甘草总黄酮纳米混悬剂冻干粉的表征及稳定性考察  

Characterization of Licorice Total Flavonoids Nanosuspension Lyophilized Powder and Investigation of Its Stability

作　　者：吴超群[1] 李小芳[1] 牟倩倩 严敏嘉 刘肖[1] 谢龙 廖艳梅 

机构地区：[1]成都中医药大学药学院中药材标准化教育部重点实验室四川省中药资源系统研究与开发利用重点实验室——省部共建国家重点实验室培育基地

出　　处：《中国实验方剂学杂志》2018年第2期29-33,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：四川省教育厅重点项目(15ZA0094)

摘　　要：目的：制备甘草总黄酮纳米混悬剂冻干粉并对其进行表征及稳定性考察。方法：采用冷冻干燥法制备甘草总黄酮纳米混悬剂冻干粉，测定其粉体学性质（休止角、堆密度），采用紫外分光光度法（uV），傅里叶变换红外光谱法（FT．IR）和x射线衍射法（XRD）等对其进行理化性质表征，考察甘草总黄酮纳米混悬剂冻干粉的初步稳定性。结果：甘草总黄酮纳米混悬剂冻干粉再分散后的平均粒径（239．7±2．1）nm，多分散指数0．193±0．032；休止角41．45度，堆密度0．267g·cm^-1，uv和FT-IR分析显示甘草总黄酮的化学结构未发生改变，XRD分析显示药物始终是以无定型状态存在，且制备剂冻干过程中未发生晶型的转变；稳定性试验显示在高温60℃，相对湿度75％，光照强度（4500±500）Lx条件下对甘草总黄酮纳米混悬剂冻干粉的外观性状、再分散性、休止角、堆密度、甘草总黄酮含量及1h溶出度均无显著影响。结论：甘草总黄酮制成纳米混悬剂冻干粉可显著提高药物的溶出度，且药物的理化性质均未发生改变，冻干粉稳定性良好，可进一步制备甘草总黄酮固体制剂，为扩大该有效部位的应用范围提供参考。Objective： To prepare licorice total flavonoids nanosuspension lyophilized powder, and rsearch for its characterization and stability. Method： Licorice total flavonoids nanosuspension lyophilized powder was prepared by freeze-drying method, its powdery properties （angle of repose and bulk density ） were determined, and it was characterized by the laser particle size analyzer, ultraviolet spectroscopy （ UV）, Fourier transform infrared spectroscopy （FT-IR） and X-ray diffraction （XRD）, then its stability was investigated Result： Mean particle size of licorice total flavonoids nanosuspension lyophilized powder was （239.7 ± 2. 1 ） nm and the polydispersity index （PDI） was 0. 193 ± 0. 032, the rangle of repose was 41.45 degree and the bulk density was 0. 267 g · cm^-3. UV and FT-IR showed that the chemical structure of licorice total flavonoids did not change, XRD analysis showed that the drug was always in the amorphous state, and no crystal transformation occurred during the freeze-drying process. The stability test showed that appearance, redispersibility, angle of repose, bulk density, total flavonoid content and dissolution in 1 h of the lyophilized powder were not significantly affected at high temperature of 60℃, relative humidity of 75% and light intensity of （4 500 ± 500 ） Lx. Conclusion： The lyophilized powder can significantly improve the dissolution of licorice total flavonoids, and the physical and chemical properties of drug do not change, the stability of lyophilized powder is good, and it can be further prepared as licorice total flavonoids solid preparation.

关 键 词：甘草 总黄酮 纳米混悬剂 冻干粉 表征 稳定性试验 体外溶出度 

分 类 号：R283.6[医药卫生—中药学] R944.2[医药卫生—中医学]