Levofloxacin injection and preparation technology

Abstract

The invention discloses a levofloxacin injection and a preparation technology. The levofloxacin injection is prepared from the following ingredients according to the following content: 500 mg of levofloxacin, 0.5-1 mol / L of hydrochloric acid and the balance of water used for injection to 20 ml. The preparation technology for the levofloxacin injection comprises the following steps of: adding the water used for injection, wherein the amount of the water used for injection occupies 60-80% of a prescription dosage; adding a proper quantity of diluted hydrochloric acid pH value conditioning agents; then, adding the levofloxacin to regulate a pH value to be 3.5-6.0, stirring and dissolving; adding the water used for injection to a total content; and carrying out sterilizing filtering, filling,adding a plug, capping, and sterilizing at a temperature of 121 DEG C for 15-20 minutes. By use of the invention, a liquid blending sequence is regulated, a certain quantity of pH conditioning agentsis firstly added, then, the levofloxacin of the prescription dosage is added, so that the solubility of the levofloxacin is improved, and production efficiency and product quality are improved. A rubber plug is a tetrafluoroethylene coated chlorinated butyl rubber plug, and therefore, the storage quality of the injection and the use of the injection in a period of validity can be guaranteed.

Description

Technical field [0001] The invention relates to the technical field of pharmaceutical preparations, and in particular to a levofloxacin injection and a preparation process. Background technique [0002] The main ingredient of Levofloxacin Injection is Levofloxacin, its chemical name is: (S)-(-)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl) )-7-oxo-7H-pyrido[1,2,3-de]-[1,4]-benzoxazine-6-carboxylic acid hemihydrate. [0003] Its structural formula is: [0004] Levofloxacin injection is suitable for the following moderate and severe infections caused by sensitive bacteria: [0005] 1. Respiratory system infection: acute bronchitis, acute exacerbation of chronic bronchitis, diffuse bronchiolitis, bronchiectasis combined with infection, pneumonia, tonsillitis (peritonsillar abscess); [0006] 2. Urinary tract infection: pyelonephritis, complicated urinary tract infection, etc.; [0007] 3. Reproductive system infections: acute prostatitis, acute epididymitis, u...

AI Technical Summary

Problems solved by technology

[0013] (1) The aqueous solution of levofloxacin is stable under acidic conditions, easy to dissolve, and the dissolution time is fast, and a yellow-green turbid scene will appear under neutral conditions, which is not conducive to observing the dissolution situation;

[0014] (2) Levofloxacin is a second-generation fluoroquinolone antibiotic, which is the levorotatory form of ofloxacin. It has a corrosive effect on ordinary butyl rubber stoppers, which makes the impurity G of levofloxacin injection significantly increase, and the number of unknown impurities increases. The yellow color deepens, the clarity is poor, and the stability is poor, which cannot effectively guarantee the storage quality of the injection and the use within the validity period

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