Vidarabine monophosphate freeze-dried powder injection for injection and preparation method thereof

Abstract

The invention provides a vidarabine monophosphate freeze-dried powder injection for injection; the vidarabine monophosphate freeze-dried powder injection for injection is prepared by freeze-drying a vidarabine monophosphate drug solution, wherein the pH of the vidarabine monophosphate drug solution is 7.0-7.5, and each 2000 mL of the vidarabine monophosphate drug solution contains 80-120 g of adenosine monophosphate, 12-18 g of mannitol, 4-6 g of tert-butanol, 18-22 g of dextran, 2-3 g of sodium chloride, 10-15 g of arginine, 4-6 g of ethylenediamine tetraacetic acid disodium salt, a proper amount of a pH regulator, and the balance water. A proper auxiliary material is added to the formula, so the appearance shape and porosity of the freeze-dried product can be improved, the surface of theproduct is more smooth, moreover, the drug properties are more stable, and the preservation and transportation of the drug are facilitated. Moreover, the preparation process is simple, the technicalrequirements are not high, and the production cycle is relatively short; the quality of the prepared product is stable and controllable, so as to be good for long-term storage.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to a vidarabine monophosphate freeze-dried powder for injection and a preparation 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 ...

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Problems solved by technology

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

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