复方穿心莲片HPLC指纹图谱研究  

Fingerprint analysis of compound Andrographis paniculate tablets by HPLC

作　　者：黄炜忠 毛鑫 黄俊忠[2] 乔莉[2] 滕云霞 张飞宇 李华[2] HUANG Weizhong;MAO Xin;HUANG Junzhong;QIAO Li;TENG Yunxia;ZHANG Feiyu;LI Hua(Guangdong Luofushan Sinopharm Co.,Ltd.,Huizhou 516133,China;Guangdong Institute for Drug Control,Key Laboratory of Rapid Drug Testing Technology of the State Drug Administration,Guangdong Biomedical Technology Collaborative Innovation Center,Guangzhou 510663,China)

机构地区：[1]广东罗浮山国药股份有限公司,广东惠州516133 [2]广东省药品检验所,国家药品监督管理局药品快速检测技术重点实验室,广东省生物医药科技协同创新中心,广州510663

出　　处：《中国药品标准》2021年第5期424-429,共6页Drug Standards of China

基　　金：国家药典委员会药品标准制修订研究课题(2019Z025)。

摘　　要：目的:建立复方穿心莲片指纹图谱研究方法,为复方穿心莲片的质量标准提出修订建议。方法:采用Thermoscientific Syncronis aQ C_(18)(4.6 mm×250mm,5μm)色谱柱,以乙腈(A)-0.2%磷酸溶液(B)为流动相,梯度洗脱;以270 nm为检测波长,柱温为30℃,流速为1.0 mL·min^(-1),建立复方穿心莲片指纹图谱,利用“中药色谱指纹图谱相似度评价系统(2012版)”对市售65批次复方穿心莲片进行相似度评价。结果:建立的复方穿心莲片指纹图谱共确定6个共有峰,65个批次相似度在0.449~0.994之间且差异较大,平均值为0.927,考虑到药材的来源及大生产带来的影响,认为供试品指纹图谱与对照指纹图谱的相似度应不得低于0.90较为合理。结论:本方法稳定可控,可用于复方穿心莲片的质量控制。Objective:To establish a fingerprint analysis of compound Andrographis paniculate tablets(CAT),and to propose amendments to the quality standard of CAT.Methods:The fingerprint of CAT was established using a Thermo Scientific Syncronis aQ C_(18)column(4.6 mm×250 mm,5μm)with a gradient elution of acetonitrile-0.2%phosphoric acid solution delivered at a flow rate of 1.0 mL·min^(-1).The detection wavelength was 270 nm and column temperature was 30℃.The similarity evaluation of 65 batches of CAT was tested using the“Chinese medicine chromatographic fingerprint similarity evaluation system(2012 version)”.Results:A total of 6 common peaks were identified in the fingerprint spectrum of CAT.The similarity of 65 batches varied greatly from 0.449 to 0.994 with an average value of 0.927.Considering the source of the herb and the impact of large-scale production,the similarity between the fingerprint of the test product and the comparison fingerprint should be no less than 0.90.Conclusion:This method is stable and controllable,and can be used for the quality control of CAT.

关 键 词：复方穿心莲片 质量标准 指纹图谱 

分 类 号：R921.2[医药卫生—药学]