CN103845357A - Vitamin D calcium chewable tablet for calcium supplementation of children and preparation method thereof - Google Patents
Vitamin D calcium chewable tablet for calcium supplementation of children and preparation method thereof Download PDFInfo
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- CN103845357A CN103845357A CN201310664047.3A CN201310664047A CN103845357A CN 103845357 A CN103845357 A CN 103845357A CN 201310664047 A CN201310664047 A CN 201310664047A CN 103845357 A CN103845357 A CN 103845357A
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- calcium
- vitamin
- chewable tablet
- granulate
- citric acid
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- 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 title claims abstract description 37
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 title claims abstract description 30
- 239000011575 calcium Substances 0.000 title claims abstract description 30
- 229910052791 calcium Inorganic materials 0.000 title claims abstract description 30
- 229930003316 Vitamin D Natural products 0.000 title claims abstract description 22
- 235000019166 vitamin D Nutrition 0.000 title claims abstract description 22
- 239000011710 vitamin D Substances 0.000 title claims abstract description 22
- 150000003710 vitamin D derivatives Chemical class 0.000 title claims abstract description 22
- 229940046008 vitamin d Drugs 0.000 title claims abstract description 22
- 239000007910 chewable tablet Substances 0.000 title claims abstract description 19
- 229940068682 chewable tablet Drugs 0.000 title claims abstract description 19
- 238000002360 preparation method Methods 0.000 title claims abstract description 13
- 230000009469 supplementation Effects 0.000 title abstract 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 75
- 239000008187 granular material Substances 0.000 claims abstract description 37
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims abstract description 36
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 36
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 20
- 239000008103 glucose Substances 0.000 claims abstract description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 19
- 239000005913 Maltodextrin Substances 0.000 claims abstract description 18
- 229920002774 Maltodextrin Polymers 0.000 claims abstract description 18
- 229910000019 calcium carbonate Inorganic materials 0.000 claims abstract description 18
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 18
- 229940035034 maltodextrin Drugs 0.000 claims abstract description 18
- 238000000034 method Methods 0.000 claims abstract description 14
- 239000007779 soft material Substances 0.000 claims abstract description 13
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims abstract description 12
- 239000000600 sorbitol Substances 0.000 claims abstract description 12
- 239000000203 mixture Substances 0.000 claims description 18
- 239000000843 powder Substances 0.000 claims description 11
- 239000008213 purified water Substances 0.000 claims description 11
- 230000000694 effects Effects 0.000 claims description 8
- 239000000080 wetting agent Substances 0.000 claims description 7
- 239000011812 mixed powder Substances 0.000 claims description 6
- 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 abstract description 8
- 235000005282 vitamin D3 Nutrition 0.000 abstract description 8
- 239000011647 vitamin D3 Substances 0.000 abstract description 8
- 229940021056 vitamin d3 Drugs 0.000 abstract description 8
- 238000010521 absorption reaction Methods 0.000 abstract description 4
- 239000002994 raw material Substances 0.000 abstract description 4
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 abstract description 3
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 abstract description 2
- 235000005979 Citrus limon Nutrition 0.000 abstract 1
- 244000248349 Citrus limon Species 0.000 abstract 1
- 239000000654 additive Substances 0.000 abstract 1
- 230000001055 chewing effect Effects 0.000 abstract 1
- 235000015165 citric acid Nutrition 0.000 abstract 1
- 238000001035 drying Methods 0.000 abstract 1
- 239000008369 fruit flavor Substances 0.000 abstract 1
- 238000007873 sieving Methods 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 9
- 239000003795 chemical substances by application Substances 0.000 description 7
- 238000004519 manufacturing process Methods 0.000 description 7
- 239000003814 drug Substances 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 5
- 239000011574 phosphorus Substances 0.000 description 5
- 229910052698 phosphorus Inorganic materials 0.000 description 5
