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Calcium granule, and preparation method and application thereof

A technology of granules and calcium salts, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. It can solve the problems of inconvenient to carry, fragile, difficult to dissolve calcium gluconate particles, etc. , to achieve the effect of slow dissolution rate, short dissolution time, good stability and taste

Active Publication Date: 2021-11-23
XINJIANG TEFENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, oral solutions often contain additives such as preservatives and flavors that will affect the health of children. The taste will deteriorate after long-term storage, and the degradation impurities will increase to a certain extent, and precipitation may also occur.
At the same time, the oral liquid bottle is inconvenient to carry and is fragile
[0005] Granules can solve the problems of poor stability and inconvenient carrying of oral solutions, but commercially available calcium gluconate granules are generally difficult to dissolve, have poor clarity, and poor taste, which reduces the clinical compliance of children.

Method used

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  • Calcium granule, and preparation method and application thereof
  • Calcium granule, and preparation method and application thereof
  • Calcium granule, and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] The preparation of embodiment 1 compound calcium gluconate granules

[0068] 1.1 Preparation of samples 1-5

[0069] 1) Take sucrose, grind it to -80 mesh, and set aside;

[0070] 2) Take 1.2L of purified water, heat to boil, add 0.5kg of calcium gluconate, 0.5kg of calcium lactate and 0.05kg of lactic acid in sequence, continue heating, stir to dissolve, add different amounts of water, stir and mix well, and obtain a solid content of 30% to 60% of granulation liquid;

[0071] 3) Add 2 kg of pulverized sucrose to the fluidized bed as solid powder for granulation, start the fluidized bed, see Table 1 for the granulation parameters, and spray the granulation solution obtained in [step 2) into the binder solution respectively, Granulate and discharge to obtain compound calcium gluconate granule samples 1-5. See Table 2 for the solid content of the granulation solution used in each sample.

[0072] Table 1 Granulation parameters

[0073]

[0074] 1.2 Preparation of s...

Embodiment 2

[0090] The preparation 2 of embodiment 2 compound calcium gluconate granules

[0091] 1) Take sucrose, grind it to -80 mesh, and set aside;

[0092] 2) Take 1.2L of purified water, heat to boil, add 0.5kg of calcium gluconate, 0.5kg of calcium lactate and 0.05kg of lactic acid in sequence, continue heating, stir to dissolve, add purified water, control the solid content to 47%, stir and mix, to obtain granulation liquid;

[0093] 3) Add 2 kg of pulverized sucrose powder in the fluidized bed as granulated solid powder, open the fluidized bed, set the intake air volume, injection air pressure and spraying rate of the injection stage according to the data listed in Table 5 , and other granulation parameters are shown in Table 4, respectively sprayed into the granulation solution obtained in the binder solution [step 2), granulated, and discharged to obtain compound calcium gluconate granule samples 7-11.

[0094] Table 4 Granulation parameters

[0095]

[0096] The granulat...

Embodiment 3

[0100] The preparation of embodiment 3 compound calcium gluconate granules 3

[0101] 1) Take sucrose, grind it to -80 mesh, and set aside;

[0102] 2) Take an appropriate amount of purified water, heat to boil, add calcium gluconate, calcium lactate and lactic acid in the prescription amount listed in Table 6, continue heating, stir to dissolve, add purified water, control the solid content to 47%, stir and mix, to obtain granulation liquid;

[0103]3) Add 2 kg of pulverized sucrose powder into the fluidized bed as solid powder for granulation, start the fluidized bed, see Table 1 for the granulation parameters, and spray the granulation solution obtained in [step 2) into the binder solution respectively, Granulate and discharge to obtain compound calcium gluconate granule samples 12-19.

[0104] Take the above 8 samples respectively, measure the dissolution time, observe the properties, and taste the mouthfeel. The results are shown in Table 6.

[0105] Table 6

[0106] ...

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Abstract

The invention relates to a calcium granule, and a preparation method and application thereof. The calcium granule comprises pharmaceutically acceptable calcium salt, lactic acid and a sweetening agent, and is prepared by a fluidized bed granulation method.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a calcium granule and its preparation method and application. Background technique [0002] The calcium deficiency rate of infants aged 0-3 is generally high, reaching 20% ​​to 50%, and the calcium deficiency rate of children aged 0-14 is about 10% to 20%. Children with insufficient calcium intake for a long time will have symptoms such as sweating, night crying, convulsions, and bald pillows. In severe cases, dysplasia of bones and teeth, rickets, etc. will occur, which will affect children's health. [0003] Children taking calcium preparations need long-term medication, which requires high product safety. Common calcium preparations include calcium carbonate, active calcium, calcium citrate, and water-soluble calcium gluconate and calcium lactate. Calcium carbonate and active calcium are highly irritating to the stomach, consume a large amount...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/19A61K31/191A61K31/375A61K47/26A61P3/02A61P17/00A61P19/10A61P19/08
CPCA61K9/1623A61K9/1694A61K31/19A61K31/191A61K31/375A61P3/02A61P17/00A61P19/10A61P19/08A61K2300/00
Inventor 云琦赵钰媛张蓉金凡唐城游佩进陶亮
Owner XINJIANG TEFENG PHARMA
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