抄録
The quality test of a commercial propranolol hydrochloride sustained-release preparation (Inderal LA) was conducted from 3 directions: weight variation, content uniformity and dissolution. The weight variation and the content uniformity were tested in accordance with the method prescribed in JP X. The dissolution test was made in the rotatory basket method and the paddle method (JP X) using 4 kinds of fluids:.distilled water (pH 4.0-5.0), 1st fluid (pH 1.2) and 2nd fluid (pH 6.8) in JP X Disintegration Test, and 2nd fluid (pH 7.4) in JP IX. The following results were obtained:
1) The weight variation of the preparation was very small. 2) The mean content was about 100% and the content variation was very small. 3) In all of the 4 test fluids, 50% dissolution time was about 5 hours, 75% dissolution time about 10 hours, and 100% dissolution time about 24 hours, thus indicating that the pH values produce almost no effect on the dissolution rate.
