清肺抑火片质量评价  

Quality evaluation for Qingfei Yihuo Tablets

作　　者：张纯 陈叶青 金佩芬 俞秀 金小燕 李建国 宋喆旎 ZHANG Chun;CHEN Ye-qing;JIN Pei-fen;YU Xiu;JIN Xiao-yan;LI Jian-guo;SONG Zhe-ni(Jiaxing Municipal Institute of Food,Drug and Product Quality Control,Jiaxing 314001,China)

机构地区：[1]嘉兴市食品药品与产品质量检验检测院,浙江嘉兴314001

出　　处：《中成药》2023年第11期3540-3547,共8页Chinese Traditional Patent Medicine

基　　金：嘉兴市科技计划项目(2021AY10078)。

摘　　要：目的对清肺抑火片质量进行评价。方法对6个厂家39批样品进行标准项目检验(重量差异、崩解时限、微生物限度),TLC法定性鉴别黄芩、栀子、黄柏、大黄、土大黄苷,HPLC法测定新芒果苷、芒果苷、栀子苷、黄芩苷、盐酸小檗碱、汉黄芩苷、黄芩素、芦荟大黄素、汉黄芩素、千层纸素A、大黄素、白花前胡甲素、大黄酚、大黄素甲醚、白花前胡乙素含量。结果所有批次样品标准项目检验合格率为100%。1家企业10批样品未检出黄芩苷主斑点。各批样品中15种成分含量差异明显,其中1家企业11批样品未检出前胡主要成分(白花前胡甲素、白花前胡乙素)。结论清肺抑火片总体质量不理想,现行标准过于简单而不能全面反映该制剂质量,需引起关注。AIM To evaluate the quality of Qingfei Yihuo Tablets.METHODS The standard item inspections(weight difference,disintegration time limit,microbial limit)were performed in thirty-nine batches of samples from six manufacturers.TLC was adopted in the qualitative identification of Scutellariae Radix,Gardeniae Fructus,Phellodendri chinensis Cortex,Rhei Radix et Rhizoma and rhaponticin.HPLC was applied to determining the contents of neomangiferin,mangiferin,geniposide,baicalin,berberine,wogonoside,baicalein,aloe-emodin,wogonin,oroxylin A,emodin,praeruptorin A,chrysophanol,physcion and praeruptorin B.RESULTS The inspection pass rates of standard items for all batches of samples were 100%.The main spots of baicalin were not detected in ten batches of samples from one manufacturer.The contents of fifteen constituents in various batches of samples demonstrated obvious differences,among which the main components of Peucedani Radix(praeruptorin A,praeruptorin B)were not detected in eleven batches of samples from one manufacturer.CONCLUSION The overall quality of Qingfei Yihuo Tablets was unideal,and current standard is too simple to comprehensively reflect the quality of this preparation,which should be paid attention to.

关 键 词：清肺抑火片 标准项目检验 定性鉴别 含量测定 TLC HPLC 

分 类 号：R283[医药卫生—中药学]