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Method for preparing norfloxacin tablets

A technology of norfloxacin tablets and norfloxacin, which is applied in the field of medicine, can solve the problems of poor tablet weight difference, poor fluidity and compressibility, and poor dry stickiness of powder, and achieve dissolution rate and dissolution volume High, increased stability, excellent compressibility effect

Active Publication Date: 2013-02-27
YUNNAN PHYTOPHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The commonly used domestic auxiliary materials such as starch, dextrin, and sugar powder have relatively poor fluidity and compressibility, and there are few domestic auxiliary materials that meet the technological requirements.
Spray-dried lactose and other foreign excipients with superior performance meet the production requirements, but they are expensive and increase the price of medicines
In addition, the uneven specific gravity of the material in the direct compression process causes the material to be stratified during the tableting process, resulting in poor tablet weight differences and uneven content; the powder is dense and the tablet is difficult to disintegrate; the powder has poor dry stickiness and is easy to drop powder and other production issues
Therefore, technically and economically, the application of this law in domestic drug production is largely restricted.

Method used

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  • Method for preparing norfloxacin tablets
  • Method for preparing norfloxacin tablets
  • Method for preparing norfloxacin tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Get norfloxacin and sieve 40 meshes, hydroxypropyl cellulose, sodium lauryl sulfate, cross-linked polyvinylpyrrolidone sieve 80 meshes, magnesium stearate and silicon dioxide sieve 120 meshes, and norfloxacin Star 100g, hydroxypropyl cellulose 9g, cross-linked polyvinylpyrrolidone 10g, mix evenly, mix 2.5g sodium lauryl sulfate, magnesium stearate 1.5g and silicon dioxide 2.0g, then mix into the aforementioned mixed powder , mixed evenly, and pressed into tablets according to the weight of 0.125g. The tablet is 7kg hard, disintegrates in 4 minutes, and dissolves 99%.

Embodiment 2

[0033] Get norfloxacin and sieve 80 mesh, mannitol, hydroxypropyl methylcellulose, carboxymethyl starch sodium sieve 100 mesh, magnesium stearate and silicon dioxide sieve 120 mesh, and norfloxacin 100g , mannitol 7.5g, hydroxypropyl methylcellulose 20.5g, sodium carboxymethyl starch 18g, mix well, magnesium stearate 2.0g and silicon dioxide 2.0g mix well, then mix into the aforementioned mixed powder, mix well , according to the weight of 0.15g tablets. The tablet is 7kg hard, disintegrates in 5 minutes, and dissolves 98%.

Embodiment 3

[0035] Take norfloxacin and sieve 80 mesh, lactose, pregelatinized starch, maltodextrin, sodium lauryl sulfate, carboxymethyl starch sodium sieve 100 mesh, magnesium stearate and silicon dioxide sieve 100 mesh , mix 100g of norfloxacin, 17g of lactose, 10g of pregelatinized starch, 10g of maltodextrin, 10g of sodium carboxymethyl starch, mix 1g of sodium lauryl sulfate, 1g of magnesium stearate, 1g of silicon dioxide Mix evenly, then mix into the above-mentioned mixed powder, mix evenly, and press into tablets according to the weight of 0.15g. The tablet is 6kg hard, disintegrates in 5.5 minutes, and dissolves 99%.

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Abstract

The invention discloses a method for preparing norfloxacin tablets. The method comprises the following steps of: sieving norfloxacin with a sieve of 40 to 100 meshes, sieving a disintegrating agent with a sieve of 60 to 100 meshes, sieving a lubricating agent and a flow aid with a sieve of 80 to 120 meshes, mixing the norfloxacin with a large part of disintegrating agent uniformly, mixing less than 2 percent of disintegrating agent, the lubricating agent and the flow aid uniformly, adding into the mixed powder, mixing uniformly, tabletting, and thus obtaining the norfloxacin tablets. The norfloxacin tablets comprise the following raw materials in percentage by weight: 20 to 80 percent of norfloxacin, 5 to 79 percent of disintegrating agent, and 1 to 8 percent of lubricating agent and flow aid. 5 to 70 percent of filling agent can also be added. The mixed materials obtain high flowability, excellent compression property and adhesive property, high attachment and low sensitivity to the lubricating agent through a large quantity of tests, advantage complementation of auxiliary materials, proper formula proportioning, reasonable granularity distribution and accurate powder mixing sequence. The method overcomes the defects of common material non-layering, non-uniform content, high tablet height difference, tablet powder fall, slow disintegration and the like in the direct tabletting production process, and solves the problems of color change of tablet cores, low dissolubility and the like of the wet granulation process.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of norfloxacin tablets. Background technique [0002] The preparation process of pharmaceutical tablets mainly includes several methods such as wet granulation, dry granulation, powder direct compression and freeze-drying. [0003] Due to the difficult process and high equipment requirements, dry granulation and tablet compression and freeze-drying are rarely used. The wet granulation method is to sieve and mix the raw and auxiliary materials evenly, use the wetting effect of the wetting agent or the viscosity of the adhesive, use the sieve to make the material into granules of a certain shape and size, add a lubricant after drying, and then press into piece. Since the powder fluidity of most raw materials is not good, the method of granulation is required to increase the fluidity, so this method is the most widely used, and this method is basically chosen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/496A61P31/04
Inventor 梅艳李俊朱光花冯春苏莎
Owner YUNNAN PHYTOPHARML
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