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Calcium-containing effervescent tablet and preparation method and application

An effervescent preparation, calcium carbonate technology, applied in medical preparations containing active ingredients, pharmaceutical formulations, aluminum/calcium/magnesium active ingredients, etc., can solve the problem of low vitamin D, poor uniformity, and no production of effervescent tablets. methods, etc.

Active Publication Date: 2014-12-03
SHANGHAI NUOCHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is currently no effective method for producing an air-stable effervescent tablet
[0003] In addition, due to the low content of vitamin D in current calcium supplement products, its uniformity in calcium supplement products is very poor

Method used

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  • Calcium-containing effervescent tablet and preparation method and application
  • Calcium-containing effervescent tablet and preparation method and application
  • Calcium-containing effervescent tablet and preparation method and application

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preparation example Construction

[0044] The present invention provides a calcium-containing effervescent preparation, wherein the active ingredients include calcium carbonate and vitamin D. The calcium carbonate is calcium carbonate known in the art and can be used to make calcium supplement products, preferably including but not limited to high-purity Medicinal calcium carbonate, high-compressibility and high-purity medicinal calcium carbonate granules, or calcium raw material intermediate products of high-density calcium carbonate tablets, etc. Or "intermediate calcium raw materials of high-density calcium carbonate tablets" have been fully disclosed in Chinese patent applications CN200410052673.8 and CN200910200057.5 respectively, and their preparation methods have been recorded in detail. The content of these published patent applications concerning the corresponding calcium carbonate is incorporated in the present application in its entirety. The vitamin D is preferably vitamin D 3 . The effervescent p...

Embodiment 1

[0114] Preparation of acid granules

[0115] To prepare a binder solution, 23.6% by weight of amb was dissolved in ethanol to obtain 6.0% amb ethanol solution, the temperature of the solution is controlled at 23°C-27°C, more preferably 25°C, before spraying.

[0116] Put citric acid and fumaric acid in a high-speed mixer and mix for 5 minutes.

[0117] Put the mixed acid source in the wet granulation pot, put The amb ethanol solution was subjected to wet granulation at a liquid addition rate of 260ml / min to obtain acid granules.

[0118] During the wet granulation, the drying air inlet temperature is controlled at 45°C, the material temperature is controlled at 40°C, and the outlet air temperature is controlled at 20°C.

[0119] In another preferred embodiment, the wet granulation of the acid granules has a mesh size of 10-30 mesh, preferably 14-20 mesh, more preferably 16 mesh.

Embodiment 2

[0121] Preparation of alkali particle intermediate

[0122] Mix calcium carbonate and vitamin D3 evenly in equal proportions.

[0123] Sodium bicarbonate, essence, aspartame, and povidone were sequentially added to the above mixture, and mixed for 15 minutes.

[0124] Pour the above mixed material into the fluidized drying bed.

[0125] 65% by weight of amb is dissolved in water to obtain a solid content of 10% amb solution.

[0126] Carry out one-step granulation, control the air inlet temperature at 75°C, control the material temperature at 35°C, and control the liquid inlet speed at 200ml / min. After spraying all the coating liquid within 3 hours, turn off the air inlet heating device and blow it with hot air. After 30 minutes, the intermediate product of alkali granules was obtained, which contained:

[0127]

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Abstract

The invention discloses a calcium-containing effervescent tablet and its preparation method and application. The preparation method of the calcium-containing effervescent preparation comprises the following step: acid particles, alkali particles and a lubricant are mixed to obtain a calcium-containing effervescent preparation. The alkali particles are obtained by the following method: (i) calcium carbonate and vitamin D which have equal proportion are mixed to obtain a mixture 1; (ii) the mixture 1 is mixed with a pharmaceutically acceptable carrier to obtain a mixture 2; and (iii) the mixture 2 is mixed with a solution containing Opadry amb, and pelletization packaging is carried out so as to obtain the alkali particles. The acid particles are obtained by the following method: citric acid is mixed with an ethanol solution containing Opadry amb, and wet granulation is carried out so as to obtain the acid particles.

Description

technical field [0001] The invention relates to calcium preparations, in particular to a calcium-containing effervescent tablet and its preparation method and application. Background technique [0002] The current calcium supplement products, including effervescent granules, effervescent tablets, etc., need special attention when storing due to the process. Once exposed to air, they are easy to deteriorate and oxidize, and the process itself has very high requirements on the environment. For example, to control the space humidity below 40%. There is currently no effective method for producing an air-stable effervescent tablet. [0003] In addition, because the content of vitamin D in current calcium supplement products is very low, its uniformity in calcium supplement products is very poor. [0004] Therefore, there is an urgent need in this field to provide a calcium supplement effervescent preparation with uniform vitamin D content and easy storage, and to provide a proc...

Claims

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Application Information

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IPC IPC(8): A61K33/06A61K9/46A61P3/02A61K31/59A61K31/593
Inventor 胡志彤毛晶晶
Owner SHANGHAI NUOCHENG PHARMA
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