混合散剤中の塩酸トルペリゾンとダントロレンナトリウムの配合変化

概要

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A ground mixture of tolperisone hydrochloride (TH)(Muscalm S^<[O!R]>) and dantrolene sodium (DS)(Dantrium^<[O!R]>) was prepared for a 4-year-old patient with cerebral paralysis. Seven days later, a change of color from orange to yellow was found. Therefore, we examined the compatibility of TH and DS in the preparation. Samples were stored for 7-30 days under the following four different conditions in a dark box : 23%, 75% of relative humidity (RH) at 37℃ and 25℃. TH and DS were measured by high-performance liquid chromatography with a UV spectromonitor. The color of the ground mixture changed after 7 days under all conditions except at 25℃ and 23% RH. When stored under the condition of 75% RH at 37℃ for 30 days, TH and DS contents in the preparation significantly decreased by 38% and 12%, respectively. When lactose was added to ground TH and DS, respectively, TH content decreased over 10%, but DS content remained unchanged for 30% days. But, the colors of these preparations did not change. These results suggest that (1) the color of DS is affected by TH and (2) TH content is decreased by both DS and lactose.
日本医療薬学会の論文
1996-10-10