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Nifedipine 硬膠囊處方之研究 The formulation study of nifedipine hard capsule

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Nifedipine 硬膠囊處方之研究

The formulation study of nifedipine hard capsule

中文摘要

一般市售的軟膠囊劑型,有變形,易沾粘的缺點,尤其是膠囊外殼之豐富水分,

易滲

透入內部液體中,造成難溶性藥品結晶析出,致使口服投與此藥時,無法達到完 全的

吸收。本研究選用難溶性藥品(Nifedipine),依各種不同處方製成液體,充填入硬 膠

囊中,其利用硬膠囊較弱的吸溼性,改善軟膠囊所造成的缺點。

本實驗藉著體外溶離試驗,來評估?不同顆粒大小?Paddle 不同轉速?不同比例之 固

體分散系?不同量的界面活性劑?不同種類的溶劑和界面活性劑對於 Nifedipine 溶 離

的影響。

由實驗結果顯示,顆粒愈小、Paddle 轉速愈快,溶離液中添加的界面活性劑含量 愈多

,Nifedipine 溶離愈快。同時不含溶劑和界面活性劑的固體分散系,Nifedipine 會隨

著親水性載體的比例增加,而加快溶離速率。在溶劑和界面活性劑的實驗中,選 用親

脂性溶劑(Captex 300)對於界面活性劑的加入,會有正面影響,而親水性溶劑(PEG 600)則因界面活性劑加入造成粘稠度提高而有負面影響。同時加入的固體分散 系,載

體 P.V.P.在某比例範圍內確可促進溶離 英文摘要

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