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目的:制备基于纳米CaCO3的辣椒素缓释漂浮微丸。方法:以海藻酸钠为基质,滴制法制备辣椒素缓释漂浮微丸,采用单因素试验,研究CaCl2浓度、纳米CaCO3与海藻酸钠比例、辣椒素与海藻酸钠比例对微丸的影响。在此基础上以微丸的漂浮能力、载药量、体外释放性能作为考察指标,用星点设计-效应面法进一步优化其处方工艺。结果:筛选的最优处方为1.87%的CaCl2,纳米CaCO3与海藻酸钠比例为2.16∶1,辣椒素与海藻酸钠比例为2.36∶1。在该条件下制备的辣椒素缓释微丸外观圆整,粒径大小分布均匀,在人工胃液中能够持续漂浮15 h以上,缓释效果较好,12 h体外累积释放度达89.93%。结论:经星点设计-效应面优化后制得的辣椒素缓释漂浮微丸具有良好的漂浮能力和缓释效果。
Objective: To prepare capsaicin sustained release floating pellets based on nano-CaCO3. Methods: Capsaicin sustained-release floating pellets were prepared by sodium alginate drip method. The effects of CaCl2 concentration, the ratio of nano-CaCO3 and sodium alginate, the ratio of capsaicin to sodium alginate on the pellets were investigated by single factor test . On this basis, the pellet’s floating ability, drug loading and in vitro release performance were taken as the index of investigation. The prescription design-response surface method was used to further optimize its prescription process. Results: The optimal prescription was 1.87% CaCl2. The ratio of nano-CaCO3 to sodium alginate was 2.16:1. The ratio of capsaicin to sodium alginate was 2.36:1. Capsaicin sustained-release pellets prepared under these conditions showed a round appearance and uniform particle size distribution. The sustained release of capsaicin sustained-release pellets in artificial gastric juice was more than 15 h, with a sustained release rate of 89.93% after 12 h. Conclusion: Capsaicin sustained-release pellets prepared by star-design-effect surface optimization have good floating ability and sustained-release effect.