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Product details
Levofloxacin hemihydrate is used as a pharmaceutical reference standard for the determination of analytes in pharmaceutical preparations by various chromatographic and spectrophotometric techniques.
These secondary standards are qualified as certified standards.
They are suitable for use in a variety of analytical applications including, but not limited to, drug release assays, drug method development for qualitative and quantitative analysis, food and beverage quality control assays, and other calibration requirements.
Uses and functions of Levofloxacin heMihydrate.
Levofloxacin heMihydrate is a fluoroquinolone antibacterial drug. Oral formulations and injectable formulations are indicated for the treatment of adults with community-acquired and hospital-acquired pneumonia caused by sensitive bacteria, acute bacterial sinusitis, acute bacterial episodes of chronic bronchitis, complex and uncomplicated skin and accessory structure infections, chronic bacterial prostattis, complex and uncomplicated urinary tract infections, acute pyelonephritis, inhalation anthrax (sudden onset) Dew after), etc.
The main mechanism of levofloxacin is to inhibit the activity of bacterial DNA cyclotase (topoisomerase 1) and topoisomerase IV, hinder the replication of bacterial DNA, and eventually lead to bacterial death.
Pharmacological Effects of Levofloxacin heMihydrate.
Levofloxacin heMihydrate is the left-handed form of ofloxacin, and its in vitro antibacterial activity is about twice that of ofloxacin.
Its mechanism of action is to cause bacterial death by inhibiting the activity of bacterial DNA deconjugating enzyme and preventing the synthesis and replication of bacterial DNA.
Levofloxacin heMihydrate and Shuanghuanglian injection have serious adverse reactions.
The National Centre for Adverse Drug Reaction Monitoring released the latest edition of Adverse Drug Reaction Information Circular, reminding healthcare workers in medical institutions and drug manufacturers and operators to be alert to the serious adverse reactions of Levofloxacin injection and Shuanghuanglian injection.
According to the introduction, levofloxacin injection serious adverse reactions/events are mainly systemic damage, central and peripheral nervous system damage, skin and its accessories damage, respiratory system damage, gastrointestinal system damage, of which the problem of allergic reaction is more typical, the main clinical manifestations are anaphylactic shock, anaphylactic-like reaction, respiratory distress, polymorphic erythema-type rash, laryngeal oedema and so on.
In the database of National Adverse Drug Reaction Monitoring Centre, the analysis of serious case reports of levofloxacin injection shows that there is clinical irrational use of this product, and some irrational use of medication has become the main factor causing serious adverse events.
For example, the instruction manual of levofloxacin injection clearly suggests that it is prohibited for patients under 18 years old.
Production method of Bulk Levofloxacin heMihydrate Powder.
From the racemic ofloxacin by high performance liquid chromatography column filled with special stationary phase directly split to obtain the levulinum; orloxacin with hydroxylamine sulfate treatment, acidification with hydrochloric acid to obtain hydrochloride, by alkaline ion-exchange columns, the amphoteric compounds obtained, the addition of (S)-(+)-mandelic acid, which with the (-) isomers into a salt to form the crystalline, which can be by ion-exchange resin, and then reduced and deaminated to obtain the product. Alternatively, 2,3,4,5-tetrafluorobenzoic acid can be used as the raw material, and ethyl 2-(ethoxymethylene)-3-oxo-3-(2,3,4,5-tetrafluorophenyl)propionate can be produced, and then asymmetric carbon atoms can be introduced into the product by reacting with (S)-2-aminopropanol, and then the product is produced by ring closure, hydrolysis, and introduction of methyl piperazine.
It can also be obtained by reacting 2,3,-difluoro-6-nitrophenol with glycidyl p-toluenesulfonate in R configuration in the presence of a phase transfer catalyst to produce an optically active compound, which is then reduced and condensed with diethyl ethyl ethoxymethylenemalonate (EMME), and finally treated with reagents, and ring-closing, hydrolysing, and introduction of piperazinyl groups.
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