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机构地区:[1]中国医科大学附属第一医院药学部,沈阳110001 [2]沈阳药科大学药学院,沈阳110016
出 处:《中南药学》2015年第9期897-900,共4页Central South Pharmacy
基 金:国家自然科学基金重大研究计划课题(No.90612002)
摘 要:目的建立牛黄解毒片(Niuhuang Jiedu tablets,NHJDT)高效毛细管电泳法(HPCE)指纹图谱,按系统指纹定量法评价其质量。方法采用高效毛细管电泳法,以甘草苷为参照物峰,确定19个共有指纹峰,建立了NHJDT-HPCE指纹图谱。以宏定性相似度Sm和宏定量相似度Pm为参量对15批NHJDTs进行聚类分析,确定用其中10批生成对照指纹图谱(RFP),以此RFP为标准用系统指纹定量法鉴别评价15批NHJDTs质量。结果鉴别出9批质量合格,1批均化系数相对偏差偏高,4批含量明显偏低,1批含量明显偏高。结论将系统指纹定量法评价HPCE指纹图谱的结果与HPLC结果相比较,结果基本一致,证明系统指纹定量法评价中药质量具有真实、可靠与准确的特点。Objective To establish and assess high performance capillary electrophoresis(HPCE) fingerprints of Niuhuang Jiedu tablets(NHJDT) by systematic quantified fingerprint method(SQFM). Methods The chromatographic fingerprints(CFPs) were determined by HPCE, in which the CFPs containing 19 co-possessing peaks were marked by choosing liquiritin peak as the referential peak. Fifteen batches of NHJDTs were identified by hierarchical clustering analysis using macro qualitative similarities and macro quantitative similarities as variables. According to the classification, the referential fingerprint(RFP) was synthesized from 10 batches of NHJDTs. With the RFP for the qualified model, the 15 batches of NHJDTs were evaluated by SQFM. Results Among the 15 batches of NHJDTs, 9 were completely qualified; the relative variance of leveling coefficient of 1 batch was obviously high; the contents of other 4 batches were low and 1 batch was high. Conclusion HPCE fingerprints evaluated by SQFM were compared with HPLC and were consistent, suggesting the SQFM is authentic and reliable.
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