摘要
目的:探讨不同饮食结构对于羟苯磺酸钙胶囊药动学的影响。方法:采用3周期交叉试验设计, 8名健康男性志愿者,年龄(25±s 4)a,体重(62±4)kg,分别于高脂饮食、标准饮食及12 h空腹后,口服羟苯磺酸钙胶囊500 mg,经1 wk清洗期后自身交叉,共3个周期。反相高效液相色谱荧光法测定血浆中羟苯磺酸钙浓度,计算服药后药动学参数并对结果进行统计分析。结果:受试者空腹、标准餐后、高脂餐后单剂量口服羟苯磺酸钙胶囊,药动学参数分别为c_(max):(20±s 7),(9．4±1．4),(9．7±1．1)mg·L^(-1); t_(max):(3．8±1．6),(5．5±1．8),(5．9±1．4)h;t_(1/2)β:(4．3±2．2),(4．1±1．5),(4．5±1．4)h;A UC_(0-∞): (135±29),(69±8),(69±5)mg·h·L^(-1);AUC(0-24):(141±33),(88±11),(97±16)mg·h·L^(-1)。餐后服药较空腹服药血浆药物浓度明显降低,部分药动学参数有差异。而标准饮食与高脂饮食比较则无显著差异。结论:提示进食对羟苯磺酸钙胶囊的药动学有一定影响。
AIM： To study the effects of different dietary structure on pharmacokinetics of calcium dobesilate. METHODS： A cross-over, controlled trial was conducted. Eight healthy male volunteers, whose aver age age at （25 ± s 4） a and average weight at （62 ± 4） kg, consumed no-diet, standard-diet or high fat diet respectively. 500 mg calcium dobesilate capsules were taken orally once time after a one-week washing-period. After the concentration of calcium dobesilate in plasma was determined by RP-HPLC FLD method, we calculated the parameters on pharmacokinetics and analyzed the results. RESULTS： The pharmacokinetic parameters were as followed： cmax were （20±7）, （9.4± 1.4） and （9.7 ± 1.1） mg·L^-1; tmax were （3.8 ± 1.6）, （5.5 ± 1.8） and （5.9 ± 1.4） h; t＋β were （4.3 ± 2.2）, （4.1 ± 1.5） and （4.5 ± 1.4） h; AUC0-∞ were （135 ± 29）, （69 ± 8） and （69 ± 5） mg·h·L^-1; AUC0-24 were （141 ± 33）, （88 ± 11） and （97 ± 16） mg·h·L^-1. Some pharmacokinetic parameters for diet groups were lower than that for no-diet group, but there were no difference between standard diet group and high fat diet group. CONCLUSION： It is suggested that diet has effect on pharmacokinetics of calcium dobesilate.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2007年第3期196-199,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
药动学
色谱法
高压液相
食品药物相互作用
羟苯磺酸钙
pharmacokinetics
chromatography, high pressure liquid
food-drug interactions
calcium dobesilate
