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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/m L,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 compare the physico-chemical properties, water solubility and initial stability of diosgenin nanosuspensions (DSG-NS) with two particle sizes. Methods DSG-NS (DSG-NS1.0, DSG-NS1.0, DSG-NS1.0 and DSG-NS1.0) were prepared by grinding media with Pluronic F127 and sodium dodecyl sulfate as stabilizers. NS0.5), freeze-dried to be cured. The physico-chemical properties of DSG-NS with two particle sizes were characterized by Malvern particle size analyzer, scanning electron microscopy (SEM), X-ray diffraction and Fourier transform infrared spectroscopy, respectively. The balance of solubility and dissolution was evaluated as The water solubility of both. Results The diameters of DSG-NS1.0 and DSG-NS0.5 were (762.5 ± 18.4) and (342.8 ± 7.3) nm, respectively. The PDIs were 0.435 ± 0.087 and 0.170 ± 0.018, respectively. (919.0 ± 27.2) and (458.0 ± 10.3) nm, respectively. The PDI values were 0.521 ± 0.094 and 0.298 ± 0.021, respectively. The SEM images showed that the diameters of DSG-NS1.0 and DSG-NS0.5 were approximately rod-shaped or The crystal forms of DSG-NS1.0 and DSG-NS0.5 remained unchanged after lyophilization, with equilibrium solubilities of (5.094 ± 2.083) and (26.121 ± 10.286) μg / m L, respectively , The cumulative dissolution rates within 60 min were 36.1% and 64.9%, respectively. The particle size of DSG-NS1.0 increased significantly after 10 days, while the particle size of DSG-NS0.5 remained unchanged within 30 days. Both freeze-dried product particle size remained stable within 3 months. CONCLUSIONS: Reducing particle size did not alter the morphology and crystal form of DSG-NS, but also helped to improve equilibrium solubility, dissolution and physical stability.