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Moxifloxacin tablet formula capable of solving influences of dissolution behaviors caused by granulating time

A moxifloxacin and tablet technology, applied in the field of moxifloxacin tablet formulation, can solve problems such as the influence of granulation time

Active Publication Date: 2015-05-20
宁波高新区美诺华医药创新研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of the deficiencies in the prior art, the object of the present invention is to provide a moxifloxacin tablet formulation that solves the problem that the dissolution behavior is affected by the granulation time, and the formulation makes the prepared The dissolution behavior of moxifloxacin tablets is completely unaffected by the length of granulation time during the preparation process

Method used

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  • Moxifloxacin tablet formula capable of solving influences of dissolution behaviors caused by granulating time
  • Moxifloxacin tablet formula capable of solving influences of dissolution behaviors caused by granulating time
  • Moxifloxacin tablet formula capable of solving influences of dissolution behaviors caused by granulating time

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: a kind of moxifloxacin tablet, its formula is as follows:

[0026]

[0027] The preparation process steps of the moxifloxacin tablet that above-mentioned prescription forms are as follows:

[0028] (1) Put moxifloxacin hydrochloride, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and crospovidone in a wet granulator, start the mixer and mix for 90 seconds, and then turn on the shear Slowly add purified water into the device, set the granulation time to 120s, and obtain soft materials.

[0029] (2) Granulate the above-mentioned soft material through a 20-mesh sieve.

[0030] (3) The prepared granules were dried at 60° C. for 120 minutes, and sized through a 18-mesh sieve.

[0031] (4) Add lubricant magnesium stearate to the granules, mix uniformly, and compress the tablet after passing the intermediate inspection.

[0032] Table 1: The dissolution profile determination result of the tablet that embodiment 1 makes

[0033] ...

Embodiment 2

[0035] Example 2: A moxifloxacin tablet, the formula composition is exactly the same as that of Example 1, and the preparation process is consistent with that of Example 1 except that the granulation time is set to 240s.

[0036] Table 2: The dissolution profile determination result of the tablet that embodiment 2 makes

[0037] time (minutes)

[0038] Dissolution profile see figure 2 .

Embodiment 3

[0039] Example 3: A moxifloxacin tablet, the formula composition is exactly the same as that of Example 1, and the preparation process is consistent with that of Example 1 except that the granulation time is set to 360s.

[0040] Table 3: The dissolution profile determination result of the tablet that embodiment 3 makes

[0041] time (minutes)

[0042] Dissolution profile see image 3 .

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Abstract

The invention belongs to the technical field of pharmacy, and specifically discloses a moxifloxacin tablet formula capable of effectively solving influences of dissolution behaviors caused by granulating time. According to the formula, a disintegrating agent is a mixed disintegrating agent consisting of crosslinked sodium carboxymethylcellulose SD-711NF and crosslinked polyvinylpolypyrrolidone XL, wherein the mixed disintegrating agent accounts for 3.0-6.0% of the total weight of tablets, and a mass ratio of crosslinked sodium carboxymethylcellulose to crosslinked polyvinylpolypyrrolidone is (2:1) to (5:1). According to the tablet formula disclosed by the invention, after the mixed disintegrating agent is added, the granulating time almost has no influences to the dissolution behaviors of the obtained tablets, so that a technical scheme disclosed by the invention is more beneficial to industrial production, and clinical medication can be safer and more effective.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a moxifloxacin tablet formula which can effectively solve the problem that the dissolution behavior is affected by the granulation time. Background technique [0002] Moxifloxacin (Moxifloxacin, Cas NO:151096-09-2) is a fourth-generation 8-methoxyfluoroquinolone broad-spectrum antibacterial drug developed by Bayer Pharmaceuticals, Germany. It is effective against Gram-negative bacteria and Gram-positive bacteria. , mycoplasma, chlamydia, and myelitis virus all have good antibacterial activity, and are clinically used to treat respiratory system infections, reproductive system infections, skin and soft tissue infections, etc. Moxifloxacin has excellent pharmacokinetic properties, rapid oral absorption, absolute bioavailability of about 91%, low plasma protein binding rate, strong tissue penetration, no metabolism through cytochrome P450 system, the original drug passes through th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4709A61K47/38A61K47/32A61P31/04A61P31/00A61P31/14
Inventor 谢树伟邵健陈杰陈蔚江
Owner 宁波高新区美诺华医药创新研究院有限公司