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目的建立牛黄解毒片(NHJDTs)5波长高效液相色谱(HPLC)均谱,用系统指纹定量法评价均谱和主成分分析评价12个指数。方法采用RP-HPLC法,将5波长HPLC指纹谱进行平均拟合得到均谱并用系统指纹定量法评价15批NHJDTs质量,用主成分分析法评价5波长HPLC指纹均谱的12指数,二者进行比较。结果以黄芩苷为参照物峰,确定51个指纹峰,建立了NHJDT-HPLC 5波长拟合均谱。用系统指纹定量法鉴别出9批质量合格,4批含量明显偏低,1批化学成分数量和分布比例不合格,1批因均化系数偏高不合格。结论用系统指纹定量法评价5波长均谱和主成分分析法评价12个指数代表的质量结果基本一致,证明系统指纹定量法评价中药质量具有真实、可靠与准确特点。
OBJECTIVE To establish a 5-wavelength high-performance liquid chromatography (HPLC) chromatogram of Niuhuangjiedu tablets (NHJDTs) and evaluate 12 indexes using the method of systematic fingerprint quantitative analysis and principal component analysis. Methods Fifteen batches of NHJDTs were determined by RP-HPLC method. The five-wavelength HPLC fingerprints were averaged and the 12 finger indexes were evaluated by principal component analysis Compare Results Baicalin was used as a reference peak, 51 fingerprint peaks were identified, and the NHJDT-HPLC 5-wavelength fitting spectrum was established. