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, affecting filling, and easy moisture absorption of citicoline sodium, etc. problems, to achieve the effect of controllable range of key process parameters, good moisture-proof function, stable and controllable quality

Active Publication Date: 2012-07-04
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: Recipe composition:

[0032]

[0033] Preparation Process:

[0034] The citicoline sodium of the recipe quantity is pulverized and passed through a 100-mesh sieve, and the pregelatinized starch and microcrystalline cellulose of the recipe quantity are respectively passed through a 40-mesh sieve, for subsequent use; the citicoline sodium, pregelatinized 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 of 300rpm, and the spheronization time of 30s. Dry at 50°C to obtain citicoline sodium immediate-release granules.

[0035] Take the moisture-proof coating material acrylic resin E100 in the recipe quantity, and prepare a coating liquid with a solid content of 5wt%. Get the above-mentioned citicoline sodium immediate-release granules and place them in a fluidized bed for coating: the inlet air temperature is 40-60 °C, and the...

Embodiment 2

[0036] Embodiment 2: Recipe composition:

[0037]

[0038] Preparation Process

[0039] The citicoline sodium of the recipe quantity is pulverized and passed through a 100-mesh sieve, and the pregelatinized starch and microcrystalline cellulose of the recipe quantity are respectively passed through a 40-mesh sieve, for subsequent use; the citicoline sodium, pregelatinized 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 of 500rpm, and the spheronization time of 1min. Use the extrusion spheronization method to prepare pellets, then at 30 Dry at -50°C to obtain citicoline sodium immediate-release pellets.

[0040] The moisture-proof coating material Opada AMB in the prescription amount was taken and prepared into a coating liquid with a solid content of 10 wt %. Get the above-mentioned citicoline sodium immediate-release pellets and place them ...

Embodiment 3

[0041] Embodiment 3: Recipe composition:

[0042]

[0043] Preparation Process:

[0044] The citicoline sodium is pulverized and passed through a 100-mesh sieve, and the pregelatinized starch and microcrystalline cellulose are respectively passed through a 40-mesh sieve for subsequent use; the sifted citicoline sodium, pregelatinized starch and microcrystalline cellulose are , and dry pressing the granules to obtain immediate-release citicoline sodium granules.

[0045] The moisture-proof coating powder of the recipe quantity was taken and prepared into a coating liquid with a solid content of 3wt%. Get 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 600-800 m 3 / h, the atomization pressure is 1.0-1.5bar, the material temperature is 30-40°C, the spray rate is 60-200g / min, keep the fluidized state after coating, and continue to dry for 5-15min ...

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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 to treat the sequelae of the nervous system caused by craniocerebral injury and cerebrovascular accident, and can be used for the treatment of Parkinson's syndrome. There are also improvement effects such as improving memory. Citicoline sodium enters the body through the blood-brain barrier and enters the brain, where it binds to 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, inhibits phospholipase A 2 It increases the levels of norepinephrine and dopamine in the brain, stabilizes cell membranes, protects brain cells, and reduces the release of free fatty acids and oxyge...

Claims

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Application Information

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Patent Type & Authority Applications(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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