不同厂家盐酸小檗胺片溶出度的比较研究  

A Comparative Study on the Dissolution of Berbamine Hydrochloride Tablets by Different Manufacturers

作　　者：周珍[1] 郝露[1] 冯慧 赵娅 叶凡[1] 赖先荣[1] ZHOU Zhen;HAO Lu;FENG Hui;ZHAO Ya;YE Fan;LAI Xianrong(Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China)

机构地区：[1]成都中医药大学,四川成都611137

出　　处：《中国民族民间医药》2018年第11期26-32,共7页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：国家自然科学基金面上项目(81774007;81473427;81173360;81303310;81560806);四川省科技厅科技支撑计划项目(2011S Z0298);四川省教育厅重点项目(16ZA0120;10ZA092);四川省高校科研创新团队建设计划项目(11TD004)

摘　　要：目的:比较不同厂家生产的盐酸小檗胺片在不同溶出介质中的溶出度。方法:根据《中国药典》2015年版溶出度测定方法第二法,以人工胃液(不加酶)和人工肠液(不加酶)为溶出介质,转速为50 r/min,于279 nm处采用紫外分光光度法测定吸光度并计算溶出度,采用相似因子、主成分分析和分层聚类分析对溶出度进行数据分析。结果:盐酸小檗胺片在人工胃液(不加酶)和人工肠液(不加酶)中累积溶出度在40%~50%之间。结论:相似因子、主成分分析和分层聚类结果表明,在相同溶出条件下盐酸小檗胺糖衣片与薄膜衣片有不同的溶出行为,且薄膜衣片比糖衣片更加稳定,可见盐酸小檗胺薄膜衣片规格的工艺较糖衣片更加合理。Objective To compare the dissolution of Berbamine Hydrochloride tablets by different manufacturers in different dissolution media（ artificial gastric and intestinal juice）. Methods Samples were collected with the artificial gastric juice（ without enzyme）and the artificial intestinal fluid（ without enzyme） as solvent and rotation speed of 50 r·min-1 according to second dissolution determination method（ slurry method） stated in Chinese Pharmacopeia（ 2015 edition）. The absorbance of samples was determined by UV spectrophotometry at detection wavelength of 279 nm. The data analysis about the dissolution was conducted by similarity factor,principal component analysis（ PCA） and hierarchical clustering analysis（ HCA）. Results The dissolution of Berbamine Hydrochloride tablets is 40% ~ 50% in the artificial gastric juice（ without enzyme） and the artificial intestinal fluid（ without enzyme）. Conclusionns The analysis results of similarity factor,principal component analysis（ PCA） and hierarchical clustering analysis（ HCA） showed that in the same conditions the dissolution of sugar-coated tablets and the film-coated tablets have the different dissolution behavior,and the film-coated tablets is more stable than sugar-coated tablets. So the process of Berbamine Hydrochloride film-coated tablets is more reasonable than sugar-coated tablets.

关 键 词：盐酸小檗胺片 紫外分光光度法 溶出度 相似因子 主成分分析 分层聚类分析 

分 类 号：R944.4[医药卫生—药剂学]