CN105168243A - Composite calcium carbonate and vitamin D3 chewable tablet for children and preparation method thereof - Google Patents
Composite calcium carbonate and vitamin D3 chewable tablet for children and preparation method thereof Download PDFInfo
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- CN105168243A CN105168243A CN201510472057.6A CN201510472057A CN105168243A CN 105168243 A CN105168243 A CN 105168243A CN 201510472057 A CN201510472057 A CN 201510472057A CN 105168243 A CN105168243 A CN 105168243A
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Abstract
The invention relates to the field of pharmaceuticals, in particular to a composite calcium carbonate and vitamin D3 chewable tablet for children and a preparation method thereof. The chewable tablet is composed of, by weight, 50-75% of calcium carbonate, 0.05-0.2% of vitamin D3 powder, 22-40% of sorbitol, 0.6-2.4% of citric acid, 0.1-0.6% of aspartame, 0.2-0.6% of essence, 0.05-0.2% of pigment and 2-6% of magnesium stearate. The chewable tablet is suitable for large-scale industrial production, and taste, color and smell of the chewable tablet are adjusted by reasonably proportioning the components and content, so that medication compliance of the children is improved.
Description
Technical field
The present invention relates to pharmaceutical field, particularly relate to a kind of child's composite calcium carbonate and vitamin D3 chewable tablet and preparation method thereof.
Background technology
Calcium is called as " life foundation stone ", has very important effect to the skeleton development of child, brain development, the aspect such as tooth development and prevention lead poisoning.Child is in growth promoter period, needs to meet from outer picked-up calcium the needs that physical growth grows by taking the modes such as children calcium product.
Child in correlation technique ties up D Biocal and/or its preparation technology exists following defect: the supplementary material that in (1) prescription, consumption is maximum is calcium carbonate and sorbitol, first both are needed to granulate, and the viscosity of calcium carbonate and sorbitol is poor, become graininess undesirable, this brings difficulty to granulation; (2) vitamin d3 levels extremely low (3ug/ sheet), ensures that its uniformity is in the product more difficult; (3) vitamin D3 character is unstable, and the impact of the environmental factorss such as light, heat, air is easily degraded, and is unfavorable in production and storage; (4) children taking compliance is not high.
Summary of the invention
The object of the present invention is to provide a kind of child's composite calcium carbonate and vitamin D3 chewable tablet and preparation method thereof, to solve the problem.
Embodiments of the invention provide a kind of child's composite calcium carbonate and vitamin D3 chewable tablet, be made up of following component by weight percentage: calcium carbonate 50%-75%, vitamin d3 powder 0.05%-0.2%, sorbitol 22%-40%, citric acid 0.6%-2.4%, Aspartane 0.1%-0.6%, essence 0.2%-0.6%, pigment 0.05%-0.2%, magnesium stearate 2%-6%.
Embodiments of the invention additionally provide the preparation method of a kind of child's composite calcium carbonate and vitamin D3 chewable tablet, comprise the steps:
1) part sorbitol is got and pigment is dissolved in appropriate purified water as binding agent;
2) calcium carbonate of recipe quantity is placed in wet mixing pelletizer, adds binding agent soft material;
3) granulation of 10-30 mesh sieve crossed by soft material;
4) granule is in 40-70 DEG C of heat-wind circulate drying, controls moisture below 1%;
5) vitamin d3 powder of recipe quantity and additional sorbitol, citric acid, Aspartane, essence and step 4) gained fine grained mixs homogeneously by equivalent dilution method, mixture and step 4) the dry granule of gained, magnesium stearate always mix, tabletting.
Further, the binding agent of this granulation is the hydrothermal solution of appropriate sorbitol and pigment, and the temperature of binding agent is 30-60 degree Celsius.
Further, above-mentioned steps 5) specifically comprise: the first premixing of this additional sorbitol, citric acid, Aspartane, essence, afterwards by equivalent dilution method with vitamin d3 powder mix homogeneously, then to mix homogeneously by equivalent dilution method with fine grained, finally and other granule and magnesium stearate always mix.
Further, this sheet Hardness Control is within the scope of 40-160N.
Compared with prior art the invention has the beneficial effects as follows: during wet granulation, a certain amount of sorbitol is dissolved in the water of suitable amount as binding agent, and its concentration and consumption are determined, obtained particle size distribution is even, mobility is better, compressibility is good; Screen the outer dosage of the kind of the adjuvant such as essence, sweeting agent, consumption and sorbitol, obtain best compression formula, this chewable tablet is trichroism three taste mixing tabs, mouthfeel is crisp, and children taking compliance is good; Vitamin d3 powder is adopted to feed intake (granule that vitamin D3 carries out wrapping up and makes by employing inclusion technique), adopt outer add mode to add simultaneously, exempt in production process be heated, the impact of the environmental factors such as air, effectively maintain the stability of vitamin D3 in product; Get additional sorbitol, citric acid, Aspartane, the first premixing of essence, press equivalent dilution method afterwards with vitamin d3 powder mix homogeneously, mix homogeneously by equivalent dilution method in right amount with fine grained, last and other granule and magnesium stearate are always mixed, and ensure that in product, vitamin d3 levels is even again.
