Recombinant adenovirus lyophilized preparation and preparing method thereof

Abstract

The present invention relates to a recombinant adenovirus freeze-dried preparation and its preparation method. The recombinant adenovirus freeze-dried preparation disclosed by said invention is the preparation which is obtained after the aqueous solution prepared by using recombinant adenovirus: protective agent (volume ratio)=1:(0.8-1.2) is frozen and dried. The above-mentioned protective agent contains animal glue, sugar, inorganic salt and amino acid culture balanced salt whose pH value is 7.2-8.0. Said recombinant adenovirus freeze-dried preparation is safe, and high in effect and good in stability.

Description

Technical field:

[0001] The invention belongs to the field of biological preparations and preparation, and in particular relates to a recombinant adenovirus freeze-dried preparation and a preparation method. Background technique:

[0002] With the gradual deepening of gene therapy research, the research on viral vectors as its basis has developed by leaps and bounds. The gene transfer technology using viral vectors to treat human diseases is not only in laboratory research, but also has entered the stage of clinical trials. Adenovirus has become a research hotspot of viral vectors in recent years because of its low pathogenicity to humans, no induction of carcinogenesis, wide range of host cells, high reproductive titer, and large loading capacity. However, even liquid recombinant adenovirus preparations containing stabilizers are relatively sensitive to temperature, which brings great difficulties to transportation and storage, which largely limits their clinical applicati...

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