基于流化床技术制备芦丁缓释微丸及质量控制的研究  

Study on the Preparation and Quality Control of Rutin Sustained-release Pellets Based on Fluidized Bed Technology

作　　者：余泉毅 崔名全[1] 鲍锐 王浩[1] 赵俊霞[1] 尹蓉莉[1] 

机构地区：[1]成都中医药大学,成都611137 [2]成都自豪药业有限公司,成都610000

出　　处：《世界科学技术-中医药现代化》2015年第1期267-271,共5页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：四川省教育厅青年基金项目(10ZB076):中药浸膏粉末改性技术在固体制剂中的应用研究;负责人:慈志敏

摘　　要：目的:制备芦丁缓释微丸,建立质量控制方法。方法:以乙基纤维素水分散体(Surelease)为缓释材料,空白丸芯为载体,采用低喷流化床包衣技术制备芦丁缓释微丸,单因素考察隔离层增重、控释层增重、致孔剂种类和用量对释放度的影响。高效液相色谱法测定含量,紫外分光光度法测定体外释放度。结果:最优包衣处方工艺为隔离层增重10%,控释层增重18%,15%的乳糖为致孔剂。所得缓释微丸的体外释放度接近一级释药模型。结论:以流化床包衣技术制备的缓释微丸体外释放效果理想,工艺简单。紫外分光光度法和高效液相色谱法可用于其质量控制。The aim is to study the preparation of rutin sustained-release pellets, and establish the method of quality control. Taking surelease as sustained release material and blank pill core as the carrier, rutin sustained-release pellets were prepared by low spray fluidized bed coating technology. The single factor test was used to investigate the effect of isolation weight, the release layer weight, type and dosage of porogen for drug release. HPLC was developed for the determination of the contents of turin sustained release pellets and in vitro release by UV spectrophotometry. The optimal coating prescription was as following： the isolation layer gain of 10%, controlled release layer weight of 18%, with 15% lactose as porogen. The sustained release in vitro was in line with first-order release equation. The pellets prepared had an obviously sustained-release effect. The process was simple, and HPLC and UV could be used for the quality control.

关 键 词：芦丁 缓释微丸 流化床 HPLC 

分 类 号：R283.6[医药卫生—中药学]