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Water-soluble sarafloxacin hydrochloride granule and preparation method thereof

A technology of sarafloxacin hydrochloride and water-soluble granules, which is applied in the field of sarafloxacin hydrochloride water-soluble granules and its preparation, can solve the problems of ineffective treatment, drug residue, and prolonged drug withdrawal period, and achieve good treatment effect, does not affect the drug withdrawal period, and the effect of strong drug loading

Active Publication Date: 2022-02-18
SHANDONG GUOBANG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, sarafloxacin hydrochloride has strong permeability into animals and fast absorption and metabolism. Existing products are made into sustained-release preparations, but it is not considered that sarafloxacin hydrochloride is a concentration-dependent drug, and conventional liposomes and coating materials will reduce the concentration of the drug. If the blood concentration of the drug is too high, it will not achieve a good therapeutic effect, and it will also lead to the extension of the withdrawal period of the drug, and the problem of drug residue is serious, and there is still drug residue after 24 hours

Method used

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  • Water-soluble sarafloxacin hydrochloride granule and preparation method thereof
  • Water-soluble sarafloxacin hydrochloride granule and preparation method thereof
  • Water-soluble sarafloxacin hydrochloride granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The present embodiment proposes a kind of method of sarafloxacin hydrochloride water-soluble granule, comprises the steps:

[0024] (1) Weigh 15 g of diethylenediamine and 150 g of cyclodextrin-methyl vinyl ether / maleic anhydride copolymer respectively, add them into hot water at 55°C, stir and mix evenly, and obtain mixture 1;

[0025] (2) Weigh 100 g of sarafloxacin hydrochloride and 735 g of anhydrous glucose respectively, and stir and mix evenly to obtain mixture 2;

[0026] (3) Throw the mixture 2 obtained in the step (2) into a three-dimensional fluidized bed, and use the mixture 1 obtained in the step (1) as a binder for fluidized bed granulation; during this period, control the inlet air temperature, Inlet air volume, atomization pressure, and finally obtain sarafloxacin hydrochloride granules.

Embodiment 2

[0028] The present embodiment proposes a kind of method of sarafloxacin hydrochloride water-soluble granule, comprises the steps:

[0029] (1) Weigh 30g of diethylenediamine and 200g of cyclodextrin-methyl vinyl ether / maleic anhydride copolymer respectively, add them into hot water at 58°C and stir and mix evenly to obtain mixture 1;

[0030] (2) Weigh 100 g of sarafloxacin hydrochloride and 670 g of anhydrous glucose respectively, and stir and mix evenly to obtain mixture 2;

[0031] (3) Throw the mixture 2 obtained in the step (2) into a three-dimensional fluidized bed, and use the mixture 1 obtained in the step (1) as a binder for fluidized bed granulation; during this period, control the inlet air temperature, Inlet air volume, atomization pressure, and finally obtain sarafloxacin hydrochloride granules.

Embodiment 3

[0033] The present embodiment proposes a kind of method of sarafloxacin hydrochloride water-soluble granule, comprises the steps:

[0034] (1) Weigh 45g of diethylenediamine and 220g of cyclodextrin-methyl vinyl ether / maleic anhydride copolymer respectively, add them into hot water at 60°C, stir and mix evenly, and obtain mixture 1;

[0035] (2) Weigh 100 g of sarafloxacin hydrochloride and 635 g of anhydrous glucose respectively, and stir and mix evenly to obtain mixture 2;

[0036] (3) Throw the mixture 2 obtained in the step (2) into a three-dimensional fluidized bed, and use the mixture 1 obtained in the step (1) as a binder for fluidized bed granulation; during this period, control the inlet air temperature, Inlet air volume, atomization pressure, and finally obtain sarafloxacin hydrochloride granules.

[0037] For the above-mentioned Examples 1 to 3, in order to facilitate comparative analysis, the stirring speed in step (1) was 150 r / min, and the stirring time was 30 m...

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Abstract

The invention provides a water-soluble sarafloxacin hydrochloride granule and a preparation method thereof. The invention aims to solve the technical problems that an existing sarafloxacin hydrochloride medicine is poor in treatment effect and serious in medicine residues. The water-soluble sarafloxacin hydrochloride granule is prepared from the following raw materials in parts by weight: 15-45 parts of diethylene diamine, 150-220 parts of a cyclodextrin-methyl vinyl ether / maleic anhydride copolymer, 100 parts of sarafloxacin hydrochloride, 635-735 parts of anhydrous dextrose and a proper amount of water. The preparation method comprises the following steps: respectively weighing the diethylene diamine and the cyclodextrin-methyl vinyl ether / maleic anhydride copolymer, adding the diethylene diamine and the cyclodextrin-methyl vinyl ether / maleic anhydride copolymer into hot water, and carrying out uniform mixing to obtain a mixture I; respectively weighing sarafloxacin hydrochloride and anhydrous dextrose, and carrying out uniform mixing to obtain a mixture II; putting the mixture II into a three-dimensional fluidized bed, and carrying out fluidized-bed granulation by taking the mixture I as an adhesive; and controlling air inlet temperature and the like during the granulation so as to finally obtain sarafloxacin hydrochloride particles. The water-soluble sarafloxacin hydrochloride granule provided by the invention can be widely applied to the technical field of veterinary drugs.

Description

technical field [0001] The application relates to the technical field of veterinary medicine, in particular to a water-soluble sarafloxacin hydrochloride granule and a preparation method thereof. Background technique [0002] Sarafloxacin hydrochloride is a third-generation fluoroquinolone antibacterial drug specially used for animals. It has a broad antibacterial spectrum and strong antibacterial activity. It has good antibacterial activity against Gram-negative bacteria, Gram-positive bacteria and mycoplasma. Antibacterial effect, especially Escherichia coli, Salmonella, Klebsiella, Proteus, Pasteurella multocida, Campylobacter and other enterobacteria. Sarafloxacin hydrochloride absorbs quickly, metabolizes quickly, has almost no residue, and has no cross-resistance with many antibacterial drugs. It is mainly used for the treatment of digestive system, respiratory system, urinary tract infection and mycoplasma caused by sensitive bacteria. [0003] Sarafloxacin hydrochlo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/40A61K31/496A61P31/04
CPCA61K9/1652A61K31/496A61P31/04
Inventor 邱正洲曲俊腾杨俊德王文静刘萃萃
Owner SHANDONG GUOBANG PHARMA
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