摘要
建立了小剂量结合雌激素缓释片在不同pH值介质中释放行为的测定方法,以评价仿制制剂(红丽来■)与原研制剂(倍美力■)释放曲线的相似性。考察了2种规格(0.625和0.45 mg)的红丽来■和倍美力■在纯化水、盐酸(pH 1.2)、乙酸盐缓冲溶液(pH 4.5)和磷酸盐缓冲溶液(pH 6.8)4种介质中的释药情况,绘制释放曲线,并采用非模型依赖的相似因子(f2)法评价仿制制剂与原研制剂在4种介质中释放曲线的相似性。结果显示,2种规格的仿制制剂与原研制剂在4种介质中释放曲线的f2值均大于50,提示二者在体外具有相似的释放行为。
A method for the determination of release behaviors of low-dose conjugated estrogens sustained-release tablets in various pH media was established.The similarity factor(f2)values of release curves between the generic preparation(HongLiLai■tablets)and reference listed drug(RLD,Premarin■tablets)were calculated to evaluate their release similarity.The release behaviors of two specifications(0.625 and 0.45 mg)of HongLiLai■tablets and RLD in four media[hydrochloric acid solution(pH 1.2),acetate buffer solution(pH 4.5),phosphate buffer solution(pH 6.8)and water]were investigated,and their release curves were drawn.The f2 values calculated by model-independent approach were all greater than 50 in four media,suggesting the release behaviors of HongLiLai■and RLD with 0.625 or 0.45 mg dosage were similar.
作者
李欣荣
梁丽薇
单宇
阿地力江·依米提
刘晓航
高晓黎
LI Xinrong;LIANG Liwei;SHAN Yu;YIMITI Adilijiang;LIU Xiaohang;GAO Xiaoli(College of Pharmacy,Xinjiang Medical University,Urumqi 830011;Hami Central Hospital,Hami 839000)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2020年第12期1558-1563,共6页
Chinese Journal of Pharmaceuticals
基金
“重大新药创制”国家科技重大专项——药物一致性评价关键技术与标准研究(2017ZX09101001)。
关键词
结合雌激素
缓释片
体外释放
相似因子
仿制制剂
释放相似性
conjugated estrogen
sustained-release tablet
in vitro release
similarity factor
generic preparation
release similarity
