枸橼酸喷托维林口腔崩解片的生物等效性评价

[Bioequivalence evaluation of orally disintegrating tablet of pentoxyverine citrate].

作者信息

Lin Ming-qin, Cai Ying, Zhang Wei, Wu Xiu-qiong, Rao Jin-jun, Liu Shu-wen

机构信息

School of Pharmaceutical Sciences, Southern Medical University, Guangzhou 510515, China.

出版信息

Nan Fang Yi Ke Da Xue Xue Bao. 2010 Jul;30(7):1621-3.

PMID:20650784

Abstract

OBJECTIVE

To evaluate the bioequivalence of orally disintegrating tablets of pentoxyverine citrate (tested preparation) in healthy male volunteers.

METHODS

A single oral dose of the tested and reference preparations at 25 mg were given to 20 healthy volunteers in a randomized two-period cross-over design. Plasma pentoxyverine citrate concentrations were determined by HPLC-MS/ESI+ method. The pharmacokinetic parameters were calculated and the bioequivalence of the two preparations were evaluated using DAS program.

RESULTS

The Tmax, Cmax, AUC0 15 and AUC0infinity of tested and reference preparations were 1.62-/+0.75 h and 2.52-/+1.21 h, 62.28-/+33.06 microg/L and 59.72-/+33.25 microg/L, 234.44-/+130.01 microg.h.L(-1) and 228.77-/+129.24 microg.h.L(-1), 246.80-/+136.19 microg.h.L(-1) and 244.11-/+140.73 microg.h.L(-1), respectively. The 90% confidence interval of C(max), AUC0 15 and AUC0infinity of tested preparations were 81.4%-138.4%, 86.0%-123.3% and 86.5%-121.2%, respectively.

CONCLUSION

The tested and reference preparations are bioequivalent.

摘要

目的

评价枸橼酸喷托维林口腔崩解片（受试制剂）在健康男性志愿者中的生物等效性。

方法

采用随机双周期交叉设计，对20名健康志愿者单次口服给予25mg受试制剂和参比制剂。采用HPLC-MS/ESI+法测定血浆中枸橼酸喷托维林的浓度。计算药代动力学参数，并使用DAS程序评估两种制剂的生物等效性。

结果

受试制剂和参比制剂的Tmax、Cmax、AUC0-15和AUC0-inf分别为1.62±0.75小时和2.52±1.21小时、62.28±33.06μg/L和59.72±33.25μg/L、234.44±130.01μg·h·L-1和228.77±129.24μg·h·L-1、246.80±136.19μg·h·L-1和244.11±140.73μg·h·L-1。受试制剂C(max)、AUC0-15和AUC0-inf的90%置信区间分别为81.4%-138.4%、86.0%-123.3%和86.5%-121.2%。