- 229940079593 drug Drugs 0.000 description 3
- 235000013399 edible fruits Nutrition 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 108010011485 Aspartame Proteins 0.000 description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 2
- 239000000605 aspartame Substances 0.000 description 2
- 229960003438 aspartame Drugs 0.000 description 2
- 235000010357 aspartame Nutrition 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 229940077918 d-cal Drugs 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 230000008676 import Effects 0.000 description 2
- 239000008101 lactose Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 210000002381 plasma Anatomy 0.000 description 2
- 239000013558 reference substance Substances 0.000 description 2
- 208000007442 rickets Diseases 0.000 description 2
- 230000001502 supplementing effect Effects 0.000 description 2
- 229940088594 vitamin Drugs 0.000 description 2
- 229930003231 vitamin Natural products 0.000 description 2
- 235000013343 vitamin Nutrition 0.000 description 2
- 239000011782 vitamin Substances 0.000 description 2
- 150000003722 vitamin derivatives Chemical class 0.000 description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
- YUGCAAVRZWBXEQ-UHFFFAOYSA-N Precholecalciferol Natural products C=1CCC2(C)C(C(C)CCCC(C)C)CCC2C=1C=CC1=C(C)CCC(O)C1 YUGCAAVRZWBXEQ-UHFFFAOYSA-N 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 208000003217 Tetany Diseases 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 1
- 208000002925 dental caries Diseases 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000010812 external standard method Methods 0.000 description 1
- 235000013402 health food Nutrition 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 206010025135 lupus erythematosus Diseases 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- PGXWDLGWMQIXDT-UHFFFAOYSA-N methylsulfinylmethane;hydrate Chemical compound O.CS(C)=O PGXWDLGWMQIXDT-UHFFFAOYSA-N 0.000 description 1
- 239000011259 mixed solution Substances 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 230000010355 oscillation Effects 0.000 description 1
- 208000005368 osteomalacia Diseases 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 239000002243 precursor Substances 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 235000013599 spices Nutrition 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 201000008827 tuberculosis Diseases 0.000 description 1
- 210000005239 tubule Anatomy 0.000 description 1
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Abstract
The invention relates to a vitamin D calcium chewable tablet for calcium supplementation of children and a preparation method thereof. The chewable tablet consists of calcium carbonate, vitamin D3 powder, sorbitol, glucose, maltodextrin, citric acid, magnesium stearate, lemon essence and water. The preparation method comprises the following steps: (1) inspecting the necessary raw materials and additives, and separately sieving through a 100 meshes sieve for later use; (2) mixing; (3) preparing a soft material; (4) granulating and drying; (5) finishing the granules and mixing all together; and (6) measuring the moisture and a midbody content, tabletting and bottling. The vitamin D calcium chewable tablet provided by the invention can promote the absorption of calcium, can guarantee the utilization rate of calcium, is taken in a chewing way, has a fruit flavor and is convenient for oral administration of children. Since vitamin D3 is poor in stability and is easy to oxidize, vitamin D3 is added in the mixing procedure, to ensure the product stability.
Description
Technical field
The invention belongs to field of medicaments.Relate in particular to prescription and preparation method that a kind of child ties up D Biocal, particularly in prescription, add natural fruit spice, taste is moderate, is convenient to children taking.
Background technology
The calcium-supplementing preparation that sell in market is now health food, how to ensure child's drug safety of replenishing the calcium, import drugs is expensive, we are under market survey is fully analyzed, carry out the development that child ties up D Biocal, and external clinical and prescription is carried out to detailed analysis and research, and carry out prescription analysis with reference to the condition of production of domestic crude drug, adopt the correctives of fruit taste, and with many enterprises produce correctives contrast, final definite moderate raw material of taste, and its consumption is screened, tightly determine eventually that child ties up D Biocal prescription.
