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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％。
The pellets of famotidine (FM) pulse controlled release capsules were prepared by using the pellet technology. The in vitro release of FM and the determination of blood concentration in the body were established. The results showed that in the release test, 0 ~ 1h and 10 ~ 12h After three oral administrations of FM pulse controlled release capsules, three healthy volunteers showed bimodal curves over time. The first peak was at 1 to 2 hours after taking the drug and the second peak was at 13 to 15 hours after taking the drug. The preliminary estimation of relative bioavailability showed that the relative bioavailability was about 80% compared to oral tablets.