西罗莫司纳米脂质载体固化制剂的制备

采用冷冻干燥法以微晶纤维素Avicel PH-101与聚乙烯吡咯烷酮(PVP)K30的混合物(4:1,w,%)为吸附性粉末固化西罗莫司纳米脂质载体分散液,并以再分散时间、平均粒径及分布、流动性和泄漏率等为指标,采用单因素试验优化固化处方。结果表明,3批按优化方法制备的西罗莫司纳米脂质载体固化制剂的休止角为(42.65±0.80)。,振实密度为(0.79±0.03)g/m1,且含量均匀度良好,再分散时间为(10.0±0.4)min,再分散液粒径(132.7+2.6)nm,分布系数0.297±0.01,ξ电位(-12.8±1.05)mV,冻干前后的泄漏率为(10.80±0.41)%。

Preparation of Solidification Preparation of Sirolimus Nanostructured Lipid Carriers

The sirolimus nanostructured lipid carriers was solidified by freeze-drying method with the mixture of microcrystalline cellulose(Avicel PH-101) and polyvinyl pyrrolidone(PVP) K30(4:1,w/w) as the adsorption powder.The preparation was optimized by single factor test with dispersing time,average particle size and distribution, fluidity and leakage rate as the indexes.The results showed that the angle of repose and tap density of three batches of the optimized solidified powder were(42.65±0.80)°and(0.79±0.03) g/ml with good content uniformity.The solidified powder could disperse within(10.0±0.4)min and the average particle size and polydispersity index(PDI) of its redispersing solution were(132.7±2.6)nm and 0.297±0.01 with the(?) potential of(-12.8±1.05)mV.The leakage rate of the products was(10.80±0.41)%.