摘要
通过对硝苯地平缓释片2种主要释放机理的生物等效性数据进行文献检索,总结了国外多个采用新型制剂技术的硝苯地平仿制制剂,非渗透泵与渗透泵制剂餐前和餐后的生物等效性特性,并结合FDA及日本IF中仿制药物的生物等效申报资料进行分析,结果显示硝苯地平采用非渗透泵技术容易受食物的影响,易出现药物餐后比餐前生物利用度高的现象。为提高生物等效性,仿制药与被仿制药物具有相同释药机理。若选用不同释药机理进行互仿,体外溶出与体内的相关性较差,需要通过人体预实验进行筛选处方工艺,研发费用可能会增加。
Through literature search on the bioequivalence data of the two main release mechanisms of nifedipine sustained-release tablets, the bioequivalence properties of several generic formulations of nifedipine, non osmotic pump and osmotic pump formulations pre meal and post meal by novel formulation techniques have been summarized.Combined with the bioequivalence declaration data of generic drugs in FDA and IF in Japan, the results showed that nifedipine was easy to be affected by food by using the non osmotic pump technology, and the bioavailability of nifedipine after meal was higher than that before meal. In order to improve the bioequivalence, the generic drug should have the same drug release mechanism as that of the imitated drugs. If different mechanisms are selected for mutual imitation, the correlation between in vitro dissolution and in vivo is poor, and a screening of the prescribing process by human pre experimentation is required, which may increase the research and development cost.
作者
傅咏梅
卢伟玲
黄后楷
FU Yongmei;LU Weiling;HUANG Houkai(Guangdong Medi-world Pharmaceutical Company Limited,Foshan 528305,China)
出处
《广东药科大学学报》
CAS
2022年第6期134-142,共9页
Journal of Guangdong Pharmaceutical University
关键词
硝苯地平
渗透泵
非渗透泵
生物等效
nifedipine
osmotic pump
non osmotic pump
bioequivalent
