国产氨酚羟考酮片人体生物等效性研究  

Study on the Demic Bioequiavailability of Domestic Paracetamol and Oxycodone Tablets

作　　者：梅巍[1] 杨永革[1] 许雪廷[1] 刘静[1] 邸晓辉[1] 

机构地区：[1]北京军区总医院药理科,北京市100700

出　　处：《中国药房》2005年第19期1479-1481,共3页China Pharmacy

摘　　要：目的:评价国产与进口氨酚羟考酮片的生物等效性。方法:22名健康男性志愿者随机交叉单剂量口服氨酚羟考酮片国产制剂或进口制剂1片,采用高效液相色谱-质谱法分别测定血清中羟考酮和对乙酰氨基酚的浓度。结果:国产与进口羟考酮片的Cmax分别为(10.4±2.2)、(11.1±3.3)μg/L,tmax分别为(1.05±0.35)、(0.92±0.40)h,t1/2ke分别为(5.36±0.91)、(5.53±1.25)h,AUC0～t分别为(44.2±7.9)、(44.5±8.3)(μg·h)/L,AUC0～∞分别为(49.3±9.4)、(51.0±11.6)(μg·h)/L,国产制剂的相对生物利用度为(102.8±27.4)%;对乙酰氨基酚的Cmax分别为(4612±696)、(4592±825)μg/L,tmax分别为(0.94±0.28)、(0.96±0.23)h,t1/2ke分别为(3.99±0.77)、(4.05±0.83)h,AUC0～t分别为(15732±3450)、(16265±3858)(μg·h)/L,AUC0～∞分别为(16618±3545)、(17205±4194)(μg·h)/L,国产制剂的相对生物利用度为(97.6±10.3)%。结论:2种制剂具有生物等效性。OBJECTIVE： To evaluate the bioequiavailability of the domestic and the imported paracetamol and oxycodone tablets. METHODS： The blood concentrations of paracetamol and oxycodone in 22 healthy male volunteers were determined by HPLC MS after a single dose orally 1 tablet of domestic or imported oxycodone tablet by a randomized crossover way. RESULTS： The main pharmacokinetic parameters of the domestic and the imported oxycodone tablets were as follows： Cmax were （10.4±2.2）,（11.1±3.3） μg/L, respectively;t were（1.05±0.35）,（0.92±0.40）h, respectively;t1/2ke were （5.36±0.91）, （5.53± 1.25） h, respectively; AUC0-t were （44.2±7.9）, （44.5± 8.3） （μg·h）/L, respectively;AUC0-∞ were（49.3±9.4）, （51.0± 11.6） （μg·h）/L, respectively; the relative bioavailability of the domestic preparation was （102.8± 27.4）%. The main pharmacokinetic parameters of the domestic and the imported paracetamol were the following： C were （4 612 ± 696）, （4 592 ± 825） μg/L, respectively ; t were （ 0.94 ± 0.28）, （ 0.96 ± 0.23） h, respectively ; t 1/2ke were （ 3.99 ± 0.77）, （ 4.05 ± 0.83） h, respectively; A UC0-t were （ 15 732 ± 3 450）, （ 16 265 ± 3 858） （μg·h）/L, respectively; A UC0-∞ were （ 16 618 ± 3 545）, （ 17 205 ± 4 194）（μg·h）/L, respectively; the relative bioavailability of the domestic one was （97.6 ± 10.3）%. CONCLUSIONS： The 2 preparations are bioequivalent.

关 键 词：氨酚羟考酮片 羟考酮 对乙酰氨基酚 高效液相色谱-质谱法 生物等效性 

分 类 号：R971.2[医药卫生—药品] R969.1[医药卫生—药学]