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目的探索中药制剂清毒胶囊对高效抗逆转录病毒治疗药物药动学的影响。方法 36只SD大鼠随机分为3组,每组12只,高效抗逆转录病毒治疗组给予单纯高效抗逆转录病毒治疗一线方案齐多夫定(zidovudine,AZT)+拉米夫定(2’,3’-dideoxy-3’-thiacytidine,3TC)+依非韦伦(efavirenz,EFV),高效抗逆转录病毒治疗+清毒胶囊组同时给予高效抗逆转录病毒治疗和清毒胶囊,高效抗逆转录病毒治疗+清毒胶囊(间隔2 h)组给予高效抗逆转录病毒治疗,间隔2 h再给予清毒胶囊,灌胃给药,在0、0.5、1、2、3、4、6、8、10、12 h眼眶采血,高效液相-液质联用法(HPLC-MS/MS)检测齐多夫定、拉米夫定、依非韦伦的血药浓度,比较各组药动学参数。结果齐多夫定的t_(1/2)的组间差异有统计学意义(P<0.05),高效抗逆转录病毒治疗+清毒胶囊(间隔2 h)组的t_(1/2)较小;齐多夫定的AUC_(0-12)、CL、ρ_(max)和t_(max)以及拉米夫定、依非韦伦各项药动学参数的组间差异均无统计学意义。结论清毒胶囊对齐多夫定+拉米夫定+依非韦伦治疗方案的药动学参数无明显影响,但需注意个体差异。
Objective To explore the effect of traditional Chinese medicine Qingdu capsule on the pharmacokinetics of highly effective antiretroviral drugs. Methods Thirty - six SD rats were randomly divided into three groups (n = 12 each). The high effective antiretroviral therapy group was given azadirachtin (AZT) plus lamivudine (2) ’, 3’-dideoxy-3’-thiacytidine, 3TC) + efavirenz (EFV), high effective antiretroviral therapy + qingdu capsule group with high effective antiretroviral therapy and qingdu capsule, Anti-retrovirus treatment + Qingdu capsules (interval 2 h) were given high effective antiretroviral therapy, and then given Qingdu capsules at 2 h intervals. The rats were administered intragastrically at 0, 0.5, 1, 2, 3, Blood samples were collected at 6, 8, 10, 12 h orbit by HPLC-MS / MS, and plasma concentrations of zidovudine, lamivudine and efavirenz were compared. Dynamic parameters. Results The difference of t_ (1/2) in zidovudine group was statistically significant (P <0.05), t_ (1/2) in high antiretroviral treatment + qingdu capsule group (interval 2 h) There were no significant differences in the pharmacokinetic parameters of zidovudine between AUC_ (0-12), CL, ρ_ (max) and t_ (max), lamivudine and efavirenz . Conclusion The pharmacokinetic parameters of Qingdu Capsule to zidovudine + lamivudine + efavirenz treatment have no significant effect, but individual differences should be noted.