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目的为改善市售盐酸氨溴索药品存在用药次数多、患者顺应性差的问题,采用常用辅料,简化工艺将其制成缓释微丸型胶囊剂。方法采用挤出滚圆法及挤出滚圆结合流化床包衣法,分别制备盐酸氨溴索骨架型及膜控型缓释微丸,对制备使用的辅料及工艺进行单因素考察,对两种释药机制进行对比研究。结果两种方法制备出的盐酸氨溴索缓释胶囊与上市药物在体外的释放行为均相似。结论通过对整个制剂辅料种类、用量和工艺进行单因素考察,经体外释放度试验与上市药物对比,证明两种工艺均可用于制备盐酸氨溴索缓释胶囊。
The purpose of improving the market ambroxol hydrochloride drugs used in the number of patients with poor compliance problems, the use of commonly used accessories, simplify the process will be made of sustained-release pellets capsules. Methods Extrusion spheronization and extrusion spheronization combined with fluidized bed coating method were used to prepare ambroxol hydrochloride skeleton-type and controlled-release sustained-release pellets, respectively. The excipients and their preparation process were investigated by single factor, Drug release mechanism for comparative study. Results The release of ambroxol hydrochloride sustained-release capsules prepared by the two methods was similar to that of the listed drugs in vitro. Conclusion Through the single-factor investigation on the type, dosage and process of the whole preparation, the two technologies can be used to prepare ambroxol hydrochloride sustained-release capsules by comparing the in vitro release test with the listed drugs.