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Moisture-proof coating citicoline sodium capsule and preparation method thereof

A technology of citicoline sodium and capsules, which is applied in the field of moisture-proof coated citicoline sodium capsules and its preparation, and can solve the problems of unclear specific components of pharmaceutical excipients, poor practicability, and easy Moisture absorption and other problems, to achieve the effect of controllable range of key process parameters, good disintegration time limit, stable and controllable quality

Active Publication Date: 2013-07-17
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Citicoline sodium is easy to absorb moisture, and it is easy to absorb moisture when it is excessively exposed to the air during the filling process of citicoline sodium capsules, causing stickiness or affecting filling; and during the capsule placement process, the moisture in the capsule shell is easily absorbed The citicoline particles in the shell are absorbed, causing the capsule shell to become brittle; after packaging, if aluminum-plastic packaging is used, the particles are easy to absorb moisture, resulting in increased moisture
[0005] Chinese patent document CN102028664 discloses citicoline sodium tablets and its preparation method, but does not involve the problem that citicoline sodium is easy to absorb moisture
Chinese patent document CN1260177 (CN98122857.7) discloses a citicoline oral preparation and preparation method, but the specific components of the pharmaceutical excipients are not specified, and the practicability is not strong

Method used

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  • Moisture-proof coating citicoline sodium capsule and preparation method thereof
  • Moisture-proof coating citicoline sodium capsule and preparation method thereof
  • Moisture-proof coating citicoline sodium capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1: prescription composition:

[0032]

[0033] Preparation Process:

[0034] The prescription amount of citicoline sodium is pulverized and passed through a 100-mesh sieve, and the prescribed amount of pregelatinized starch and microcrystalline cellulose are respectively passed through a 40-mesh sieve for subsequent use; the sieved citicoline sodium, pregelatinized For starch and microcrystalline cellulose, use water as a wetting agent to make soft materials, set the extrusion rate of the extrusion spheronizer to 20-30HZ, the spheronization speed to 300rpm, and the spheronization time to 30s. Dry at 50°C to obtain immediate-release granules of citicoline sodium.

[0035] Take the prescribed amount of moisture-proof coating material acrylic resin E100, and prepare a coating solution with a solid content of 5 wt%. Take the above-mentioned citicoline sodium immediate-release granules and place them in a fluidized bed for coating: the inlet air temperature i...

Embodiment 2

[0036] Embodiment 2: prescription composition:

[0037]

[0038] Preparation Process

[0039] The prescription amount of citicoline sodium is pulverized and passed through a 100-mesh sieve, and the prescribed amount of pregelatinized starch and microcrystalline cellulose are respectively passed through a 40-mesh sieve for subsequent use; the sieved citicoline sodium, pregelatinized Starch and microcrystalline cellulose, using water as a wetting agent to make soft materials, set the extrusion rate of the extrusion spheronizer to 20-30HZ, the spheronization speed to 500rpm, and the spheronization time to 1min. Dry at -50°C to obtain immediate-release pellets of citicoline sodium.

[0040] Take the prescribed amount of moisture-proof coating material Oubada AMB, and prepare a coating solution with a solid content of 10 wt%. Take the above-mentioned citicoline sodium immediate-release pellets and place them in a fluidized bed for coating: the inlet air temperature is 40-60°C,...

Embodiment 3

[0041] Embodiment 3: prescription composition:

[0042]

[0043] Preparation Process:

[0044] Citicoline sodium is crushed and passed through a 100-mesh sieve, pregelatinized starch and microcrystalline cellulose are respectively passed through a 40-mesh sieve, and set aside; the sieved citicoline sodium, pregelatinized starch and microcrystalline cellulose , dry-compressed granules to obtain immediate-release granules of citicoline sodium.

[0045] Take the moisture-proof coating powder of the prescribed amount, and prepare a coating solution with a solid content of 3 wt%. Take the above-mentioned citicoline sodium immediate-release granules and place them in a fluidized bed for coating: the inlet air temperature is 50-70°C, and the inlet air volume is 600-800m 3 / h, the atomization pressure is 1.0-1.5bar, the material temperature is 30-40°C, the spray speed is 60-200g / min, keep the fluidized state after coating, and continue to dry for 5-15min to obtain citicoline Sod...

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Abstract

The invention provides a moisture-proof coating citicoline sodium capsule and a preparation method thereof. The citicoline sodium capsule is composed of a capsule casing and quick-release moisture-proof micro pills or granules. All components in each capsule containing citicoline sodium quick-release moisture-proof micro pills or granules by percentage are 40% to 70% of citicoline sodium, 10% to 30% of microcrystalline cellulose, 10% to 30% of pregelatinized starch and 2% to 10% of moisture-proof coatings. The moisture-proof micro pills or granules are obtained by being extruded and rounded or pressed and granulated to be coated with moisture-proof coatings. The citicoline sodium capsule is good in moisture-proof function and resolves the problems that the capsule is prone to absorb waterdue to the fact that citicoline sodium is strong in moisture absorption, the capsule casing is prone to be fragile, and the like.

Description

technical field [0001] The invention relates to a moisture-proof coated citicoline sodium capsule and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Citicoline sodium is used for the treatment of neurological sequelae caused by craniocerebral injury and cerebrovascular accident, and can be used for the treatment of Parkinson's syndrome, and also has a certain effect on senile dementia; other such as delaying aging, Improving memory, etc. is also effective. After entering the body, citicoline enters the brain through the blood-brain barrier, combines with the membrane phospholipids of brain cells, promotes the synthesis of membrane phospholipids, promotes the metabolism of the brain, increases mitochondrial ATPase and membrane Na + / K + 2ATPase activity, inhibition of phospholipase A 2 activity, increase the level of brain norepinephrine and dopamine, stabilize cell membranes, protect brain cells...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/7068A61K47/38A61P25/00A61P25/16A61P25/28A61P39/06
Inventor 王晶翼李长军杨清敏张明会
Owner QILU PHARMA CO LTD
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