血塞通片体外溶出行为研究  

Study on In Vitro Dissolution Behavior of Xuesaitong Tablets

作　　者：罗慧玉 闫伟伟 谢颖 陈正源 吴长年 丁杰 刘琪 LUO Hui-yu;YAN Wei-wei;XIE Ying;CHEN Zheng-yuan;WU Chang-nian;DING Jie;LIU Qi(Zhangjiakou Food and Drug Inspection Center,Zhangjiakou 075000,China)

机构地区：[1]张家口市食品药品检验中心,河北张家口075000

出　　处：《食品与药品》2024年第4期323-327,共5页Food and Drug

摘　　要：目的 建立血塞通片溶出度检验方法,测定血塞通片中三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Re、人参皂苷Rb_(1)和人参皂苷Rd的整合溶出度。方法 以小杯法进行溶出度实验,采用高效液相色谱法(HPLC)测定5种指标成分的溶出量,采用质量分数权重系数法进行溶出度整合。绘制溶出曲线,采用f_(2)相似因子法比较各成分溶出曲线与整合溶出曲线的相似性,对整合溶出数据进行模型拟合,计算溶出参数T_(50)、T_(d)和T_(85)。结果 以水为溶出介质,转速50 r/min,60 min取样。5种指标成分溶出曲线与整合溶出度溶出曲线的f_(2)相似因子分别为64.5,61.6,79.8,60.0和68.2。溶出数据拟合模型以Weibull模型最优,溶出参数T_(50)、T_(d)和T_(85)分别为12.29 min、18.09 min和56.09 min。结论 建立的溶出度检查方法准确、可行,采用质量分数权重系数法整合溶出度能较好地表征血塞通片的体外溶出行为,可为血塞通片的质量一致性评价研究及质量控制提供技术借鉴。Objective To establish a method for determination of dissolution of Xuesaitong Tablets and determine the integrated dissolution of notoginsenoside R_1,ginsenoside Rg_1,ginsenoside Re,ginsenoside Rb_(1 )and ginsenoside Rd in Xuesaitong Tablets.Methods The small cup method was used and the dissolution of five index components were determined by HPLC.The dissolution was integrated by the mass fraction weight coefficient method.The dissolution curves were drawn and f_(2) similarity factor method was used to compare the similarity between the dissolution curve of each index component and the integrated dissolution curve.The model fitting of the integrated dissolution data was carried out,and the dissolution parameters including T_(50),T_(d) and T_(85) were calculated.Results Water was selected as the dissolution medium.The samples were collected at a speed of 50 r/min during 60 min of dissolution.The f_(2) similarity factors between the dissolution curve of each component and the integrated dissolution curve were64.5,61.6,79.8,60.0 and 68.2,respectively.The Weibull model was the best model to fit the dissolution data.The dissolution parameters T_(50),T_(d )and T_(85) were 12.29 min,18.09 min and 56.09 min,respectively.Conclusion The method for determination of dissolution was accurate and feasible.The in vitro dissolution of Xuesaitong Tablets can be well characterized by integrating dissolution using mass fraction weight coefficient method,which can be used as a technical reference for quality consistency evaluation and quality control of Xuesaitong Tablets.

关 键 词：血塞通片 溶出行为 整合溶出度 溶出曲线 相似因子 

分 类 号：R943[医药卫生—药剂学]