目的 比较2种粒径的薯蓣皂苷元纳米混悬液（DSG-NS）的物理化学性质、水溶解性和初步稳定性。方法 采用介质研磨的方法，以普朗尼克F127和十二烷基硫酸钠为稳定剂，分别应用直径为1.0、0.5 mm的研磨珠制备DSG-NS（分别称为DSG-NS1.0、DSG-NS0.5），冷冻干燥将其固化。分别应用马尔文粒度测定仪、扫描电子显微镜（SEM）、X射线衍射和傅里叶红外光谱对2种粒径的DSG-NS的物理化学性质进行表征；以平衡溶解度和溶出度为指标，评价二者的水溶解性。结果 DSG-NS1.0、DSG-NS0.5的粒径分别为（762.5±18.4）、（342.8±7.3）nm，多分散指数（PDI）分别为0.435±0.087、0.170±0.018；冻干粉复溶后的粒径分别为（919.0±27.2）、（458.0±10.3）nm，PDI分别为0.521±0.094、0.298±0.021；SEM照片显示DSG-NS1.0、DSG-NS0.5均呈近似棒状或片状，且晶体间无明显的聚集；DSG-NS1.0、DSG-NS0.5在冻干后仍维持晶体状态，平衡溶解度分别为（5.094±2.083）、（26.121±10.286）μg/mL，60 min内的累积溶出率分别为36.1%和64.9%；DSG-NS1.0的粒径在10 d后有明显的增加，而DSG-NS0.5的粒径在30 d内基本无变化，二者冻干产品的粒径在3个月内保持稳定。结论 减小粒径没有改变DSG-NS的形态和晶型，而且有助于提高平衡溶解度、溶出度和物理稳定性。

Objective To investigate the effect of particle size on the physicochemical properties, aqueous solubility and physical stability of diosgenin nanosuspensions (DSG-NS). Methods DSG-NS with different particle sizes were prepared using the milling bead with the diameter of 0.5 (DSG-NS0.5) and 1.0 mm (DSG-NS1.0) by media milling method using the combination of Pluronic F127 and sodium dodecyl sulfate as stabilizer, respectively. The DSG-NS were solidified by freeze drying method. The physicochemical properties of DSG-NS were characterized in term of particle distribution, scanning electron microscope, X-Ray diffraction and Fourier transform infrared spectroscopy. The aqueous solubility of DSG-NS with two particle size was compared by equilibrium solubility and dissolution rate. Results The particle sizes of the DSG-NS1.0 and DSG-NS0.5 prepared in this paper were (762.5 ±18.4) and (342.8 ±7.3) nm with the polydisperson index (PDI) of 0.435 ±0.087 and 0.170 ±0.018, respectively. The re-dispersed freeze drying products had particle sizes of (919.0 ±27.2) and (458.0 ±10.3) nm with the polydisperson index of 0.521 ±0.094 and 0.298 ±0.021, respectively. Both DSG-NS1.0 and DSG-NS0.5 had an irregular rod-shape or flake without any aggregates. The DSG retained its original crystalline state during the manufacturing process of DSG-NS1.0 and DSG-NS0.5. The solubilities of freeze drying DSG-NS1.0 and DSG-NS0.5 were (5.094 ±2.083) and (26.121 ±10.286) μg/mL. The accumulated dissolution rate of freeze drying DSG-NS1.0 and DSG-NS0.5 was 36.1% and 64.9% in 60 min, respectively. The particle size presented significant increase in 10 d for the DSG-NS1.0, whereas it had no change in 30 d for DSG-NS0.5. However, the particle size and distribution of the freeze drying DSG-NS1.0 and DSG-NS0.5 were stable during the storage of 3 month. Conclusion The reduction of particle size had no effect on the changing of morphology and original crystalline state and contributed to the improvement of solubility, dissolution rate and physical stability of DSG-NS.

河北省自然科学基金资助项目（H2014406036）；河北省高等学校科学技术研究项目（QN2015127）；河北省高校重点学科建设项目（冀教高[2013]4号）