CN103494836A - Preparation method and application of composite calcium carbonate and vitamin D3 chewable tablets - Google Patents
Preparation method and application of composite calcium carbonate and vitamin D3 chewable tablets Download PDFInfo
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- CN103494836A CN103494836A CN201310433713.2A CN201310433713A CN103494836A CN 103494836 A CN103494836 A CN 103494836A CN 201310433713 A CN201310433713 A CN 201310433713A CN 103494836 A CN103494836 A CN 103494836A
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Abstract
The invention relates to a composite calcium carbonate/vitamin D3 (vitamin D3 and beta-cyclodextrin inclusion complex) chewable tablet which is suitable for children, old people and other people who are difficult to absorb calcium sources. The composite calcium carbonate/vitamin D3 chewable tablet is prepared from raw materials of calcium carbonate/vitamin D3 and auxiliary materials, each tablet of the preparation contains 300mg of calcium carbonate and 100IU of vitamin D3 (vitamin D3 and beta-cyclodextrin inclusion complex), and the auxiliary materials are selected from a diluent, a binding agent, a wetting agent and a flavoring agent. The invention further relates to a preparation method of composite calcium carbonate/vitamin D3 tablets for children and old people. The formula and the preparation process are feasible and suitable for large-scale production, and the prepared composite calcium carbonate/vitamin D3 tablets have the advantages of good taste and sweet taste and are more suitable for children to take; furthermore, the tablets contain the vitamin D3 to enable the calcium sources to be relatively easy to be absorbed; the products have relatively good uniformity and relatively high dissolution rate. The composite calcium carbonate/vitamin D3 tablets for children, disclosed by the invention, are suitable for children, old people and people who are difficult to swallow and particularly suitable for children.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, preparation method and the application of specific design composite calcium carbonate vitamin D3 chewable tablet
Background technology
For child's (comprising pupil and middle school student) of school age, this is skeleton development and growth in stature the fastest period in life, and the bone mineral content of human body percent 50 is all to store in this period, is calcium demand maximum period in life.If at this moment guarantee sufficient calcium every day, can make skeleton, internal organs, brain be grown fully, extremely important for the increase of height and body weight.
Calcium is the important component part of human body, is a kind of mineral that in-vivo content is maximum.Calcium content during the neonate birth in body is only 28 grams, and with advancing age, in body, the content of calcium also constantly increases.Calcium while growing up in body is about 1000-1200 gram left and right, relevant with sex height, and in males of imposing stature, calcium content is also high, and in body, percent 99 calcium concentrates in human skeleton and tooth, makes their keep firmer.
Calcium in skeleton and tooth is not unalterable, but need to constantly upgrade.Be that the calcium absorbed every day enters in skeleton, in skeleton, original calcium enters in extracellular fluid and soft tissue, and the calcium in skeleton is constantly updated.The speed of less renewal of age is faster.With regard to update all once, renewal speed descends the every 1-2 of calcium in child's skeleton gradually with age later.Calcium also has other some effects, as maintained nervimuscular activity, maintains the rhythm and pace of moving things of heart, promotes the activity of a lot of enzymes in body, and to protein, the metabolism of fat all plays an important role.Calcium also participates in Blood coagulation and maintains acid-base balance in body.Therefore say that calcium plays a very important role in vivo.
CN102716149A discloses effervescent tablet of calcium carbonate D3 and preparation method thereof, but above-mentioned preparation method only provides the mixed method of simple calcium carbonate and vitamin D3 and the furnace drying method of granulation, can not by vitamin D3 fully and calcium carbonate mix, adopt simple drying means simultaneously, affected the content of vitamin D3.
Summary of the invention
Goal of the invention: in order to address the above problem, the object of the present invention is to provide a kind of vitamin D3 substitute that mixes with calcium carbonate and preparation method of Calcichew D3 chewable tablet of being easy to.
Another object of the present invention is to provide a kind of composite calcium carbonate vitamin D3 chewable tablet to apply in improving the difficult absorption crowd in the calcium sources such as child and old man.
Technical scheme: the objective of the invention is to realize by following scheme:
The preparation method of the chewable tablet of a kind of composite calcium carbonate and vitamin D3, by calcium carbonate 750g, containing vitamin D3 2.5mg inclusion complex (vitamin D3 and Benexate Hydrochloride), as raw material, make, it is characterized in that method used is comprised of the following step: get part calcium carbonate, vitamin D3 (vitamin D3 and Benexate Hydrochloride), orange flavor, Sorbitol and mix, mixture is mixed homogeneously with the residue calcium carbonate, add 70% appropriate amount of ethanol to granulate, microwave vacuum is dried, add magnesium stearate appropriate, be pressed into 1000, every heavily about 0.8g.
