FIELD: medicine.
SUBSTANCE: group of inventions relates to packaging for the treatment of hernia, lysosomal disease, keloids, hypertrophic scars, muscular dystrophy or spinal cord injury, including a pharmaceutical composition and a container, where the pharmaceutical composition is a lyophilized preparation containing chondroitinase ABC as an active ingredient and an excipient, the container includes pharmaceutical composition and has at least one material selected from the group consisting of fine ceramics, silicone resins and fluorine-containing resins on the inner surface of the container, and the amount of chondroitinase ABC per container is less than 10 mcg, and also relates to a method for producing a package for treatment hernia, lysosomal disease, keloids, hypertrophic scars, muscular dystrophy or spinal cord injury, comprising a pharmaceutical composition and a container containing a pharmaceutical composition, comprising: the step of placing a solution containing chondroitinase ABC and an excipient into a container having at least one material selected from the group consisting of fine ceramics, silicone resins and fluorine-containing resins on its inner surface, and a solution lyophilization step, where the amount of chondroitinase ABC per container is less than 10 mcg.
EFFECT: group of inventions provides suppression of decrease in enzyme activity during lyophilization.
8 cl, 4 tbl, 4 ex
Authors
Dates
2023-06-16—Published
2019-02-27—Filed