Quality Test of Anti-inflammatory Enzyme Preparations Containing Seaprose S

Abstract

To evaluate quality of 3 brands of capsules (A, B and C) and 2 brands of tablets (D and E) of seaprose S, weight variation test, content test and dissolution test were made. All products met weight variation test of capsule or tablet (J. P. IX). In the content test, mean content percentage of products B and C were about 82% of each labeled amount and those of the remaining 3 products were not less than 90%. To test acid resistance of the enteric-coated films of each product, activity of seaprose S dissolved in the 1st fluid and the 2nd fluid of disintegration test (J. P. IX) were determined. It was found that the acid resistance of the enteric-coated granules of products A and B was insufficient; especially, the activity of product A dissolved in the 2nd fluid decreased to a half of the activity recorded in the content test. Then, to find the cause of the decrease in activity, protein content and activity of seaprose S dissolved in both fluids were measured simultaneously. It is suggested that seaprose S in granules was partially deactivated by permeation of the 1st fluid through the enteric-coated films and, after that, seaprose S was slowly dissolved in the test fluids. Maximum activities of products A and B in pH shift test solution were 20 and 30%, respectively, of those recorded in the content test. It is, as a result, considered that products D and E are satisfactory enteric-coated preparations.