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目的:制备水飞蓟素纳米结晶微丸并表征其性质、考察其稳定性。方法:采用流化床喷雾干燥技术制备水飞蓟素纳米结晶微丸,通过激光粒度法,紫外光谱法(UV),差示扫描量热法(DSC),红外光谱法(FT-IR)及X-射线衍射法(XRD)对其进行表征,并考察水飞蓟素纳米结晶微丸的初步稳定性(高温、高湿、光照试验)。结果:水飞蓟素纳米结晶微丸再分散后平均粒径(251.6±3.8)nm,多分散指数0.184±0.015。通过UV和FT-IR分析显示药物的化学结构未发生改变,DSC和XRD分析显示药物以无定型或分子状态分散于载体中;分别在60℃,相对湿度75%和照度(4 500±500)Lux的条件下,水飞蓟素纳米结晶微丸外观性状、再分散性能、水飞蓟素含量及溶出度均未发生明显变化。结论:水飞蓟素纳米结晶微丸释药快速、稳定性良好,有望进一步制成口服固体制剂,为水飞蓟素的应用与推广提供参考。
Objective: To prepare silymarin nano-crystalline pellets and characterize their properties and investigate their stability. METHODS: Silymarin nanoparticles were prepared by fluidized bed spray drying technique and characterized by laser particle size, UV, DSC, FT-IR and X-ray (XRD), and the initial stability of silymarin nano-crystalline pellets was investigated (high temperature, high humidity, light test). Results: The average size of silymarin nano-crystalline pellets after re-dispersion was (251.6 ± 3.8) nm and the polydispersity index was 0.184 ± 0.015. The chemical structure of the drug was not changed by UV and FT-IR analysis. The DSC and XRD analysis showed that the drug was dispersed in the carrier in an amorphous or molecular state; at 60 ℃, relative humidity 75% and illuminance (4 500 ± 500) Lux conditions, the silymarin nano-crystalline pellets appearance properties, redispersibility, silymarin content and dissolution did not change significantly. Conclusion: Silymarin nano-crystalline microspheres release fast, good stability, is expected to be further oral solid preparations, for the application and promotion of silymarin provide a reference.