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Pefloxacin mesylate freeze-dried powder injection for injection and containing double auxiliary materials

A technology of pefloxacin mesylate and freeze-dried powder injection is applied in the field of pefloxacin mesylate freeze-dried powder for injection with double excipients and its preparation field, and can solve the problems of low qualified rate of finished product clarity and drying temperature. High temperature, long freeze-drying time and other problems, to achieve the effect of excellent product quality, lower drying temperature, and improved product clarity qualification rate

Inactive Publication Date: 2018-03-30
刘兴付
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Currently commercially available pefloxacin mesylate freeze-dried powder for injection is produced with a single excipient, mannitol, which has the disadvantages of long freeze-drying time during production, high drying temperature, high energy consumption, and qualified rate of clarity of the finished product. low disadvantage

Method used

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  • Pefloxacin mesylate freeze-dried powder injection for injection and containing double auxiliary materials
  • Pefloxacin mesylate freeze-dried powder injection for injection and containing double auxiliary materials
  • Pefloxacin mesylate freeze-dried powder injection for injection and containing double auxiliary materials

Examples

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Effect test

Embodiment 1

[0029] Embodiment 1, pefloxacin mesylate freeze-dried powder for injection, in 1000 bottles

[0030] Prescription (specification: 0.2g / bottle):

[0031]

[0032] Preparation Process:

[0033] a) Dissolve the prescribed amount of mannitol in 1200ml of water for injection, place in a constant temperature water bath magnetic stirrer at 70°C and stir until completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4, and continue stirring until completely dissolved ;

[0034] b) Filter the prepared mannitol and hydroxyethyl starch 130 / 0.4 solution through a 0.45 μm filter membrane, add the prescribed amount of pefloxacin mesylate, stir and dissolve at 80°C, and adjust the pH value of the solution to make it at 4.2 -4.7 range; then pass through 0.45μm and 0.22μm filter membranes successively for sterilizing and circulating filtration for 35 minutes; after the sampling inspection meets the requirements, determine the filling volume and fill it into a clea...

Embodiment 2

[0035] Embodiment two, pefloxacin mesylate freeze-dried powder for injection, in 1000 bottles

[0036] Prescription (specification: 0.4g):

[0037]

[0038] Preparation Process:

[0039] a) Dissolve the prescribed amount of mannitol in the prescribed amount of water for injection, place in a constant temperature water bath magnetic stirrer at 70°C and stir until completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4, and continue stirring until completely dissolved can;

[0040] b) Filter the prepared mannitol and hydroxyethyl starch 130 / 0.4 solution through a 0.45 μm filter membrane, add the prescribed amount of pefloxacin mesylate, stir and dissolve at 80°C, and adjust the pH value of the solution to make it at 4.2 -4.7 range; then pass through 0.45μm and 0.22μm filter membranes successively for sterilizing cycle filtration for 35 minutes; take samples for inspection, determine the filling volume and pour them into cleaned and sterilized via...

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Abstract

The invention provides a freeze-dried powder injection of pefloxacin mesylate for injection with dual auxiliary materials, relates to the field of pharmaceutical preparations and preparation methods, and mainly solves the production formula of the freeze-dried powder injection of pefloxacin mesylate for injection in the prior art. The existing auxiliary materials have the disadvantages of long freeze-drying time, high drying temperature, large energy consumption and low qualified rate of finished product clarity during production. The pefloxacin mesylate freeze-dried powder injection for injection uses double excipients, the excipients include mannitol and hydroxyethyl starch 130 / 0.4, the main drug is pefloxacin mesylate, and the main drug is pefloxacin mesylate, wherein the main drug is pefloxacin mesylate The weight ratio of star to auxiliary material is 100:100‑100:150, and the weight ratio between mannitol and hydroxyethyl starch 130 / 0.4 is 100:40‑100:70. A freeze-dried powder injection of pefloxacin mesylate for injection is prepared by using the above-mentioned main drug and auxiliary materials. The freeze-dried powder injection of pefloxacin mesylate for injection provided by the invention has reliable quality, safety and effectiveness, simple product production process, short freeze-drying time during production, low drying temperature, low energy consumption, and high qualified rate of finished product clarity.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical preparations and preparation methods, in particular to a pefloxacin mesylate freeze-dried powder injection with double auxiliary materials for injection and a preparation method thereof. Background technique: [0002] Pefloxacin mesylate is a chemically synthesized drug, and it is currently the most active and clinically effective new quinolone drug. Pefloxacin mesylate kills pathogenic bacteria mainly by combining with bacterial DNA to form a complex of drug DNA and DNA gyrase to inhibit enzyme activity, thereby blocking DNA replication and achieving therapeutic purposes. Pefloxacin mesylate has a long half-life, and its effective concentration in the body can be maintained for more than 24 hours after a single administration. After the drug is injected, it can quickly enter various organs and tissues and play a bactericidal effect. Clinical studies have shown that the drug has the most significa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/496A61K47/26A61K47/36A61P31/04
CPCA61K31/496A61K9/0019A61K9/19A61K47/26A61K47/36
Inventor 刘兴付
Owner 刘兴付