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
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