摘要
目的:研究氨酚伪麻美芬片Ⅱ/氨麻苯美片中对乙酰氨基酚的人体药动学和生物等效性。方法:采用随机交叉试验设计,20名健康男性受试者分别单剂量口服氨酚伪麻美芬片Ⅱ/氨麻苯美片受试制剂和参比制剂2片,高效液相色谱法测定血浆中对乙酰氨基酚的浓度。结果:氨酚伪麻美芬片Ⅱ受试制剂和参比制剂中对乙酰氨基酚的c_(max)分别为(7.6±s 2.1)和(6.6±1.2)mg·L^(-1),t_(max)分别为(0.9±0.6)和(1.1±0.6)h,AUC_(0～16)分别为(29±4)和(28±5)mg·h·L^(-1),受试制剂中对乙酰氨基酚的相对生物利用度为(103±8)%。氨麻苯美片中c_(max)分别为(6.0±1.0)和(6.2±1.2)mg·L^(-1),t_(max)分别为(1.5±0.7)和(1.3±0.7)h,AUC_(0～16)分别为(29±6)和(29±7)mg·h·L^(-1),相对生物利用度为(99±10)%。结论:按对乙酰氨基酚测定,受试制剂与参比制剂具有生物等效性。
AIM： To study the pharmacokinetics and bioequivalence of paracetamol in the compound tablets of paracetamol, pseudoephedrine and dextromethorphan or paracetamol, pseudoephedrine, diphen- hydramine and dextromethorphan in healthy volunteers. METHODS： In a randomized crossover study, 20 healthy male volunteers were given orally individual administration of two compound tablets containing paracetamol, pseudoephedrine and dextromethorphan or paracetamol, pseudoephedrine, diphenhydramine and dextromethorphan. Paracetamol in plasma was determined by a HPLC method. RESULTS： As regard to the compound tablets of paracetamol, pseudoephedrine and dextromethorphan, the main pharmacokinetic parameters for paracetamol of test and reference preparations were Cmax（7.6 ± s 2.1）, （6.6 ± 1.2） mg·L^-1; tmax（0.9± 0.6）, （1.1 ± 0.6） h; AUC0-16 （29 ± 4）, （28 ± 5） mg·h·L^-1, respectively. The relative bioavailability of paracetamol in test preparation was （103± 8） %. To the compound tablets of paracetamol, pseudoephedrine, diphenhydramine and dextromethorphan, the main pharmacokinetic parameters for paracetamol of test and reference preparations were Cmax （6.0 ± 1.0）, （6.2 ± 1.2） mg·L^-1; tm （1.5± 0.7）, （1.3 ± 0.7） h; AUC0-16 （29 ± 6）, （29 ± 7） mg·h·L^-1, respectively. The relative bioavailability of paracetamol was （99 ± 10） %. CONCLUSION： For detection of paracetamol, the test and reference preparations are bioequivalent.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2007年第12期908-911,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
对乙酰氨基酚
药动学
色谱法
高压液相
生物筝效性
paracetamol
pharmacokinetics
chromatography, high pressure liquid
bioequivalence
