摘要
目的建立金嗓散结丸体外溶出测定方法,并对其溶出情况进行评价。方法采用桨法,分别以水、0.1 mol·L^(-1)盐酸溶液、人工胃液和pH 6.8磷酸盐缓冲液为溶出介质,体积1000 mL,转速100 r·min^(-1)。采用HPLC测定金嗓散结丸中2种成分的累积溶出量。绘制溶出曲线图,以人工胃液为参比,采用相似因子(f2)法进行溶出度比较。采用不同的数据模型对溶出数据进行模型拟合,确定金嗓散结丸的最佳溶出模型。结果在人工胃液和0.1 mol·L^(-1)盐酸溶液中,不同批次的金嗓散结丸2种指标成分溶出行为差异性较小,120 min溶出达到平衡,同一样品2种指标成分的溶出呈现同步性。在水和pH 6.8磷酸盐缓冲液中绿原酸和黄芩苷溶出量较低。在水中,其溶出行为存在显著性差异。各批次金嗓散结丸2种指标成分的溶出数据拟合结果略有不同,主要以Weibull方程的数据模型最佳。结论金嗓散结丸在0.1 mol·L^(-1)盐酸中更有利于其指标成分的溶出,偏碱性溶液对指标成分的溶出影响较大。该研究准确可靠,可用于金嗓散结丸的质量控制,同时也为其质量一致性评价研究及工艺的分析改进提供了数据支撑。
Objective To determine and evaluate the in vitro dissolution of Jinsang Sanjie pills.Methods Water,0.1 mol·L^(-1)hydrochloric acid solution,artificial gastric juice and pH 6.8 phosphate buffer were used as the dissolution media by paddle method with a volume of 1000 mL and a rotation speed of 100 r·min^(-1).The cumulative dissolution of the two components in Jinsang Sanjie pills was determined by HPLC.The dissolution curve was obtained,and the dissolution degree was compared by f2 similarity factor method with the artificial gastric juice as the reference.Different data models were used to fit the dissolution data to determine the optimal dissolution model of Jinsang Sanjie pills.Results There was limited difference in the dissolution behavior of the two index components in different batches of Jinsang Sanjie pills in both the artificial gastric juice and 0.1 mol·L^(-1)hydrochloric acid solution.The dissolution reached equilibrium within 120 min.The two index components in the same sample showed synchronized dissolution.Lower amounts of chlorogenic acid and baicalin were dissolved in water and pH 6.8 phosphate buffer.In water,the dissolution behavior was significantly different.The fitting of dissolution data of each batch of Jinsang Sanjie pills was slightly different,and Weibull model was the best.Conclusion Jinsang Sanjie pills is dissolve better in 0.1 mol·L^(-1)hydrochloric acid.Alkaline solution has a greater effect on the dissolution of the index components.This method is accurate and reliable,which can be used fo the quality control of Jinsang Sanjie pills,and provide data support for the quality consistency evaluation and process analysis improvement.
作者
汪海宣
程庆兵
郑正
许倩
刘静
陶俊钰
WANG Hai-xuan;CHENG Qing-bing;ZHENG Zheng;XU Qian;LIU Jing;TAO Jun-yu(Hefei Center for Food and Drug Control,Hefei 230088)
出处
《中南药学》
2023年第7期1781-1785,共5页
Central South Pharmacy
基金
安徽省药品监督管理局科技创新项目(编号:AHYJ-KJ-202122)。
关键词
金嗓散结丸
溶出行为
HPLC
溶出曲线
相似因子
Jinsang Sanjie pill
dissolution behavior
HPLC
dissolution curve
similarity factor
