摘要
目的:研究国产阿司达莫缓释胶囊与进口制剂的生物等效性。方法:20名健康志愿者单剂量及多剂量交叉口服受试制剂和参比制剂后,采用高效液相-质谱法分别测定血浆中水杨酸和双嘧达莫的浓度,计算两者的药动学参数,并进行生物等效性评价。结果:单剂量试验:水杨酸的相对生物利用度为(99.5±15.4)%,双嘧达莫为(104.9±11.0)%;多剂量试验:双嘧达莫的相对生物利用度为(101.7±6.2)%。多剂量口服后,受试制剂中的缓释成分双嘧达莫与单剂量口服比较,C_(max)降低,T_(max)延长,波动度(DF)较小。结论:两成分测定结果经方差分析及双单侧t检验,表明两种制剂具有生物等效性。
Objective： To study the pharmacokinetics and bioequivalence of dipyridamole compound sustained release capsules in healthy volunteers. Methods： The concentrations of salicylic acid and dipyridamole in plasma samples from the volunteers were determined by HPLC-MS after oral administration of a single and multiple oral doses of the test capsules and references. Results： In the single dose, the relative bioavailability of salicylic acid and dipyridamole were （99.5 ± 15.4） % and （ 104.9 ± 11.0） %, respectively. In the multiple doses, the relative bioavailability of dipyridamole was （101.7± 6.2）%. Cmax of dipyridamole was significantly decreased and Tmax was significantly extended in the multi-dose studies, compared with those of dipyridamole compound sustained-release capsules in the single-dose studies. Conclusion： The results of statistic analysis showed that the test dipyridamole compound sustained-release capsules and the reference capsules were bioequivalent.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2008年第9期787-791,共5页
Chinese Journal of New Drugs
