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唾液作为相对生物利用度研究中的生物体液的应用:与血浆结果的比较和关联。

The use of saliva as a biological fluid in relative bioavailability studies: comparison and correlation with plasma results.

机构信息

Quality Control of Medications, Faculty of Exact Sciences, National University of La Plata, Argentina.

出版信息

Biopharm Drug Dispos. 2010 Nov;31(8-9):476-85. doi: 10.1002/bdd.728. Epub 2010 Sep 27.

Abstract

The aim of the present study was to present new evidence supporting the use of saliva as a biological fluid in relative bioavailability studies. Carbamazepine was chosen as a model drug because of its suitability for salivary therapeutic drug monitoring and its well-documented plasma bioavailability. A relative bioavailability study of four different immediate release carbamazepine products was performed. Stimulated saliva samples were collected by chewing on parafilm wax and by the spitting method. In vitro dissolution testing of formulations, using 900 ml of 1% sodium lauryl sulphate in water, was also carried out. The in vitro-in vivo correlations obtained in this salivary study were consistent with previous correlations assessed using plasma. These results support the suitability of saliva as the biological fluid in relative bioavailability studies.

摘要

本研究旨在提供新的证据支持将唾液作为相对生物利用度研究中的生物流体。选择卡马西平作为模型药物,是因为它适合唾液治疗药物监测,并且其血浆生物利用度有充分的文献记载。对四种不同的卡马西平速释产品进行了相对生物利用度研究。通过咀嚼蜡膜和吐口水的方法收集刺激唾液样本。还使用 900ml 水的 1%十二烷基硫酸钠进行了配方的体外溶出度测试。本唾液研究中获得的体外-体内相关性与以前使用血浆评估的相关性一致。这些结果支持将唾液作为相对生物利用度研究中的生物流体的适用性。

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