Preparation containing recombinant adenovirus

Abstract

The invention relates to a preparation containing recombinant adenovirus. The preparation consists of the recombinant adenovirus, buffer liquid or a buffer system and a protective agent, wherein the buffer liquid or buffer system is any of Tris-HCl buffer liquid, disodium hydrogen phosphate-citric acid buffer liquid and arginine-hydrochloric acid, and the protective agent is selected from propylene glycol, polyethylene glycol 400 and dimethyl sulfoxide. The preparation disclosed by the invention has the outstanding advantages that the ingredients are simple, divalent cationic salts and nonionic surfactants, such as MgCl2 and tween 80, are not contained, however, the adenovirus can be excellently conserved at the temperature of 2-8 DEG C even room temperature and is enabled to have good stability, and the like.

Description

technical field [0001] The present invention relates to a recombinant adenovirus, in particular to a preparation containing the recombinant adenovirus. Background technique [0002] According to the "Notice on Issuing the Basic Technical Requirements for Chemical Drug Injections and Multi-Component Biochemical Drug Injections" issued by the State Food and Drug Administration (National Food and Drug Administration Note [2008] No. 7), the basic principles for the selection of excipients: Under the premise of need, the types and dosage of excipients used in injections should be as small as possible. Recombinant adenovirus is used as a clinical drug, and on the premise of maintaining its stability, in principle, it is required that the types and amounts of preparation excipients be as small as possible. [0003] In the reported prior art, U.S. Patent US2006 / 0205080A1 discloses a compound containing Tris-HCl, MgCl 2 , glycine and an aqueous co-solvent selected from propylene gl...

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Problems solved by technology

[0003] In the reported prior art, U.S. Patent US2006 / 0205080A1 discloses a compound containing Tris-HCl, MgCl 2 , glycine and an aqueous co-solvent selected from propylene glycol, DMSO, PEG, sucrose, glycerin, tetrahydrofuran, and glycol ether. The preparation can maintain the activity of adenovirus well at 2-8°C, but the composition There are more components in the product, which leads to more complicated product production, and even increases the safety risk of gene therapy drugs

[0004] In addition, Chinese patent CN101163794A discloses an adenovirus composition, which contains adenovirus particles, buffer solution and glycerin that can maintain the pH at 8.0-9.6, and has the advantage of simple components, but it can be used at 2-8°C The stability of long-term storage of adenovirus is not ideal

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