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Celecoxib capsules and production technology thereof

A technology for celecoxib and production process, applied in the field of celecoxib capsules and production process thereof, can solve the problems of low dissolution rate, difficult absorption and the like, and achieve the effects of high dissolution rate, easy absorption and low cost of raw materials

Inactive Publication Date: 2016-01-13
青岛百洋制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problem that celecoxib has a low dissolution rate and is difficult to be absorbed by the human body during use, we have proposed a celecoxib capsule and its production process. The invention can achieve high absorption efficiency and high dissolution rate. high purpose

Method used

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  • Celecoxib capsules and production technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] A celecoxib capsule comprising the following raw materials in mass percentage: celecoxib: 65.43%; lactose monohydrate: 25.31%; povidone: 4.07%; croscarmellose sodium: 0.56%; Sodium Dialkyl Sulfate: 4.07%; Magnesium Stearate: 0.56%. The batch (8.10kg) production prescription is as follows: Celecoxib 5.3kg, lactose monohydrate 2.05kg, povidone 0.33kg, croscarmellose sodium 0.045kg, sodium lauryl sulfate 0.33kg, stearin Magnesium acid 0.045kg.

[0067] The production steps are as follows:

[0068] (1) Material distribution: Weigh each material in the weighing room according to the batch prescription, put them into PE bags, and put them into stainless steel barrels, and place them together.

[0069] (2) Preparation of granulation solution: add deionized water into a stainless steel container, stir until a vortex is formed, slowly add sodium lauryl sulfate, continue stirring for more than 15 minutes at a speed that can form a vortex, and disperse until it is completely dis...

Embodiment 2

[0083] A celecoxib capsule comprising the following raw materials in mass percentage: celecoxib: 74.07%; lactose monohydrate: 18.43%; povidone: 2.5%; croscarmellose sodium: 1%; Sodium Dialkyl Sulfate: 3%; Magnesium Stearate: 1%. The batch (8.10kg) production prescription is as follows: celecoxib 6.00kg, lactose monohydrate 1.50kg, povidone 0.20kg, croscarmellose sodium 0.08kg, sodium lauryl sulfate 0.24kg, stearin Magnesium acid 0.08kg.

[0084] The production steps are basically the same as in Example 1, and the detection steps are also basically the same as in Example 1.

Embodiment 3

[0086] A celecoxib capsule comprising the following raw materials in mass percentage: celecoxib: 84.57%; lactose monohydrate: 12.22%; povidone: 1.05%; croscarmellose sodium: 0.56%; Sodium Dialkyl Sulfate: 1.05%; Magnesium Stearate: 0.56%. The batch (8.10kg) production prescription is as follows: Celecoxib 6.85kg, lactose monohydrate 0.99kg, povidone 0.085kg, croscarmellose sodium 0.045kg, sodium lauryl sulfate 0.085kg, stearin Magnesium acid 0.045kg.

[0087] The production steps are basically the same as in Example 1, and the detection steps are also basically the same as in Example 1.

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Abstract

The invention discloses celecoxib capsules. The celecoxib capsules are prepared from celecoxib, lactose monohydrate, povidone, crosslinking sodium carboxymethylcellulose, lauryl sodium sulfate and magnesium stearate. The invention also discloses a production technology of the celecoxib capsules. The production technology comprises the steps of material distribution, preparation of a granulation solution, premixing, granulation, wet size stabilization, drying, dry size stabilization, final mixing, granule discharging, capsule filling and packaging. The celecoxib capsules and the production technology thereof have the advantages that formulation raw materials are low in cost, and the technology is simple; the dissolution rate of celecoxib is high, and celecoxib can be easily absorbed by the human body.

Description

technical field [0001] The invention relates to the field of chemical medicines, in particular to a celecoxib capsule and a production process thereof. Background technique [0002] Celecoxib, namely 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1hydro-1-pyrazol-1-yl]benzenesulfonamide, was the first Selective COX-2 inhibitors are currently the most prescribed non-steroidal anti-inflammatory analgesics in the world. They not only have significant analgesic effects, can significantly reduce joint tenderness, pain and joint swelling, but also have superior gastrointestinal tract Safety, according to the SUCCESS study report published in the "American Journal of Medicine" in 2006, in a comparative study involving 13,274 patients from 39 countries, the odds of symptomatic ulcers and ulcer complications in the celecoxib group Patients in the traditional NSAID group were 87.5 percent lower. Because celecoxib is easy to deteriorate when exposed to light and has hygroscopicity; it has...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/635A61P29/00
Inventor 徐文振郑爱菊王克庆
Owner 青岛百洋制药有限公司
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