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Oral cephalosporin ester capsule

A technology of ceftriaxone and cefuroxime axetil, applied in the field of pharmaceutical compositions, can solve the problems of low drug dissolution rate, low bioavailability and the like, and achieve the effects of simple preparation process, low cost and good dissolution rate

Inactive Publication Date: 2010-09-29
杭州锐思医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] For cephalosporins, capsules are used to successfully cover up the bad smell. However, during the dissolution test of the capsules, the drug gels when it encounters the dissolution medium (water or gastric juice, etc.), and the medium cannot continue to penetrate into the interior, and the drug dissolution rate is very low. , leading to low bioavailability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Mix all the ingredients in Table 1 evenly, and fill the capsules.

[0025] According to the dissolution test method (second method) stipulated in the second appendix XIC of Chinese Pharmacopoeia version in 2005, measure the dissolution rate of cefuroxime axetil capsule (RC-6 type dissolution tester, Tianjin University Precision Instrument Factory), its condition is Add the tablet into 900 ml of 0.07 mol / l hydrochloric acid at 37° C. at a speed of 55 rpm. Take 5ml of the solution at 15 minutes and 45 minutes respectively, filter, and replenish fresh medium in the operation container in time. Measured by ultraviolet spectrophotometry, the limit is 60% in 15 minutes and 75% in 45 minutes, which should meet the regulations. The dissolution conditions and limits are the Chinese Pharmacopoeia Tablet Standard.

[0026] As a result, 61.4% and 78.8% were dissolved in 15 minutes and 45 minutes respectively, meeting the regulations.

Embodiment 2

[0029] Mix micropowder silica gel and cefuroxime axetil evenly, mix evenly with calcium carbonate, and fill the capsules.

[0030] As described in Example 1, the cumulative dissolution rate (%) at each time was measured, and the result was that 67.1% and 88.2% were dissolved in 15 minutes and 45 minutes, which met the requirements.

Embodiment 3

[0033] Mix micropowder silica gel and cefuroxime axetil evenly, mix evenly with calcium carbonate, and fill the capsules.

[0034] The cumulative dissolution rate (%) at each time was measured as described in Example 1, and the result was that 65.3% and 81.1% were dissolved in 15 minutes and 45 minutes respectively, meeting the regulations.

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PUM

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Abstract

The invention relates to an oral cephalosporin ester capsule which comprises the components: 30-90wt% of cephalosporin ester, 5-50wt% of weak acid salt based on the total weight of the content of the capsule. The cephalosporin ester capsule further comprises filler, organic acid, disintegrating agent and surface active agent.The cephalosporin ester capsule does not exceed the solubility limit of corresponding cephalosporin ester tablets, thus overcoming the defects of low dissolving out limitation of the original cephalosporin ester capsule and not thorough odor masking of other preparations, and having simple technique and low cost.

Description

Technical field [0001] The invention relates to the technical field of pharmaceutical compositions, in particular to capsules of oral cephalosporin antibiotics. Background technique [0002] Cephalosporin antibiotics have become the most widely used antibiotics in clinical practice. They are generally divided into oral and injection according to the route of administration. Oral dosage forms include tablets (including dispersible tablets, etc.), capsules, granules, dry suspensions, etc. However, cephalosporin antibiotics all have a bad smell, and cephalosporins such as cefuroxime axetil and cefpodoxime axetil also have a strong bitter taste, and patients' compliance is poor. For this reason, people adopt coating to mask the taste of tablets, or adopt capsule dosage forms, or add flavoring agents in granules and dry suspensions. Among the above-mentioned approaches, the taste-masking effect of capsules is the best, and the medicine is isolated from the human oral cavity. . ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/546A61K47/02A61P31/04
Inventor 程开生臧洪梅童慧红
Owner 杭州锐思医药科技有限公司