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Enteric sustained-release preparation containing zaltoprofen and preparation method thereof

A technology for zaltoprofen and sustained-release preparations, which is applied in the field of enteric-coated sustained-release preparations and its preparation, and can solve problems such as poor reproducibility of release between batches, poor fluidity, and unsuitability for industrial production.

Inactive Publication Date: 2011-05-11
HEBEI AOXING GROUP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are two relatively big problems in the preparation of sustained-release preparations by process ①: (1) the residual solvent needs to be measured in the granules; (2) special equipment is required to granulate the melted raw and auxiliary materials, and the conventional swinging granulator with a screen It is difficult to prepare granules that meet the requirements. If the temperature of the agglomerate is too high, the prepared granules will re-condense after passing through the screen. Mostly powder, poor fluidity, and poor compressibility
The formulations of the above-mentioned patents without exception fell into the trap mentioned above by the inventor of this patent. The preparations prepared according to the methods described in these patents either have poor reproducibility and large differences in the release rate between batches. , or the process is complicated and not suitable for industrial production

Method used

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  • Enteric sustained-release preparation containing zaltoprofen and preparation method thereof
  • Enteric sustained-release preparation containing zaltoprofen and preparation method thereof
  • Enteric sustained-release preparation containing zaltoprofen and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Zaltoprofen crystal (particle size 200-300μm, spherical crystal) 200g

[0051]Glyceryl Behenate 10g

[0052] Precisely weigh 200g of Zaltobuprofen spherical crystals, place them in a fluidized bed for boiling at a constant temperature, and control the inlet temperature at about 50°C; take glyceryl behenate and heat and melt it, and finally keep the temperature at 85°C; The glyceride liquid is introduced into the fluidized bed, atomized by high-pressure air, and top spray technology is used to coat the liquid atomized glyceryl behenate droplets on the surface of the fluidized tobuprofen crystals in the fluidized bed. Since the crystal temperature is lower than the melting point of glyceryl behenate, when the liquid atomized glyceryl behenate droplets meet zaltoprofen crystals, they will quickly condense into tiny solid particles and be coated with zaltoprofen On the surface of the particles, the spray speed of glyceryl behenate needs to be controlled so that the tiny so...

Embodiment 2

[0055] Zaltoprofen crystal (particle size 200-300μm, spherical crystal) 200g

[0056] Glyceryl Behenate 20g

[0057] Precisely weigh 200g of Zaltobuprofen spherical crystals, place them in a fluidized bed for boiling at a constant temperature, and control the inlet temperature at about 50°C; take glyceryl behenate and heat and melt it, and finally keep the temperature at 85°C; Glyceride liquid is introduced in the fluidized bed, adopts high-pressure air atomization (atomization pressure is the same as embodiment 1), adopts top spray technology, makes liquid atomization glyceryl behenate small droplet be coated on fluidized bed On the surface of zaltoprofen crystals, since the crystal temperature is lower than the melting point of glyceryl behenate, the small droplets of liquid atomized glyceryl behenate will quickly condense into tiny solid particles after meeting zaltoprofen crystals And be coated on zaltoprofen crystal surface, need control the spray speed of glyceryl behen...

Embodiment 3

[0060] Zaltoprofen crystal (particle size 200-300μm, spherical crystal) 200g

[0061] Glyceryl Behenate 30g

[0062] Precisely weigh 200g of Zaltobuprofen spherical crystals, place them in a fluidized bed for boiling at a constant temperature, and control the inlet temperature at about 50°C; take glyceryl behenate and heat and melt it, and finally keep the temperature at 85°C; Glyceride liquid is introduced in the fluidized bed, adopts high-pressure air atomization (atomization pressure is the same as embodiment 1), adopts top spray technology, makes liquid atomization glyceryl behenate small droplet be coated on fluidized bed On the surface of zaltoprofen crystals, since the crystal temperature is lower than the melting point of glyceryl behenate, the small droplets of liquid atomized glyceryl behenate will quickly condense into tiny solid particles after meeting zaltoprofen crystals And be coated on zaltoprofen crystal surface, need control the spray speed of glyceryl behen...

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Abstract

The invention discloses a new formulation of novel nonsteroidal antiinflammatory medicament-zaltoprofen, namely an enteric sustained-release preparation containing zaltoprofen. Matrix which is insoluble in water and is insoluble in gastrointestinal fluid is used as a sustained-release auxiliary material to prepare the enteric sustained-release preparation. The enteric sustained-release preparation prepared in the invention has no fast release phenomenon of the medicament, and the repeatability of in vitro medicament release action of the preparation with different batches is good, so as to bebeneficial to keep in-vivo plasma concentration of a patient stable after taking the medicament.

Description

technical field [0001] The invention relates to an enteric-coated sustained-release preparation and a preparation method thereof, in particular to an enteric-coated sustained-release preparation of a novel non-steroidal anti-inflammatory drug zaltoprofen and a preparation method thereof. Background technique [0002] Zaltoprofen is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic effects. It mainly works by inhibiting the synthesis of prostaglandins and blocking inflammatory mediators. It is used for the treatment of pain and rheumatoid Musculoskeletal disorders such as arthritis. The drug was developed by Chemiphar Corporation of Japan, and it was first listed in Japan in 1993. From 2003 to 2004, another 8 companies went on the market to sell the product. The product was launched in South Korea in 1999. [0003] The analgesic effect of this product and the effect on acute inflammation are strong, and it is also effective on subacute...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/16A61K31/38A61K47/14A61K47/44A61P29/00A61K47/06A61K47/10
Inventor 刘福利滑千里王乃浩杨丽英赵学刚赵晓雷张雪雷陈永帅张丽霞
Owner HEBEI AOXING GROUP PHARMA
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