Cefuroxime axetil pharmaceutical composition prepared by direct compression method

Abstract

The invention discloses a cefuroxime axetil pharmaceutical composition prepared by powder direct compression method, wherein the weight ratio of all components in the preparation is 38.8-63.1% of cefuroxime axetil (in terms of cefuroxime), 10.7 to 35.5% of filler, 1.5 to 15% of disintegrant, 0.3 to 3.5% of wetting agent and 0.3 to 2.0% of glidant, the single composition weight is 400 to 600mg. Theinvention solves the problems of poor raw material flowability and instability of wet granulation, avoids the problem of dissolution caused by multiple compression and comminution on the material inthe dry granulation process, effectively reduces the energy consumption in the production process, and is more benefit to enlarge production.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a fast-dissolving cefuroxime axetil pharmaceutical composition prepared by a powder direct tableting method. Background technique [0002] The development and application of new excipients have promoted the development of powder direct compression technology. Compared with the traditional wet granulation process, the powder direct compression process has the advantages of simple process and easy scale-up. Specifically, the powder direct compression process saves the step of material granulation, and the process is simpler. The excipients can be pressed into tablets after simple handling and mixing, which avoids the influence of factors such as humidity and heat on the stability of active ingredients, and provides great convenience for the development of pharmaceutical preparations. [0003] Cefuroxime axetil is a second-generation cephalosporin antibiotic with a broad antibact...

AI Technical Summary

Problems solved by technology

[0005] Patent CN200910104304.1 discloses a cefuroxime axetil preparation suitable for direct powder compression. This method improves the bulk density of the total blended material by selecting suitable density auxiliary materials, and solves the problem of poor fluidity of the mixed material after the total blending, which is not suitable for direct Tablet Problems

However, during the implementation of this scheme, the monitoring of the density of raw materials and mixing materials is relatively frequent, and the parameter restrictions are relatively strict, which increases the risk and workload in the production process

[0006] Patent CN201410451652.7 discloses a cefuroxime axetil pharmaceutical composition and its preparation method. The preparation process is also powder direct compression. This method omits the monitoring of material density during the implementation process, but the processing of raw and auxiliary materials and The mixing process requires cumbersome: first mix the raw materials and some auxiliary materials and then sieve; add the auxiliary materials except magnesium stearate and then sieve; add magnesium stearate and mix to get the total blended material

During the implementation of this scheme, a large amount of dust may be generated, which will pollute the production environment and have adverse effects on the health of the operators. It is not suitable for large-scale industrial production.

[0007] Patent CN201110170978.9 discloses a cefuroxime axetil tablet and its full powder direct compression method, which has the characteristics of time-saving, labor-saving, energy-saving and high-efficiency direct compression process, but the invention uses ion-exchange resin to improve the prescription. Fluidity and compressibility, the bulk density of the ion exchange resin used is 0.54g / cm 3 ~0.69g / cm 3 Most of the commercially available raw materials of cefuroxime axetil are produced by spray drying method, and the bulk density is relatively small, usually around 0.2g / cm3.

[0008] Although the above powder direct compression process simplifies the production steps compared with the dry granulation process, it still cannot improve the universality of the process, and has the disadvantages of frequent monitoring of intermediates and complicated pretreatment steps.

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