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Production method of high-assay calcium ascorbate granules capable of directly being compressed

A calcium ascorbate and a production method technology, applied in the field of production of high-content calcium ascorbate granules, can solve problems such as poor tablet compression performance and stability, and achieve the effects of reducing yellowing, improving tablet compression performance, and good stability

Active Publication Date: 2009-03-25
DSM JIANGSHAN PHARMACEUTICAL (JIANGSU) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a kind of production method of the high-content calcium ascorbate granules that can be directly compressed into tablets, which can solve the poor tableting performance and stability of the prepared calcium ascorbate granules under the situation of only using a small amount of auxiliary materials. The problem

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Add 1940 g of crushed and sieved calcium ascorbate and 50 g of powdered hydroxypropyl methylcellulose into the mixer, mix thoroughly for 5 minutes, set the experimental dry granulator to granulate, and simultaneously granulate with a 24-mesh sieve. The granulated materials are all put into the fluidized bed. Another 10 g of hydroxypropyl methylcellulose adhesive was taken and completely dissolved in the aqueous solution, and the concentration at this time was 10%. Slowly spray the adhesive into the fluidized bed, and control the air inlet temperature of the fluidized bed to be 80°C and the material temperature to be 48°C during spraying. After the adhesive is sprayed, continue to enter the air for 5 minutes to dry and discharge.

[0018] Take 995 grams of granules, add 5 grams of stearic acid and mix for 2 minutes, and press the tablet at a speed of 35,000 tablets per hour. The measured tablet data is: friability 0.49%; tablet hardness 19.25kg; disintegration time limi...

Embodiment 2

[0020] Add 97Kg of crushed and sieved calcium ascorbate and 2.5Kg of powdered hydroxypropyl methylcellulose into the mixer, mix thoroughly for 12 minutes, put it in a dry granulator to granulate, and simultaneously use a 20-mesh sieve for granulation. The granulated materials are all put into the fluidized bed. Take another 0.5Kg of hydroxypropyl methylcellulose binder and make it completely dissolved in the aqueous solution, and the concentration at this time is 10%. Slowly spray the adhesive into the fluidized bed, and control the air inlet temperature of the fluidized bed to be 70°C and the material temperature to be 45°C during spraying. After the adhesive is sprayed, continue to enter the air for 10 minutes to dry and discharge.

[0021] Take 995 grams of granules, add 5 grams of stearic acid and mix for 2 minutes, and press the tablet at a speed of 35,000 tablets per hour. The measured tablet data is: friability 0.58%; tablet hardness 17.95kg; disintegration time limit ...

Embodiment 3

[0023] Add 97Kg of crushed and sieved calcium ascorbate and 2.2Kg of powdered hydroxypropyl methylcellulose into the mixer, mix thoroughly for 15 minutes, put in a dry granulator to granulate, and granulate with a 20-mesh sieve at the same time. The granulated materials are all put into the fluidized bed. Take another 0.8Kg of hydroxypropyl methylcellulose binder and make it completely dissolved in the aqueous solution, and the concentration at this time is 10%. Slowly spray the binder into the fluidized bed, and control the inlet air temperature of the fluidized bed to be 75°C and the material temperature to be 46°C during spraying. After the adhesive is sprayed, continue to enter the air for 10 minutes to dry and discharge.

[0024] Take 995 grams of granules, add 5 grams of stearic acid and mix for 2 minutes, press the tablet at a speed of 35,000 tablets per hour, the measured tablet data is: friability 0.39%; tablet hardness 19.05kg; disintegration time limit and dissolut...

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Abstract

The invention discloses a direct-compression production method of high content calcium ascorbate particles. The production method includes: the calcium ascorbate crystalloid raw material is crushed; powder adhesive is added and is mixed evenly with the calcium ascorbate crystalloid raw material; then the mixture is placed in a dry granulator for granules preparation; the granules are placed in a fluidized bed hopper while paste adhesive is sprayed; the granules coated with paste adhesive is dried by the continuously fed wind; direct-compression high content calcium ascorbate particles are obtained after discharging. When the method is adopted, the tablet hardness of prepared particles can reach more than 15 kg; the friability is less than 1%; the compression performance is improved; meanwhile, because the dosage of adhesive is reduced in the production method, the drying time is reduced, so as to avoid the yellow-changing phenomenon of the material; the stability is good.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a method for producing high-content calcium ascorbate granules capable of direct compression into tablets. Background technique [0002] In the field of pharmaceutical preparations, many active ingredients are made into tablets, but due to the poor compressibility, fluidity and dispersibility of many active ingredients, they cannot be directly used for tablet compression. In order to overcome this incompatibility To give enough plasticity, it is more common practice to preform the active substance into granules suitable for tableting. In general, granulation is a technique that increases the particle size of a powder in order to convert the powder solids into aggregates of different sizes and porosity, which are known as granules. After being made into granules, it has practical properties, such as dust reduction, better fluidity, good dispersibility, stronge...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/375A23L1/30A23K1/16A23K20/00A23L33/10
Inventor 王健黄加宏张华峰刘杰
Owner DSM JIANGSHAN PHARMACEUTICAL (JIANGSU) CO LTD
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