CN107569510A - A kind of children's calcium carbonate D3 particulate compositions and preparation method thereof - Google Patents
A kind of children's calcium carbonate D3 particulate compositions and preparation method thereof Download PDFInfo
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- CN107569510A CN107569510A CN201710405027.2A CN201710405027A CN107569510A CN 107569510 A CN107569510 A CN 107569510A CN 201710405027 A CN201710405027 A CN 201710405027A CN 107569510 A CN107569510 A CN 107569510A
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Abstract
A kind of children's calcium carbonate D3 particulate compositions and preparation method thereof.Comprise the following steps：(1) it is standby to cross 80 mesh sieves for supplementary material；(2) calcium carbonate, maltodextrin, glucose is put after mixing 30min in mixer, adds the ethanol of adhesive 50% while stirring, softwood is made；(3) softwood is put into oscillating granulator with 16 mesh stainless steel sieve series grains；(4) wet granular is put 50~65 DEG C of air dry oven dryings and stopped to moisture no more than 5.0%, after letting cool, sieves whole grain through 30 mesh stainless steels, obtains calcium carbonate granule；(5) vitamin d3 powder is well mixed with above-mentioned calcium carbonate granule using the equivalent method of progressively increasing, adds sodium citrate and continue to mix with remaining calcium carbonate granule.The present invention is added using vitamin d3 powder in total mix, and avoids destroying its microcapsule structure during pelleting, so as to improve the stability of preparation, while the optimization for passing through technique, it is ensured that the vitamin d3 levels uniformity of preparation is in RSD ＜ 10%.
Description
Technical field
The invention belongs to field of pharmaceutical preparations.Specifically, the present invention relates to a kind of children's calcium carbonate D3 particulate compositions
And preparation method thereof.
Background technology
Children's calcium carbonate D3 particles are a kind of compound preparations, and this product (C27H44O) containing vitamine D3 should be labelled amount
90.0%~165.0%；Calcium carbonate (CaCO3) should be the 90.0%~125.0% of labelled amount.Calcium be maintain human nerve,
Muscle, skeletal system, cell membrane and capillary permeability normal function institute are required.Vitamin D can participate in the metabolism of calcium and phosphorus,
Promote it to absorb and New bone formation is played an important role, children's calcium carbonate D3 particles are a kind of compound systems of calcic and vitamin D
Agent, available for gestation and the calcium complement agent of women breast-feeding their children, climacteric women, the elderly, children etc., and help to prevent and treat sclerotin and dredge
Loose disease.
As people replenish the calcium the raising of consciousness, the country is in great demand to calcium supplementing product, but the system of replenishing the calcium sold now
Agent is health food, and quality is uneven, and import calcium-supplementing preparation is expensive, has certain limitation.
The content of the invention
It is an object of the invention to provide a kind of children's calcium carbonate D3 particulate compositions and preparation method thereof, solves in the market
Calcium-supplementing preparation vitamin D place the problem of content reduces for a long time, improve the stability of product, ensure calcium absorptivity, solve simultaneously
The certainly dissolution Similar Problems of own product and import drugs, make it have higher similitude.
To achieve the above object, the present invention uses following technical scheme：
A kind of children's calcium carbonate D3 particulate compositions, are made up of following components：
Present invention also offers a kind of children's calcium carbonate D3 particulate composition preparation methods, this method comprises the following steps：
(1) it is standby to cross 80 mesh sieves for supplementary material；
(2) calcium carbonate, maltodextrin, glucose is put after mixing 30min in mixer, adds adhesive 50% while stirring
Ethanol, softwood is made；
(3) softwood is put into oscillating granulator with 16 mesh stainless steel sieve series grains；
(4) wet granular is put 50~65 DEG C of air dry oven dryings and stopped to moisture no more than 5.0%, after letting cool, through 30 mesh
Stainless steel sieves whole grain, obtains calcium carbonate granule；
(5) vitamin d3 powder is well mixed with above-mentioned calcium carbonate granule using the equivalent method of progressively increasing, adds sodium citrate
Continue to mix with remaining calcium carbonate granule, sample, detection particle proterties, content；
(6) it is filling according to actual measurement granule content regulation loading amount.
Preferably, drying temperature is 65 DEG C in the step (4), and moisture is below 3.0%.
The present invention is added using vitamin d3 powder in total mix, and avoids destroying its microcapsule structure during pelleting, from
And the stability of preparation is improved, while the optimization for passing through technique, it is ensured that the vitamin d3 levels uniformity of preparation is in RSD ＜
10%.The tablet prepared carries out outward appearance, content, stripping curve with D-Cal product and contrasted, and as a result shows indifference, we use
It is that auxiliary material is domestic auxiliary material, production cost is significantly lower than imported product, has important meaning to the supplement of Chinese calcium supplementing product
Justice.
Embodiment
In order to which the present invention is apparent to understand, with reference to specific embodiment, the invention will be further described, to help
Understand present disclosure.
Embodiment one
First, it is formulated
2nd, preparation method
(1) it is standby to cross 80 mesh sieves for supplementary material.
(2) calcium carbonate, maltodextrin, glucose is put after mixing 30min in mixer, adds adhesive 50% while stirring
Ethanol, softwood is made.
(3) softwood is put into oscillating granulator with 16 mesh stainless steel sieve series grains.
(4) wet granular, which is put 50-65 DEG C of air dry oven (steam heating) and dried to moisture, is no more than 5.0% stopping, letting cool
Afterwards, whole grain is sieved through 30 mesh stainless steels, obtains calcium carbonate granule.
