对乙酰氨基酚片的溶出速率与生物利用度之间的关系。

Relationship between dissolution rate and bioavailability of paracetamol tablet.

作者信息

Huang Xiao-ping, Wan Xin-xiang, Liu Qiang

机构信息

Teaching and Research Section of Pharmacy, Department of Medical Laboratory Technology, First Military Medical University, Guangzhou 510315, China.

出版信息

Di Yi Jun Yi Da Xue Xue Bao. 2003 Apr;23(4):367-8, 371.

PMID:12697478

Abstract

OBJECTIVE

To investigate the relationship between the dissolution rate and bioavailability of paracetamol tablets.

METHODS

The dissolution rate of paracetamol tablet was determined according to methods described in the Pharmacopoeia of the People's Republic of China. Ultraviolet spectrophotometry was employed to measure urine concentration of paracetamol, and the relative bioavailability was determined in 25 male healthy volunteers, with the relationship between the dissolution rate and bioavailability of paracetamol assessed.

RESULTS

The 15-min dissolution rates of 5 kinds of paracetamol tablets were 100.43+/-2.61, 99.76+/-1.97, 96.47+/-3.52, 89.58+/-1.85, and 85.85+/-1.83 respectively, with their bioavailability of 86.34+/-10.06, 85.82+/-11.21, 87.10+/-10.86, 81.71+/-12.34, and 76.53+/-11.73 respectively, showing obvious linear relationship between them, which conformed to the equation y = 0.6122x + 25.175, r = 0.9642.

CONCLUSION

As there is a good linear relationship between the dissolution rate and bioavailability of paracetamol tablets, the latter parameter can be derived from the measurement of the former.

摘要

目的

研究对乙酰氨基酚片的溶出速率与生物利用度之间的关系。

方法

按照《中华人民共和国药典》所述方法测定对乙酰氨基酚片的溶出速率。采用紫外分光光度法测定对乙酰氨基酚的尿药浓度，并在25名男性健康志愿者中测定相对生物利用度，评估对乙酰氨基酚溶出速率与生物利用度之间的关系。

结果

5种对乙酰氨基酚片的15分钟溶出速率分别为100.43±2.61、99.76±1.97、96.47±3.52、89.58±1.85和85.85±1.83，其生物利用度分别为86.34±10.06、85.82±11.21、87.10±10.86、81.71±12.34和76.53±11.73，两者之间呈现明显的线性关系，符合方程y = 0.6122x + 25.175，r = 0.9642。