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市售四环素产品的生物利用度。

Bioavailability of commercial tetracycline products.

机构信息

Section of Therapeutics, Academic Division of Medicine, University of Sheffield, Royal Infirmary, Sheffield.

出版信息

Br J Clin Pharmacol. 1974 Aug;1(4):319-23. doi: 10.1111/j.1365-2125.1974.tb00260.x.

Abstract

1 Thirteen commercial tetracycline products were assessed for bioavailability by in vitro and in vivo tests. Three failed the B.P. disintegration test and three products in a dissolution test released less than 50% of their stated potency by 3 hours. 2 In vivo bioavailability was assessed by serum and urinary data. Six products were tested by serum data over 48 h and their bioavailability profiles varied but their ranking correlated well with in vitro dissolution in water; three were better than the others. In a further study, based on urinary excretion alone, the thirteen products showed considerable variation in bioavailability. One product gave an extremely poor result (6 mg excreted in 24 hours). 3 These findings of generic non-equivalence illustrate the need for adequate standards of bioavailability testing.

摘要
  1. 对 13 种市售四环素产品进行了体外和体内生物利用度评估。有 3 种产品未能通过英国药典崩解试验,有 3 种产品在溶出度试验中 3 小时内释放出的效价低于其标示量的 50%。2. 通过血清和尿药数据评估体内生物利用度。6 种产品通过血清数据进行了 48 小时的测试,它们的生物利用度曲线有所不同,但与水的体外溶出度相关性良好;其中 3 种产品优于其他产品。在进一步的研究中,基于单独的尿药排泄数据,这 13 种产品的生物利用度有很大差异。有 1 种产品的结果极差(24 小时内排泄 6 毫克)。3. 这些非等效通用药物的发现表明需要有足够的生物利用度测试标准。

相似文献

1
Bioavailability of commercial tetracycline products.市售四环素产品的生物利用度。
Br J Clin Pharmacol. 1974 Aug;1(4):319-23. doi: 10.1111/j.1365-2125.1974.tb00260.x.

本文引用的文献

7
Cross-over study of ten tetracycline preparations.十种四环素制剂的交叉研究。
Eur J Clin Pharmacol. 1973 Jun;6(1):64-8. doi: 10.1007/BF00561804.
8
Biological availability and in vitro release from oral oxytetracycline and tetracycline preparations.
Acta Pharmacol Toxicol (Copenh). 1973;33(2):138-56. doi: 10.1111/j.1600-0773.1973.tb01517.x.
9
Generic equivalence and non-equivalence of drugs.药物的一般等效性与非等效性
Lancet. 1972 Sep 9;2(7776):528-30. doi: 10.1016/s0140-6736(72)91919-8.

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