基于生物检测的双黄连片溶出度研究

摘要

It has been difficult to perform dissolution test on solid preparations of traditional Chinese medicines(TCMs).TCMs are different from chemical drugs in that their chemical compositions are complicated.The measurement method based on chemical approach alone is incomplete.In order to solve this problem,in this study a bioassay-based dissolution test was developed.Microcalorimetry was used to obtain growth power-time curves and biothermodynamic parameters of Staphylococcus aureus inhibited by the solution of ShuangHuangLian(SHL)tablet,which was dissolved in phosphate buffer(pH 6.8)for different times.The results of the bioassay-based dissolution test of SHL tablet demonstrated that the bioassay method might be a promising alternative for its quality control.%中药固体制剂的溶出度研究一直是中药现代化的难点问题.中药与化学合成药不同,中药药效物质十分复杂,临床疗效可能取决于其中的未知成分,也可能取决于各个成分的协同作用.单独使用化学方法测定中药固体制剂的溶出度不能全面反映其内在质量,本课题组首次提出基于生物检测的一种新的溶出度评价方法.在试验中,以清热解毒类中药固体制剂双黄连片为模型药,进行了溶出度研究.在pH值为6.8的溶解介质,即磷酸盐缓冲液中双黄连片不同溶出时间的溶液对金黄色葡萄球菌的抑制作用不同,应用微量量热法获得金黄色葡萄球菌的生长功率一时间曲线和该抑制作用的一系列生物热动力学参数.结果表明,基于生物热动力学的方法可以用于控制中药固体制剂的内在质量.生物热活性检测有望成为中药固体制剂体外溶出度评价的重要手段之一.