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Medicine composition with norfloxacin and method for preparing medicine composition

A technology of norfloxacin and composition, which is applied in the field of norfloxacin pharmaceutical composition and its preparation, can solve the problems of drug dissolution reduction, dissolution rate reduction, empty capsules not meeting the regulations, etc., and achieve bioavailability improvement, Enhanced stability and uniform content

Active Publication Date: 2016-02-24
ZHEJIANG WANBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

3) Empty capsules do not comply with the regulations: cross-linking reactions occur between the hollow capsules and the active ingredients, resulting in a decrease in drug dissolution
In actual production, it was found that when norfloxacin powder is directly filled into capsules or filled into capsules after granulation, the dissolution rate is significantly reduced during the accelerated process or the long-term lofting process, and the effectiveness in the body cannot be guaranteed.
Norfloxacin is slightly soluble in water and does not have water absorption and water retention properties, so it is not easy to prepare skeleton-type pellets for norfloxacin; the specifications of norfloxacin capsules are 0.1g, 0.2g, 0.4g, and the proportion of raw material prescriptions is too low Capsules cannot be completely filled when

Method used

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  • Medicine composition with norfloxacin and method for preparing medicine composition
  • Medicine composition with norfloxacin and method for preparing medicine composition
  • Medicine composition with norfloxacin and method for preparing medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Embodiment 1. Norfloxacin capsule prescription composition: specification 0.1g, prescription quantity is 1000 capsules.

[0046] Ball core

[0047]

[0048] coating layer

[0049] Film coating premix 4.6g

[0050] Preparation method: crush norfloxacin through an 80-mesh sieve, and pass other materials through a 60-mesh sieve; weigh each material according to the prescription amount, and set aside; hydroxypropyl cellulose is made into a solution (as a binder) with 130 g of 50% ethanol; prescription Measure norfloxacin, microcrystalline cellulose, crospovidone, and talcum powder in a wet mixing granulator, stir and mix evenly, add the prepared adhesive, stir and shear to make soft material; add soft material to Extrusion spheronization machine, extrusion spheronization method to prepare pellets; pellets are dried in a fluidized bed; film coating premix is ​​prepared with 42g of purified water as a dispersion medium, and the fluidized bed coats the pellets; 50 mesh coa...

Embodiment 2

[0052] Embodiment 2. Norfloxacin Capsules prescription composition: specification 0.1g, prescription quantity is 1000 capsules.

[0053] Ball core

[0054]

[0055] coating layer

[0056] Film coating premix 10g

[0057] Preparation method: crush norfloxacin through an 80-mesh sieve, and pass other materials through a 60-mesh sieve; weigh each material according to the prescription amount, and set aside; hydroxypropyl cellulose is made into a solution (as a binder) with 260 g of 50% ethanol; prescription Measure norfloxacin, microcrystalline cellulose, crospovidone, and talcum powder in a wet mixing granulator, stir and mix evenly, add the prepared adhesive, stir and shear to make soft material; add soft material to Extrude and spheronize the pellets to prepare pellets; dry the pellets in a fluidized bed; use 30 g of purified water as a dispersion medium for the film coating premix, and coat the pellets in a fluidized bed; Pills, filled capsules.

[0058] Norfloxacin Ca...

Embodiment 3

[0059] Example 3. Norfloxacin Capsules Prescription Composition: Specification 0.1g, prescription quantity is 1000 capsules.

[0060] Ball core

[0061]

[0062] coating layer

[0063] Film coating premix 1.25g

[0064] Preparation method: crush norfloxacin through an 80-mesh sieve, and other materials through a 60-mesh sieve; weigh each material according to the prescription amount, and set aside; hydroxypropyl cellulose is made into a solution (as a binder) with 100 g of 50% ethanol; prescription Measure norfloxacin, microcrystalline cellulose, crospovidone, and talcum powder in a wet mixing granulator, stir and mix evenly, add the prepared adhesive, stir and shear to make soft material; add soft material to Extrusion spheronization machine, extrusion spheronization method to prepare pellets; pellets are placed in a fluidized bed to dry; film coating premix is ​​prepared with 55g of purified water as a dispersion medium, and the fluidized bed coats the pellets; 50 mesh...

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Abstract

The invention relates to a medicine composition with norfloxacin and a method for preparing the medicine composition. The medicine composition comprises an effective quantity of the norfloxacin and pharmaceutical excipients. Proportions of main medicines are 50-80%; the ball forming excipients are selectively one type of microcrystalline cellulose, powdered cellulose, low-substituted hydroxypropyl cellulose and corn starch or combinations of the microcrystalline cellulose, the powdered cellulose, the low-substituted hydroxypropyl cellulose and the corn starch. The medicine composition with the norfloxacin and the method have the advantages that on the one hand, the dissolving-out speeds of oral preparations can be controlled, and on the other hand, the stability of the preparations can be improved.

Description

technical field [0001] The invention relates to a norfloxacin pharmaceutical composition and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Norfloxacin (Norfloxacin, also known as Noroxin, Fulgram), aliases: Ribolol, Norfloxacin, Linbuxing. This product is a third-generation quinolone antibacterial drug with a broad-spectrum antibacterial effect. It will hinder the action of DNA gyrase (DNAGyrase) of pathogenic bacteria in the digestive tract, hinder bacterial DNA replication, and have an inhibitory effect on bacteria, especially for aerobic leather. Blue-negative bacilli have high antibacterial activity, and are commonly used clinically for urinary tract infections and intestinal infections caused by sensitive bacteria. [0003] The chemical name of norfloxacin is 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. The structural formula is shown in the following for...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/496A61K47/38A61K47/36A61K47/32A61P31/04
CPCA61K9/50A61K31/496A61K47/32A61K47/36A61K47/38
Inventor 陈安邹永华叶明谷许海军赵守明
Owner ZHEJIANG WANBANG PHARMA
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