坎地沙坦酯片沿刻痕分割后的药学质量评价  

Tablet Scoring Feature Evaluation for Candesartan Cilexetil Tablets after Tablet-splitting

作　　者：尹山 姜孟寅 阮舒恬 田芸 沈琦[1] YIN Shan;JIANG Mengyin;RUAN Shutian;TIAN Yun;SHEN Qi(College of Pharmac,Shanghai Jiao Tong University,Shanghai 200240;Prinbury Biopharm Co.,Ltd,Shanghai 201203)

机构地区：[1]上海交通大学药学院,上海200240 [2]普霖贝利生物医药研发(上海)有限公司,上海201203

出　　处：《中国医药工业杂志》2021年第3期359-363,共5页Chinese Journal of Pharmaceuticals

摘　　要：药物片剂带有中刻痕便于临床调整剂量,但刻痕片分割后的质量需进行研究并加以控制。本研究以有中刻痕的坎地沙坦酯片(8 mg)为例,对刻痕片进行药学研究。分别以手掰和切药器分割法将受试片剂沿中刻痕分割成2个半片,考察分割后片剂的质量损失、含量均匀性、溶出度、脆碎度和稳定性。结果显示,2种分割方式都可将受试制剂均匀分为两半,且分割造成的质量损失<3.0%,脆碎度考察结果小于1.0%。2种方式分割后单个半片的含量均匀度测试结果符合美国药典标准(AV值≤15.0);45 min时溶出率与整片的原研制剂和受试制剂无明显差异。室温放置90 d,分割后片剂的含量、杂质水平和溶出度相对于刚分割时没有明显变化。本试验表明,有中刻痕的坎地沙坦酯片可以被均匀地分割,分割后能维持质量稳定、正常溶出,有利于临床上实施个性化给药。The score on the tablet benefits the dose adjustments for clinical use,therefore the quality of the scored tablets needs to be evaluated and controlled.Candesartan cilexetil tablets have scored feature on the tablets,so tablet scoring characteristics on candesartan cilexetil tablets have been evaluated.In this study,the candesartan cilexetil tablets(8 mg)were taken as an example.The test tablet was split into two halves along the score through hand breaking or a tablet splitter,and the mass loss,content uniformity,dissolution,friability and stability of the halves were investigated.The results showed that both tablet-splitting methods could uniformly divided the test tablet into two halves with the mass loss below 3.0%and the friability less than 1.0%.The content uniformity of the split halves complied with the requirements in the United States pharmacopoeia(AV≤15.0).There were no significant differences between the split halves by two tablet-splitting methods and the whole tablets of test tablets and reference listed drug in dissolution at 45 min.Furthermore,there were no obvious differences in drug content,impurities and dissolution between the split halves before and after stability test(storage for 90 d at room temperature).In summary,the test candesartan cilexetil tablets with a middle score line can be divided evenly,the quality of split halves can maintain stable,which is beneficial to the implementation of personalized medicine.

关 键 词：坎地沙坦酯 刻痕片 分割性 稳定性 

分 类 号：R944.4[医药卫生—药剂学]