国产四环素片生物利用度的研究
THE BIOAVAILABILITY OF TETRACYLINE TABLETS MANUFACTURIED BY PHARMACEUTICAL FACTORIES IN CHINA
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摘要: 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。Abstract: The dissolution rates of 28 tetracycline tablet samples obtained from various factories were determined. The absorption of six of the 28 samples were determined using tetracycline solution as reference standard in 18 volunteers by urine test for 72 hours. The absorption of two of the six samples were also determined in ten volunteers by plasma test for 12 hours. The observed absorption of the six samples showed distinct statistical difference. The availabilities of the six samples were 87.40%, 81.40%, 79.08%, 75.15%, 57.05% and 39.15% respectively. The correlation between bioavailability and dissolution rate was not significant. A dissolution rate limit was suggested.
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