基于喷雾干燥方式的丹皮酚-β-环糊精包合工艺研究  

Study on the Inclusion Technology of Paeonol-β-cyclodextrin by Spray Drying Method

作　　者：钟霞 余欣彤 刘路芳 王瑜婷 刘燎原 程学仁 王寿富 Zhong Xia;Yu Xintong;Liu Lufang;Wang Yuting;Liu Liaoyuan;Cheng Xueren;Wang Shoufu(Guangdong YiFang Pharmaceutical Co.,Ltd.,Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Formula Granule,Foshan 528244,China)

机构地区：[1]广东一方制药有限公司广东省中药配方颗粒企业重点实验室,广东佛山528244

出　　处：《亚太传统医药》2022年第1期75-79,共5页Asia-Pacific Traditional Medicine

基　　金：广东省科技计划(2018B030323004)。

摘　　要：目的:优选以喷雾干燥方式制备丹皮酚-β-环糊精(β-cyclodextrin,β-CD)的包合工艺。方法:采用L_(9)(3^(4))正交试验设计,以β-CD与丹皮酚的用量比、β-CD与水的用量比、包合时间、喷雾干燥进出风温度为考察因素,以包合物得率和丹皮酚包合率的综合评分为评价指标,优选丹皮酚-β-CD的包合工艺。对包合物和物理混合物进行热稳定性、湿稳定性试验,考察其稳定性。结果:优选的包合工艺为:取丹皮酚结晶置于研钵中,加适量95%乙醇溶解,β-CD与丹皮酚的用量比为10∶1、β-CD与水的用量比为1∶6、包合时间为2h、喷雾干燥进出风温度为185/90℃。验证试验的包合物得率均值为80.59%、丹皮酚包合率均值为81.84%,各指标的RSD均小于3%。在高温、高湿条件下,丹皮酚经包合后较物理混合物的稳定性有显著提升。结论:优选的包合工艺稳定可行,为丹皮酚-β-CD包合物的产业化生产提供了新方法。Objective:To optimize the inclusion technology of paeonol-β-cyclodextrin(β-CD)by spray drying method.Methods:The inclusion technology of paeonol-β-CD was optimized by L_(9)(3^(4))orthogonal experimental design with the ratio ofβ-CD and paeonol,the ratio ofβ-CD and water,inclusion time and spray drying inlet and outlet temperature as the investigation factors,with the inclusion yield and paeonol encapsulation efficiency as the evaluation index.The thermal stability and wet stability of the inclusion compound and the physical mixture were tested.Results:The preferred inclusion process is as follows,paeonol was placed in a mortar and dissolved with 95% ethanol,the ratio ofβ-CD and paeonol was 10∶1,the ratio ofβ-CD and water was 1∶6,inclusion for two hours,spray drying inlet and outlet temperature was 185/90℃.The average value of inclusion yield was 80.59%and paeonol encapsulation efficiency was 81.84%under this inclusion process,the RSDof each indicator is less than 3%.At high temperature and high humidity,the stability of inclusion compound was significantly improved than that of physical mixture.Conclusion:The optimized process is stable and feasible,which provides a new idea for the industrial production of paeonol-β-CD inclusion compound.

关 键 词：喷雾干燥法 丹皮酚 Β-环糊精 正交试验 包合工艺 稳定性 

分 类 号：R284.2[医药卫生—中药学]