摘要
目的:建立咳特灵片的HPLC指纹图谱研究方法,为咳特灵片的质量标准提出修订建议。方法:采用Kromasil C_(18)柱(4.6 mm×250 mm,5μm)色谱柱,以甲醇(A)-0.05%磷酸溶液(B)为流动相,梯度洗脱,体积流量1.0 mL·min^(-1),柱温35℃,检测波长270 nm,建立咳特灵片指纹图谱。以异牡荆苷为参照峰,采用中药色谱指纹图谱相似度评价系统软件(2012A版)对市售55批咳特灵片进行相似度评价。结果:建立的咳特灵片指纹图谱共确定了11个共有峰,通过对照品指认了9个特征峰化学成分,55批次样品相似度在0.837~0.998之间,平均值为0.984,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:建立了咳特灵片的HPLC指纹图谱,该法简便、准确、重现性好,可用于咳特灵片的质量控制。
Objective:To established an HPLC fingerprint method of Keteling tablets and propose a revision for the quality standard of Keteling tablets.Methods:The chromatographic analysis was performed on a Kromasil C_(18)column(4.6 mm×250 mm,5μm)using a gradient elution of methanol-0.05%phosphoric acid solution delivered at a flow rate of 1.0 mL·min^(-1)at the column temperature of 35℃.The detection wavelength was 270 nm.Taking isovitexin as the reference peak,the similarity of 55 batches of commercially available Keteling tablets was evaluated by the similarity evaluation system software(2012A version).Results:A total of 11 common peaks were identified in the fingerprint of Keteling tablets,and 9 characteristic peaks were identified by the reference substance.The similarity of55 batches of samples ranged from 0.837 to 0.998,with an average of 0.984.Considering the source of medicinal materials and the influence of large-scale production,the similarity of the fingerprints of the test substance and the control should not be less than 0.90.Conclusion:The HPLC fingerprint of Keteling tablets has been established The method is simple,accurate and reproducible,which can be used for the quality control of Keteling tablets.
作者
黄炜忠
王新雨
黄俊忠
乔莉
滕云霞
张曼娜
李华
HUANG Weizhong;WANG Xinyu;HUANG Junzhong;QIAO Li;TENG Yunxia;ZHANG Manna;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)
出处
《中国药品标准》
CAS
2022年第1期29-34,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(2019Z049)。
