錠剤の崩壊時間におよぼす試験液量の影響

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Since the volume of immersion fluid of the disintegration test in the Japanese Pharmacopoeiae IX is not determined precisely, two different interpretations are possible. One is that the surface of the fluid coincides with the upper surface of the basket-rack assembly when the assembly is at the lowest point of the downward stroke. The other is that the surface of the fluid coincides with the surface of the assembly when the basket is at the highest position of the upward stroke. The difference in volume of these two interpretations was found to be 1000 ml in the former (method 1) and 1440 ml in the latter (method 2), and these considerable differences mgiht bring about non-negligible difference in the results of disintegration time of tablets. More than 30 tablets including uncoated and coated commercial preparations on the market were selected at random and were subjected to the disintegration test under these two conditions in volume of the immersion fluid. Although a good correlation in the disintegration time was obtained by methods 1 and 2 (γ : 0994) the time obtained by method 2 was apparently shorter than that from method 1,and this inclination became more apparent when the disintegration time was increased. Effect of the disk was also examined with these two methods. The disk accelerated the disintegration time of respective tablets, while the correlation between these two methods remained unchanged. These results suggested that a more strict prescription of immersion fluid in the J.P.IX might be necessary, because evaluations of tablet preparations might differ according to different volume in the disintegration test.
公益社団法人日本薬学会の論文
1977-06-25

錠剤の崩壊時間におよぼす試験液量の影響

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