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对来自不同厂家生产的28个批号的四环素片,在测定溶出速度的基础上,选择了6个样品在18个人体上进行了生物利用度试验。试验采取交叉服药,每周一次,每次0.5g四环素片,连续6周,以四环素溶液为参考标准,测定了18个人72小时尿药浓度。其中2个样品测定了10个人12小时的血药浓度。含量用荧光法测定。结果说明6个样品的吸收置存在显著性差异。生物利用度分别为87.40％,81.40％,79.08％,75.15％,57.05％,39.15％。生物利用度与溶出速度之间的相关关系不显著。此外,根据体内实验结果提出了四环素片剂溶出速度的限度。
Sixteen batches of tetracycline tablets from different manufacturers were tested for bioavailability on 18 human body samples based on the determination of dissolution rate. Tested taking crossover medication, once a week, each 0.5g tetracycline tablets, continuous 6 weeks to tetracycline solution as a reference standard, measured 18 people 72 hours urine concentration. Two of these samples measured plasma concentrations of 10 individuals for 12 hours. The content was measured by fluorescence method. The results show that there are significant differences in the absorption of 6 samples. Bioavailability were 87.40%, 81.40%, 79.08%, 75.15%, 57.05%, 39.15% respectively. The correlation between bioavailability and dissolution rate was not significant. In addition, the limit of the tetracycline tablet dissolution rate was proposed based on in vivo experimental results.