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Cefuroxime axetil pharmaceutical composition and preparation method thereof

A technology of cefuroxime axetil and pharmaceutical preparations, which is applied in the field of medicine, can solve problems such as cefuroxime axetil not being tightly packaged, product taste decline, and taste decline, and achieve improved drug dissolution rate, good dissolution effect, and easy-to-obtain equipment Effect

Active Publication Date: 2015-05-06
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The hot-melt spray in this method only slightly increases the protection content on the basis of GlaxoSmithKline’s patent, and the hot-melt granulation is similar to the patent of Shandong Lukang Pharmaceutical Co., Ltd., but the molten particles are not crushed, but sheared. For granulation, the addition of a large amount of diluent and disintegrant to stearic acid will inevitably lead to poor encapsulation of cefuroxime axetil, thus reducing the taste of the product
[0009] Patent CN103877027A discloses a cefuroxime axetil hot-melt coating composition and its preparation method. The method also adopts GlaxoSmithKline’s hot-melt spray technology, adding porogen povidone to stearic acid to improve dissolution rate , the principle is similar to the patent of Shandong Lukang Pharmaceutical Co., Ltd., but the improvement of dissolution should start with insoluble cefuroxime axetil, not stearic acid as a taste masking agent. Strict, leading to a decline in taste

Method used

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  • Cefuroxime axetil pharmaceutical composition and preparation method thereof
  • Cefuroxime axetil pharmaceutical composition and preparation method thereof
  • Cefuroxime axetil pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1 (1000 bags of dry suspensions)

[0041]

[0042]

[0043] The preparation method is as follows:

[0044] (1) Glyceryl monostearate is heated and melted, and the melting temperature is 90°C.

[0045] (2) In the fluidized bed, adjust an appropriate air volume to fully fluidize the cefuroxime axetil raw material.

[0046] (3) In the fluidized bed, adjust the temperature of the material to 40°C to 50°C, and the atomization pressure to 0.1 to 0.3Mpa. Under the action of compressed air, the glyceryl monostearate is passed through the spray device to form atomized droplets, which are slowly sprayed on the surface of the fully fluidized cefuroxime axetil raw material, so that it is uniformly coated.

[0047] (4) Add sucrose, mannitol, low-substituted hydroxypropyl cellulose and hydroxypropyl cellulose to the above powder, granulate, add the remaining excipients after drying, mix and pack separately, and prepare a dry suspension.

Embodiment 2

[0048] Embodiment 2 (1000 bags of dry suspensions)

[0049]

[0050] The preparation method is as follows:

[0051] (1) Glyceryl monostearate is heated and melted, and the melting temperature is 90°C.

[0052] (2) In the fluidized bed, adjust an appropriate air volume to fully fluidize the cefuroxime axetil raw material.

[0053] (3) In the fluidized bed, adjust the temperature of the material to 40°C to 50°C, and the atomization pressure to 0.1 to 0.3Mpa. Under the action of compressed air, the glyceryl monostearate is passed through the spray device to form atomized droplets, which are slowly sprayed on the surface of the fully fluidized cefuroxime axetil raw material, so that it is uniformly coated.

[0054] (4) Add sucrose, mannitol, low-substituted hydroxypropyl cellulose and hydroxypropyl cellulose to the above powder, granulate, add the remaining adjuvant after drying, mix and pack, and prepare a dry suspension.

Embodiment 3

[0055] Embodiment 3 (1000 bags of dry suspensions)

[0056]

[0057] The preparation method is as follows:

[0058] (1) Glyceryl monostearate is heated and melted, and the melting temperature is 90°C.

[0059] (2) In the fluidized bed, adjust an appropriate air volume to fully fluidize the cefuroxime axetil raw material.

[0060] (3) In the fluidized bed, adjust the temperature of the material to 40°C to 50°C, and the atomization pressure to 0.1 to 0.3Mpa. Under the action of compressed air, the glyceryl monostearate is passed through the spray device to form atomized droplets, which are slowly sprayed on the surface of the fully fluidized cefuroxime axetil raw material, so that it is uniformly coated.

[0061] (4) Add sucrose, mannitol, low-substituted hydroxypropyl cellulose and hydroxypropyl cellulose to the above powder, granulate, add the remaining excipients after drying, mix and pack separately, and prepare a dry suspension.

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Abstract

The invention provides a cefuroxime axetil pharmaceutical composition and a preparation method thereof. The method comprises the following steps: fully fluidizing cefuroxime axetil with specific particle size distribution in a fluidized bed; slowly spraying molten refractory materials on the surface of cefuroxime axetil through a spraying device, and fully enveloping the surface of the cefuroxime axetil; and adding other auxiliary materials, mixing evenly, and preparing a cefuroxime axetil dry suspension or granule. The preparation process can be finished in the fluidized bed; a hot melt pelletizer or a spray dryer is not used; and industrialized mass production of the modern pharmaceutical industry is facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a cefuroxime axetil pharmaceutical composition and a preparation method thereof. Background technique [0002] Cefuroxime axetil is a β-lactam antibiotic and a semi-synthetic second-generation cephalosporin. Clinical studies have shown that it has the advantages of high stability to β-lactamase, broad antibacterial spectrum, strong antibacterial activity and small adverse reactions. Clinically, it is mainly used for acute pharyngitis or tonsillitis in adults, acute otitis media, maxillary sinusitis, acute exacerbation of chronic bronchitis, acute bronchitis, simple urinary tract infection, etc. Pharyngitis or tonsillitis in children, acute otitis media and impetigo. [0003] After oral administration, cefuroxime axetil is hydrolyzed into cefuroxime by non-specific esterase after being absorbed in the gastrointestinal tract to exert antibacterial effect. Its bactericidal mech...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K9/16A61K9/00A61P31/04
Inventor 曲继广赵晓雷许燕芹夏国龙程彦超杨帆刘芳菊袁兴利张月红张玉红
Owner SHIJIAZHUANG NO 4 PHARMA
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