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High-dissolubility children's calcium carbonate D3 granule and preparation method thereof

A technology of calcium carbonate and dissolution rate, which is applied in pharmaceutical formulations, active ingredients of aluminum/calcium/magnesium, medical preparations of non-active ingredients, etc., can solve problems such as unsatisfactory dissolution rate of calcium carbonate particles, and is suitable for large-scale production , less ingredients, the effect of improving the uniformity

Inactive Publication Date: 2015-12-02
JIANGSU FUBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to overcome the defects of the unsatisfactory dissolution rate of calcium carbonate granules in the prior art, the present invention provides a high-dissolution infant calcium carbonate D 3 Granules and preparation method thereof, by improving the dissolution rate of calcium carbonate granules, the absorption rate of calcium after calcium supplementation preparations enter the human body is promoted

Method used

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  • High-dissolubility children's calcium carbonate D3 granule and preparation method thereof
  • High-dissolubility children's calcium carbonate D3 granule and preparation method thereof
  • High-dissolubility children's calcium carbonate D3 granule and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Prescription 1

[0021]

[0022] Preparation

[0023] (1) After crushing 120g of calcium carbonate, pass through a 160-mesh sieve, 18g of glucose, 23g of maltodextrin and 1.5g of sodium citrate, pass through a 80-mesh sieve respectively, and then place the fine powder in a high-efficiency wet mixing granulator , mixed for 10min.

[0024] (2) Dissolve 0.95g of PVP-K30 in absolute ethanol to prepare a 10% PVP-K30 ethanol solution.

[0025] (3) Weigh 0.3mg vitamin D 3 , dissolved in PVP-K30 ethanol solution with a mass concentration of 10%, stirred to dissolve it completely, and then vitamin D 3 Add the solution into a high-efficiency wet mixing granulator, and rinse the container with an appropriate amount of absolute ethanol for 3 times. The sodium citrate mixture was mixed for 15 minutes, then an appropriate amount of 30% ethanol aqueous solution was added, cut and mixed for 4 minutes, and then the soft material was transferred to a swing granulator, and passed t...

Embodiment 2

[0029] Prescription 2

[0030]

[0031] Preparation

[0032] (1) After crushing 130g of calcium carbonate, pass through a 160-mesh sieve, 19g of glucose, 28g of maltodextrin and 2g of sodium citrate and pass through a 80-mesh sieve respectively, and then place the fine powder in a high-efficiency wet mixing granulator, Mix for 10 min.

[0033] (2) Dissolve 1 g of PVP-K30 in absolute ethanol to prepare a 10% PVP-K30 ethanol solution.

[0034] (3) Weigh 0.5mg vitamin D 3 , dissolved in PVP-K30 ethanol solution with a mass concentration of 10%, stirred to dissolve it completely, and then vitamin D 3 Add the solution into a high-efficiency wet mixing granulator, and rinse the container with an appropriate amount of absolute ethanol for 3 times. The sodium citrate mixture was mixed for 15 minutes, then an appropriate amount of 30% ethanol aqueous solution was added, cut and mixed for 4 minutes, and then the soft material was transferred to a swing granulator, and passed thro...

Embodiment 3

[0038] Prescription 3

[0039]

[0040] Preparation

[0041] (1) Grind 138g of calcium carbonate and pass through a 160-mesh sieve, 20g of glucose, 29g of maltodextrin and 2.5g of sodium citrate and pass through a 80-mesh sieve respectively, and then place the fine powder in a high-efficiency wet mixing granulator , mixed for 10min.

[0042] (2) Dissolve 1.05g of PVP-K30 in absolute ethanol to prepare a 10% PVP-K30 ethanol solution.

[0043] (3) Weigh 0.8mg vitamin D 3 , dissolved in PVP-K30 ethanol solution with a mass concentration of 10%, stirred to dissolve it completely, and then vitamin D 3 Add the solution into a high-efficiency wet mixing granulator, and rinse the container with an appropriate amount of absolute ethanol for 3 times. The sodium citrate mixture was mixed for 15 minutes, then an appropriate amount of 30% ethanol aqueous solution was added, cut and mixed for 4 minutes, and then the soft material was transferred to a swing granulator, and passed thro...

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Abstract

The invention discloses a high-dissolubility children's calcium carbonate D3 granule. The high-dissolubility children's calcium carbonate D3 granule comprises, by weight, 12,000-14,000 parts of calcium carbonate, 0.03-0.1 part of vitamin D3, 1,800-2,100 parts of glucose, 2,300-3,100 parts of maltodextrin, 150-300 parts of sodium citrate and 95-108 parts of polyvinylpyrrolidone K30. The invention further discloses a preparation method of the high-dissolubility children's calcium carbonate D3 granule. The high-dissolubility children's calcium carbonate D3 granule and the preparation method thereof have the advantages that since granularity of fine powder and dosage of raw and minor ingredients and a preparation technology are controlled effectively, granule uniformity is improved, and the high-dissolubility children's calcium carbonate D3 granule is higher in dissolubility, vitamin D3 content and administration compliance and beneficial to calcium absorption of human bodies; the preparation method is simple, convenient, feasible and suitable for large-scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a high-dissolution infant calcium carbonate D 3 Particles and methods for their preparation. Background technique [0002] Calcium carbonate has high calcium content, low price, and high safety. It is currently recognized as the calcium source with the highest performance-price ratio at home and abroad. It has been widely used as the first choice raw material for calcium supplement preparations by domestic and foreign pharmaceutical companies. Calcium carbonate is insoluble in water, and its ordinary solid preparation products need to react with gastric acid to produce ionized calcium that can be absorbed by the human body after taking it, resulting in a large consumption of gastric acid, which is not up to expectations for those with achlorhydria, children and the elderly For the purpose of calcium supplementation, it will cause adverse reactions such as indigestion a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/10A61K9/16A61K47/26A61K47/36A61K47/32A61P3/02A61K31/539
Inventor 姜和平黄金友何林受卢俊
Owner JIANGSU FUBANG PHARMA
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