デキストラン硫酸ナトリウム錠の崩壊および溶出試験について

抄録

A disintegration test was performed on two different marketed dextran sodium sulphate tablets according to the testing method of “Japanese Pharmacopoeia 8”. Solutions of two different pH values: pH 4.1 and pH 7.1, were employed for this test. Firstly, it was confirmed that with pH 4.1 solution these tablets fit as the enteric tablet. Then the test was followed by pH 7.1 solution until disintegration was completed. Because the rate of disintegration and its completion time were not accurate, the dissolution test was added to determine the dissolution state of major ingredients.
The test employed was colloid titration method which used in the quantitative assay of high molecular ion. The experiment revealed that 95% of the ingredients of both products dissolve in about a half the time required in the disintegration test and also that in case of the disintegration test the changes observed are describable only in general terms whereas in the dissolution test they can be expressed specifically in percentage and moreover the completion time of dissolution could be more clearly detected than in the disintegration test.