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本文研究了控释吲哚美辛栓剂(CRIS)的体外溶出速率,应用改进的荧光分光光度法测定了健康成人给药后的血药浓度,并经计算机处理得各药代动力学参数。CRIS的体外溶出属零级动力学过程,K_r~o=11.37%/h(t≤8 h)。体内试验表明CRIS达到了一定的控释效果,给药后血药水平较为稳定,持续时间长,体内0～8h的吸收速度亦符合表观零级动力学过程,K_α~o=9.60%/h。CRIS的体内外数据具有显著的相关性(r=0.9979,p<0.001)。
In this paper, we studied the in vitro dissolution rate of controlled release indomethacin suppository (CRIS). The plasma concentration of healthy indomethacin was determined by improved fluorescence spectrophotometry. The pharmacokinetic parameters of each drug were calculated by computer. In vitro dissolution of CRIS is a zero-order kinetic process, K_r ~ o = 11.37% / h (t ≤ 8 h). In vivo tests showed that CRIS achieved a controlled release effect after administration of blood drug levels are relatively stable, long duration, the body 0 ~ 8h absorption rate also in line with the apparent zero-order kinetics, K_α ~ o = 9.60% / h . There was a significant correlation between CRIS in vitro and in vivo data (r = 0.9979, p <0.001).