Pefloxacin mesylate injection and preparation method and application thereof

A technology of pefloxacin mesylate and injection, which is applied in the field of antibiotic injection and its preparation, can solve problems such as poor heating or placement stability, large blood vessel irritation, and increased allergies, so as to avoid high fever Bacterial process, less irritation, and the effect of reducing related substances

Active Publication Date: 2012-10-17
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

[0051] 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.

[0052] Table 1

[0053]

[0054]The above test results show that pefloxacin mesylate injection is prone to oxidative discoloration after being irradiated by strong light, so it is necessary to add a suitable antioxidant to prevent the finished product from oxidative discoloration. After adding a certain amount of sodium bisulfite, L-cysteine, sodium pyrosulfite, vitamin C antioxidant, the prepared sample still meets the standard after being irradiated by strong light, but the content of the prepared sample according to formula 3 is higher, And the amount of antioxidant consumed is less, so sodium metabisulfite is selected as the optimal antioxidant, and i...

Embodiment 2

[0057] Pefloxacin mesylate 8% by weight (calculated as pefloxacin)

[0058] Edetate disodium 0.02% by weight

[0059] Sodium metabisulfite 0.1% by weight

[0060] Propylene glycol 10% by volume

[0061] Sodium acetate 0.15% by weight

[0062] Add water for injection to 5000ml

[0063] The preparation method of the pefloxacin mesylate injection of above-mentioned formula is as follows:

[0064] Add 3000ml of water for injection, weigh 5g of sodium metabisulfite and 1g of edetate disodium into the preparation container, and dissolve them.

[0065] 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.

[0066] Add water for injection to 5000ml, and the solution is subjected to 0.22μm coarse filtration, and then 0.22μm sterile filtration.

[0067] Canned, melt-seal...

Embodiment 3

[0076] Pefloxacin mesylate 8% by weight (calculated as pefloxacin)

[0077] Edetate disodium 0.04% by weight

[0078] Sodium metabisulfite 0.2% by weight

[0079] Propylene glycol 10% by volume

[0080] Sodium acetate 0.15% by weight

[0081] Add water for injection to 5000ml

[0082] The preparation method of the pefloxacin mesylate injection of above-mentioned formula is as follows:

[0083] Add 3000ml of water for injection, weigh 10g of sodium metabisulfite and 2g of edetate disodium into the preparation container, and dissolve them.

[0084] 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.

[0085] Add water for injection to 5000ml, and the solution is subjected to 0.22μm coarse filtration, and then 0.22μm sterile filtration.

[0086] Filling, melting a...

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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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Patent Type & Authority Patents(China)
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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