to technical scheme, this area
Replacement that technical staff is done under conditions of not changing the flesh and blood of the present invention or change each fall within the protection model of the present invention
Enclose.
Claims (10)
1. a preparation method for Biocal, is characterized in that comprising the steps:
(1) weight share weighs: carbonic acid Ca45～55 parts, defatted milk powder 30～40 parts, Fructus Fragariae Ananssae powder 8～15 parts, vitamin D3
1～3 part；
(2) take calcium carbonate, add the purified water of 4～6 times of weight of calcium carbonate, stir；
(3) while whipping step (2) material, the defatted milk powder of formula ratio is slowly added into, until dissolving；
(4) colloid mill is used to grind 3～5 times step (3) gained feed liquid；
(5) it is spray-dried；
(6) dried material being crossed 40 mesh sieves, oversize is pulverized, until all passing through；
(7) undersize material is mixed homogeneously with Fructus Fragariae Ananssae powder, vitamin D3；
(8) without any adjuvant, direct compression.
Preparation method the most according to claim 1, it is characterised in that step (1) is weighed by following weight quota: calcium carbonate
48～52 parts, defatted milk powder 32～38 parts, Fructus Fragariae Ananssae powder 10～14 parts, vitamin D3 1.5～3 parts.
Preparation method the most according to claim 1, it is characterised in that step (1) is weighed by following weight quota: calcium carbonate
49～51 parts, defatted milk powder 34～36 parts, Fructus Fragariae Ananssae powder 11～13 parts, vitamin D3 2～3 parts.
Preparation method the most according to claim 1, it is characterised in that step (1) is weighed by following weight quota: calcium carbonate
50 parts, defatted milk powder 35 parts, Fructus Fragariae Ananssae powder 12 parts, vitamin D3 3 parts.
5. according to the preparation method described in claim 1-4 any claim, it is characterised in that colloid barreling in step (4)
Colloid bistrique rotating speed 3300-3600r/min is set during mill.
6. according to the preparation method described in claim 1-4 any claim, it is characterised in that colloid barreling in step (4)
Colloid bistrique rotating speed 3400-3500r/min is set during mill.
7. according to the preparation method described in claim 1-4 any claim, it is characterised in that step (5) is spray-dried
Inlet temperature 170～190 DEG C, feed liquor speed 30～45ml/min, atomizing pressure 0.30～0.50MPa are set.
8. according to the preparation method described in claim 1-4 any claim, it is characterised in that step (5) is spray-dried
Inlet temperature 170～178 DEG C, feed liquor speed 35～40ml/min, atomizing pressure 0.30～0.40MPa are set.
Preparation method the most according to claim 1, it is characterised in that step (5) is spray-dried the water of gained mixed powder
It is divided into 1.8～2.5%.
10. the Biocal that prepared by the method for any one of claim 1-4 claim.
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| CN201610490725.2A CN106074767A (en) | 2016-06-27 | 2016-06-27 | A kind of Biocal and preparation method thereof |
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| CN201610490725.2A CN106074767A (en) | 2016-06-27 | 2016-06-27 | A kind of Biocal and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106619706A (en) * | 2016-12-29 | 2017-05-10 | 山东达因海洋生物制药股份有限公司 | Calcium carbonate D3 chewable tablets for children calcium supplement, and preparation method of chewable tablets |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1317254A (en) * | 2001-02-22 | 2001-10-17 | 李晓林 | Directly eatable milk powder and its preparing process |
| CN103349081A (en) * | 2013-06-14 | 2013-10-16 | 芜湖市诺康生物科技有限公司 | Multi-flavored calcium chewing tablet and preparation process thereof |
-
2016
- 2016-06-27 CN CN201610490725.2A patent/CN106074767A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1317254A (en) * | 2001-02-22 | 2001-10-17 | 李晓林 | Directly eatable milk powder and its preparing process |
| CN103349081A (en) * | 2013-06-14 | 2013-10-16 | 芜湖市诺康生物科技有限公司 | Multi-flavored calcium chewing tablet and preparation process thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106619706A (en) * | 2016-12-29 | 2017-05-10 | 山东达因海洋生物制药股份有限公司 | Calcium carbonate D3 chewable tablets for children calcium supplement, and preparation method of chewable tablets |
| CN106619706B (en) * | 2016-12-29 | 2019-08-30 | 山东达因海洋生物制药股份有限公司 | A kind of calcium carbonate D to replenish the calcium for children3Chewable tablets and preparation method thereof |
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