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MEDICINAL SOLID PREPARATION OF TOLVAPTAN AND PREPARATION METHOD THEREFOR

机译:托伐普坦的药用固体制剂及其制备方法

摘要

A medicinal solid preparation containing tolvaptan and a preparation method therefor. The preparation method comprises converting active pharmaceutical ingredients of tolvaptan into amorphous forms by spray-drying, which is characterized by controlling the amorphous solid dispersion powder to be 35-80 microns in particle size D90; and adding lactose, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate and other auxiliary materials, and granulating by means of a fluidized bed to obtain the medicinal solid preparation of tolvaptan.
机译:一种含有托伐普坦的药用固体制剂及其制备方法。该制备方法包括通过喷雾干燥将托伐普坦的活性药物成分转化为非晶态形式,其特征在于将非晶态固体分散体粉末控制为粒度为D90的35-80微米;加入乳糖、玉米淀粉、微晶纤维素、羟丙基纤维素、低取代羟丙基纤维素、硬脂酸镁等辅料,通过流化床造粒得到托伐普坦的药用固体制剂。

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