感冒灵颗粒中药成分对化药成分人体药动学的影响研究

目的研究感冒灵颗粒中中药成分对对乙酰氨基酚、咖啡因和氯苯那敏人体药动学的影响。方法 12名健康男性志愿者,按2×2交叉试验设计,分别单次、多次口服感冒灵颗粒(试验制剂)或相应的化药组合(参比制剂),血浆中对乙酰氨基酚浓度采用HPLC-UV法测定,咖啡因和氯苯那敏的浓度采用HPLC-MS/MS测定,比较2组主要药动学参数的差异,评价中药成分对化药药动学参数的影响。结果试验制剂与参比制剂单次及多次给药后的药动学参数包括AUC0^t、Cmax、tmax间差异均无统计学意义(P>0.05)。结论感冒灵颗粒中的中药成分对各化药成分在人体的药动学无明显影响,其组方在药动学方面具有合理性。

Effect of traditional Chinese components in Ganmaoling granules on pharmacokinetics of paracetamol,caffeine and chlorphenamine maleate

Objective To study the pharmacokinetics of paracetamol, caffeine, chlorphenamine maleate in Ganmaoling granules and the influence of traditional Chinese medicine on them. Methods Twelve healthy volunteers enrolled in the experiment by 2×2 crossover design and were randomly administered a bag of test preparation（GML-01） or reference preparation（GML-02）. The concentrations of APAP in the plasma were determined by HPLC-UV and the concentrations of CAF and CPM in the plasma were determined by HPLC-MS/MS. Results The main pharmacokinetic parameters（AUC0 ~ t, Cmax and tmax） of the test preparation and reference preparation had no significant difference（P 0.05） after single and multiple doses. Conclusion The traditional Chinese medicine in Ganmaoling granules have no significant influence on pharmacokinetics of APAP, CAF and CPM. The formula of Ganmaoling granule is reasonable in pharmacokinetics.