国产与原研复方缬沙坦氨氯地平片质量对比研究  

Comparative study on the quality of generic and original compound valsartan and amlodipine besylate tablets

作　　者：赵欣 倪薇 宋帆帆 黄雅菲 ZHAO Xin;NI Wei;SONG Fanfan;HUANG Yafei(Department of Pharmacy,Nanjing Lishui People's Hospital,Nanjing,Jiangsu 211200,China)

机构地区：[1]南京市溧水区人民医院药剂科,江苏南京211200

出　　处：《安徽医药》2023年第7期1307-1311,共5页Anhui Medical and Pharmaceutical Journal

摘　　要：目的通过测定国产与原研复方缬沙坦氨氯地平片的硬度、崩解时限、溶出度以及体外溶出曲线,评估国产与原研制剂的质量。方法2020年10月至2022年2月,分别测定国产与原研复方缬沙坦氨氯地平片的硬度、崩解时限、溶出度,并采用f2相似因子法比较了两种制剂分别在pH 1.2盐酸溶液、pH 4.5醋酸盐缓冲液和pH 6.8磷酸盐缓冲液中的溶出相似性。结果国产与原研复方缬沙坦氨氯地平片的硬度略有差异,崩解时限基本一致,在pH 6.8磷酸盐缓冲液30 min内缬沙坦和氨氯地平的溶出度均达到80%以上;两种制剂在三种溶出介质中的溶出曲线的f2相似因子值均大于80,体外溶出相似性较高。结论国产与原研复方缬沙坦氨氯地平片在三种溶出介质中的溶出相似性较好,可为复方缬沙坦氨氯地平片的质量一致性评价提供参考。Objective To evaluate the quality of generic and original valsartan and amlodipine besylate tablets by measuring the hardness,disintegration time limited,dissolution and in vitro dissolution profiles.Methods The hardness,disintegration time limited,and dissolution of generic and original valsartan and amlodipine besylate tablets were determined respectively from October 2020 to February 2022.And the f2 similarity factor method was used to compare the dissolution similarity of the two formulations in pH 1.2 hydrochloric acid solution,pH 4.5 acetate buffer and pH 6.8 phosphate buffer,respectively.Results The hardness of generic and original valsartan and amlodipine besylate tablets was slightly different,and the disintegration time limited was basically similar.The dissolution of both valsartan and amlodipine besylate reached more than 80% within 30 minutes in pH 6.8 phosphate buffer.The f2 similarity factor of the dissolution profiles of the two formulations in the three dissolution media were all greater than 80,indicating high in vitro dissolution similarity.Conclusion The generic and original valsartan and amlodipine besylate tablets have good similarity in the three dissolution media,and it can provide reference for the quality consistency evaluation of valsartan and amlodipine besylate tablets.

关 键 词：抗高血压药 生物仿制药 复方缬沙坦氨氯地平片 硬度 崩解时限 溶出度 溶出曲线 相似性 

分 类 号：R927.1[医药卫生—药学]