利可君原料药及片剂国家药品标准研究OA
Study on the Pharmacopoeia Standards for Leucogen and Its Tablets
利可君片作为国内主流的促进白细胞增生口服制剂,临床上被广泛用于预防和治疗白细胞减少症及血小板减少症、再生障碍性贫血等.为更好地控制药品质量,国家药典委员会主导开展了利可君原料药及片剂国家药品标准提高工作,并将其新增收入《中华人民共和国药典》2025 年版二部.该文重点针对利可君及片剂国家药品标准中有关物质和溶出度的修订和提高过程进行了分析,阐明了利可君原料药及其片剂国家药品标准提高及药典标准制定工作的思路和过程,同时也为其他药品标准的提升及药典标准制定提供了参考.
As a mainstream oral preparation to promote leukocytosis in China,Leucogen is widely used in clinical prac-tice for the prevention and treatment of leukopenia,thrombocytopenia,aplastic anemia and other related conditions.In order to improve drug quality control,Chinese Pharmacopoeia Commission had led the enhancement of the national drug standards for leu-cogen and its tablets,which have been newly included in the 2025 edition of Chinese Pharmacopoeia(Volume Ⅱ).This study focused on analyzing the revision and improvement process of related substances and dissolution tests,and clarified the rationale and procedures behind the enhancement and establishment of the pharmacopoeia standards for leucogen and leucogen tablets,while also providing a reference for the improvement of other drug standards and the establishment of pharmacopoeia standards.
李海岛;郑萍;岳志华;赵志刚
江苏吉贝尔药业股份有限公司,镇江 212009成都市药品检验研究院,成都 610045国家药典委员会,北京 100061首都医科大学附属北京天坛医院药学部,北京 100070
医药卫生
利可君原料药利可君片药典标准质量控制
Leucogen active pharmaceutical ingredientLeucogen tabletsPharmacopoeia standardsQuality control
《医药导报》 2026 (4)
706-710,5
国家药典委员会2019年度国家药品标准提高项目课题(2019H041/2019H042).
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