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用微生物方法测定了同一药厂2个批号的红霉素肠溶片的体外溶出和8名健康志愿者口服的体内吸收,结果表明国内文献方法和美国药典方法测定的溶出度无统计学差异;两种肠溶片体外溶出度有明显差异,体外溶出度大的肠溶片其体内吸收和生物利用度也大。提示体外溶出试验应作为红霉素肠溶片剂的质控指标。
In vitro dissolution of two batches of erythromycin enteric-coated tablets in the same pharmaceutical factory and in vivo absorption in eight healthy volunteers were determined by the microbiological method. The results showed that there was no significant difference between the domestic literatures and that of the United States Pharmacopoeia. In vitro dissolution of two enteric-coated tablets have significant differences in vitro dissolution of large enteric-coated tablets in vivo absorption and bioavailability are also large. Prompt in vitro dissolution test should be used as quality control indicators of erythromycin enteric-coated tablets.