Detailed description of the invention
Below by specific embodiment, the present invention is described in further detail.
The present embodiment provides a kind of child's composite calcium carbonate and vitamin D3 chewable tablet, be made up of following component by weight percentage: calcium carbonate 50%-75% (can be 55%, 60%, 65%), vitamin d3 powder 0.05%-0.2% (can be 0.08%, 0.1%, 0.15%), sorbitol 22%-40% (can be 30%, 35%, 38%), citric acid 0.6%-2.4% (can be 0.7%, 1.6%, 2.2%), Aspartane 0.1%-0.6% (can be 0.15%, 0.3%, 0.55%), essence 0.2%-0.6% (can be 0.22%, 0.38%, 0.52%), pigment 0.05%-0.2% (can be 0.08%, 0.13%, 0.17%), magnesium stearate 2%-6% (can be 3%, 4.6%, 5.7%).
Child's composite calcium carbonate that the present embodiment provides and vitamin D3 chewable tablet, be suitable for carrying out large-scale commercial production, carries out rational proportion, regulate its mouthfeel, color, taste, improve the compliance that child takes medicine by component and content.
The present embodiment additionally provides the preparation method of a kind of child's composite calcium carbonate and vitamin D3 chewable tablet, comprises the steps:
1) part sorbitol is got and pigment is dissolved in appropriate purified water as binding agent;
2) calcium carbonate of recipe quantity is placed in wet mixing pelletizer, adds binding agent soft material;
3) granulation of 10-30 mesh sieve crossed by soft material;
4) granule is in 40-70 DEG C of heat-wind circulate drying, controls moisture below 1%;
5) vitamin d3 powder of recipe quantity and additional sorbitol, citric acid, Aspartane, essence and fine grained (the 4th) step particle screening gained) mix homogeneously by equivalent dilution method, mixture and the 4th) the dry granule of step gained, magnesium stearate always mix, tabletting.
In the present embodiment, the binding agent of this granulation is the hydrothermal solution of appropriate sorbitol and pigment, and the temperature of binding agent is 30-60 degree Celsius.
In the present embodiment, above-mentioned steps 5) specifically comprise: the first premixing of this additional sorbitol, citric acid, Aspartane, essence, press equivalent dilution method afterwards with vitamin d3 powder mix homogeneously, mix homogeneously by equivalent dilution method with fine grained, last and other granule and magnesium stearate are always mixed again.
In the present embodiment, this sheet Hardness Control is within the scope of 40-160N.
Child's composite calcium carbonate that the present embodiment provides and the preparation method of vitamin D3 chewable tablet have following beneficial effect:
(1) during wet granulation be dissolved in a certain amount of sorbitol as binding agent in the water of suitable amount, and determine its concentration and consumption, obtained particle size distribution is even, mobility is better, compressibility is good.
(2) screen the outer dosage of the kind of the adjuvant such as essence, sweeting agent, consumption and sorbitol, obtain best compression formula, this chewable tablet is trichroism three taste mixing tabs, mouthfeel is crisp, and children taking compliance is good.
(3) vitamin d3 powder is adopted to feed intake (granule that vitamin D3 carries out wrapping up and makes by employing inclusion technique), adopt outer add mode to add simultaneously, exempt in production process be heated, the impact of the environmental factors such as air, effectively maintain the stability of vitamin D3 in product.
(4) additional sorbitol, citric acid, Aspartane, the first premixing of essence is got, press equivalent dilution method afterwards with vitamin d3 powder mix homogeneously, mix homogeneously by equivalent dilution method in right amount with fine grained again, last and other granule and magnesium stearate are always mixed, and ensure that in product, vitamin d3 levels is even.
Be described further with instantiation below:
Embodiment 1
Coordinate by weight proportion:
Get part sorbitol and pigment is dissolved in appropriate purified water as binding agent; The calcium carbonate of recipe quantity is placed in wet mixing pelletizer, adds binding agent soft material; Soft material is crossed 10-30 mesh sieve and is granulated; Granule, in 40-70 DEG C of heat-wind circulate drying, controls moisture below 1%; The vitamin d3 powder of recipe quantity is mixed homogeneously by equivalent dilution method with additional sorbitol, citric acid, Aspartane, essence and fine grained; Mixture and dry granule, magnesium stearate are always mixed, tabletting.
Embodiment 2
Coordinate by weight proportion:
Get part sorbitol and pigment is dissolved in appropriate purified water as binding agent; The calcium carbonate of recipe quantity is placed in wet mixing pelletizer, adds binding agent soft material; Soft material is crossed 10-30 mesh sieve and is granulated; Granule, in 40-70 DEG C of heat-wind circulate drying, controls moisture below 1%; The vitamin d3 powder of recipe quantity is mixed homogeneously by equivalent dilution method with additional sorbitol, citric acid, Aspartane, essence and fine grained; Mixture and dry granule, magnesium stearate are always mixed, tabletting.
