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作 者:赵欢 张春然[1] 王宇驰 王瑛瑛[1] 张静霞[1] 李诗媛 Zhao Huan;Zhang Chun-ran;Wang Yu-chi;Wang Ying-ying;Zhang Jing-xia;Li Shi-yuan(Chengdu University,Chengdu 610106;West China College of Pharmacy,Sichuan University,Chengdu 610065)
机构地区:[1]成都大学,成都610106 [2]四川大学华西药学院,成都610065
出 处:《国外医药(抗生素分册)》2024年第1期35-43,共9页World Notes on Antibiotics
摘 要:抗血小板药物近年来呈现蓬勃发展的态势,其质量控制标准也在不断发展和完善。本综述基于《中华人民共和国药典》2020年版(ChP 2020)、《美国药典》43版(USP 43)、《日本药典》17版(JP 17)等国内外及相关指导原则等参考资料,全面归纳了抗血小板药物在药典中的收录情况,对常见的抗血小板药物的质量控制方法进行总结,对含量测定和体内药物分析方法等项目进行全面分析,期望为抗血小板药物的研究与开发提供参考。In recent years,antithrombotic drugs have been increasingly developed,and the related quality control standards have also been improved.The inclusion of antithrombotic drugs in these pharmacopeias was summarized based on the 2020 edition of the People's Republic of China Pharmacopoeia(ChP 2020),the 43 edition of the United States Pharmacopeia(USP 43),the 17 edition of the Japanese Pharmacopeia(JP 17),and pertinent domestic and foreign guidelines.In addition,the elements of quality control,such as assay and in vivo drug analysis methods,were specifically included to serve as a point of reference for the research and development of quality control methods for antithrombotic drugs.
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