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目的考察稳定剂种类和用法对甘草次酸纳晶混悬液粒径及其放置稳定性的影响,获得最优稳定化处方。方法采用反溶剂沉淀-高剪切法制备甘草次酸纳晶混悬液;以粒径分布、再分散指数、沉降比为指标,系统考察稳定剂单用、复配及空间稳定剂的加入对混悬液的影响,筛选最优稳定化方案。结果 TPGS-SDS-PVPK30复合体系制得的纳晶混悬液平均粒径为54nm(PI=0.370),放置3个月后粒径为47.2 nm(PI=0.252)。结论在复合稳定剂体系的多重作用下,甘草次酸纳晶混悬液的工艺重现性和放置稳定性均良好。
Objective To investigate the effect of stabilizer type and usage on the particle size and the stability of glycyrrhetinic acid nanocrystal suspension to obtain the optimal stable prescription. Methods The anti-solvent precipitation-high shear method was used to prepare the nanocrystalline glycyrrhetinic acid suspension. The particle size distribution, redispersion index and sedimentation ratio were taken as indexes to investigate the effects of single, complex and steric stabilizers Suspension influence, screening optimal stabilization program. Results The average diameter of nanocrystalline suspension prepared by TPGS-SDS-PVPK30 composite system was 54 nm (PI = 0.370). After 3 months, the particle size was 47.2 nm (PI = 0.252). Conclusion The reproducibility and placement stability of glycyrrhetinic acid nanosuspensions are good under the multiple action of the complex stabilizer system.