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Pefloxacin mesylate injection

A technology of pefloxacin mesylate and injections, which is applied in drug delivery, inorganic non-active ingredients, antibacterial drugs, etc., and can solve problems such as increased allergies, darker solution color, and poor stability

Inactive Publication Date: 2018-01-09
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The pefloxacin mesylate injection currently on the market generally suffers from poor stability after being placed, the color of the solution becomes darker, and related substances increase significantly when placed or accelerated experiments are carried out, which leads to the increase of allergies. Under light irradiation, the color of the solution also deepens.

Method used

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  • Pefloxacin mesylate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 3

[0051] Pefloxacin sulfonate 400g (calculated as pefloxacin)

[0052] Sodium thiosulfate 2.5g

[0053] Activated carbon 7.5g

[0054] Add water for injection to 5000ml

[0055] Made 1000 pieces

[0056] making process:

[0057] 1. Take the prescribed amount of sodium thiosulfate and place it in a concentrated tank, add 75% water for injection to dissolve. Self-made 0.5mol / L NaOH solution for subsequent use;

[0058] 2. Take the prescribed amount of pefloxacin mesylate and add it to the solution to dissolve it;

[0059] 3. Use 0.5mol / L NaOH solution to adjust the pH between 4.5 and 5.0;

[0060] 4. Add water for injection and make the volume to 5000ml;

[0061] 5. When the temperature drops to 50°C, add activated carbon and stir for 30 minutes;

[0062] 6. Filter with a 0.45um filter membrane first, and then filter with a 0.22um filter membrane;

[0063] 7. Potting and sealing, the finished product is sterilized at 115°C for 30 minutes.

[0064] 8. In the above process...

experiment example

[0079]Experimental example: Take the above sample and store it under the condition of 40℃±2℃ / RH75±5% for six months, and take a sample at the end of the first, second, third and sixth months respectively, according to the second part of "Chinese Pharmacopoeia" The pefloxacin mesylate injection standard was used as the basis for investigation, and the properties, acidity, color, clarity, related substances (such as unknown impurities), content, etc. were tested, and the results were compared in October. See Table 1 for the results

[0080] Table 1

[0081]

[0082] The result shows: the color of the sample of the present invention is slightly yellow when the accelerated test is carried out for 6 months, and meets the standard of the Pharmacopoeia. At the same time, the change of its pH value is not large, within the fluctuation range. The total impurity <0.5%, and the content does not change much. Therefore, the samples produced under this prescription process have good s...

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Abstract

The invention provides a pefloxacin mesylate injection, which is characterized in that the weight percentage of the injection prescription is: pefloxacin mesylate 90%-98%, sodium thiosulfate 1%-3%, Activated carbon 1% to 3%, water for injection is added to 5000ml. The prescription of the injection is scientific and reasonable, the preparation process is simple, and the finished product has good stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pefloxacin mesylate injection. 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. The molecular formula is C17H20FN3O3 CH3SO3H, and the molecular weight is 429.27. [0003] 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, but it is prone to oxidation reaction under strong light irradiation, and the color of the solution becomes darker. [0004] Pefloxacin mesylate is a quinolone antibacterial drug with a spectrum antibacterial effect. It is e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/496A61K47/02A61P31/04
Inventor 张春盛张仕杰吴健民姜勇张静
Owner KAMP PHARMA
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