摘要
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(4500±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 nanocrystal pellets and rsearch for its characterization and stability test.Method:Silymarin nanocrystal pellets were prepared by fluid-bed spray drying technology and characterized by laser particle size analysis,ultraviolet spectroscopy(UV),infrared spectroscopy(FT-IR),differential thermal analysis(DSC)and X-ray diffraction(XRD).Preliminary stability were investigated(high temperature,high humidity and light test).Result:Average particle size of silymarin nanocrystal pellets was(251.6±3.8)nm,and the polydispersity index(PDI)was 0.184±0.015.The chemical structure of silymarin did not change by the analysis of UV and FT-IR.Silymarin was dispersed in carrier with an amorphous or molecular state.Under the conditions of 60℃,relative humidity of 75%and light irradiation of(4500±500)Lux,the appearance,redispersion,content of silymarin and dissolution rate of nanocrystal pellets were not changed obviously.Conclusion:Silymarin nanocrystal pellets offers rapid drug release and good stability,which is expected to be further developed into oral solid preparations.
作者
罗开沛
李小芳
罗佳
杨露
林浩
牟倩倩
LUO Kai-pei;LI Xiao-fang;LUO Jia;YANG Lu;LIN Hao;MOU Qian-qian(Pharmacy College,Chengdu University of Traditional Chinese Medicine,Key Laboratory of Standardization of Chinese Herbal Medicine,Ministry of Education,Key Laboratory of Systematic Research,Development and Utilization of Chinese Medicine Resources in Sichuan Province,Key Laboratory Breeding Base of Co-founded by Sichuan Province and Ministry of Science and Technology,Chengdu 611137,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2017年第4期7-11,共5页
Chinese Journal of Experimental Traditional Medical Formulae
基金
四川省科技厅“苗子工程”重点项目(2016RZ0037)
四川省教育厅重点项目(15ZA0094)
关键词
水飞蓟素
纳米混悬剂
纳米结晶微丸
多分散指数
表征
溶出度
稳定性
silymarin
nanosuspensions
nanocrystal pellets
polydispersity index
characterization
dissolution
stability
