散剤の混合度に及ぼす混和条件の定量的解析 I. : 主薬(フェニトイン, ジゴキシン)の混合度に及ぼす混和回数および篩過効果

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When phenytoin fine granules and diluted digoxin powder are mixed with diluents. an especially high uniformity of mixing is required in clinical practice. In the present study, a quantitative analysis was performed to evaluate of mixing properties of either phenytoin fine granules or diluted digoxin powder, using fine lactose and corn starch as the diluents (mixing ratio, 7 : 3). Twenty grams each of phenytoin and the diluents was put into a mortar without sieving and then was mixed in a spiral manner with a pestle, while the mortar was fixed with the left hand on the dispensing table (method A) or the pastle was moved in the opposite direction (method B). At least 80 times of the mixing was required in method A to obtain a permissible limit of good mixing (less than 6.08% as the coefficients of variation (CV) of phenytoin), while only 60 times was required in the method B. In addition, the effect of sieving on the degree of mixing was also investigated. When 20 g each of digoxin and diluents was mixed by method B, the CV was more than 12% even after 80 times of mixing. However, when digoxin and the diluents were mixed after sieving (32 mesh, 500 μm), the CV of digoxin decreased drastically and a permissible limit of good mixing was obtained at 60 times of mixing. These differences in the mixing efficiency with and without sieving could thus be explained by electron microscopic observations. On the other hand, in the case of phenytoin, sieving had scarcely any effect. Based on these results, in the case of phenytoin, at least 60 times of mixing with a pestle accompanied with the round movement of the mortar is required. On the other hand. in the case of digoxin which requires a high degree of mixing, the similar mixing after sieving is required.
日本医療薬学会の論文
1997-08-10

散剤の混合度に及ぼす混和条件の定量的解析 I. : 主薬(フェニトイン, ジゴキシン)の混合度に及ぼす混和回数および篩過効果

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