Vitamin D is a kind of fatsoluble vitamin, also be counted as a kind of hormone precursor that acts on calcium, phosphorus metabolism, vitamin vitamin D3 has following physiological function: 1, improve the absorption of human body to calcium, phosphorus, make the level of plasma calcium and the blood plasma phosphorus degree that reaches capacity.2, promote growth and skeleton calcification, promote tooth sound; 3, increase the absorption of phosphorus by intestinal wall, and increase absorbing again of phosphorus by renal tubules; 4, maintain the normal level of citrate in blood; 5, prevent that aminoacid from losing by kidney.For rickets, osteomalacia and infantile tetany, rickets has dental caries person concurrently and also can prevent and treat with these product.Heavy dose is also for tuberculosis of skin, skin and the various lupus erythematosus of mucosa etc.
Along with the raising of people's consciousness of replenishing the calcium, calcium supplementing product particularly child's calcium supplementing product quality is uneven, and we, can be for clinical expansion by child being tieed up to developing of D Biocal.Therefore low, the good effect of cost, guarantee child's safety of replenishing the calcium, be more suitable for the product that Children in China replenishes the calcium and have great importance.
By the test to the proud taste agent of difference and the selection of consumption thereof, the final proud taste agent of determining is that domestic market has supply and is pharmaceutical grade.The accurate font size medicine of medicine that child replenishes the calcium now only has the D-Cal of import, for child ties up D Biocal, expensive, according to the prescription compacting of our development in flakes, carry out outward appearance, dissolution, content, the contrast of disintegration quality with D-Cal, two kinds of examination and test of products results of result are without obvious difference.But we adopt domestic supplementary material, and production cost is starkly lower than imported product, but product quality does not have difference.
Summary of the invention
The object of this invention is to provide chewable tablet that a kind of child of being applicable to replenishes the calcium and preparation method thereof.Solved on market the utilization rate at calcium of some calcium-supplementing preparations low, take difficult shortcoming, the preparation that we develop adds vitamin d3 powder, can promote the absorption of calcium, can ensure calcium utilization, chew take, fruit taste convenient for children is oral.Due to vitamin D3 poor stability, oxidizable, in total mixing, add, to guarantee product stability.
In order to realize above-mentioned object, the present invention has adopted following technical scheme:
Be applicable to the chewable tablet that child replenishes the calcium, this chewable tablet is made up of following component by mass percentage:
Vitamin d3 powder 0.05%-0.2%,
Maltodextrin 5%-20%,
Citric acid 0.5%-2%,
Magnesium stearate 1%-3%,
Fructus Citri Limoniae essence 0.5-1.5%;
Surplus is water.
As preferably, this chewable tablet is made up of following component by mass percentage:
Vitamin d3 powder 0.05%-0.15%,
Citric acid 0.5%-1.5%,
Magnesium stearate 1%-2.5%,
Fructus Citri Limoniae essence 1.0-1.5%;
Surplus is water.
As preferred again, this chewable tablet is made up of following component by mass percentage:
Calcium carbonate 55%,
Vitamin d3 powder 0.08%,
Sorbitol 12%,
Glucose 12%,
Maltodextrin 15%,
Citric acid 0.8%,
Magnesium stearate 1.8%,
Fructus Citri Limoniae essence 1.2%;
Surplus is water.
The above raw material and adjuvant are pharmaceutical grade, and calcium carbonate, vitamin D3 are raw material, and all the other are adjuvant, and wherein sorbitol, glucose are as sweeting agent and filler, and maltodextrin is as binding agent, and magnesium stearate is lubricant, and purified water is wetting agent.
