对乙酰氨基酚(扑热息痛)PVP片的药代动力学及生物利用度研究

来源 :中国临床药理学杂志 | 被引量 : 0次 | 上传用户:zxjds
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本文建立了高效液相色谱法测定人血清中的对乙酰氨基酚浓度,结果表明该方法精密度高,灵敏度好,线性关系良好,r=0.9998(n=6),最低检测浓度为0.1mg/l,平均日内和日间变异系数<9%。8名健康志愿者交叉口服对乙酰氨基酚片和对乙酰氨基酚PVP片,药代动力学参数分别为,Ka:1.86±0.95,3.23±2.601/h;T1/2:3.17±1.13,2.70±0.85h;Cmax:7.56±2.08,8.24±1.37mg/l;Tpk:1.06±0.39,0.79±0.30h,AUC:32.91±8.45,34.25±8.45mg·h~(-1)·l~(-1)。两种片剂的药代动力学参数(除Ka值外)均无显著性差异,P>0.05。其中对乙酰氨基酚PVP片吸收明显快于对乙酰氨基酚(P<0.05)。平均生物利用度为104.07%,两种片剂生物等效。 In this paper, HPLC was established for the determination of paracetamol in human serum. The results showed that the method has high precision, good sensitivity and good linearity (r = 0.9998 (n = 6), the lowest detection concentration is 0 .1mg / l, the average daily and intra-day coefficient of variation <9%. Pharmacokinetic parameters of paracetamol tablets and paracetamol PVP tablets were respectively taken orally by eight healthy volunteers. The Ka: 1.86 ± 0.95 and 3.23 ± 2.601 / h, T1 / 2: 3.17 ± 1.13, 2.70 ± 0.85 h; Cmax: 7.56 ± 2.08, 8.24 ± 1.37 mg / l; Tpk: 1.06 ± 0.39, 79 ± 0.30h, AUC: 32.91 ± 8.45,34.25 ± 8.45mg · h -1 · -1. Pharmacokinetic parameters (except Ka value) of the two tablets showed no significant difference, P> 0.05. Paracetamol PVP tablet absorption was significantly faster than acetaminophen (P <0.05). The average bioavailability was 104.07%, and both tablets were bioequivalent.
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