摘要
目的制备葛根总黄酮纳米混悬剂(PF-NS),并对其进行质量评价。方法采用高速剪切-高压均质联用制备PF-NS,通过单因素试验和响应面法分别优化处方组成和高压均质工艺参数。采用桨法测定PF-NS的体外溶出度;并测定其30 d内物理稳定性。结果 PF-NS处方组成为2%PF原料药,1%SDS作为稳定剂;制备方法 :先高速剪切2 min(10 000 r/min),后经高压均质19次,均质压力为940 bar/次,粒径分布为(258.4±2.59)nm、PDI为(0.339±0.01)、Zeta电位(-25.4±0.46)mv;PF-NS体外溶出量明显高于其物理混合物;PF-NS在4℃避光条件下粒径和PDI变化小,更加稳定。结论 PF-NS制备方法简便、稳定、可行,有望成为葛根总黄酮新型口服纳米给药系统,并为其应用提供参考。
Objective To prepare and characterize pueraria flavonoids in nanosuspeusion（PF-NS）, then evaluate its quality. Methods The high-speed shear and high pressure homogenization is adopted to prepare PFNS,Taking diameter and PDI as index, the singal test and response surface methodology are adopted to optimize the composition of prescription and preparation parameters; To determine the in vitro dissolution by paddle method and physical stability in 30 days. Results The optimal formulation is as follows：drug concentration 2 % and SDS 1 % for stabilizer. The preparation is as follows： high-speed shear 2 min（10 000 r/min）, then homogeneous 19 times（940 bar/time）, the diameter, PDI and zeta potential of PF-NS are found to be（258.4 ± 2.59） nm,（0.339 ± 0.01） and（-25.4 ± 0.46） mv. The in vitro accumulated dissolution rate of nanosuspeusion is higher than physical mixture. The diameter and PDI have little change at 4 ℃ in the dark. Conclusion The preparation of PF-NS is simple, stability and feasible, which is expected to be a new oral nano-drug delivery system of pueraria flavonoids, then provide a reference for application.
作者
陈程
冯锁民
罗国平
张存劳
闫梦茹
CHEN Cheng;FENG Suo-min;LUO Guo-ping;ZHANG Cun-lao;YAN Meng-ru(Pharmaceutical Institute, Xi＇an Medical University, Xi＇an 710021, China)
出处
《现代中药研究与实践》
CAS
2018年第2期37-40,44,共5页
Research and Practice on Chinese Medicines
基金
陕西省教育厅2017自然科技专项(17JK0649)
西安医学院学科建设资助(1007)
西安医学院2016本科教学改革研究项目(2016JG-21)
