流通池法测定消糜栓5种成分溶出度的研究

Study on the determination of five indexes dissolution in Xiaomi suppository by flow-cell dissolution method

关键词:  消糜栓  流通池法  溶出度

Key words:  xiaomi suppository  flow-cell dissolution method  dissolution

摘要:

[目的]研究流通池法测定消糜栓中5种指标成分溶出度。[方法]采用流通池闭合装置，在流通池内以层流方式流动，分别考察不同流速，不同溶出介质下消糜栓指标成分的溶出度特性，对不同溶出条件下5种指标成分的溶出度进行统计学分析。[结果]在8 mL/min的流速下分别以水和醋酸-醋酸钠缓冲液（pH 4.5）作为溶出介质对于测定消糜栓中儿茶素、表儿茶素、人参皂苷Re的溶出度无显著影响，对于测定苦参碱、盐酸小檗碱的溶出度具有显著性影响；水作为溶出介质时，分别以4、8和16 mL/min为流速对于测定消糜栓中苦参碱、儿茶素、表儿茶素的溶出度具有显著影响。[结论]流通池法不同参数的设定对消糜栓中指标成分的溶出度测定具有重要的影响。

Abstract:

[Objective] Determination of dissolution rate of five indexes in Xiaomi suppository by flow-celldissolution method.[Methods] Using the closing device of flow-cell, The flow in the laminar mode was used to investigate the dissolution characteristics of the main components of the Xiaomi suppository at different flow rates and in different dissolution media. The dissolution rate of five index components under different dissolution conditions was statistically analyzed.[Results] At the flow rate of 8 mL/min,with waterand acetate buffer (pH4.5) as dissolution medium has no significant effect on the determination of dissolution rate of catechin, epicatechin, ginsenoside Re and has significant effect on the determination of dissolution rate of matrine and berberine hydrochloride. When water was used as dissolution medium, the dissolution rate of matrine, catechin and epicatechin was significantly influenced by the flow rate of 4 mL/min, 8 mL/min and 16 mL/min.[Conclusion] The setting of different parameters in the flow cell method has important influence on the determination of dissolution rate of index components in Xiaomi suppository.