Prepare a described method that is applicable to the chewable tablet that child replenishes the calcium, it is characterized in that the method comprises the steps:
1. required former auxiliary being up to the standards, crosses respectively 100 mesh sieves for subsequent use;
2. mix: vitamin d3 powder is mixed homogeneously with citric acid, adopt the equivalent method of progressively increasing to mix;
3. soft material processed: take calcium carbonate, maltodextrin and the glucose of recipe quantity, set high in effect wet granulator mix homogeneously; Add purified water as wetting agent, soft material processed;
4. granulate, be dried: adopt 18 mesh sieves to granulate, in 45 ℃ of-65 ℃ of baking ovens, be dried, control moisture 2% ~ 4%;
5. granulate, always mixed: be dried 18 eye mesh screen granulate for granule afterwards, after granulate, add the mixed powder of citric acid and vitamin D3, in the side's of putting cone mixer, mix homogeneously; The magnesium stearate that adds again recipe quantity, mixes;
6. measure moisture and intermediate content, tabletting, bottling.
As an alternative, vitamin D3 is used instead in the time of total mixing and added.
As preferably, described sheet Hardness Control is within the scope of 9～16kg.
The present invention has realized that cost is low, determined curative effect, production technology is simple, technique is simple, supplementary material is domestic a kind of preparation all, and said preparation is through long-term 12 months, the acceleration examine stability of 6 months, and constant product quality is good, with imported product without obvious difference, prescription and production technology that we are described are reasonable, can be for large production, and have that production cost is low, constant product quality, be easy to the oral feature of child.
Accompanying drawing explanation
Fig. 1 is production technological process of the present invention.
Fig. 2 is assay liquid chromatogram.
The specific embodiment
Embodiment 1
Coordinate by weight proportion:
Calcium carbonate 55%
Vitamin D
3powder 0.08%
Sorbitol 12%
Glucose 12%
Maltodextrin 15%
Citric acid 0.8%
Magnesium stearate 1.8%
Fructus Citri Limoniae essence 1.2%
Purified water 70ml;
Required former auxiliary being up to the standards, crosses respectively 100 mesh sieves for subsequent use.Mix: vitamin D
3powder is mixed homogeneously with citric acid, adopts the equivalent method of progressively increasing to mix.Soft material processed: take calcium carbonate, maltodextrin and the glucose of recipe quantity, set high in effect wet granulator mix homogeneously; Add purified water as wetting agent, soft material processed.Granulate, be dried: adopt 18 mesh sieves to granulate, in 45 ℃ of-65 ℃ of baking ovens, be dried, control moisture at 2%---4%.Granulate, always mixed: 18 eye mesh screen granulate for granule after dry, add citric acid and vitamin D after granulate
3mixed powder, in the side of putting cone mixer, mix homogeneously.The magnesium stearate that adds again recipe quantity, mixes.Measure moisture and intermediate content, tabletting, bottling.
embodiment 2
Coordinate by weight proportion:
Vitamin D
3powder 0.1%
Sorbitol 10%
Glucose 15%
Maltodextrin 10%
Citric acid 1.5%
Magnesium stearate 1.2%
Fructus Citri Limoniae essence 1.5%
Purified water 90ml;
Required former auxiliary being up to the standards, crosses respectively 100 mesh sieves for subsequent use.Mix: vitamin D
3powder is mixed homogeneously with citric acid, adopts the equivalent method of progressively increasing to mix.Soft material processed: take calcium carbonate, maltodextrin and the glucose of recipe quantity, set high in effect wet granulator mix homogeneously; Add purified water as wetting agent, soft material processed.Granulate, be dried: adopt 18 mesh sieves to granulate, in 45 ℃ of-65 ℃ of baking ovens, be dried, control moisture at 2%---4.Granulate, always mixed: 18 eye mesh screen granulate for granule after dry, add citric acid and vitamin D after granulate
3mixed powder, in the side of putting cone mixer, mix homogeneously.The magnesium stearate that adds again recipe quantity, mixes.Measure moisture and intermediate content, tabletting, bottling.
