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Hydrochloric acid lomefloxacin injection and preparation method thereof

A technology of lomefloxacin hydrochloride and injection, which is applied in the direction of antibacterial drugs, can solve the problems of unstable effect, poor stability, and easy decomposition, and achieve the effect of simple and easy preparation method, good stability, and difficult decomposition

Inactive Publication Date: 2008-05-21
浙江道格凯特实业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the lomefloxacin hydrochloride injection currently on the market is poor in stability, easy to decompose, easy to separate out, and the effect is unstable

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] A preparation method of lomefloxacin hydrochloride injection, the steps of which are:

[0034] (1) Weigh 10 parts by weight of lomefloxacin hydrochloride, then add 200 parts by weight of DMF, and stir thoroughly;

[0035] (2) Add 20 parts by weight of Tween-80 and stir thoroughly;

[0036] (3) Add 10 parts by weight of nicotinamide and stir thoroughly;

[0037] (4). Add 660 parts by weight of water for injection and stir thoroughly;

[0038] (5) Adjust the PH value to 4 with hydrochloric acid or sodium hydroxide, and add water for injection to 1000 parts by weight;

[0039] (6) Add 1 part by weight of activated carbon for needles, let it stand for 10 minutes, filter, encapsulate, and sterilize at 100°C for 30 minutes to prepare a lomefloxacin hydrochloride injection.

Embodiment 2

[0041] A preparation method of lomefloxacin hydrochloride injection, the steps of which are:

[0042] (1) Weigh 5 parts by weight of lomefloxacin hydrochloride, then add 150 parts by weight of DMF, and stir thoroughly;

[0043] (2) Add 10 parts by weight of Tween-80 and stir thoroughly;

[0044] (3) Add 5 parts by weight of nicotinamide and stir fully;

[0045] (4). Add 680 parts by weight of water for injection and stir fully;

[0046] (5) Adjust the PH value to 4 with hydrochloric acid or sodium hydroxide, and add water for injection to 1000 parts by weight;

[0047] (6) Add 0.5 parts by weight of activated carbon for needles, stand for 20 minutes, filter, encapsulate, and sterilize at 80°C for 40 minutes to prepare a lomefloxacin hydrochloride injection.

Embodiment 3

[0049] A preparation method of lomefloxacin hydrochloride injection, the steps of which are:

[0050] (1) Weigh 15 parts by weight of lomefloxacin hydrochloride, then add 250 parts by weight of DMF, and stir thoroughly;

[0051] (2) Add 30 parts by weight of Tween-80 and stir thoroughly;

[0052] (3) Add 15 parts by weight of nicotinamide and stir fully;

[0053] (4). Add 640 parts by weight of water for injection and stir fully;

[0054] (5) Adjust the PH value to 5 with hydrochloric acid or sodium hydroxide, and add water for injection to 1000 parts by weight;

[0055] (6) Add 2 parts by weight of activated charcoal for needles, stand for 30 minutes, filter, encapsulate, and sterilize at 120°C for 20 minutes to prepare a lomefloxacin hydrochloride injection.

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PUM

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Abstract

The invention relates to a lomefloxacin hydrochloride injection and the preparation method, the components and the parts by weight of the injection are: 5 to 15 weight parts of lomefloxacin hydrochloride; 150 to 250 weight parts of DMF; 10 to 30 parts of Tween-80; 5 to 15 weight parts of nicotinamide and 600 to 850 weight parts of injection water. The steps of the preparation method are as follows: (1) the lomefloxacin hydrochloride is weighed according to the weight parts, and then the DMF is added; (2) Tween-80 is added according to the weight parts; (3) the nicotinamide is added according to the weight parts; (4) the injection water is added according to the weight parts; (5) the pH value is adjusted to 3.5 to 5.5, and the injection water is added till 1000 weight parts; (6) 0.5 to 2 weight parts of activated carbon for needle use is added, the mixture is placed still for 10 to 30 minutes, the filtration and filling-sealing are carried out, and the mixture is sterilized at 80 to 120 DEG C for 20 to 40 minutes, so as to prepare the lomefloxacin hydrochloride injection finished product. The product of the invention has good stability, exact efficacy, difficult decomposition and precipitation; furthermore, the invention can realize large-scale industrial production.

Description

Technical field [0001] The invention belongs to the field of chemical preparations, and relates to a lomefloxacin hydrochloride injection and a preparation method thereof. Background technique [0002] Lomefloxacin hydrochloride is the hydrochloride salt of lomefloxacin, a third-generation quinolone broad-spectrum antibacterial drug, and its chemical name is 1-ethyl-6,8-difluoro-1,4-dihydro-7-( 3-Methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride, which shows strong bactericidal activity against gram-negative bacteria, gram-positive bacteria and some anaerobes; Methicillin-resistant Staphylococcus aureus, ampicillin-resistant influenza bacilli, pipemidic acid-resistant Escherichia coli and bacteria resistant to other drugs have good antibacterial efficacy, which is better than norfloxacin and enoxacin. [0003] However, the lomefloxacin hydrochloride injection currently on the market has poor stability, is easy to decompose, easy to precipitate, and the effect i...

Claims

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Application Information

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IPC IPC(8): A61K31/496A61K47/34A61P31/04A61K47/26
Inventor 张兴龙华云芳许新增
Owner 浙江道格凯特实业有限公司
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