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本文就西咪替丁缓释片人体内外试验之相关性进行了研究。结果表明,西咪替丁缓释片体外溶出度与体内吸收量之间呈良好的相关性,相关系数r=0.9543,(P>0.05)。西咪替丁缓释片口服后,体内血药浓度波动小,作用平稳持久。有效血药浓度(>0.25μg/ml)持续12h,整个给药过程未超过可产生中毒症状的血药浓度(<2μg/ml)。根据体内外试验相关方程可推测体内吸收量,以保证服药安全有效,也为今后评价其他缓、控释制剂提供借鉴。
In this paper, cimetidine sustained release tablets in vitro and in vivo studies were carried out. The results showed that there was a good correlation between the in vitro dissolution rate of cimetidine sustained-release tablets and the absorption in vivo. The correlation coefficient was 0.9543 (P> 0.05). Cimetidine sustained-release tablets after oral administration, small fluctuations in blood concentration in vivo, the role of stable and lasting. The effective plasma concentration (> 0.25μg / ml) for 12h, the entire course of administration does not exceed the concentration of plasma drug toxicity (<2μg / ml). Based on in vitro and in vivo test-related equations can be estimated in vivo absorption, in order to ensure safe and effective medication, but also for the future evaluation of other slow, controlled release formulations to provide reference.