The preparation method of above-mentioned composite calcium carbonate vitamin D3 chewable tablet, described vitamin D3 is vitamin D3 and Benexate Hydrochloride, the amount of its preparation is to mean containing vitamin D3.
The preparation method of above-mentioned composite calcium carbonate vitamin D3 chewable tablet, the concentration of alcohol of granulation is 60-70%, and drying means is vacuum microwave drying, and be 10-15 minute drying time.
Above-mentioned composite calcium carbonate vitamin D3 chewable tablet is applied in improving the difficult absorption crowd in the calcium sources such as child and old man.
In prior art, the commercially available average dissolution of calcium carbonate D3 chewable tablet Dissolution Rate Testing calcium is 88.70%, the average dissolution of vitamin D3 is 85.35%, the average dissolution of calcium carbonate D3 chewable tablet Dissolution Rate Testing calcium that adopts the present invention to be prepared into is 99.51%, and the average dissolution of vitamin D3 is 99.15%.Illustrate that the calcium carbonate D3 chewable tablet bioavailability that this method makes is high.
Specific implementation method
Form by the following examples, foregoing of the present invention is described in further detail again, but this should be interpreted as to the scope of the above-mentioned theme of the present invention only limits to following example, all technology realized based on foregoing of the present invention all belong to scope of the present invention.
Embodiment 1
Get calcium carbonate 750g, make as raw material containing vitamin D3 2.5mg inclusion complex (vitamin D3 and Benexate Hydrochloride): get part calcium carbonate 2g, vitamin D3 2.5mg (vitamin D3 and Benexate Hydrochloride), orange flavor, Sorbitol mixes, mixture is mixed homogeneously with the residue calcium carbonate, add 70% appropriate amount of ethanol to granulate, microwave vacuum is dried 10 minutes, add magnesium stearate appropriate, be pressed into 1000, every heavily about 0.8g.
Dissolution Rate Testing, dissolubility of calcium is 99.71%, the vitamin D3 dissolution is 99.22%.
Embodiment 2
Get calcium carbonate 750g, make as raw material containing vitamin D3 2.5mg inclusion complex (vitamin D3 and Benexate Hydrochloride): get part calcium carbonate 2g, vitamin D3 2.5mg (vitamin D3 and Benexate Hydrochloride), orange flavor, Sorbitol mixes, mixture is mixed homogeneously with the residue calcium carbonate, add 60% appropriate amount of ethanol to granulate, microwave vacuum is dried 15 minutes, add magnesium stearate appropriate, be pressed into 1000, every heavily about 0.8g.
Dissolution Rate Testing, dissolubility of calcium is 99.65%, the vitamin D3 dissolution is 99.17%.
Embodiment 3
Get calcium carbonate 1500g, make as raw material containing vitamin D3 5mg inclusion complex (vitamin D3 and Benexate Hydrochloride): get part calcium carbonate 2g, vitamin D3 2.5mg (vitamin D3 and Benexate Hydrochloride), orange flavor, Sorbitol mixes, mixture is mixed homogeneously with the residue calcium carbonate, add 70% appropriate amount of ethanol to granulate, microwave vacuum is dried 15 minutes, add magnesium stearate appropriate, be pressed into 2000, every heavily about 0.8g.
Dissolution Rate Testing, dissolubility of calcium is 99.18%, the vitamin D3 dissolution is 99.06%.
