Cefuroxime axetil capsule in non-gel state in water and preparation method of cefuroxime axetil capsule

A cefuroxime axetil and non-gel technology, which is applied in the field of pharmaceutical preparations, can solve the problems of gelation and slow dissolution, and achieve the effects of improving dissolution, reducing quality, and good hygroscopicity

Active Publication Date: 2013-04-03
SUZHOU CHUNGHWA CHEM & PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by the present invention is to overcome the severe gelation phenomenon of cefuroxime axetil capsules in the prior art when it is dissolved in water, thereby causing a slow dissolution rate, and to provide a non-gelled cephalosporin in water. Fuocityl ester capsules and preparation method thereof, the obtained capsules have good dispersibility and hydrophilicity during dissolution, no gelation phenomenon, and the dissolution rate is greatly improved

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0028] The capsule fillers shown in Examples 1-4 were prepared by the following method and the formula shown in Table 1: the cefuroxime axetil raw material, micropowder silica gel, anti-gelling auxiliary agent and 50% disintegrant were sieved respectively, Then, the above-mentioned sieved raw and auxiliary materials are mixed uniformly and compressed into large tablets, which are then sieved and granulated, and then the remaining disintegrants and fillers are added and mixed uniformly. The details are shown in Table 1:

[0029] Table 1 Capsule formula statistics table (weight percent) of embodiment 1-4

[0030] .

Embodiment 5-7

[0032] The capsule filling material shown in Example 5-7 was prepared with the following method and the formula shown in Table 2: the cefuroxime axetil raw material, micropowder silica gel, stearic acid, and the added disintegrant were respectively sieved through a 40-mesh sieve, then The above-mentioned sieved raw materials and auxiliary materials are mixed uniformly and then pressed into large tablets, which are then passed through a 24-mesh sieve for granulation, and finally, the filler microcrystalline cellulose 102 that has passed through a 40-mesh sieve and a disintegrant are added and mixed uniformly. Wherein, the disintegrating agent croscarmellose sodium adopts the modes of all internal addition, internal and external addition, and all external additions, as shown in Table 2:

[0033] Table 2 The disintegrant of embodiment 5-7 is added inside and outside the situation statistics table (weight percent)

[0034] .

Embodiment 8-10

[0036] Embodiment 8-10 adopts following formula to prepare capsule filling material: by weight percentage, cefuroxime axetil 62%, micropowder silica gel 3%, anti-gelling agent stearic acid 3%, disintegrant cross-linked carboxymethyl Cellulose sodium 11%, plus disintegrant croscarmellose sodium 11%, filler microcrystalline cellulose 102 10%.

[0037] The preparation method is as follows: mixing part of cefuroxime axetil raw material (premixed cefuroxime axetil) and part of micropowder silica gel (premixed micropowder silica gel) evenly, sieving, and then mixing with other cefuroxime axetil raw materials, which have passed through a 40-mesh sieve respectively, Micropowder silica gel, anti-gelling agent stearic acid, and 50% disintegrant are mixed, compressed into large tablets, and then passed through a 24-mesh sieve to granulate, and then the remaining disintegrant and filler that have passed through a 40-mesh sieve are added, and the mixture is uniform. , as shown in Table 3: ...

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Abstract

The invention relates to a cefuroxime axetil capsule in a non-gel state in water and a preparation method of the cefuroxime axetil capsule, and belongs to the technical field of medicinal preparation. The cefuroxime axetil capsule comprises the following raw materials and auxiliary materials in percentage by weight: 55-70 percent of cefuroxime axetil, 1-3 percent of micro-powder silica gel, 1-3 percent of gel-resistant auxiliaries, 15-30 percent of disintegrating agents and 5-20 percent of filling agents. The gel-resistant auxiliaries can be stearic acid and / or talcum powder. By using a dry granulating method, a problem of low dissolution rate resulted from the serious gelation phenomenon caused by dissolving the cefuroxime axetil capsule out of water in the prior art is avoided, so that the prepared capsule is good in dispersibility and hydrophily when being dissolved out, the gelation phenomenon is avoided, and the dissolution rate is greatly improved.

Description

technical field [0001] The invention relates to cefuroxime axetil capsules, in particular to a cefuroxime axetil capsule in a non-gel state when exposed to water and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Cefuroxime axetil is the precursor of cefuroxime, which belongs to broad-spectrum antibacterial drugs and has strong antibacterial activity against Gram-positive cocci, Gram-negative bacteria and Escherichia coli. Fuxin exerts antibacterial activity, and most importantly, the drug is less toxic to the kidneys. [0003] Cefuroxime axetil has a bitter taste, loose texture, poor fluidity, and is prone to gelation when exposed to water. It is mainly available in the market as tablets and capsules. Tablet preparation mainly adopts three kinds of tableting after dry granulation, direct powder compression and tableting after wet granulation. Generally, it is necessary to add a large amount of fi...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/546A61K47/04A61P31/04
Inventor 李远福陈娟翟晶晶
Owner SUZHOU CHUNGHWA CHEM & PHARMA IND
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