embodiment 3
Coordinate by weight proportion:
Calcium carbonate 65%
Vitamin D
3powder 0.12%
Sorbitol 12%
Maltodextrin 8%
Citric acid 0.8%
Magnesium stearate 2.0%
Fructus Citri Limoniae essence 0.5%
Purified water 80ml;
Required former auxiliary being up to the standards, crosses respectively 100 mesh sieves for subsequent use.Mix: vitamin D
3powder is mixed homogeneously with citric acid, adopts the equivalent method of progressively increasing to mix.Soft material processed: take calcium carbonate, maltodextrin and the glucose of recipe quantity, set high in effect wet granulator mix homogeneously; Add purified water as wetting agent, soft material processed.Granulate, be dried: adopt 18 mesh sieves to granulate, in 45 ℃ of-65 ℃ of baking ovens, be dried, control moisture at 2%---4.Granulate, always mixed: 18 eye mesh screen granulate for granule after dry, add citric acid and vitamin D after granulate
3mixed powder, in the side of putting cone mixer, mix homogeneously.The magnesium stearate that adds again recipe quantity, mixes.Measure moisture and intermediate content, tabletting, bottling.
embodiment 4
Coordinate by weight proportion:
Calcium carbonate 70%
Vitamin D
3powder 0.15%
Sorbitol 10%
Maltodextrin 7%
Citric acid 0.8%
Magnesium stearate 2.0%
Fructus Citri Limoniae essence 0.5%
Purified water 80ml;
Required former auxiliary being up to the standards, crosses respectively 100 mesh sieves for subsequent use.Mix: vitamin D
3powder is mixed homogeneously with citric acid, adopts the equivalent method of progressively increasing to mix.Soft material processed: take calcium carbonate, maltodextrin and the glucose of recipe quantity, set high in effect wet granulator mix homogeneously; Add purified water as wetting agent, soft material processed.Granulate, be dried: adopt 18 mesh sieves to granulate, in 45 ℃ of-65 ℃ of baking ovens, be dried, control moisture at 2%---4.Granulate, always mixed: 18 eye mesh screen granulate for granule after dry, add citric acid and vitamin D after granulate
3mixed powder, in the side of putting cone mixer, mix homogeneously.The magnesium stearate that adds again recipe quantity, mixes.Measure moisture and intermediate content, tabletting, bottling.
prescription screening experiment
The selection of short taste agent: the short taste agent of conventional tablet has glucose, lactose, citric acid, Fructus Citri Limoniae essence, aspartame, multitudinous sugar etc., select result of the test as follows:
The short taste agent of table 1 selection result
Glucose (A), lactose (B), citric acid (C), Fructus Citri Limoniae essence (D), aspartame (E), multitudinous sugar (F)
From above experimental result, prescription 6, prescription 7, prescription 8 all close regulation, and prescription 6 sugared content are higher, and sheet is easily gone mouldy, and prescription 7 and prescription 8 all conform with the regulations, and can be used for as short taste agent.
Table 2, stability study (long-term December result of the test)
3, content assaying method:
With amino bonded silica gel be filler, take n-hexane-isopropyl alcohol (99:1) as mobile phase, flow velocity 1.5ml/min, detects wavelength 265nm.Get reference substance and test, vitamin D
3with provitamin D
3the separating degree at peak is not less than 5.
［ solution A ］: add solution (take dimethyl sulfoxide-water (10:2) mixed solution as solvent, the concentration that contains BHT is 0.2mg/ml).
Lucifuge operation: it is appropriate that precision takes this product, and porphyrize is put in 100ml brown bottle, add solution work A 50ml, sonic oscillation 15 minutes (ultrasonic water must not be crossed 30 ℃), jolting, add ［ solution A ］ 25ml, jolting 15 minutes, centrifugal 5 minutes, get upper solution, lucifuge left standstill after 1 hour must make need testing solution by molten clear solution, and precision measures 100 μ l injection liquid chromatographies, does not get vitamin D3 reference substance appropriate, add ［ solution A ］ and make contrast solution, adopt external standard method with calculated by peak area.Assay liquid chromatogram is as Fig. 2.
