摘要
采用微丸技术制备了法莫替丁(FM)脉冲控释胶囊剂,建立了FM体外释放度和体内血浓测定方法,结果表明:释放度试验中,0～1h和10～12h有二次脉冲释药;三名健康志愿者口服FM脉冲控释胶囊后,血浓经时曲线均呈双峰现象,第一峰在服药后1～2h,第二峰在服药后13～15h。相对生物利用度的初步估算结果表明:与口服普通片剂相比,相对生物利用度约为80％。
Famotidine pulsatile controlled-release capsules were prepared with suitable excipients and by using pellets technology. Methods were established to test dissolution of capsules and determine FM in plasma. The dissolution results showed that FM pulsatile controlled-release capsules had a characteristic of pulse release within 0~1 h and 10~ 12 h in vitro. The plasma concentration-time curve exhibited double peak phenomena after three healthy volunteers were orally administrated of FM pulsatile controlled-release capsules(40 mg). Tpeak1 was 1~2 h and Tpeak2 was 13~15 h. Preliminary calculation of relative bioavailability indicated that Frel was about 80% compared with the FM tablets.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
1997年第3期150-154,共5页
Journal of China Pharmaceutical University
关键词
法莫替丁
脉冲控释胶囊
Famotidine
Pulsatile controlled-release capsules
RP-HPLC
in ritro
in vivo
