清肺抑火片的质量标准提升研究  

Study on the Improvement of Quality Standard of Qingfei Yihuo Pian

作　　者：田淋淋 高嵩 刘欣 李﹐双 张斌 宋艳朋 徐建 TIAN Lin-lin;GAO Song;LIU Xin;LI Shuang;ZHANG Bin;SONG Yan-peng;XU Jian(Key Laboratory of Key Engineering Technology for Standardization of Traditional Chinese Medicine in Jilin ProvinceJilin XiuZheng Pharmaceutical New Drug Development Co.,Ltd.,Changchun,Jilin,130103;XiZheng Pharmaceutical Group Co.,Ltd.,Baishan,Jilin,134000)

机构地区：[1]吉林修正药业新药开发有限公司,吉林省中药标准化关键工程技术重点实验室,长春130103 [2]修正药业集团股份有限公司,通化134000

出　　处：《人参研究》2021年第1期34-36,共3页Ginseng Research

基　　金：吉林省科技发展计划项目,项目编号:20170307013YY.

摘　　要：目的提高清肺抑火片的质量标准。方法采用显微鉴别法,薄层色谱(TLC)法对制剂中的大黄、桔梗,黄柏、苦参进行定性鉴别;采用高效液相色谱(HPLC)法对栀子中栀子苷进行定量分析。结果在显微鉴别中检出草酸钙簇晶大,直径60~140μm(大黄)。联结乳管直径14~25μm,含淡黄色颗粒状物(桔梗);在薄层色谱中检出黄柏.苦参;栀子苷进样量在0.154~3.083μg范围内线性关系良好,r=0.9999,平均加样回收率99.80%,RSD=0.43%(n=6)。结论所建立的方法准确,可靠,专属性强,可有效控制该制剂的质量。Objective To improve the quality standard of Qingfei Yihuo pian.Methods Microscopic identification and TLC were used to qualitatively identify rhubarb,platycodon,phellodendron,andsophora flavescens in the preparation;HPLC was used to quantitatively analyze geniposide ingardenia.Results The large clusters of calcium oxalate were detected in the microscopicidentification,with a diameter of 60~140μm(rhubarb).The connecting milk tube has a diameter of 14~25μm and contains light yellow granular material(platycodon);Phellodendron and Sophoraflavescens were detected in TLC;the injection amount of geniposide has a good linear relationshipwithin the range of 0.154~3.083μg.r=0.9999,The average sample recovery rate was 99.80%,RSD=0.43%(n=6).Conclusion The established method is accurate,reliable and specific,and caneffectively control the quality of the preparation.

关 键 词：清肺抑火片 显微 薄层色谱 高效液相色谱 栀子苷 

分 类 号：R286.0[医药卫生—中药学]