Claims (6)
1. be applicable to the chewable tablet that child replenishes the calcium, it is characterized in that, this chewable tablet is made up of following component by mass percentage:
Calcium carbonate 50%-80%,
Vitamin D
3powder 0.05%-0.2%,
Sorbitol 10%-30%,
Glucose 10%-30%,
Maltodextrin 5%-20%,
Citric acid 0.5%-2%,
Magnesium stearate 1%-3%,
Fructus Citri Limoniae essence 0.5-1.5%;
Surplus is water.
2. the chewable tablet of replenishing the calcium according to a kind of child of being applicable to described in right 1, is characterized in that this chewable tablet is made up of following component by mass percentage:
Calcium carbonate 50%-60%,
Vitamin D
3powder 0.05%-0.15%,
Sorbitol 10%-20%,
Glucose 10%-20%,
Maltodextrin 10%-15%,
Citric acid 0.5%-1.5%,
Magnesium stearate 1%-2.5%,
Fructus Citri Limoniae essence 1.0-1.5%;
Surplus is water.
3. the chewable tablet of replenishing the calcium according to a kind of child of being applicable to described in right 1, is characterized in that this chewable tablet is made up of following component by mass percentage:
Calcium carbonate 55%,
Vitamin D
3powder 0.08%,
Sorbitol 12%,
Glucose 12%,
Maltodextrin 15%,
Citric acid 0.8%,
Magnesium stearate 1.8%,
Fructus Citri Limoniae essence 1.2%;
Surplus is water.
4. prepare the method that is applicable to the chewable tablet that child replenishes the calcium described in claim 1 ~ 3 any one claim, it is characterized in that the method comprises the steps:
1. required former auxiliary being up to the standards, crosses respectively 100 mesh sieves for subsequent use;
2. mix: vitamin d3 powder is mixed homogeneously with citric acid, adopt the equivalent method of progressively increasing to mix;
3. soft material processed: take calcium carbonate, maltodextrin and the glucose of recipe quantity, set high in effect wet granulator mix homogeneously; Add purified water as wetting agent, soft material processed;
4. granulate, be dried: adopt 18 mesh sieves to granulate, in 45 ℃ of-65 ℃ of baking ovens, be dried, control moisture 2% ~ 4%;
5. granulate, always mixed: 18 eye mesh screen granulate for granule after dry, add citric acid and vitamin D after granulate
3mixed powder, in the side of putting cone mixer, mix homogeneously; The magnesium stearate that adds again recipe quantity, mixes;
6. measure moisture and intermediate content, tabletting, bottling.
5. the preparation method of the chewable tablet of replenishing the calcium according to a kind of child of being applicable to described in right 4, is characterized in that vitamin D
3use instead in the time of total mixing and add.
