葛根乙醇提取物固体分散体制备工艺优化  

Optimization of solid dispersions preparation process of Puerariae Lobatae Radix ethanol extract

作　　者：王海燕[1] 金盖宇 贺欣佩 杨俊杰[1] WANG Hai-yan;JIN Gai-yu;HE Xin-pei;YANG Jun-jie(School of Pharmacy,Xinyang Agricultural and Forestry University,Xinyang 464000,China;No.954 Hospital of PLA Army,Shannan 856000,China)

机构地区：[1]信阳农林学院药学院,河南信阳464000 [2]陆军第九五四医院,西藏山南856000

出　　处：《河南城建学院学报》2025年第1期116-123,共8页Journal of Henan University of Urban Construction

基　　金：河南省重点研发专项(241111311400);信阳农林学院科技创新团队项目(XNKJTD-008)。

摘　　要：采用50%乙醇提取葛根饮片,制成葛根乙醇提取物,以葛根总黄酮和葛根素的累积溶出度为指标,对熔融法、溶剂法、溶剂-熔融法制备葛根乙醇提取物固体分散体进行方法筛选。在单因素试验的基础上,采用L_(9)(3^(4))正交实验设计,对载体(PEG6000-Poloxamer188)比、药载比、熔融温度等因素进行考察。通过体外溶出度测定、扫描电镜(SEM)和傅里叶红外光谱(FT-IR)进行体外质量表征。结果表明,葛根乙醇提取物固体分散体最佳制备工艺条件为:载体比3:1,药载比1:5,熔融温度60℃。葛根乙醇提取物固体分散体的形态和红外光谱与葛根乙醇提取物有明显差异,120 min内总黄酮和葛根素的累积溶出度分别为93.86%、79.78%,固体分散体可明显改善葛根乙醇提取物中总黄酮和葛根素的溶出效率,可为葛根资源的综合高效利用提供依据。The medicinal material of Puerariae Lobatae Radix was extracted with 50%ethanol and prepared into Puerariae Lobatae Radix ethanol extract.Using the cumulative dissolution rates of total flavonoids and puerarin as evaluation indices,the methods for preparing solid dispersions—melting method,solvent method,and solvent-melting method—were screened.With carrier(PEG6000-Poloxamer188)ratio,drug-carrier ratio and melting temperature as experimental factors,the preparation process was optimized by L_(9)(3^(4))orthogonal experimental design on the basis of single factor test.Subsequently,the in vitro characterization was performed by in vitro dissolution determination,scanning electron microscopy(SEM)and Fourier transform infrared spectroscopy(FT-IR).The results showed that the optimal conditions were determined to be 3:1 for carrier ratio,1:5 for drug-carrier ratio,and 60℃for melting temperature.The obtained solid dispersions had significant differences in morphology and infrared spectroscopy with Puerariae Lobatae Radix ethanol extract.The cumulative dissolution rate of total flavonoids and puerarin within 120 minutes were 93.86%and 79.78%respectively.The solid dispersions can obviously improve the dissolution of total flavonoids and puerarin in Puerariae Lobatae Radix ethanol extract.The experimental results can provide a basis for the comprehensive and efficient utilization of Puerariae Lobatae Radix.

关 键 词：葛根 乙醇提取物 固体分散体 累积溶出度 葛根素 正交实验设计 

分 类 号：R284[医药卫生—中药学]