复方赖诺普利氨氯地平片制备工艺研究

The Preparation Technology Study of the Compound Lisinopril and Amlodipine Tablets

为研究复方赖诺普利氨氯地平片的制备工艺,文章依据确定的处方,在制备工艺部分主要研究了原辅料前处理、原辅料加入方法、混合时间、流动性、片剂硬度等工艺参数,采用粉末直接压片工艺压制片剂,以片剂外观、可压性、崩解时限、溶出度、含量均匀度等为指标,经影响因素初步稳定性考察,确定了处方工艺。本研究确定了复方赖诺普利氨氯地平片的制备工艺,各项质量指标均符合规定并不低于原研产品,并得出结论:本品制备工艺合理,质量稳定,为实现大生产提供了依据。

To study preparation technology of the Compound Lisinopril and Amlodipine Tablets,based on the determinated prescription, the paper studies the pre-process of the raw materials,how to add raw materials,mixing time,fluidity,tablet hardness,such as process parameters were studied in the research of process.Direct powder compression technique was used to prepare tablets,the appearance,compressibility,disintegration time,dissolution and content uniformity were selected as indictors to make sure the preparation technology ,as well studied the stress testing. The preparation technology of the Compound Lisinopril and Amlodipine Tablets was determinated in this research,each quality index was met the specification,and not worse than the original product, and make the conclusion：the preparation of the product was reasonable,the quality was stable.The study also provided a basis for the realization of further industrialized production.