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Preparation method of damp-proof potassium aspartate ball

A technology of potassium aspartate and pellets, which is applied in microcapsules, metabolic diseases, capsule delivery, etc. It can solve problems such as unsatisfactory coating moisture-proof effect, difficulties in industrial production, and difficulties in solvent recovery, so as to reduce the difficulty of preparation and Production cost, increase in stability, effect of reducing hygroscopicity

Inactive Publication Date: 2017-10-31
LIAONING YAOLIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The coating moisture-proof effect of this method is often not ideal; the operation process often requires the use of a large amount of solvent, which causes problems such as long operation time, difficult solvent recovery, high cost, and environmental pollution in the coating process, which brings great difficulties to industrial production.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Prescription composition: potassium aspartate 500g; microcrystalline cellulose 100g; hydroxypropyl methylcellulose 25g; PEG6000 10g; stearic acid 50g; magnesium stearate 15g.

[0020] Preparation process: Weigh potassium aspartate, microcrystalline cellulose, and hydroxypropyl methylcellulose in the prescribed amount, prepare a soft material with 50% ethanol as a binder, and place the soft material in an extruder at 30rmp Extruded under the same conditions, first spheronized at 30rmp for 2min in a spheronizer, and then spheronized at 60rmp for 10min. The pellets were dried in an oven at 40°C for 12 hours, sieved, and the particles with a particle size of 16-24 mesh were taken. Pass the stearic acid and PEG6000 according to the prescription amount through an 80-mesh sieve, and mix them evenly. Add the prepared spherical particles into the coating pan, slowly add the hot-melt coating material into the coating pan, and perform coating according to the following parameters...

Embodiment 2

[0022] Prescription composition: potassium aspartate 500g; mannitol 100g; sodium carboxymethyl starch 25g; povidone K30 12g; stearic acid 60g; talcum powder 20g.

[0023] Preparation process: Weigh the prescribed amount of potassium aspartate, mannitol and sodium carboxymethyl starch, prepare a soft material with 50% (v / v) ethanol as a binder, put the soft material in an extruder at 30rmp Extruded under the same conditions, the strip-shaped extrudate was first spheronized at 30rmp for 2min in a spheronizer, and then spheronized at 60rmp for 10min. The pellets were dried in an oven at 40°C for 12 hours, sieved, and the particles with a particle size of 16-24 mesh were taken. Pass stearic acid and povidone through an 80-mesh sieve according to the prescription, and mix well. Add the prepared spherical particles into the coating pan, slowly add the hot-melt coating material into the coating pan, and perform coating according to the following parameters: temperature 60-70°C, host...

Embodiment 3

[0025] Prescription composition: potassium aspartate 500g; lactose 80g; croscarmellose sodium 25g; glyceryl monostearate 50g; PEG6000 10g; talcum powder 15g.

[0026] Preparation process: Weigh the prescribed amount of potassium aspartate, lactose and croscarmellose sodium, prepare a soft material with 50% (v / v) ethanol as a binder, and place the soft material in an extruder Extruded under the condition of 30rmp, the strip extrudate was first spheronized at 30rmp for 2min in the spheronizer, and then spheronized at 60rmp for 10min. The pellets were dried in an oven at 40°C for 12 hours, sieved, and the particle size was between 16-24 mesh. Glyceryl monostearate and PEG6000 are passed through an 80-mesh sieve according to the prescription, and mixed. Add the prepared spherical particles into the coating pan, slowly add the hot-melt coating material into the coating pan, and perform coating according to the following parameters: temperature 60-70°C, host speed 30rpm. Take it o...

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PUM

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Abstract

The invention discloses a preparation method of a damp-proof ball mainly containing potassium aspartate. The preparation method comprises the steps of preparing spherical particles from the potassium aspartate raw material by virtue of extrusion and rolling techniques, uniformly mixing 1%-15% of a waterproof coating material and 0-5% of a hydrophilic coating material, carrying out hot melting and coating on the spherical particles by virtue of a coating pot, adding 0-5% of a lubricating agent during and in the end of the coating process so as to prevent adhesion of the particles, and cooling after the coating.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a preparation method of potassium aspartate moisture-proof pellets. Background technique [0002] Potassium L-aspartate is a potassium supplement preparation, its molecular formula is C4H6KNO4·1 / 2H2O, and its structural formula is: [0003] Potassium is the main cation in cells, which is necessary for cell survival and has various physiological functions. 98% of the potassium is present in the cells, and the extracellular fluid contains only 2%. Potassium in the extracellular fluid mainly exists in the ion state. In addition to the ion state in the intracellular fluid, part of the potassium is combined with protein, and the other part is combined with sugar and phosphate. Potassium plays an important role in cell metabolism, maintenance of intracellular osmotic pressure, maintenance of intracellular acid-base balance, transmission of nerve impulses, muscle con...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K31/198A61P3/12
Inventor 于航于佳
Owner LIAONING YAOLIAN PHARMA
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