Levofloxacin composition freeze-dried orally disintegrating tablets and preparation method thereof

A technology of levofloxacin and orally disintegrating tablets, which is applied in the field of levofloxacin composition freeze-dried orally disintegrating tablets and its preparation, can solve the problems of reducing patients' clinical medication compliance, and achieve improved bioavailability, small gastrointestinal irritation, Little hepatic first-pass 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, conventional dosage forms such as tablets and capsules are not suitable for children, elderly patients and patients

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Prescription: 1000 tablets

[0046]

[0047] Dissolve the prescription amount of medium-substituted hydroxypropyl-β-cyclodextrin in 80% of the total prescription water

[0048] In purified water, heat to 55°C while stirring, slowly add the prescribed amount of levofloxacin, continue to stir for 10 hours, after the medium-substituted hydroxypropyl-β-cyclodextrin will clathrate levofloxacin, add the prescribed amount of mannitol , Sucralose, dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption, heat until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, according to the combination of levofloxacin lyophilized orally disintegrating tablets, after determining the loading amount, the combined medicinal solution is divided into drug-containing dishes according to the loading amount, and put into a freeze-drying box, and the medicinal solution is...

Embodiment 2

[0050] Prescription: 1000 tablets

[0051]

[0052]Dissolve the prescribed amount of hydroxypropyl-β-cyclodextrin with a medium degree of substitution in purified water of 80% of the total amount of prescribed water, heat to 55°C while stirring, slowly add the prescribed amount of levofloxacin, and continue stirring for 10 hours. After the levofloxacin is clathrated by hydroxypropyl-β-cyclodextrin with medium degree of substitution, add the prescribed amount of mannitol and sucralose, dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water amount, and heat until completely dissolved , combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, according to the specifications of the levofloxacin composition freeze-dried orally disintegrating tablets, after determining the filling volume, divide the combined liquid medicine according to the filling volume The medicine is stored in a dish, and pu...

Embodiment 3

[0054] Prescription: 1000 tablets

[0055]

[0056] Dissolve the prescribed amount of hydroxypropyl-β-cyclodextrin with a medium degree of substitution in purified water of 80% of the total amount of prescribed water, heat to 55°C while stirring, slowly add the prescribed amount of levofloxacin, and continue stirring for 10 hours. After the levofloxacin is clathrated by hydroxypropyl-β-cyclodextrin with medium degree of substitution, add the prescribed amount of mannitol and sucralose, dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water amount, and heat until completely dissolved , combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, according to the specifications of the levofloxacin composition freeze-dried orally disintegrating tablets, after determining the filling volume, divide the combined liquid medicine according to the filling volume The medicine is stored in a dish, and p...

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Abstract

The invention provides levofloxacin 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 ordinary preparation prepared by levofloxacin is poor in curative effect and not suitable for children and the patients who are difficult to swallow. The levofloxacin composition freeze-dried orally disintegrating tablets are prepared from the following components by weight: 10-24% of levofloxacin, 24-50% of mannitol, 2-4% of gelatin, 32-74% of hydroxypropyl-beta-cyclodextrin with medium substitution degree, 0.1-0.2% of trichlorosucrose and 50-70% of purified water. The levofloxacin 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 levofloxacin 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 medicine preparation methods, in particular to a levofloxacin composition freeze-dried orally disintegrating tablet and a preparation method thereof. Background technique: [0002] Levofloxacin is the active ingredient L-isomer in ofloxacin (racemic). Its mechanism of action and antibacterial characteristics are the same as those of ofloxacin, but its antibacterial effect is slightly stronger than that of ofloxacin. Levofloxacin can inhibit DNA gyrase, block DNA replication, and lyse bacteria in an environment several times higher than the minimum inhibitory concentration. Levofloxacin has definite in vitro antibacterial effect on Gram-positive and negative bacteria. The antibacterial effect of levofloxacin on Gram-negative bacilli is much greater than that of Gram-positive bacteria. Its in vitro antibacterial effect is slightly stronger or similar to that of norfloxacin, and the antibact...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/5383A61K47/42A61K47/40A61P31/04
Inventor 郝结兵汪六一汪金灿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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