尼扎替丁分散片原辅料相容性研究  

Drug-excipient compatibility of nizatidine dispersible tablets

作　　者：易必新 周明 石笑弋 谭英 YI Bi-xin;ZHOU Ming;SHI Xiao-yi;TAN Ying(Hunan Drug Inspection Center,Changsha 410001;Hunan Center for Drug Evaluation and Adverse Drug Reactions,Changsha 410031;Hunan Institute for Drug Control,Changsha 410001)

机构地区：[1]湖南省药品审核查验中心,长沙410001 [2]湖南省药品审评与不良反应监测中心,长沙410031 [3]湖南省药品检验检测研究院,长沙410001

出　　处：《中南药学》2023年第11期2947-2949,共3页Central South Pharmacy

摘　　要：目的采用HPLC-MS/MS法考察尼扎替丁分散片中原辅料相容性。方法将尼扎替丁原料药与各种辅料混合后,通过稳定性影响因素试验,采用HPLC-MS/MS法考察尼扎替丁中N-亚硝基二甲胺(NDMA)含量的变化。结果尼扎替丁分散片中羧甲基淀粉钠、低取代羟丙基纤维素、硬脂酸镁、交联聚维酮、包衣粉对NDMA无促进作用。经碱水洗至中性的微晶纤维素比正常的微晶纤维素更能抑制尼扎替丁中NDMA的产生。结论处方中所使用的微晶纤维素应尽可能接近中性条件以降低制剂中NDMA的含量。Objective To determine the drug-excipient compatibility of Nizatidine dispersible tablets by HPLC-MS/MS method.Methods Nizatidine was mixed with various excipients,before the accelerated stability tests.Change of N-nitrosodimethylamine(NDMA)content in nizatidine was determined by HPLC-MS/MS.Results Sodium carboxymethyl starch,low-substituted hydroxypropyl cellulos,magnesium stearate,crosslinked povidone and powder coating did not promote the production of NDMA in Nizatidine dispersible tablets.The neutral microcrystalline cellulose washed with alkaline water better inhibited the production of NDMA in nizatidine dispersible tablets than normal microcrystalline cellulose.Conclusion Microcrystalline cellulose close to neutral conditions in the prescription is recommened is to reduce the content of NDMA.

关 键 词：HPLC-MS/MS 尼扎替丁分散片 NDMA 辅料 微晶纤维素 

分 类 号：R94[医药卫生—药剂学] R927[医药卫生—药学]