Moxifloxacin hydrochloride film-coated tablet and preparation method thereof

A technology of moxifloxacin hydrochloride and film-coated tablets, applied in sugar-coated pills, pill delivery, antibacterial drugs and other directions, can solve the problems of poor water solubility, affected safety, difficult to granulate, etc., and achieves easy operation and pharmaceutical excipients. Few, simple methods

Inactive Publication Date: 2015-11-11
HARBIN ZHENBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

10-25% pregelatinized starch and 2-8% povidone are used as mixed hardening agents to make the tablet have sufficient hardness and release degree, but the amount of pregelatinized starch in the prescription is 124mg, accounting for 18% of the weight, which has reached the upper limit of the single-tablet dosage of the excipient in the excipient database of the New Drug Approval Center of the State Food and Drug Administration, and the safety of long-term use of the drug will be affected
[0007] The currently commercially available moxifloxacin oral preparations are mainly tablets. Moxifloxacin has poor fluidity, light powder, and poor water solubility, which is difficult to granulate and increases the difficulty of tablet compression.

Method used

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  • Moxifloxacin hydrochloride film-coated tablet and preparation method thereof
  • Moxifloxacin hydrochloride film-coated tablet and preparation method thereof
  • Moxifloxacin hydrochloride film-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1: Moxifloxacin hydrochloride film-coated tablet

[0035] 1. Composition: The film-coated tablet is calculated by weight percentage, and the prescription of 1000 tablets (calculated on the basis of uncoated tablet) is as follows:

[0036]

[0037] 2. Preparation process:

[0038] (1) The raw and auxiliary materials are processed through an 80-mesh sieve;

[0039] (2) Wet mixing and granulation: Moxifloxacin hydrochloride, microcrystalline cellulose, pregelatinized starch, and croscarmellose sodium that have been sieved are put into a wet granulator and stirred at high speed, and microcrystalline Purified water with twice the volume of the cellulose prescription is used to make wet granules with a 20-mesh screen in a swing granulator, and the wet granules are dried in a hot air circulation oven at 55°C until the moisture is less than 3%;

[0040] (3) Tablet compression: dry granules are mixed with sieved magnesium stearate, put into a motion mixer for mix...

Embodiment 2

[0042] Embodiment 2: Moxifloxacin hydrochloride film-coated tablet

[0043] 1. Composition: The film-coated tablet is calculated by weight percentage, and the prescription of 1000 tablets (calculated on the basis of uncoated tablet) is as follows:

[0044]

[0045]

[0046] 2. Preparation process:

[0047] (1) The raw and auxiliary materials are processed through an 80-mesh sieve;

[0048] (2) Wet mixing and granulation: Moxifloxacin hydrochloride, microcrystalline cellulose, pregelatinized starch, and croscarmellose sodium that have been sieved are put into a wet granulator and stirred at high speed, and microcrystalline Purified water with twice the volume of the cellulose prescription is used to make wet granules with a 20-mesh screen in a swing granulator, and the wet granules are dried in a hot air circulation oven at 50°C until the moisture is less than 4%;

[0049] (3) Tablet compression: dry granules are mixed with sieved magnesium stearate, put into a motion mix...

Embodiment 3

[0051] Embodiment 3: Moxifloxacin hydrochloride film-coated tablet

[0052] 1. Composition: The film-coated tablet is calculated by weight percentage, and the prescription of 1000 tablets (calculated on the basis of uncoated tablet) is as follows:

[0053]

[0054] 2. Preparation process:

[0055] (1) The raw and auxiliary materials are processed through an 80-mesh sieve;

[0056] (2) Wet mixing and granulation: Moxifloxacin hydrochloride, microcrystalline cellulose, pregelatinized starch, and croscarmellose sodium that have been sieved are put into a wet granulator and stirred at high speed, and microcrystalline Purified water with twice the volume of the cellulose prescription is used to make wet granules with a 20-mesh screen in a swing granulator, and the wet granules are dried in a hot air circulation oven at 60°C until the moisture is less than 2%;

[0057] (3) Tablet compression: dry granules are mixed with sieved magnesium stearate, put into a motion mixer for mix...

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Abstract

The invention relates to a moxifloxacin hydrochloride film-coated tablet, which comprises the following components of moxifloxacin hydrochloride, pregelatinized starch, microcrystalline cellulose, croscarmellose sodium and magnesium stearate. The preparation method of a moxifloxacin hydrochloride preparation provided by the invention is simple in method, relatively few in pharmaceutical adjuvants, easy to operate and suitable for industrial production.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a moxifloxacin hydrochloride film-coated tablet and a preparation method thereof. Background technique [0002] Moxifloxacin, Chinese alias 1-cyclopropyl-7-(S,S-2,8-diazabicyclo[4.3.0]nonan-8-yl)-6-fluoro-8-methyl Oxy-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid, referred to as CDCH, is a new generation of fluoroquinolone broad-spectrum fully synthetic antibacterial drugs. Clinically, it is mainly used to treat upper and lower respiratory tract infections, such as acute sinusitis, chronic bronchial exacerbation, community-acquired pneumonia, and skin and soft tissue infections. [0003] Moxifloxacin hydrochloride is the fourth-generation fluoroquinolone broad-spectrum antibacterial drug developed by German Bayer company. In 2002, moxifloxacin hydrochloride tablets were launched in China, and in 2005, moxifloxacin hydrochloride sodium chloride injection was launched in China. Name:...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4709A61K47/38A61K47/36A61P31/04
Inventor 方同华王维龙于征帆徐秀杰王博董丽丽周广红范玉奇
Owner HARBIN ZHENBAO PHARMA
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