Acocella G, Nonis A, Gialdroni-Grassi G, Grassi C
Reference Center for Chemotherapy of Mycobacterial Diseases, Istituto Forlanini, Pavia, Italy.
Am Rev Respir Dis. 1988 Oct;138(4):882-5. doi: 10.1164/ajrccm/138.4.882.
A comparative bioavailability study of the antituberculosis drugs isoniazid, rifampin, and pyrazinamide was carried out in a group of 10 healthy volunteers after administration of the three compounds, once in individual association and once in a combined, fixed preparation. The investigation was designed as an open, crossover study where each subject received five tablets of a preparation containing 50 mg isoniazid, 120 mg rifampin, and 300 mg pyrazinamide (corresponding to a total dose of 250 mg isoniazid, 600 mg rifampin, and 1,500 mg pyrazinamide). The same doses were administered in the session where the drugs were combined using the individual formulations. For each subject and experimental session, 15 blood samples were collected over a period of 24 h, and the plasma concentrations of the three drugs were assessed. The results indicated the absence of negative pharmacokinetic interactions between the drugs when administered in both free and this new, fixed combination.
在一组10名健康志愿者中开展了抗结核药物异烟肼、利福平及吡嗪酰胺的比较生物利用度研究，这三种化合物分别单次单独给药，以及单次以固定复方制剂给药。该研究设计为开放交叉研究，每位受试者服用5片制剂，每片含50毫克异烟肼、120毫克利福平及300毫克吡嗪酰胺（相当于异烟肼总剂量250毫克、利福平总剂量600毫克及吡嗪酰胺总剂量1500毫克）。在使用各单体制剂组合用药的试验环节中给予相同剂量。对每位受试者及每个试验环节，在24小时内采集15份血样，并评估三种药物的血浆浓度。结果表明，这些药物以游离形式及新的固定复方制剂形式给药时均不存在负面药代动力学相互作用。
