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Celecoxib capsule and preparation method thereof

A technology of celecoxib and capsules, which is applied in the field of celecoxib capsules and its preparation, can solve the problems of poor dissolution effect, large specific surface area, and small weight difference, and achieve small weight difference, large specific surface area, and release The effect of drug stabilization

Active Publication Date: 2021-09-21
AMICOGEN CHINA BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] On the other hand, micropill capsules do not require a glidant. Compared with powder-filled capsules, the weight difference is small, the fluidity is good, the drug release of the micropills is stable, and the dissolution is better. The drug adheres to the surface of the micropills and has a large specific surface area. The bioavailability is high, making celecoxib into pellets and capsules is a more scientific and reasonable method than wet granulation, but the conventional pellet preparation method is not suitable for direct celecoxib raw materials, because the commonly used preparation method The main drug and auxiliary materials need to be sprayed alternately, and organic solvents (usually ethanol) are used. The preparation process takes a long time and the process is complicated. When spraying with ethanol, it needs to be heated. This process is not safe and the dissolution effect is not good.

Method used

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  • Celecoxib capsule and preparation method thereof
  • Celecoxib capsule and preparation method thereof
  • Celecoxib capsule and preparation method thereof

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preparation example Construction

[0055] The present invention also includes the preparation method of celecoxib capsules, comprising the following steps:

[0056] In parts by weight, add 25-80 parts of celecoxib, 19-72 parts of blank pellet core and 0.2-1 part of absorption enhancer into the centrifugal fluidized bed, turn on the blower, and set the blowing airflow to 2.0-2.5m3 / min , the inlet air temperature is 45~55℃, and the rotating speed of the turntable is 180~220r / min;

[0057] The absorption enhancer is mannitol or / and sorbitol;

[0058] Add 0.5~2 parts of wetting agent into purified water to prepare an aqueous solution with a mass concentration of 12~18%;

[0059] Turn on the peristaltic pump, control the pump speed at 14~18r / min, the nozzle diameter of the spray gun is 0.8mm, and the atomization pressure is 0.04~0.06MPa, spray the above aqueous solution into the centrifugal fluidized bed, granulate and dry, and fill to In the capsule shell, celecoxib capsules are obtained;

[0060] The wettin...

Embodiment 1

[0075] A celecoxib capsule, comprising the following materials: celecoxib 250g, blank core 190g, wetting agent 5g and absorption accelerator 2g;

[0076] Described wetting agent is sodium lauryl sulfate;

[0077] The absorption enhancer is mannitol.

Embodiment 2

[0079] A celecoxib capsule, comprising the following materials: celecoxib 800g, blank core 720g, wetting agent 20g and absorption accelerator 10g;

[0080] The wetting agent is sodium lauroyl acid;

[0081] The absorption enhancer is sorbitol.

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PUM

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Abstract

The invention discloses a celecoxib capsule and a preparation method thereof, and the celecoxib capsule comprises the following materials in parts by weight: 25-80 parts of celecoxib, 19-72 parts of a blank pellet core, 0.5-2 parts of a wetting agent and 0.2-1 part of an absorption enhancer, the wetting agent is one or two of lauryl sodium sulfate, sodium lauroyl amino acid or potassium lauryl phosphate; the absorption enhancer is mannitol or / and sorbitol; according to the celecoxib capsule, the novel surfactant serves as a wetting agent, mannitol or / and sorbitol serves as the absorption enhancer, and celecoxib is good in dissolution effect, easy to absorb, high in bioavailability and good in clinical utilization value.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical engineering, in particular to a celecoxib capsule and a preparation method thereof. Background technique [0002] Celecoxib is the first specific cyclooxygenase-2 (COX-2) inhibitor developed by Searle in the United States for the treatment of osteoarthritis and rheumatoid arthritis. The most prescribed NSAID analgesic. [0003] Due to its crystal structure, celecoxib is almost insoluble in water and is an insoluble drug, and its physical and chemical properties are extremely poor in preparation performance; first, it is almost insoluble in water, and its solubility in water at 25°C is only 0.007mg / ml , the dissolution is slow in the commonly used dissolution media. If the unpulverized drug is directly filled into capsules, the unpulverized celecoxib is not easy to dissolve and disperse, so it cannot be rapidly absorbed in the gastrointestinal tract; second, the texture is light , low bulk...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/635A61K47/36A61K47/38A61K47/26A61K47/24A61K47/18A61K47/20A61P19/02A61P29/00C08F251/00C08F222/06
CPCA61K9/1676A61K9/1623A61K9/1652A61K9/1617A61K9/1694A61K31/635A61P19/02A61P29/00C08F251/00C08F222/06
Inventor 刘洪芝杨申永李建国方军王玲
Owner AMICOGEN CHINA BIOPHARM CO LTD
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