银翘解毒丸质量评价方法研究  

Quality Assessment of Yinqiao Jiedu Pills

作　　者：杨美丽[1] 张少杰[1] 杨金蕊[1] 杜冬勤 王楠 YANG Meili;ZHANG Shaojie;YANG Jinrui;DU Dongqin;WANG Nan(Baoding Institute for Food and Drug Control,Baoning,Hebei,China 0712000)

机构地区：[1]河北省保定市食品药品检验所,河北保定071000

出　　处：《中国药业》2021年第5期63-69,共7页China Pharmaceuticals

基　　金：河北省保定市科技计划项目[1951ZF088]。

摘　　要：目的建立银翘解毒丸指纹图谱及多成分同时定量分析法,为其质量控制及评价提供技术支持。方法采用高效液相色谱-二极管阵列(HPLC-DAD)法建立指纹图谱,并同时测定绿原酸、连翘酯苷A、牛蒡苷3个指标性成分的含量,对26批银翘解毒丸进行分析;采用高效液相色谱-蒸发光散射(HPLC-ELSD)法初步筛查山银花替代金银花非法投料情况。结果银翘解毒丸指纹图谱中标定了15个共有峰,相似度为0.709~0.997;聚类分析结果显示,指纹图谱相似度为0.85以下的样品为质量存疑。26批样品中有5批质量存疑;2批绿原酸及牛蒡苷的含量极低,3批连翘酯苷A的含量极低,质量分析结果与指纹图谱结果具有一致性。26批样品中,山银花阳性检出3批,阳性检出率为11.54%。结论该方法准确、可靠,可检测不按标准投料、非法投料等问题,可用于银翘解毒丸的质量控制及评价。Objective To establish the fingerprint and multi-component quantitative analysis of Yinqiao Jiedu Pills,and to provide reliable technical support for its quality control and assessment.Methods High-performance liquid chromatography-diode array detector(HPLC-DAD)was used to establish the fingerprint and simultaneously determine the contents of chlorogenic acid,forsythiaside A and arctiin in 26 batches of Yinqiao Jiedu Pills.HPLC-evaporative light scattering detector(ELSD)was used to screen the illegal substitution of Lonicerae Flos for Lonicerae Japonicae Flos.Results There were 15 common peaks were identified in the established fingerprint of Yinqiao Jiedu Pills and the similarity was 0.709-0.997.The cluster analysis showed that the samples with a similarity of less than0.85 were of questionable quality.Among the 26 batches of samples,there were five batches of samples with questionable quality,the contents of chlorogenic acid and arctiin in two batches were extremely low,and forsythiaside A in three batches was extremely low,and the quality analysis results were consistent with the fingerprints.Among the 26 batches of samples,Lonicerae Flos(positive samples)could be detected in the batches of samples,and the positive rate was 11.54%.Conclusion The method is accurate and reliable,which can be used for the quality control and assessment of Yinqiao Jiedu Pills.

关 键 词：银翘解毒丸 指纹图谱 多成分定量分析 非标准检验 质量控制 质量评价 

分 类 号：R932[医药卫生—生药学] R284[医药卫生—药学]