Santosh K K, Raghuram T C, Krishnaswamy K
National Institute of Nutrition, Hyderabad, India.
Int J Clin Pharmacol Ther Toxicol. 1992 Jan;30(1):13-7.
Chemical estimation of seven different marketed brands of tetracycline/Hcl capsules for tetracycline content showed six brands were not meeting the Indian pharmacopia 1985 prescribed standards. However, their dissolution rate and disintegration time were in accordance with United States pharmacopia 1985 specifications. One standard and one substandard brand of tetracycline were selected and their bioavailability, after single dose and plasma steady-state levels after multiple dosing in well nourished and undernourished subjects were determined. The bioavailability of substandard product as determined from 48 h urinary tetracycline excretion was significantly lower as compared to standard product both in well-nourished and undernourished subjects. The plasma steady-state concentrations with the substandard product were below the generally recommended minimum inhibitory concentrations, more so in undernourished subjects. These results indicate that the use of sub-standard tetracycline products in undernourished subjects may lead to therapeutic failures and/or result in the development of resistant microorganisms.
对七种不同市售品牌的四环素/盐酸胶囊进行四环素含量的化学测定,结果显示有六个品牌不符合1985年《印度药典》规定的标准。然而,它们的溶出率和崩解时间符合1985年《美国药典》的规格。选取了一个标准品牌和一个不合格品牌的四环素,测定了营养良好和营养不良受试者单次给药后的生物利用度以及多次给药后的血浆稳态水平。通过48小时尿四环素排泄量测定,发现不合格产品在营养良好和营养不良受试者中的生物利用度均显著低于标准产品。使用不合格产品时,血浆稳态浓度低于一般推荐的最低抑菌浓度,在营养不良受试者中更是如此。这些结果表明,在营养不良受试者中使用不合格的四环素产品可能导致治疗失败和/或导致耐药微生物的产生。