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Enosaxin for injection and its preparation method

A technology of enoxacin and a production method, which is applied in the directions of medical preparations, pharmaceutical formulations, and drug delivery containing active ingredients, can solve the problems of drug decomposition, easy oxidation of drugs, etc., achieves good stability, and is beneficial to long-term Storage, overcoming the effect of drug decomposition

Inactive Publication Date: 2004-02-18
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The enoxacin preparations are all in the form of tablets, capsules and water injections, and the drug is prone to oxidation during the production process, and the drug is easily decomposed due to high temperature during the production process

Method used

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Examples

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Embodiment Construction

[0008] The present invention will be further described in detail below.

[0009] 1. Solution preparation. Take enoxacin and water for injection in proportion, dissolve enoxacin in half of the water for injection, control the temperature of the water for injection between 55°C and 65°C, add 7.5-12.5% ​​lactic acid solution to adjust the pH to make the solution The pH value is between 4.5-5.5. Stir to dissolve enoxacin, keep warm at a temperature of 55°C-65°C for 30-90 minutes, then cool to room temperature, then add mannitol and the other half of water for injection in proportion, and then Add 0.02-0.04% of the total amount of activated carbon, stir at room temperature for 20-40 minutes, filter until clear, and then sterilize and filter with a 0.22 μm microporous membrane to obtain a fine filtrate.

[0010] 2. Freeze-drying process. Take the above-mentioned fine filtrate and put it in a control vial, and use a butyl rubber stopper to half-tamp it under an environment with a t...

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PUM

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Abstract

An enoxacin injection is prepared from enoxacin, mannitol and water for injection through preparing solution and low-temp freeze drying in vacuum condition. Its advantages are high purity and stability and long storage time.

Description

technical field [0001] The invention relates to fluoroquinolone antibiotic chemicals and a preparation method thereof, in particular to enoxacin for injection and a preparation method thereof. Background technique [0002] Enoxacin is the third-generation fluoroquinolone compound, which has a broad antibacterial spectrum, convenient administration, wide distribution in the body, good clinical curative effect, and low price. It is effective against most Gram-negative bacilli and Staphylococcus aureus. Has a strong killing effect. The relevant enoxacin preparations are all in the form of tablets, capsules and aqueous injections, and the drug is prone to oxidation during the production process, and the drug is likely to decompose due to high temperature during the production process. Contents of the invention [0003] The object of the present invention is to provide a kind of injection enoxacin and preparation method thereof. [...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/496A61P31/04
Inventor 汤旭东
Owner HAINAN GENERAL & KANGLI PHARMA
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