盐酸咪达普利片剂及其制备方法

本发明公开了一种盐酸咪达普利片剂及其制备方法。该盐酸咪达普利片剂，其原料包括下述质量份的物质：盐酸咪达普利10份、乳糖70-74份、聚乙二醇6000 7-8份、硬脂酸镁0.4-0.5份。所述盐酸咪达普利的粒径D90≤30μm；所述乳糖是型号为200目的乳糖与乳糖T80按照质量比4:1-2的混合物。制备方法如下：将质量40-50％的乳糖、盐酸咪达普利、剩余量的乳糖，依次倒入湿法混合制粒机中混匀；加入聚乙二醇6000的水溶液制软材；制粒；使用流化床进行颗粒干燥、整粒；将硬脂酸镁与干燥颗粒共置于三维运动混合机中混合均匀，压片。本发明制备的盐酸咪达普利片剂与传统制片方法制得的片剂相比，药品含量均匀度显著提高，溶出效果更好，产品质量更高。 The invention discloses an imidapril hydrochloride tablet and a preparation method thereof. The imidapril hydrochloride tablet is prepared from the following substances in parts by weight: 10 parts ofimidapril hydrochloride, 70 to 74 parts of lactose, 7 to 8 parts of polyethylene glycol 6000 and 0.4 to 0.5 part of magnesium stearate. The particle size D90 of the midapril hydrochloride is less than or equal to 30 microns; and the lactose is a mixture of lactose with the model of 200 meshes and lactose T80 according to the mass ratio of 4: (1-2). The preparation method comprises the steps of sequentially pouring 40-50% by mass of lactose, imidapril hydrochloride and the balance of lactose into a we