肠溶阿司匹林的体外实验及磁控胶囊内镜人体研究  

Transition and Disintegration of Enteric-coated Aspirin Tablets and Aspirin Enteric-coated Sustainedrelease Tablets:in Vitro and in Vivo Magnetic Controlled Capsule Endoscopy-aided Studies

作　　者：王茜婷[1] 焦红梅[1] 李丽[1] 陈夏欢[1] 李嘉欣[1] 刘梅林[1] WANG Xiting;JIAO Hongmei;LI Li;CHEN Xiahuan;LI Jiaxin;LIU Meilin(Department of Geriatrics,Peking University First Hospital,Beijing 100034,China)

机构地区：[1]北京大学第一医院老年内科,北京市100034

出　　处：《中国循环杂志》2021年第12期1215-1220,共6页Chinese Circulation Journal

基　　金：北大百度基金资助项目(2019BD019);北京大学第一医院青年临床研究专项(2021CR17)。

摘　　要：目的:观察阿司匹林肠溶片及肠溶缓释片在不同pH水平体外溶液及人体消化道内的转运及崩解过程。方法:(1)体外实验:将0.9%生理盐水分别与盐酸及碳酸氢钠混合,模拟空腹胃液、餐后胃液及小肠液pH水平,观察阿司匹林肠溶片及阿司匹林肠溶缓释片在不同pH溶液中的崩解情况。(2)人体研究:选择2020年10~12月在北京大学第一医院老年内科住院治疗且无消化道症状的冠心病患者6例,健康志愿者6例,进行磁控胶囊内镜检查。根据检查过程中服用阿司匹林剂型分为阿司匹林肠溶缓释片组及阿司匹林肠溶片组,观察阿司匹林在消化道内的转运及崩解情况,对比两组患者的临床资料及内镜下相关时间指标。结果:(1)体外实验:肠溶阿司匹林仅在碱性溶液中崩解,阿司匹林肠溶片开始崩解时间更早(0.5~1.0 h vs.3.0 h),崩解速度更快(2.0~3.0 h vs.6.0 h);(2)人体研究:人群中肠溶阿司匹林的胃通过时间差异较大(6~70 min)且与剂型无关(23.0 min vs.23.5 min,P=0.720),3例患者服药后药片嵌入胃底皱襞,平均22.0 min(19.0~25.0 min)后脱落。阿司匹林肠溶片组更早开始崩解(97.5 min vs.182.5 min,P=0.006),崩解速度更快。结论:阿司匹林肠溶缓释片相对于肠溶片,开始崩解时间更晚、崩解速度更慢;建议空腹服用肠溶剂型阿司匹林。Objectives:This study aimed to observe the transition and disintegration of enteric-coated aspirin tablets and aspirin enteric-coated sustained-release tablets in vitro solution with different pH levels and in human digestive tract.Methods:(1)In vitro study:0.9%normal saline was mixed with hydrochloric acid and sodium bicarbonate respectively to mimic fasting gastric fluid,postprandial gastric fluid and small intestine fluid.The disintegration of aspirin enteric-coated tablets and aspirin enteric-coated sustained-release tablets under different pH solutions was observed respectively.(2)In vivo study:6 patients with coronary heart disease hospitalized in Department of Geriatrics,Peking University First Hospital from 2020.10 to 2020.12 and 6 healthy volunteers were included and underwent magnetic controlled capsule endoscopy.The subjects were divided into aspirin enteric-coated sustained-release tablets group and aspirin enteric-coated tablets group.We observed the transport and disintegration time of aspirin in the gastrointestinal tract and analyzed the difference on general clinical data and time indexes of endoscopy between the two groups.Results:(1)In vitro study:Enteric-coated aspirin disintegrated in case of pH>7.0.The aspirin enteric-coated tablet disintegrated earlier(0.5-1.0 h vs.3.0 h)and faster(2.0-3.0 h vs.6.0 h).(2)In vivo study:The gastric transit time of entericcoated aspirin in the study population varied significantly(6-70 min),independent of the forms of aspirin(23.0 min vs.23.5 min,P=0.720).Tablets were embedded in gastric fundus folds in 25.0%of subjects and fell off after 22.0 min(19-25 min)on average.Aspirin enteric-coated tablet disintegrated earlier(97.5 min vs 182.5 min,P=0.006)and faster.Conclusions:Compared with aspirin enteric-coated tablets,aspirin enteric-coated sustained-release tablets disintegrates later and slower.We thus recommend to take enteric-coated aspirin on empty stomach.

关 键 词：磁控胶囊内镜 阿司匹林肠溶片 阿司匹林肠溶缓释片 胃通过时间 

分 类 号：R54[医药卫生—心血管疾病]