ニフェジピン軟カプセル剤の品質試験

概要

論文の詳細を見る
The quality of the soft capsules containing 10mg of nifedipine in 4 brands (A to D) was studied in the tests on dissolution, weight variation, disintegration and content. Weight variation of these preparations was 1.5 to 2.8% and content was 9.86 to 10.23 mg, while disintegration time was 8.5 to 16.4 min. These results met the requirements specified in J.P. X. In the dissolution test, nifedipine was determined by absorptiometric method. However, the standard curve was corrected due to the effect of the soft capsule itself on absorbance. In the dissolution test with use of the first fluid (disintegration, J. P. X), preparation A showed significantly more rapid dissolution time than the other preparations. A good correlation was observed between the dissolution rate and the disintegration time. In addition, effect of pH on 50% dissolution time (T_<50>) and maximum dissolution percentage was studied. T_<50> of preparation C was considerably influenced by pH of dissolution fluid. But the maximum dissolution percentage of each preparation was not affected by pH. Furthermore, no significant differences were observed among the brands.
日本医療薬学会の論文
1983-12-20