(5) vitamin d3 powder is well mixed with above-mentioned calcium carbonate granule using the equivalent method of progressively increasing, adds sodium citrate
Continue to mix with remaining calcium carbonate granule, sample, detection particle proterties, content.
(6) it is filling according to actual measurement granule content regulation loading amount.
The stripping curve of children's calcium carbonate D3 particles made from embodiment one and reference preparation D-Cal product is measured,
As a result it is as shown in table 1：
Table 1 is that the Dissolution profiles of children's calcium carbonate D3 particles obtained by embodiment one and reference preparation D-Cal product determine
As a result
| 5min | 10min | 15min | 20min | 30min | |
| Reference preparation | 89.5 | 94.8 | 97.1 | 98.2 | 99.5 |
| Embodiment one | 88.8 | 93.5 | 97.2 | 99.6 | 101.2 |
The sample of children's calcium carbonate D3 particles obtained by embodiment one and reference preparation D-Cal product is carried out influence because
Plain 60 DEG C of high temperature keeps sample and carries out assay, as a result as shown in table 2：
Table 2 is 60 DEG C of the high-temperature sample of children's calcium carbonate D3 particles obtained by embodiment one and reference preparation D-Cal product
Keep sample sample size measurement result
As can be seen from the above table, children's calcium carbonate D3 granule stabilities of the invention are preferable, and are better than reference preparation.
General principle, principal character and the advantages of the present invention of the present invention, the technology of the industry has been shown and described above
Personnel under the premise without departing from the spirit and scope of the present invention, can also it will be appreciated that the present invention is not limited to the above embodiments
There are various changes and modifications, these changes and improvement all fall within the protetion scope of the claimed invention.
Claims (3)
- A kind of 1. children's calcium carbonate D3 particulate compositions, it is characterised in that：It is made up of following components：。
- 2. a kind of children's calcium carbonate D3 particulate composition preparation methods, it is characterised in that this method comprises the following steps：(1) it is standby to cross 80 mesh sieves for supplementary material；(2) calcium carbonate, maltodextrin, glucose is put after mixing 30min in mixer, adds the second of adhesive 50% while stirring Alcohol, softwood is made；(3) softwood is put into oscillating granulator with 16 mesh stainless steel sieve series grains；(4) wet granular is put 50~65 DEG C of air dry oven dryings and stopped to moisture no more than 5.0%, stainless through 30 mesh after letting cool Steel sieves whole grain, obtains calcium carbonate granule；(5) vitamin d3 powder is well mixed with above-mentioned calcium carbonate granule using the equivalent method of progressively increasing, adds sodium citrate with remaining Remaining calcium carbonate granule continues to mix, sampling, detection particle proterties, content；(6) it is filling according to actual measurement granule content regulation loading amount.
- 3. preparation method according to claim 2, it is characterised in that：Drying temperature is 65 DEG C in the step (4), moisture Below 3.0%.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710405027.2A CN107569510A (en) | 2017-06-01 | 2017-06-01 | A kind of children's calcium carbonate D3 particulate compositions and preparation method thereof |
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| CN201710405027.2A CN107569510A (en) | 2017-06-01 | 2017-06-01 | A kind of children's calcium carbonate D3 particulate compositions and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113952358A (en) * | 2021-11-24 | 2022-01-21 | 合肥远志医药科技开发有限公司 | Calcium carbonate and vitamin D3 composition and preparation method thereof |
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|---|---|---|---|---|
| CN102908359A (en) * | 2012-10-26 | 2013-02-06 | 北京康远制药有限公司 | Composite calcium carbonate/vitamin D3 granules for children and preparation method thereof |
| CN103463126A (en) * | 2013-09-25 | 2013-12-25 | 贵州联盛药业有限公司 | Calcium carbonate D3 granula and preparation method thereof |
| CN105106233A (en) * | 2015-08-28 | 2015-12-02 | 江苏福邦药业有限公司 | High-dissolubility children's calcium carbonate D3 granule and preparation method thereof |
| CN105535018A (en) * | 2015-12-28 | 2016-05-04 | 海南葫芦娃制药有限公司 | Calcium carbonate D3 granules and preparation method thereof |
| CN106420808A (en) * | 2015-08-11 | 2017-02-22 | 北京远方通达医药技术有限公司 | Preparation containing vitamin D3 and calcium carbonate and preparation method for preparation |
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2017
- 2017-06-01 CN CN201710405027.2A patent/CN107569510A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102908359A (en) * | 2012-10-26 | 2013-02-06 | 北京康远制药有限公司 | Composite calcium carbonate/vitamin D3 granules for children and preparation method thereof |
| CN103463126A (en) * | 2013-09-25 | 2013-12-25 | 贵州联盛药业有限公司 | Calcium carbonate D3 granula and preparation method thereof |
| CN106420808A (en) * | 2015-08-11 | 2017-02-22 | 北京远方通达医药技术有限公司 | Preparation containing vitamin D3 and calcium carbonate and preparation method for preparation |
| CN105106233A (en) * | 2015-08-28 | 2015-12-02 | 江苏福邦药业有限公司 | High-dissolubility children's calcium carbonate D3 granule and preparation method thereof |
| CN105535018A (en) * | 2015-12-28 | 2016-05-04 | 海南葫芦娃制药有限公司 | Calcium carbonate D3 granules and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113952358A (en) * | 2021-11-24 | 2022-01-21 | 合肥远志医药科技开发有限公司 | Calcium carbonate and vitamin D3 composition and preparation method thereof |
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Application publication date: 20180112 |
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