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目的：评价自制盐酸氨溴索（Ａｍｂ）缓释胶囊的体外质量，并研究人体内吸收与体外释放的相关性。方法：采用转篮法考察转速对释放度的影响，常温留样和加速实验观察制剂稳定性，并进行ｐＨ－时间－释放度的三维释放实验和健康人体内单剂量生物利用度实验，计算累积释药分数并根据 Ｗａｇｎｅｒ－Ｎｅｌｓｏｎ法计算体内药物吸收分数，经回归显示相关性。结果： Ａｍｂ缓释胶囊释药受介质ｐＨ影响较小，且不受转速的影响，制剂贮存３个月，质量稳定。不同ｐＨ介质中，体外释放度与体内吸收量间都呈极显著线性相关（Ｐ＜０．０１）。结论：Ａｍｂ口服后，血药浓度平稳、持久。根据体内外相关方程可推测药物体内吸收量，因此可将体外释放度作为筛选缓释处方的依据。
OBJECTIVE: To evaluate the in vitro qualities of homemade ambroxol hydrochloride sustained release capsules and to investigate the correlation between absorption in humans and in vitro release. Methods: The effect of revolving speed on the release rate was investigated by spin basket method. The stability of formulation was observed at room temperature and acceleration test. The three-dimensional pH-time-release test and the single-dose bioavailability test in healthy human were performed to calculate the cumulative The drug release scores were calculated and the in vivo drug absorption scores were calculated according to the Wagner-Nelson method and the correlation was shown by regression. Results: The release of Amb sustained-release capsules was less affected by the medium pH, and was not affected by rotational speed. The formulations were stored for 3 months and were of stable quality. There was a significant linear correlation between in vitro release and in vivo absorption in different pH media (P <0.01). Conclusion: After oral administration of Amb, plasma concentration is steady and lasting. According to in vitro and in vivo equations can be speculated that the amount of drug absorption in vivo, so the release rate in vitro can be used as a screening based on sustained-release prescription.