采用高分辨显微成像技术从药物制剂结构角度分析盐酸特拉唑嗪片溶出度测定结果  

Analysis of the Dissolution Test Results of Terazosin Hydrochloride Tablets from the Perspective of Pharmaceutical Preparation Structure by High-resolution Microscopic Imaging Technology

作　　者：昝孟晴 黄韩韩 张广超 马玲云[1] 许鸣镝[1] 牛剑钊[1] 刘倩[1] Zan Mengqing;Huang Hanhan;Zhang Guangchao;Ma Lingyun;Xu Mingdi;Niu Jianzhao;Liu Qian(National Institutes for Food and Drug Control,Key Laboratory for Research and Evaluation of Chemical Drug Quality,National Medical Products Administration,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京100050

出　　处：《中国药事》2023年第2期187-191,共5页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划——重大疾病治疗药物制剂质量研究评价技术联合研究(编号2020YFE0201700)。

摘　　要：目的:探究盐酸特拉唑嗪片溶出度测定结果不满足标准限度要求的原因。方法:利用高分辨率显微CT技术对盐酸特拉唑嗪片的内部微观结构进行观察分析。结果:对二者的内部三维结构进行对比发现,溶出度测定结果不满足标准限度要求的样品与参比制剂相比具有更大的孔隙率。结论:推测由于样品孔隙率过大,导致样品在常规溶出杯500 mL介质中产生了堆积效应,在主成分溶解前被辅料覆盖聚集于溶出杯底部,导致溶出度测定结果不满足标准限度要求。Objective:To explore the reasons for the dissolution test results of terazosin hydrochloride tablets failed to meet the standard limit requirements.Methods:The internal microstructure of terazosin hydrochloride tablets was observed and analyzed by high-resolution micro-CT technology.Results:Comparing the internal three-dimensional structures of the two,it was found that the samples in which dissolution test results did not meet the requirements of the standard limit had larger porosity than that of the reference preparation.Conclusion:It is speculated that due to the excessive porosity of the sample,the sample has a stacking eff ect in the 500 mL medium of the conventional dissolution vessel.The sample is covered by the excipients and aggregated at the bottom of the dissolution vessel before the main component is dissolved,resulting in the dissolution test result not meeting the standard limit requirements.

关 键 词：溶出度 孔隙率 桨法 异形溶出杯 高分辨率显微CT技术 

分 类 号：R917[医药卫生—药物分析学]