塩化リゾチーム製剤の品質比較試験
1978 年 4 巻 2 号 p. 74-82
詳細
1978 年 4 巻 2 号 p. 74-82
Fourteen lots of tablets, capsules and granules of commercial lysozyme chloride preparations, manufactured by six differerent companies, were evaluated for their pharmaceutical qualities. Significant difference of in vitro dissolution rate was noted between these products, when tested with 1st and 2nd fluids in the disintegration test of J. P. IX as dissolution media in the rotation method of U. S. P. XIX. The dissolution rate may have relationship with clinical effect of the products. By disc electrophoresis, impure protein was found to be contained in the preparations of all but one manufacturer. New quantitative analytical method by means of the area of bacteriolysis on gel-plate was developed in this study. The new method proved to produce results same as those obtained by the conventional method on the basis of the change in turbidity depending on bacteriolysis.
