复方穿心莲片HPLC含量测定方法研究  

Study on the Determination Method of Fufang Chuanxinlian Tablets by HPLC

作　　者：滕云霞 张飞宇 毛鑫 黄炜忠 Teng Yunxia;Zhang Feiyu;Mao Xin;Huang Weizhong(Guangdong Luofushan Sinopharm Co.,Ltd.,Huizhou 516133,China)

机构地区：[1]广东罗浮山国药股份有限公司研发中心,广东惠州516133

出　　处：《广东化工》2023年第13期201-204,共4页Guangdong Chemical Industry

基　　金：2020年度惠州市级知识产权专项资金项目。

摘　　要：目的:建立复方穿心莲片中穿心莲药材的含量测定方法及含量限度,更好地控制药品质量。方法:采用Kromasil C18(4.6 mm×250 mm,5μm)色谱柱,以甲醇-水(55∶45)为流动相;检测波长分别为225 nm和254 nm,测定穿心莲内酯含量和穿心莲内酯与脱水穿心莲内酯的总量。结果:经方法学考察,该方法具有较好的专属性、准确性、重现性和可行性。穿心莲内酯和脱水穿心莲内酯分别在进样量为0.0506~4.0479μg范围内和0.1007~10.0692μg范围内与峰面积有良好的线性关系;平均回收率(n=6)分别为101.43%(RSD为2.33%)和97.12%(RSD为1.53%);经40批市售样品检测结果分析,本品含量限度除应制定穿心莲内酯和脱水穿心莲内酯的总量外,亦需规定穿心莲内酯的限度。结论:本方法稳定可控,含量限定合理,能较好地控制复方穿心莲片的质量。Objective:To establish a method for the content determination of Andrographis paniculata in Fufang Chuanxinlian Tablets(FCT)and establish content limit,so as to better control the quality of FCT.Methods:A Kromasil C18 column(4.6 mm×250 mm,5μm)was used,methanol-water(55∶45)as mobile phase.The detection wavelength was 225 nm and 254 nm,respectively.Determine the content of andrographolide and the total amount of andrographolide and dehydroandrographolide.Results:The method has good specificity,accuracy,reproducibility and feasibility.Andrographolide and dehydroandrographolide had a good linear relationship with the peak area in the range of 0.0506μg to 4.0479μg and 0.1007μg to 10.0692μg,respectively.The average recoveries(n=6)were 101.43%(RSD 2.33%)and 97.12%(RSD 1.53%),respectively.According to the analysis of the test results of 40 batches of samples,we suggest that apart from the content limit of andrographolide and dehydroandrographolide,the content of andrographolide should also be limited.Conclusion The method is stable and controllable,the content limit is reasonable,and the quality of FCT can be controlled well.

关 键 词：复方穿心莲片 HPLC含量测定 穿心莲内酯 脱水穿心莲内脂 含量限度 

分 类 号：TQ[化学工程]