硫酸氢氯吡格雷阿司匹林片的处方工艺研究  

Study on preparation process of Clopidogrel Bisulfate and Aspirin Tablet

作　　者：李欣 邢雪敏 颜红 

机构地区：[1]山东省药学科学院山东省化学药物重点实验室,山东济南250101 [2]山东福瑞达医药集团公司山东省黏膜与皮肤给药技术重点实验室,山东济南250101

出　　处：《药学研究》2015年第10期584-587,共4页Journal of Pharmaceutical Research

摘　　要：目的探讨硫酸氢氯吡格雷阿司匹林片的制备工艺。方法采用正交设计筛选处方,设计采用粉未直接压片工艺制备双层片,选出最优处方并进行验证及质量考察。结果样品的片重差异、溶出度、含量、有关物质等均符合要求。工艺合理,质量可控。结论所制备的硫酸氢氯吡格雷阿司匹林片工艺简单、质量稳定、适合于工业化生产。Objective To study the preparation technology of Compound Clopidogrel Bisulfate and Aspirin Tablet. Methods The orthogonal design was adopted to screen the formula technology. Powder direct tableting process preparation of double- deck tabtet was used. The screened optimal formula was performed and the verification and quality investigation. Results The tablet weight variation,dissolution rate,content and related substances of the samples were all in accordance with the corresponding requirements. The technology was rational and the quality was controllable. Conclusion The preparation technology of Compound Clopidogrel Bisulfate and Aspirin Double- deck Tablet was simple with stable quality and suitable for industrial production.

关 键 词：硫酸氢氯吡格雷 阿司匹林 双层片 制备 

分 类 号：R944[医药卫生—药剂学]