Vidarabine monophosphate for injection and method for producing vidarabine monophosphate

Abstract

The invention discloses vidarabine monophosphate for injection and a method for producing the vidarabine monophosphate. The vidarabine monophosphate for the injection comprises 100.0g of the vidarabine monophosphate, 50.0g of mannitol, 5.0g of medicinal carbon, and 2000ml of water for the injection. The method sequentially comprises the following steps: (1) washing, drying and disinfecting a bottle, (2) washing and disinfecting a plug, (3) conducting preparation, (4) conducting filling, (5) conducting freeze drying, (6) rolling a cover, (7) conducting light inspection, and (8) conducting lettering, packaging and storage. Compared with the prior art, the vidarabine monophosphate produced by the method is good in crystal form, simple in step and short in cycle, and the production efficiency is improved.

Description

technical field [0001] The invention relates to a vidarabine monophosphate for injection and a production method thereof. Background technique [0002] Vidarabine Monophosphate (Ara-AMP) is a monophosphate compound of vidarabine monophosphate, which is a purine nucleoside compound artificially synthesized. Adenosine monophosphate can inhibit the synthesis of viral DNA. Specifically, after adenosine monophosphate enters cells, it is phosphorylated to generate adenosine adenosine diphosphate (Ara-ADP) and adenosine adenosine triphosphate ( Ara-ATP), its antiviral activity is mainly caused by arabinosine adenosine triphosphate (Ara-ATP), which competes with deoxyadenosine triphosphate (dATP). To the viral DNAP, thereby inhibiting the activity of the enzyme and the synthesis of viral DNA. At the same time, it inhibits the activity of viral nucleotide reductase and the synthesis of viral DNA. It can also inhibit the activity of viral DNA terminal deoxynucleotidyl transferase, s...

AI Technical Summary

Problems solved by technology

[0003] At present, most of the dosage forms of vidarabine monophosphate in clinical use are injection dosage forms. Among them, water injections are widely used due to their quick effect and easy preparation. For example, Chinese patent CN200410021225.1 discloses a single Adenosine vidarabine phosphate and its preparation method, but compared with water injection, freeze-dried powder injection not only has good curative effect, but also has advantages in transportation, storage, etc., and although the prior art has some for monophosphate Research on the freeze-drying process and formula of sugar adenosine, but the formula and preparation method of frozen powder injection in the prior art generally have problems such as long production cycle, low output, complicated operation process, and high technical content requirements

[0004] Chinese patent 2011103559447 and Chinese patent 2012104260761 both disclose the preparation method of adenosine vidarabine monophosphate freeze-dried powder injection, which still has problems such as long production cycle, low output, complicated operation process and high technical content requirements