6. the preparation method of the chewable tablet of replenishing the calcium according to a kind of child of being applicable to described in right 4, is characterized in that sheet Hardness Control is within the scope of 9～16kg.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310664047.3A CN103845357A (en) | 2013-12-09 | 2013-12-09 | Vitamin D calcium chewable tablet for calcium supplementation of children and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310664047.3A CN103845357A (en) | 2013-12-09 | 2013-12-09 | Vitamin D calcium chewable tablet for calcium supplementation of children and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103845357A true CN103845357A (en) | 2014-06-11 |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105106154A (en) * | 2015-09-17 | 2015-12-02 | 福建省幸福生物科技有限公司 | Sugar-free calcium tablets for middle-aged and aged people and preparation method thereof |
| CN105168243A (en) * | 2015-08-04 | 2015-12-23 | 广州白云山光华制药股份有限公司 | Composite calcium carbonate and vitamin D3 chewable tablet for children and preparation method thereof |
| CN106138087A (en) * | 2016-07-31 | 2016-11-23 | 合肥远志医药科技开发有限公司 | A kind of dimension D calcium composition chewable tablet and preparation method thereof |
| CN106265725A (en) * | 2015-05-14 | 2017-01-04 | 北京科信必成医药科技发展有限公司 | A kind of calcium carbonate taste masked particle agent and preparation method thereof |
| CN106333961A (en) * | 2016-10-28 | 2017-01-18 | 芜湖市诺康生物科技有限公司 | Vitamin D calcium chewable tablet and preparation method thereof |
| CN109620808A (en) * | 2018-11-02 | 2019-04-16 | 济南维瑞医药科技开发有限公司 | A kind of chewing compound calcium carbonate tablet preparation method effectively improving children's calcium absorptivity |
| CN111617042A (en) * | 2020-02-26 | 2020-09-04 | 安士制药（中山）有限公司 | Composite calcium carbonate vitamin D3Water-free swallow granule and preparation method thereof |
| CN113750062A (en) * | 2021-09-05 | 2021-12-07 | 西安麦德森斯医疗科技有限公司 | Organic calcium vitamin D chewable tablet and preparation method thereof |
| CN113952311A (en) * | 2021-10-25 | 2022-01-21 | 哈药集团技术中心 | Preparation method of calcium carbonate vitamin D3 chewable tablet |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101001611A (en) * | 2004-05-24 | 2007-07-18 | 奈科明制药有限公司 | Particulate comprising a calcium-containing compound and a sugar alcohol |
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- 2013-12-09 CN CN201310664047.3A patent/CN103845357A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101001611A (en) * | 2004-05-24 | 2007-07-18 | 奈科明制药有限公司 | Particulate comprising a calcium-containing compound and a sugar alcohol |
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265725A (en) * | 2015-05-14 | 2017-01-04 | 北京科信必成医药科技发展有限公司 | A kind of calcium carbonate taste masked particle agent and preparation method thereof |
| CN106265725B (en) * | 2015-05-14 | 2021-02-09 | 北京科信必成医药科技发展有限公司 | Calcium carbonate taste-masking granules and preparation method thereof |
| CN105168243A (en) * | 2015-08-04 | 2015-12-23 | 广州白云山光华制药股份有限公司 | Composite calcium carbonate and vitamin D3 chewable tablet for children and preparation method thereof |
| CN105106154A (en) * | 2015-09-17 | 2015-12-02 | 福建省幸福生物科技有限公司 | Sugar-free calcium tablets for middle-aged and aged people and preparation method thereof |
| CN105106154B (en) * | 2015-09-17 | 2018-06-29 | 福建省幸福生物科技有限公司 | A kind of person in middle and old age's sugar-free calcium tablet and preparation method thereof |
| CN106138087A (en) * | 2016-07-31 | 2016-11-23 | 合肥远志医药科技开发有限公司 | A kind of dimension D calcium composition chewable tablet and preparation method thereof |
| CN106333961A (en) * | 2016-10-28 | 2017-01-18 | 芜湖市诺康生物科技有限公司 | Vitamin D calcium chewable tablet and preparation method thereof |
| CN109620808A (en) * | 2018-11-02 | 2019-04-16 | 济南维瑞医药科技开发有限公司 | A kind of chewing compound calcium carbonate tablet preparation method effectively improving children's calcium absorptivity |
| CN111617042A (en) * | 2020-02-26 | 2020-09-04 | 安士制药（中山）有限公司 | Composite calcium carbonate vitamin D3Water-free swallow granule and preparation method thereof |
| CN113750062A (en) * | 2021-09-05 | 2021-12-07 | 西安麦德森斯医疗科技有限公司 | Organic calcium vitamin D chewable tablet and preparation method thereof |
| CN113952311A (en) * | 2021-10-25 | 2022-01-21 | 哈药集团技术中心 | Preparation method of calcium carbonate vitamin D3 chewable tablet |
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Application publication date: 20140611 |