白屈菜总生物碱缓释片制备工艺研究  

Study on Preparation Process of Chelidonium Majus Total Alkaloid Sustained-release Tablets

作　　者：王钫键 龙杰 高娜 马小娟 李瑞海[1] 贾天柱[1] WANG Fangjian;LONG Jie;GAO Na;MA Xiaojuan;LI Ruihai;JIA Tianzhu(School of Pharmacy,Liaoning University of Traditional Chinese Medicine,Dalian 116600,China)

机构地区：[1]辽宁中医药大学药学院,辽宁大连116600

出　　处：《中国民族民间医药》2024年第4期13-17,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：国家药典委员会项目(20180604005)。

摘　　要：目的:以羟丙基甲基纤维素为缓释材料制备白屈菜总生物碱缓释薄膜衣片解决白屈菜有效成分药物浓度不稳定的缺点,并建立可靠的含量测定方法。方法:采用单因素实验对白屈菜总碱缓释薄膜衣片制备工艺进行筛选,以释放度为依据;采用高效液相色谱法(HPLC)建立了白屈菜总碱缓释薄膜衣片中血根碱的含量测定方法。结果:优化的缓释片工艺处方:30%白屈菜总碱提取物、30%HPMC、20%可压性淀粉、10%乳糖、10%微晶纤维素,挤压制粒,加1%硬脂酸镁,压片,即得。结论:该工艺制得白屈菜总碱缓释片释药曲线平缓,缓释效果良好,方法简单易行,所得薄膜衣片外观和可压性良好。Objective To prepare Chelidonium majus total alkaloid sustained-release film-coated tablets using hydroxypropyl methyl cellulose as sustained-release material to solve the shortcomings of unstable drug concentration of celandine active ingredient,and to establish a reliable content determination method.Methods A single-factor experiment was used to screen the preparation process of celandine total alkali sustained-release film-coated tablets,and the release degree was the basis.A method for determining the content of ethrogen in celandine total alkali sustained-release film-coated tablets was established by high performance liquid chromatography(HPLC).Results The optimized process of sustained-release tablets was formulated:30%celandine total alkali extract,30%HPMC,20%compressible starch,10%lactose,10%microcrystalline cellulose,extruded granulation,plus 1%magnesium stearate,tableting,that is.Conclusion The process yields a gentle slow-release curve of celandine total alkali sustained-release tablets,good sustained release effect,simple and easy method,and good appearance and compressibility of the resulting film-coated tablets.

关 键 词：白屈菜总碱 缓释片 制备工艺 薄膜衣片 

分 类 号：R283[医药卫生—中药学]