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目的：研究磷酸可待因缓释片在肿瘤患者体内的多剂量达稳态药动学和生物利用度。方法：采用RP-HPLC法测定可待因的血药浓度，研究10名肿瘤患者多剂量口服磷酸可待因缓释片及 普通片达稳态后的药动学及相对生物利用度。结果：多剂量口服 缓释片及普通片达稳态后，AUCss0→τ分别为（599.8± 137.9）和（242.4±51.8） ng·h·ml-1；Tmax分别为（ 4.5±0.5）和（2.2±0.7） h，Cmax分别为（75.0±15.1 ）和（80.6±16.4） ng·ml-1，Cmin分别为（30.7±1 3.0）和（15.7±5.5） ng·ml-1，DF%分别为（91.8±19.1 ）%和（162.5±35.2）%，两种制剂的AUCss0→τ、Tma x、Cmin、DF%差异均有显著性（P<0.05）。磷酸可待因缓释 片相对生物利用度为（123.6±8.1）%。结论：磷酸可待因缓释片在多剂量给药时具有显著的缓释特性。
Objective: To study the multidose steady-state pharmacokinetics and bioavailability of codeine phosphate sustained-release tablets in cancer patients. Methods: The plasma concentration of codeine was determined by RP-HPLC. The pharmacokinetics and relative bioavailability of multidose oral codeine phosphate budesonide and common tablets after steady-state administration were studied in 10 cancer patients. Results: The AUCss0 → τ were (599.8 ± 137.9) and (242.4 ± 51.8) ng · h · ml-1, respectively, and the Tmax were (4.5 ± 0.5) and 2.2 ± 0.7 h and Cmax were (75.0 ± 15.1) and (80.6 ± 16.4) ng · ml-1, respectively, and Cmin were (30.7 ± 1.30) and (15.7 ± 5.5) ng · ml- (91.8 ± 19.1)% and (162.5 ± 35.2)%, respectively. The AUCss0 → τ, Tma x, Cmin and DF% of the two preparations were significantly different (P <0.05). The relative bioavailability of codeine phosphate sustained-release tablets was (123.6 ± 8.1)%. Conclusion: The codeine phosphate sustained-release tablets have significant sustained-release properties when administered in multiple doses.