ニコチン酸dl-α-トコフェロール製剤の品質試験

概要

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The quality of dl-α-tocopheryl nicotinate capsules (A to D) of four manufactures was evaluated in the tests on dissolution, weight variation disintegration and content. Weight variation, disintegration time as well as mean value of content were measured according to J.P.IX. The solvent containing 250ml of the first fluid (disintegration, J.P.IX.) and 750ml of 99.5% ethanol was used as dissolution medium. 50% dissolution time (T_50) and maximum dissolution percentage were compared using Apparatus 1 (rotating basket method) and Apparatus 2 (paddle method) described in U.S.P.XX. T_50 of preparations A,B, and D by the rotating basket method were 16.8-20.0 min, whereas those of the paddle method were 10.0-15.0 min ; T_50 of preparation C was 19.2min in both methods. The maximum dissolution percentage of each preparation did not vary between the different methods. Weight variation of these preparations was 1.1-2.8%, while disintegration time was 6.7-8.9min. These results met the requirements specified in J.P.IX. Content was 108-117%.
日本医療薬学会の論文
1982-02-20