Embodiment 4: with the comparative study of commercially available prod dissolution
The chewable tablet of embodiment 3 and commercially available calcium carbonate D3 chewable tablet are measured the dissolution of calcium and vitamin D3 according to " Chinese Pharmacopoeia (2010 editions) " dissolution methods (appendix XC the second method).With simulated gastric fluid (get dilute hydrochloric acid 16.4ml, add about 800ml and pepsin 10g, after shaking up, thin up becomes 1000ml and get final product), 900ml is dissolution medium, rotating speed 50r/min, and 37 ℃ ± 0.5 ℃ of temperature, operate according to pharmacopeia regulation method.Take out solution 10ml at 30min, use the titration measuring calcium content, use the Syrups by HPLC vitamin d3 levels, the results are shown in Table 1:
The dissolution contrast test of table 1 and commercially available medicine
| Sample number into spectrum | Dissolubility of calcium (%) | Vitamin D3 dissolution (%) |
| Embodiment 1 sample | 99.71 | 99.22 |
| Embodiment 2 samples | 99.65 | 99.17 |
| Embodiment 3 samples | 99.18 | 99.06 |
| Commercially available sample 1 | 89.12 | 86.03 |
| Commercially available sample 2 | 88.43 | 85.16 |
| Commercially available sample 3 | 88.57 | 84.86 |
Conclusion: in the Dissolution Rate Testing of " Chinese Pharmacopoeia (2010 editions) " regulation, the composite calcium carbonate vitamin D3 chewable tablet dissolution prepared by the present invention is better than commercially available dissolution.
Claims (4)
- The preparation method of a kind of composite calcium carbonate and vitamin D3 chewable tablet and application thereof1. the preparation method of the chewable tablet of a composite calcium carbonate and vitamin D3, by calcium carbonate 750g, vitamin D3 2.5mg (vitamin D3 and Benexate Hydrochloride), as raw material, made, it is characterized in that method used is comprised of the following step: get part calcium carbonate, vitamin D3 (vitamin D3 and Benexate Hydrochloride), orange flavor, Sorbitol and mix, mixture is mixed homogeneously with the residue calcium carbonate, add the appropriate amount of ethanol of 60-70% to granulate, microwave vacuum is dried, add magnesium stearate appropriate, be pressed into 1000, every heavily about 0.8g.
- 2. the preparation method of composite calcium carbonate vitamin D3 chewable tablet according to claim 1, is characterized in that described vitamin D3 is vitamin D3 and Benexate Hydrochloride, and the amount of its preparation is to mean containing vitamin D3.
- 3. the preparation method of composite calcium carbonate vitamin D3 chewable tablet according to claim 1, the concentration of alcohol that it is characterized in that described granulation is 60-70%, and drying means is vacuum microwave drying, and be 10-15 minute drying time.
- 4. composite calcium carbonate vitamin D3 chewable tablet is applied in improving the difficult absorption crowd in the calcium sources such as child and old man according to claim 1.
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| CN201310433713.2A CN103494836A (en) | 2013-09-23 | 2013-09-23 | Preparation method and application of composite calcium carbonate and vitamin D3 chewable tablets |
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| CN201310433713.2A CN103494836A (en) | 2013-09-23 | 2013-09-23 | Preparation method and application of composite calcium carbonate and vitamin D3 chewable tablets |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| CN107753438A (en) * | 2017-11-01 | 2018-03-06 | 浙江康恩贝制药股份有限公司 | A kind of children's calcium carbonate D3Particle |
| CN109453126A (en) * | 2018-12-07 | 2019-03-12 | 浙江核力欣健药业有限公司 | A kind of calcium carbonate D3Composition of chewable tablets 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 |
| WO2020215238A1 (en) * | 2019-04-24 | 2020-10-29 | 黄辉 | Water-soluble calcium carbonate d3 preparation |
| US11103528B1 (en) | 2019-07-18 | 2021-08-31 | United States Of America As Represented By The Secretary Of The Air Force | Slow release calcium composition |
-
2013
- 2013-09-23 CN CN201310433713.2A patent/CN103494836A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
| CN106420808B (en) * | 2015-08-11 | 2019-07-19 | 北京远方通达医药技术有限公司 | A kind of preparation and preparation method thereof containing vitamin d3 and calcium carbonate |
| 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 |
| CN107753438A (en) * | 2017-11-01 | 2018-03-06 | 浙江康恩贝制药股份有限公司 | A kind of children's calcium carbonate D3Particle |
| CN107753438B (en) * | 2017-11-01 | 2019-12-27 | 浙江康恩贝制药股份有限公司 | Calcium carbonate D for children3Granules |
| 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 |
| CN109453126A (en) * | 2018-12-07 | 2019-03-12 | 浙江核力欣健药业有限公司 | A kind of calcium carbonate D3Composition of chewable tablets and preparation method thereof |
| WO2020215238A1 (en) * | 2019-04-24 | 2020-10-29 | 黄辉 | Water-soluble calcium carbonate d3 preparation |
| US11103528B1 (en) | 2019-07-18 | 2021-08-31 | United States Of America As Represented By The Secretary Of The Air Force | Slow release calcium composition |
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