Cefuroxime axetil composition freeze-dried orally disintegrating tablets and preparation method thereof

A technology of cefuroxime axetil and orally disintegrating tablets, which is applied in the direction of non-active ingredients of polymer compounds, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problems of reducing patients' clinical medication compliance, oral mucosal irritation, Humidity, heat instability and other problems, to achieve good taste, reduce germs, no gritty effect

Inactive Publication Date: 2012-11-21
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, cefuroxime axetil is a lipophilic compound with poor water solubility and aggregates when exposed to water. The raw materials are unstable to humidity and heat. The existing dosage forms mainly include tablets, dispersible tablets, capsules, and dry suspen...

Method used

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  • Cefuroxime axetil composition freeze-dried orally disintegrating tablets and preparation method thereof
  • Cefuroxime axetil composition freeze-dried orally disintegrating tablets and preparation method thereof
  • Cefuroxime axetil composition freeze-dried orally disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Taking 125mg / tablet as an example to prepare cefuroxime axetil composition freeze-dried orally disintegrating tablets,

[0050] Prescription: 1000 tablets

[0051]

[0052] Dissolve the prescribed amount of cefuroxime axetil in the prescribed amount of tert-butanol (in solution a), stir and dissolve at room temperature, continue to stir, and dissolve the prescribed amount of mannitol and sucralose in the total amount of purified water for prescription 70 %-80% purified water (solution b); then dissolve the prescribed amount of gelatin in purified water (solution c) with a prescription water consumption of 20%-30%, and heat until completely dissolved; combine the above two types of b and c The solution was solution d, and stirred evenly, and then the mixed solution was cooled to below 5°C. Mix the two solutions a and d, and stir evenly, adjust the pH to 5.5-6.5 with sodium bicarbonate, according to the specifications of cefuroxime axetil composition freeze-dried orally...

Embodiment 2

[0054] Taking 125mg / tablet as an example to prepare cefuroxime axetil composition freeze-dried orally disintegrating tablets,

[0055] Prescription: 1000 tablets

[0056]

[0057] Dissolve the prescribed amount of cefuroxime axetil in the prescribed amount of tert-butanol (in solution a), stir and dissolve at room temperature, continue to stir, and dissolve the prescribed amount of mannitol and sucralose in the total amount of purified water for prescription 70 %-80% purified water (solution b); then dissolve the prescribed amount of gelatin in purified water (solution c) with a prescription water consumption of 20%-30%, and heat until completely dissolved; combine the above two types of b and c The solution was solution d, and stirred evenly, and then the mixed solution was cooled to below 5°C. Mix the two solutions a and d, and stir evenly, adjust the pH to 5.5-6.5 with sodium bicarbonate, according to the specifications of cefuroxime axetil composition freeze-dried oral...

Embodiment 3

[0059] Taking 125mg / tablet as an example to prepare cefuroxime axetil composition freeze-dried orally disintegrating tablets,

[0060] Prescription: 1000 tablets

[0061]

[0062]

[0063] Dissolve the prescribed amount of cefuroxime axetil in the prescribed amount of tert-butanol (in solution a), stir and dissolve at room temperature, continue to stir, and dissolve the prescribed amount of mannitol and sucralose in the total amount of purified water for prescription 70 %-80% purified water (solution b); then dissolve the prescribed amount of gelatin in purified water (solution c) with a prescription water consumption of 20%-30%, and heat until completely dissolved; combine the above two types of b and c The solution was solution d, and stirred evenly, and then the mixed solution was cooled to below 5°C. Mix the two solutions a and d, and stir evenly, adjust the pH to 5.5-6.5 with sodium bicarbonate, according to the specifications of cefuroxime axetil composition freez...

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Abstract

The invention provides cefuroxime axetil composition freeze-dried orally disintegrating tablets and a preparation method of the orally disintegrating tablets, relates to the field of a medicine and a medicine preparation method technology and mainly solves the problems in the prior art that the cefuroxime axetil preparation is poor in curative effect and not suitable for children and the patients who are difficult to swallow. The cefuroxime axetil composition freeze-dried orally disintegrating tablets are prepared from the following components by weight: 25-50% of cefuroxime axetil, 25-75% of mannitol, 2-4% of gelatin, 0.1-0.15% of trichlorosucrose and 42-67% of tertiary butanol-water. The cefuroxime axetil composition freeze-dried orally disintegrating tablets prepared by the above components are easy in preparation process, and simple in components, and mainly meet the administration requirements of children and the patients who are difficult to swallow; moreover, the cefuroxime axetil composition freeze-dried orally disintegrating tablets have the advantages of being fast to disintegrate, convenient to take, and good in taste; and the tablets take effect quickly and are fully absorbed, and the first pass effect of the liver is avoided.

Description

Technical field: [0001] The invention relates to the technical field of medicines and preparation methods of medicines, in particular to a freeze-dried orally disintegrating tablet of a cefuroxime axetil composition and a preparation method thereof. Background technique: [0002] The chemical name of cefuroxime axetil is: (6R,7R)-7-[2-furyl(methoxyimino)acetamido]-3-carbamoyloxymethyl-8-oxo-5-thia- 1-Azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 1-acetoxyethyl ester. C20H22N4O10S, molecular weight 510.48, soluble in acetone, insoluble in water. Its chemical structural formula is: [0003] [0004] Cefuroxime axetil is an esterification preparation of the second-generation cephalosporin cefuroxime. After oral administration, it is decomposed by esterase in the intestinal mucosa and blood to form cefuroxime and its effect. It has a broad antibacterial spectrum and strong antibacterial activity, and has good antibacterial activity against both Gram-positive and Gram-negat...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/546A61K47/42A61P31/04
Inventor 吴函峰汪六一汪金灿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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