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目的：研究单剂量口服（ｐｏ）自制盐酸氨溴索（Ａｍ ｂ）缓释胶囊的药代动力学和生物利用度。方法：采用ＲＰ－ＨＰＬＣ法测定８名健康志愿者单剂量ｐｏ ７５ ｍ ｇ 自制（Ａ）和进口（Ｂ）Ａｍ ｂ 缓释胶囊后的血药浓度，计算药代动力学参数与相对生物利用度，并以配对ｔ检验进行统计分析。结果：单剂量ｐｏ Ａ 与Ｂ的ｔｍ ａｘ ，ｔ１／２，ｃｍ ａｘ ，ＡＵＣ０～ｔ分别为（５．００±１．０７），（４．６２±１．１９） ｈ；（４．０６±０．６１），（４．２１±０．９３） ｈ；（１５３．６２±２９．２０），（１４８．３６±１７．９１） ｎｇ／ｍ ｌ；（１ ４１０．３６±３３６．０６），（１ ２９４．３６±２２５．０７）ｈ·ｎｇ／ｍ ｌ。结论：两种制剂的体内吸收和峰浓度以及经对数转换都无显著性差异（Ｐ＜ ０．０５），具有生物等效性，自制胶囊的相对生物利用度为（１０８．２７±１５．５７）％ 。
OBJECTIVE: To study the pharmacokinetics and bioavailability of single-dose oral po (po) homemade ambroxol hydrochloride sustained-release capsules. Methods: The plasma concentrations of single-dose po 75 m g homemade (A) and imported (B) Am b sustained-release capsules from eight healthy volunteers were determined by RP-HPLC. The pharmacokinetic parameters and relative bioavailability , And paired t test for statistical analysis. Results: The tm ax, t1 / 2, cm ax and AUC0 ~ t of single dose po A and B were (5.00 ± 1.07) and (4.62 ± 1.19) h respectively; (4.06 ± (4.21 ± 0.93) h; (153.62 ± 29.20), (148.36 ± 17.91) ng / m l; (1 410.36 ± 336.06) , (1 294.36 ± 225.07) h · ng / m l. CONCLUSION: The in vivo absorption and peak concentration of the two preparations have no significant difference (P <0.05), and have bioequivalence. The relative bioavailability of the two preparations is (108.27 ± 15. 57)%.