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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)%。
The mixture of microcrystalline cellulose Avicel PH-101 and polyvinylpyrrolidone (PVP) K30 (4: 1, w,%) was used as the adsorptive powder to freeze the sirolimus nanometer lipid carrier dispersion by freeze- Redispersion time, average particle size and distribution, fluidity and leakage rate as indicators, using single factor test to optimize curing prescription. The results showed that the angle of repose of the three batches of sirolimus-containing nanosized lipid-based carrier prepared by the optimization method was (42.65 ± 0.80). , The tap density was (0.79 ± 0.03) g / m1, and the content uniformity was good. The redispersion time was (10.0 ± 0.4) min. The particle size of the redispersion solution was (132.7 ± 2.6) nm and the distribution coefficient was 0.297 ± 0.01, Potential (-12.8 ± 1.05) mV, the leak rate before and after freeze-drying was (10.80 ± 0.41)%.