Azithromycin injection and preparation method thereof

Abstract

The invention discloses an azithromycin injection, which comprises the following components by weight in 3000 ml injection: 250.0 g or 500.0 g of azithromycin, 1.0 g of citric acid, 120.0 g of mannitol, 18.0 g of medicinal carbon and the balance of water for injection. The preparation method comprises the following steps of: (1) adding the mannitol into the water for injection, heating for dissolving, adding the medicinal carbon, boiling for 30 minutes, decarburizing and filtrating; (2) preparing a suspension by adding the azithromycin to the water for injection; (3) after dissolving the citric acid, adding the dissolved citric acid into the azithromycin suspension for fully dissolving the azithromycin with the pH value controlled to be 5.7-5.9, adding the medicinal carbon, stirring, standing, decarburizing and filtrating; (4) adding the mannitole filtrate into the azithromycin solution with the pH value controlled to be 5.7-5.9, adding the water for injection till a prepared full dose, filtrating through microfiltration membranes with 0.45 micrometers and 0.22 micrometers; (5) measuring the content of a semi-finished product by adopting an optical rotation test method; (6) if the semi-finished product is tested to be qualified, transmitting the medicinal solution to a bottling department, wherein the bottled injection holding volume is 3 ml; (7) freeze-drying, totally pressing pistons, pressing covers, and light-inspecting, and if the semi-finished product is qualified after the quality test, label-sticking, packaging and obtaining the product.

Description

Technical field: [0001] The invention relates to an injection and a production method thereof, in particular to a formula of azithromycin injection and a preparation method thereof, belonging to the field of biomedicine. Background technique: [0002] Azithromycin is the first 15-membered macrolide antibiotic, also known as azolide antibiotic due to the insertion of a nitrogen atom in the ring. It is this unique molecular structure that endows azithromycin with many important chemical and pharmacological properties. Azithromycin has broad-spectrum antibacterial activity. In addition to retaining the effect of erythromycin on Gram-positive bacteria, Azithromycin also has good antibacterial activity against some Gram-negative bacteria, anaerobic bacteria and intracellular pathogens, which is especially helpful for the treatment of mixed infections. For example, the activity of azithromycin against Haemophilus influenzae and Neisseria gonorrhoeae is more than 4 times stronger...

AI Technical Summary

Problems solved by technology

[0003] Because azithromycin is insoluble in water, many companies and research institutes are conducting research on azithromycin injections, but most of them turn azithromycin into salts, double salts or organic salts, and make injections after dissolving in water, which is cumbersome to operate. It takes a long time, and the prepared liquid medicine has a potting and sterilization time limit, so the stability is poor and side effects are prone to occur

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