総合消化酵素剤の腸溶性皮膜の耐酸性に関する評価

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The acid resistance of 2 kinds of tablets (A and B) and 3 kinds of capsules (C, D and E) containing enteric-coated granules was compared. Alkaline protease activity dissolved from samples was measured in different test solutions : (a) pH 5.0, 6.5 and 7.5 test solutions, (b) 1st fluid and 2nd fluid in disintegration test (J.P.IX), and (c) pH shift test solution in consideration of pH values of gastrointestinal tract. The following results were obtained : (1) At pH 5.0, 4 of the 5 samples (except C) did not disintegrated after 120 min, and at pH 6.5 only sample B scarcely disintegrated. At pH 7.5, the disintegration times of tablets tested were 2-3 times longer than those of the enteric-coated granules. (2) Enteric-coated granules in sample C met disintegration test (J.P.IX), but the enzyme activity in 2nd fluid was 30% weaker than that at the optimal pH. (3) For the pH shift test solution, enzyme activities of samples A, B and E rapidly increased 180 min after start of the test, when pH of dissolution medium exceeded 6.0. Maximum activities of these three samples were slightly weaker than those at the optimal pH, and the activity of sample C decreased 70%. Digestive potential of the samples estimated from the area under activity curve according to Berndt method was compared with each other. The acid-resistance of samples A, B and E was better than C, indicating that digestive potentials of the three preparations were higher. The digestive potential was very useful for evaluation of the acid-resistance of enteric-coated film.
日本医療薬学会の論文
1980-05-20

総合消化酵素剤の腸溶性皮膜の耐酸性に関する評価

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