抄録
Pharmaceutical properties of 2 kinds of tablets and 3 kinds of capsules of anti-inflammatory enzyme preparations were compared. All preparations tested passed weight variation test and disintegration test (J. P. IX). In order to test the stability of enzyme in the, solutions of different pH, alkaline protease activity of each preparation was measured at 3 different pH values; 6.2, 7.2 and 8.0. In all preparations tested, the enzyme was more stable at pH 7.2 than at any other pH's. Acid resistance of films of 4 kinds (A, B, C and D) of enteric-coated tablets and granules was tested in accordance with disintegration test (J. P. IX). The enteric-coated films of 3 (A, B, C) of the 4 samples kept satisfactory acid resistance in the 1st fluid (J. P. IX), because maximum activity of enzyme dissolved from each preparation in the 2nd fluid (J. P. IX) was equal to the activity of optimal pH range of the enzyme. In consideration of the pH value in gastrointestinal tract, a pH shift test solution was prepared, and the activities of enzyme dissolved from each preparation into this solution were observed. The result was that the activity curves showed different pattern from each other and especially maximum activity of sample D decreased to the 40% level of that in optimal pH range. Enteric-coated enzyme preparations should, therefore, be perfectly coated with enteric-soluble materials and the pH shift test method in this test must be effective in a quality test of the preparations of such type.
