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姜黄素固体脂质纳米粒干粉吸入剂的制备工艺研究
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| 篇名： | 姜黄素固体脂质纳米粒干粉吸入剂的制备工艺研究 |
| TITLE： | |
| 摘要： | 目的：制备姜黄素（Cur）固体脂质纳米粒（SLN）干粉吸入剂（DPI）。方法：以粒径、多分散系数、包封率和药物沉积率等为指标筛选Cur-SLN的干燥方法（喷雾干燥和冷冻干燥）；基于优化后干燥方法，以药物沉积率、排空率、休止角、吸湿增重率、含量均匀度等指标对Cur-SLN-DPI处方（乳糖-干粉比例、单剂量每粒胶囊装量）进行单因素考察并进行验证试验。结果：喷雾、冷冻干燥法所得Cur-SLN的体外有效部位沉积率分别为29.98％和15.69％，以前者为优；优化后的单剂量处方为乳糖-干粉（1 ∶ 1）混合物50 mg、第3组分乳糖10 mg，填充于4号胶囊中；所制3批干粉各指标平均值为粒径3.35 μm、水分4.57％、含量均匀度3.65、体外有效部位沉积率28.73％、排空率95.17％、休止角24.03 °、吸湿增重率2.2％（RSD均小于2％，n＝3）。结论：建议选用喷雾干燥法制备Cur-SLN；优化处方后所制Cur-SLN-DPI质量符合要求。 |
| ABSTRACT： | OBJECTIVE： To prepare Dry powder inhaler of curcumin-loaded solid lipid nanoparticles （Cur-SLN-DPI）. METHODS： With the particle size， polydispersity coefficient， encapsulation efficiency and drug deposition rate as the indexes， the Cur-SLN drying methods （spray drying and freeze drying） were screened. Based on the optimized drying method， with the drug deposition rate， emptying rate， the angle of repose， moisture-absorption weight gain rate and content uniformity as the indexes， single factor observation was made on the formulation of Cur-SLN-DPI （lactose-dry powder ratio， the filling amount of each single-dose capsule）， and verification tests were carried out. RESULTS： The rates of effective in vitro deposition of Cur-SLN obtained by spray and freeze drying were 29.98％ and 15.69％ respectively， and the former was better. The optimized single-dose formulation was as follows as lactose-dry powder （1 ∶ 1） mixture of 50 mg， lactose of 10 mg as the third component， in a No.4 capsule. The average values of all indexes of 3 lots of the prepared dry powder were as follows as particle size of 3.35 μm， 4.57％ of moisture， content uniformity represented as 3.65， effective in vitro deposition rate of 28.73％， emptying rate of 95.17％， the angle of repose of 24.03 ° and moisture-absorption weight gain rate of 2.2％ （RSD lower than 2％， n＝3）. CONCLUSIONS： It is suggested that Cur-SLN should be prepared by spray drying. The Cur-SLN-DPI prepared according to the optimized formulation conforms to quality standards. |
| 期刊： | 2016年第27卷第28期 |
| 作者： | 李楠，于美丽 |
| AUTHORS： | LI Nan，YU Meili |
| 关键字： | 姜黄素；固体脂质纳米粒；干粉吸入剂；制备工艺；干燥方法；体外有效部位沉积率 |
| KEYWORDS： | Curcumin； Solid lipid nanoparticles； Dry powder inhaler； Preparation technology； Drying method； Effective in vitro deposition rate |
| 阅读数： | 334 次 |
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