Embodiment 3
Coordinate by weight proportion:
Get part sorbitol and pigment is dissolved in appropriate purified water as binding agent; The calcium carbonate of recipe quantity is placed in wet mixing pelletizer, adds binding agent soft material; Soft material is crossed 10-30 mesh sieve and is granulated; Granule, in 40-70 DEG C of heat-wind circulate drying, controls moisture below 1%; The vitamin d3 powder of recipe quantity is mixed homogeneously by equivalent dilution method with additional sorbitol, citric acid, Aspartane, essence and fine grained; Mixture and dry granule, magnesium stearate are always mixed, tabletting.
The preparation method that above-described embodiment provides, vitamin d3 powder is the clathrate of vitamin D3, the steady quality of vitamin D3 in preparation and storage process can be maintained, preparation method is simple, be suitable for carrying out large-scale commercial production, production cost can be reduced from raw material and technique two aspects, simultaneously, obtained tablet chews that to take mouthfeel good, is beneficial to children.
A series of detailed description listed is above only illustrating for feasibility embodiment of the present invention; they are also not used to limit the scope of the invention, all do not depart from the skill of the present invention equivalent implementations done of spirit or change all should be included within protection scope of the present invention.
To those skilled in the art, obviously the invention is not restricted to the details of above-mentioned one exemplary embodiment, and when not deviating from spirit of the present invention or basic feature, the present invention can be realized in other specific forms.Therefore, no matter from which point, all should embodiment be regarded as exemplary, and be nonrestrictive, scope of the present invention is limited by claims instead of above-mentioned explanation, and all changes be therefore intended in the implication of the equivalency by dropping on claim and scope are included in the present invention.
Claims (5)
1. child's composite calcium carbonate and vitamin D3 chewable tablet, it is characterized in that, be made up of following component by weight percentage: calcium carbonate 50%-75%, vitamin d3 powder 0.05%-0.2%, sorbitol 22%-40%, citric acid 0.6%-2.4%, Aspartane 0.1%-0.6%, essence 0.2%-0.6%, pigment 0.05%-0.2%, magnesium stearate 2%-6%.
2. a preparation method for child's composite calcium carbonate and vitamin D3 chewable tablet, is characterized in that, comprises the steps:
1) part sorbitol is got and pigment is dissolved in appropriate purified water as binding agent;
2) calcium carbonate of recipe quantity is placed in wet mixing pelletizer, adds binding agent soft material;
3) granulation of 10-30 mesh sieve crossed by soft material;
4) granule is in 40-70 DEG C of heat-wind circulate drying, controls moisture below 1%;
5) vitamin d3 powder of recipe quantity and additional sorbitol, citric acid, Aspartane, essence and step 4) gained fine grained mixs homogeneously by equivalent dilution method, mixture and step 4) the dry granule of gained, magnesium stearate always mix, tabletting.
3. preparation method according to claim 2, is characterized in that, the binding agent of described granulation is the hydrothermal solution of appropriate sorbitol and pigment, and the temperature of binding agent is 30-60 degree Celsius.
4. preparation method according to claim 2, it is characterized in that, described step 5) specifically comprise: the first premixing of described additional sorbitol, citric acid, Aspartane, essence, press equivalent dilution method afterwards with vitamin d3 powder mix homogeneously, mix homogeneously by equivalent dilution method with fine grained, last and other granule and magnesium stearate are always mixed again.
5. preparation method according to claim 2, is characterized in that, described Hardness Control is within the scope of 40-160N.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| CN110575440A (en) * | 2018-06-08 | 2019-12-17 | 北京新领先医药科技发展有限公司 | Preparation method of calcium carbonate pharmaceutical composition |
| CN110693842A (en) * | 2019-10-28 | 2020-01-17 | 浙江华康药业股份有限公司 | Sorbitol tablet and preparation method and application thereof |
| 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 |
| CN112716972A (en) * | 2021-01-20 | 2021-04-30 | 北京民康百草医药科技有限公司 | Calcium carbonate vitamin D3 chewable tablet and preparation method thereof |
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| CN103845357A (en) * | 2013-12-09 | 2014-06-11 | 浙江佐力药业股份有限公司 | Vitamin D calcium chewable tablet for calcium supplementation of children and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
| CN110575440A (en) * | 2018-06-08 | 2019-12-17 | 北京新领先医药科技发展有限公司 | Preparation method of calcium carbonate pharmaceutical composition |
| 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 |
| CN110693842A (en) * | 2019-10-28 | 2020-01-17 | 浙江华康药业股份有限公司 | Sorbitol tablet and preparation method and application thereof |
| 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 |
| CN112716972A (en) * | 2021-01-20 | 2021-04-30 | 北京民康百草医药科技有限公司 | Calcium carbonate vitamin D3 chewable tablet and preparation method thereof |
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Application publication date: 20151223 |