复方氯唑沙宗分散片的相对生物利用度研究

Study on bioavailability of complex chlorzoxazone dispersible tablet in healthy volunteers

目的考祭复方氯唑沙宗分散片在健康人体内的药动学过程及相对生物利用度方法18名健康男性受试者交叉单剂量口服复方氯唑沙宗分散片和鲁南贝特参比制剂后,采用高效液相色谱法,分别测定血浆中氯唑沙宗和对乙酰氨基酚的浓度结果健康志愿者服用供试制剂和参比制剂后,氯唑沙宗的cmax分别为(19.7±5.9)和(19.4±5.9)μg·mL 1;t1/2分别为(1.3±0.5)和(1.1±0.2)h;AUC分别为(50.6±18.3)和(52.8±19.8)μg·h·mL-1;对乙酰氨基酚的cmax分别为(8.4±2.6)和(9.9±2 1)μg·mL-1;t1/2分别为(2.9±0.6)和(2.9±0.6)h;AUC分别为(28.9±5.3)和(31.0±4.4)μg·h·mL-1 供试制剂相对于参比制剂的生物利用度为(96.6±8.8)%(氯唑沙宗)和(93.3±11.5)%(对乙酰氨基酚)

OBJECTIVE: To compare the pharmacokinetics and relative bioavailability of complex chlorzoxazone tablet. METHODS: In randomized crossover design, a single dose complex chlorzoxazone tablet was given to 18 healthy male volunteers. The plasma concentrations of chlorzoxazone and paracetamol were determined by HPLC method. RESULTS The pharmacokinetic parameters of the two products were included: cmax were (19.7 ± 5.9) and (19.4 ± 5.9) μg&middotml-1; t1/2 were (1.3 ± 0.5) and (1.1 ± 0.2) h; AUC were (50.6 ± 18.3) and (52.8 ± 19.8) μg&middoth&middotmL-1, respectively. The mean relative bioavailability of the two tablets was (96.6 ± 8.8)%. CONCLUSION: The results suggested that these two products were ralative bioavailability.