摘要
目的建立金银花配方颗粒HPLC指纹图谱,并结合化学计量学分析方法比较9家企业产品的质量差异。方法采用高效液相色谱建立254 nm波长下的指纹图谱,与对照品比较,确定特征峰及其归属。测定9家企业的29批产品,通过相似度评价,结合聚类分析(HCA)和主成分分析(PCA),对不同批次金银花配方颗进行质量评价。结果通过建立的29批金银花配方颗粒HPLC指纹图谱确证了17个共有峰,并对其中10个共有峰进行了指认;金银花配方颗粒的相似度为0.84~0.99,样品按厂家基本可聚为一类,其中绿原酸特征峰对指纹图谱影响最大。结论金银花配方颗粒HPLC指纹图谱的构建和化学模式的识别为其质量控制提供了更全面的参考。为科学评价及有效控制其质量提供了可靠的方法。
OBJECTIVE To establish the HPLC fingerprint of Jinyinhua formula granules(JYHFG),and compare the qualities of the products from nine enterprises by chemical metrology analysis.METHODS HPLC was used to establish fingerprint at 254 nm.Twenty-nine batches of products from nine enterprises were determined,and the quality of JYHFG of different batches was evaluated through similarity evaluation,clustering analysis(HCA)and principal component analysis(PCA).RESULTS Seventeen common peaks were confirmed in the HPLC fingerprint of 29 batches of JYHFG,and 10 of them were identified.The similarity of JYHFG was 0.84-0.99,and the samples could be grouped into one category according to enterprise,among which the characteristic peak of chlorogenic acid had the greatest influence on the fingerprint.CONCLUSION The establishment of HPLC fingerprint and the identification of chemical pattern provide a more comprehensive reference for the quality control of JYHFG.It provides a reliable method for scientific evaluation and effective quality control.
作者
王赵
王亚丹
李静
金红宇
马双成
WANG Zhao;WANG Ya-dan;LI Jing;JIN Hong-yu;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2020年第8期631-636,共6页
Chinese Pharmaceutical Journal
