摘要
药品疗效的优劣(即药物体内吸收的程度),主要是与生物利用度紧密相关的。口服制剂溶出曲线的检测是一种模拟口服固定制剂在胃肠道中崩解和溶出的体外试验方法,体现了药物在体内的吸收程度。以头孢呋辛酯片(250mg)为实验实例,本实验依照中国药典2010年版二部附录XC第二法,用国产自动取样溶出系统测定溶出曲线同中国食品药品检定研究院数据库相应曲线进行对比,进行一致性评价,判定自动溶出仪精确性。
The pros and cons of drugs curative effect( the extent of absorption of drugs in the body),mainly related to bioavailability closely. The detecting of Oral solid preparations stripping curve Is a kind of simulation Oral solid preparations in the gastrointestinal tract disintegration and dissolution in vitro test method Take cefuroxime axetil tablets (250mg) for the experimental examples, the experiment according to Chinese Pharmacopoeia 2010 edition of Appendix XC second method, using homemade automatic sampling system mea-sured dissolution dissolution profile test with National Institutes for Food and Drug Control database corresponding curve comparison, consistency evaluation to determine the accuracy of the automatic dissolution tester.
出处
《化工管理》
2014年第18期56-57,共2页
Chemical Engineering Management
关键词
头孢呋辛酯片
溶出曲线
自动取样
一致性评价
Cefuroxime Axetil Tablets
stripping curve
Auto-matic sampling
Generics consistency evaluation