Seikagaku Corporation

Mine Higuchi

Shin-ichi Ishikawa

A pharmaceutical composition containing a lyophilized saccharide-degrading enzyme having excellent titer, and a package containing the pharmaceutical composition. The pharmaceutical composition is a unit dose formulation containing a lyophilized saccharide-degrading enzyme with a titer of not less than 0.3 unit/μg as an active ingredient, and contains the saccharide-degrading enzyme in an amount of not less than 2 μg and not more than 6 μg.

Pharmaceutical composition, package and method for producing the same

There is provided a package wherein a pharmaceutical composition containing a saccharide-degrading enzyme is contained in a container, whereby reduction in titer caused by a low amount of enzyme is suppressed. A package comprising a pharmaceutical composition and a container, wherein the pharmaceutical composition is a lyophilized preparation containing a saccharide-degrading enzyme as an active ingredient, and the container contains the pharmaceutical composition, the inner surface of the container comprising at least one material selected from the group consisting of fine ceramics, silicone resins and fluorine resins.

Package and method for producing the same

There are provided a pharmaceutical composition containing a lyophilized saccharide-degrading enzyme having excellent titer, and a package containing the pharmaceutical composition. The pharmaceutical composition is a unit dose formulation containing a lyophilized saccharide-degrading enzyme with a titer of not less than 0.3 unit/&#x3bc;g as an active ingredient, and containing the saccharide-degrading enzyme in an amount of not less than 2 &#x3bc;g and not more than 8 &#x3bc;g.

This invention provides pharmaceutical compositions containing chondroitinase wherein a decrease in enzyme activity is very little even after long-term storage, and the pharmaceutical compositions are characterized in that they contain chondroitinase and a pharmaceutical carrier, and that an amount of reducing impurities per 1 g of said pharmaceutical carrier is 0.4 mL or less as a titer by a titration method with 0.01 N of ammonium ceric nitrate.

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Tokyo, Japan

Mine Higuchi