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Pefloxacin mesylate injection and preparation method and application thereof

A technology for pefloxacin mesylate and injection, which is applied to the field of antibiotic injection and its preparation, can solve the problems of poor heating or placement stability, darkening of solution color, increase in allergic phenomena, and the like, so as to avoid high heat extinction Bacterial process, improve stability, reduce the effect of related substances

Active Publication Date: 2011-05-11
HAIKOU PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] However, pefloxacin mesylate injection currently on the market generally has poor heating or storage stability, the solution becomes darker, and related substances increase significantly due to storage or accelerated tests, resulting in increased allergies.
In addition, commercially available preparations are more irritating to blood vessels

Method used

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  • Pefloxacin mesylate injection and preparation method and application thereof
  • Pefloxacin mesylate injection and preparation method and application thereof
  • Pefloxacin mesylate injection and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Add an appropriate amount of water for injection in the preparation container, take antioxidant, complexing agent and pefloxacin mesylate raw materials according to the formula shown in Table 1 and add them to the container, stir until completely dissolved, add propylene glycol and sodium acetate, Adjust the pH value with acetic acid, decolorize with activated carbon, filter the filtrate through a microporous membrane, fill in a can, seal it by melting, and check for leaks to obtain pefloxacin mesylate injection.

[0046] The obtained product is carried out light test, compares the result (see Table 1, the quality (g) in the 100ml injection liquid that numerical value in the table is the quality (g) in 100ml injection liquid) that adopts different antioxidants and the injection solution that different dosages are made after light.

[0047] Table 1

[0048]

[0049] The above test results show that pefloxacin mesylate injection is prone to oxidative discoloration afte...

Embodiment 2

[0051] Pefloxacin Mesylate Injection Formula:

[0052]

[0053]

[0054] The preparation method of the pefloxacin mesylate injection of above-mentioned formula is as follows:

[0055] Add 3000ml of water for injection, weigh 5g of sodium metabisulfite and 1g of edetate disodium into the preparation container, and dissolve them.

[0056] Take another 400g of pefloxacin mesylate raw material, add it to the liquid medicine, stir until completely dissolved, add 500ml of propylene glycol, 7.5g of sodium acetate, add acetic acid to adjust the pH value to 4.5, add 0.1% activated carbon, and keep for 15min.

[0057] Add water for injection to 5000ml, and the solution is subjected to 0.22μm coarse filtration, and then 0.22μm sterile filtration.

[0058] Canned, melt-sealed, and leak-checked to obtain pefloxacin mesylate injection.

[0059] In order to evaluate the stability of above-mentioned sample, carry out accelerated test, test process is as follows:

[0060] Take the above...

Embodiment 3

[0066] Pefloxacin Mesylate Injection Formula:

[0067]

[0068] The preparation method of the pefloxacin mesylate injection of above-mentioned formula is as follows:

[0069] Add 3000ml of water for injection, weigh 10g of sodium metabisulfite and 2g of edetate disodium into the preparation container, and dissolve them.

[0070] Take another 400g of pefloxacin mesylate raw material, add it to the liquid medicine, stir until completely dissolved, add 500ml of propylene glycol, 7.5g of sodium acetate, add acetic acid to adjust the pH to 4.5-4.8, add 0.1% activated carbon, and keep for 15min.

[0071] Add water for injection to 5000ml, and the solution is subjected to 0.22μm coarse filtration, and then 0.22μm sterile filtration.

[0072] Filling, melting and sealing, leak detection, and you get it.

[0073] In order to evaluate the stability of above-mentioned sample, carry out accelerated test, test process is as follows:

[0074] Take the trial-manufactured sample and pla...

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Abstract

The invention provides a pefloxacin mesylate injection, which comprises the following components in percent by weight: 8-10 percent of pefloxacin, 0.05-0.5 percent of antioxidant, 0.02-0.1 percent of complexing agent and the balance of other pharmaceutic adjuvants. The invention also provides a method for preparing the pefloxacin mesylate injection, which comprises the following steps of: (1) taking the 8-10 percent of pefloxacin, the 0.05-0.5 percent of antioxidant, the 0.02-0.1 percent of complexing agent and the balance of other pharmaceutic adjuvants for mixing, and dissolving; (2) adjusting the pH value of the solution obtained in the step 1; and (3) filtering the solution obtained in the step 2 by adopting a filtration membrane. The pefloxacin mesylate injection prepared by the method has the advantages of high stability and small vascular stimulation.

Description

technical field [0001] The invention relates to an antibiotic injection and a preparation method thereof, in particular to a pefloxacin mesylate injection and a preparation method thereof. Background technique [0002] Pefloxacin mesylate is a quinolone antibacterial drug, its chemical name is: 1-ethyl-6-fluoro-1,4-dihydro-7-(N-4-methyl-piperazinyl)-4 -Oxy-3-quinolinecarboxylic acid methanesulfonate. Molecular formula is C 17 h 20 FN 3 o 3 ·CH 3 SO 3 H, the molecular weight is 429.47. [0003] Its chemical structural formula is: [0004] [0005] Formula I [0006] Pefloxacin mesylate is a white crystalline powder with a melting point of 300°C. The product is easily soluble in water and is acidic in water. Almost insoluble in alcohol, chloroform or ether. Non-flammable, no flash point, no volatile irritating odor. In general, the chemical properties are relatively stable. However, it is prone to oxidation reaction under strong light irradiation, and the colo...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/496A61K47/18A61K47/20A61K47/22A61P31/04A61P11/00A61P13/12A61P13/10A61P13/08A61P13/02A61P1/00A61P1/12A61P1/16A61P17/00A61P7/00A61P9/00A61P25/00A61P17/02
CPCY02A50/30
Inventor 许力宏陈义弘王俊红潘丽
Owner HAIKOU PHARMA FACTORY
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