Preparation containing recombinant adenoviruses

Abstract

The invention relates to a preparation containing recombinant adenoviruses. The preparation consists of the recombinant adenoviruses, buffer solution or a buffer system and a protective agent, wherein the buffer solution or the buffer system is selected from any one of Tris-HCl buffer solution, disodium hydrogen phosphate-citric acid buffer solution and arginine-hydrochloric acid; and the protective agent is selected from propylene glycol, polyethylene glycol 400 or dimethyl sulfoxide. The preparation has simple components, does not contain bivalent cationic salt or nonionic surfactant such as MgCl2 and Tween-80 and the like, can well store the adenoviruses at the temperature of between 2 and 8 DEG C and even room temperature, and has 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 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 are: 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 US 2006 / 0205080A1 discloses a compound containing Tris-HCl, MgCl 2 , glycine and an aqueous co-solvent selected from propylene g...

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Problems solved by technology

[0003] In the reported prior art, U.S. Patent US 2006 / 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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