摘要
目的 :比较自制盐酸鲁拉西酮片与原研药溶出行为。方法 :分别测定自制盐酸鲁拉西酮片和原研药在pH1.2盐酸溶液、pH 3.8 Mcllvaine缓冲溶液、水、pH 6.8磷酸盐缓冲溶液中的溶出曲线,并计算相似因子(f2)。结果 :自制盐酸鲁拉西酮片与原研片剂在pH 1.2的盐酸溶液和水中的溶出相似因子f2分别为60、64,在pH 3.8的稀释的Mcllvaine缓冲溶液中15 min的累积溶出度均大于85%、而两者在p H 6.8的磷酸盐缓冲溶液中几乎都不溶出。结论 :自制盐酸鲁拉西酮片与原研片剂的溶出行为相似。
Objective:To compare the dissolution behavior of home-made and original lurasidone hydrochloride tablets.Methods:The dissolution curves of lurasidone hydrochloride in different dissolution media such as hydrochloric acid solution(pH 1.2),diluted Mcllvaine buffer solution(pH 3.8),water and phosphate buffer solution(pH 6.8)were drawn after HPLC determination and the similarity factor(f2)was calculated.Results:The similarity factors of home-made and original lurasidone hydrochloride tablets in hydrochloric acid solution(pH 1.2)and water were 60 and 64 and their accumulative dissolutions at 15 min were over 85%in diluted Mcllvaine buffer solution(pH 3.8).However,both tablets were hardly dissolved in pH 6.8 phosphate buffer solution.Conclusion:The dissolution behavior of home-made lurasidone hydrochloride tablets is similar to that of the original tablets.
作者
王文娣
刘文丽
WANG Wendi;LIU Wenli(Shanghai Pharmaceuticals Holding Co.,Ltd.,Shanghai 201203,China)
出处
《上海医药》
CAS
2018年第7期73-76,共4页
Shanghai Medical & Pharmaceutical Journal
关键词
精神分裂症
盐酸鲁拉西酮
累积溶出度
相似因子
schizophrenia
lurasidone hydrochloride
accumulative dissolution
similarity factor
