氯吡格雷阿司匹林片制备及体外溶出一致性评价
Preparation and in vitro dissolution consistency of clopidogrel and aspirin tablets
钱方 1伍贤志2
作者信息
- 1. 安徽中医药大学药学院,合肥 230012;长三角药物高等研究院,江苏 南通 226133;江苏万高药业股份有限公司,江苏 南通 226100
- 2. 长三角药物高等研究院,江苏 南通 226133;江苏万高药业股份有限公司,江苏 南通 226100
- 折叠
摘要
目的 制备氯吡格雷阿司匹林片,并对其处方工艺进行优化,以实现与参比制剂体外溶出行为一致.方法 氯吡格雷采用热熔制粒制备工艺,阿司匹林采用粉末直压、肠溶包衣制备工艺.单因素考察制备过程的关键处方工艺因素,以获得最优的处方工艺条件.通过高效液相色谱法对氯吡格雷和阿司匹林的溶出度进行测定,采用相似因子f2 法比较自制制剂与参比制剂的溶出曲线.结果 经过优化的自制制剂与参比制剂在不同介质中的f2 均大于 50,溶出曲线相似.结论 氯吡格雷阿司匹林片自制制剂与参比制剂体外溶出行为一致.
Abstract
Objective To prepare clopidogrel and aspirin tablets and optimize the formulation process to achieve consistency with the reference preparation on dissolution behavior in vitro.Methods Clopidogrel was prepared by hot melt granulation and aspirin was prepared by direct powder compression method and enteric coating.The key formulation factors of the preparation process were determined by single factor to obtain the optimal formulation conditions.The dissolution of clopidogrel and aspirin was determined by high performance liquid chromatography.The dissolution curves of self-made preparation and reference preparation were compared by similarity factor f2 method.Results The f2 of the optimized self-made preparation and the reference preparation in different media was greater than 50,with similar dissolution curves.Conclusion The dissolution behavior of self-made clopidogrel and aspirin tablets in vitro is consistent with that of reference preparation.
关键词
氯吡格雷/阿司匹林/体外溶出/热熔制粒/相似因子Key words
clopidogrel/aspirin/dissolution in vitro/hot melt granulation/similarity factor引用本文复制引用
出版年
2024
NETL
NSTL
万方数据