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Antofloxacin oral preparation and its application

A technology for antofloxacin and oral tablets, which is applied in the direction of pill delivery, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc. Not enough hardness and other problems

Active Publication Date: 2011-12-21
ANHUI GLOBAL PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Antofloxacin is prepared according to the proportion of conventional oral preparations, which often does not reach a certain hardness, or the dissolution rate of the active ingredients of the drug is not ideal, which affects its effective effect and limits its popularization and use

Method used

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  • Antofloxacin oral preparation and its application
  • Antofloxacin oral preparation and its application
  • Antofloxacin oral preparation and its application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Tablets containing 50 mg of the active compound of Antofloxacin, the content of the active compound is about 47.98% (calculated on the basis of uncoated tablets):

[0036] Antofloxacin hydrochloride 55mg

[0037] Microcrystalline Cellulose 20mg

[0038] Sodium carboxymethyl starch 21.2mg

[0039] Starch 4.3mg

[0040] 3% starch slurry 0.8mg

[0041] Magnesium Stearate 2.9mg

[0042] Coated 4.5mg

[0043] Antofloxacin hydrochloride, 3% starch slurry, microcrystalline cellulose, starch and 10.6 mg of sodium carboxymethyl starch are granulated, then the prepared granules are mixed with 10.6 mg of sodium carboxymethyl starch and stearic acid Magnesium is mixed, and finally carries out conventional tabletting and coating to obtain the oral tablet of Antofloxacin. The oral tablet has sufficient hardness, and at the same time, the oral tablet has better dissolution rate.

[0044] The prepared oral tablet of Antofloxacin can be used for treating or preventing human or an...

Embodiment 2

[0046] The active compound formulation containing 50 mg of Antofloxacin has an active compound content of about 64.10% (calculated on the basis of uncoated tablets):

[0047] Antofloxacin hydrochloride 55mg

[0048] Microcrystalline Cellulose 6mg

[0049] Sodium carboxymethyl starch 12mg

[0050] Starch 2mg

[0051] 3% starch slurry 0.3mg

[0052] Magnesium Stearate 2.7mg

[0053] Coated 3.2mg

[0054] The prepared oral preparation of Antofloxacin can be used for treating or preventing human or animal bacterial infection.

Embodiment 3

[0056] Tablets containing 100 mg of the active compound of Antofloxacin, the content of the active compound is about 59.24% (calculated on the basis of uncoated tablets):

[0057] Antofloxacin Hydrochloride 110mg

[0058] Microcrystalline Cellulose 20mg

[0059] Sodium carboxymethyl starch 30mg

[0060] Starch 3mg

[0061] 3% starch slurry 0.8mg

[0062] Magnesium Stearate 5mg

[0063] Coated 6.5mg

[0064] See attached figure 1 , wherein: the solid line is the dissolution rate and time relation curve of the Antofloxacin oral tablet of the present invention, and the dotted line is the dissolution rate and time relation curve of the Antofloxacin tablet containing 8% carboxymethyl starch sodium. Comparing the solid line and the curve, it can be clearly seen that the Antofloxacin tablet containing a specific amount of sodium starch glycolate has more dissolution within the specified time limit (such as 20min, 30min, 40min).

[0065] The prepared oral tablet of Antofloxacin c...

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PUM

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Abstract

The present invention relates to an oral preparation of Antofloxacin, which contains Antofloxacin or its salt and / or its hydrate, at least one filler, at least one binder, and also contains 10%-25% by weight of carboxylate Sodium Methyl Starch. The oral preparation of Antofloxacin has sufficient hardness and good dissolution rate. The antofloxacin oral preparation of the present invention is mainly used for treating or preventing human or animal bacterial infection.

Description

technical field [0001] The invention relates to an oral preparation, in particular to an oral preparation of Antofloxacin and its application. Background technique [0002] Antofloxacin (common name) is a quinolone antibacterial drug, and its chemical structural formula is: [0003] [0004] Its chemical name is: (S)-(-)-9-fluoro-2,3-dihydro-3-methyl-8-amino-10-(4-methyl-1-piperazinyl)-7- Oxo-7H-pyrido[1,2,3-de]-[1,4]benzoxazine-6-carboxylic acid. [0005] Antofloxacin is a highly effective anti-infective drug. The main mechanism of action of this product is to achieve antibacterial effect by inhibiting the activity of bacterial DNA gyrase (bacterial topoisomerase II) and hindering the replication of bacterial DNA. [0006] Antibacterial test results show that Antofloxacin has antibacterial activity against most Gram-negative bacteria and Gram-positive bacteria. In vitro tests have shown antibacterial activity against Gram-positive bacteria, Gram-negative bacteria, an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K9/20A61K31/5383A61K47/36A61P31/04
Inventor 王祥张沭王开孝常世忠魏科
Owner ANHUI GLOBAL PHARM CO LTD