穿心莲片中内酯类成分的“一测多评”

目的:建立同时测定穿心莲片中穿心莲内酯、新穿心莲内酯、去氧穿心莲内酯、脱水穿心莲内酯的HPLC方法,在此基础上,建立"一测多评"法的方法学考察方式,验证该方法在穿心莲片质量控制中应用的可行性和技术适用性。方法:以穿心莲片中主要成分脱水穿心莲内酯为指标,建立其与穿心莲内酯、新穿心莲内酯、去氧穿心莲内酯间的相对校正因子,并用该校正因子计算穿心莲内酯、新穿心莲内酯、去氧穿心莲内酯的量,对"一测多评"法的计算值与外标法实测值进行比较。结果:建立了穿心莲片中4种内酯类成分"一测多评"法方法学的考察模式;"一测多评"法对不同的色谱柱和仪器的计算值与外标法实测值之间没有显著性差异。结论:同时测定脱水穿心莲内酯、穿心莲内酯、新穿心莲内酯、去氧穿心莲内酯4种内酯类成分的"一测多评"法方法可靠,结果准确,可用于控制穿心莲片的质量。

Quantitative Analysis of Multi-components with Single Marker for Determination of Lactones in Chuanxinlian Tablets

Objective:To establish an HPLC method for simultaneously measuring the contents of andrographolide,neoandrographolide,deoxyandrographolide and dehydroandrographolide in Chuanxinlian tablets,and on this basis,the multiple components were examined by a single test to validate the method’s feasibility and technical suitability of quality control applications for Chuanxinlian tablets.Methods:Taking dehydroandrographolide,the main component in Chuanxinlian tablets,as an indicator,a relative correction factor between dehydroandrographolide and other Lactones was established.Then the correction factor was used to calculate the contents of the other three lactones in Chuanxinlian tablets.In this way,the calculated value was compared with the external standard method.Results:A measuring method of evaluating the four Lactones in Chuanxinlian tablets was established via using a single test;there was no significant difference compared with the external standard method.Conclusion:The method for simultaneously measuring the content of dehydroandrographolide,andrographolide,neoandrographolide and deoxyandrographolide in Chuanxinlian tablets is reliable and accurate,which could be used to control the quality of Chuanxinlian tablets.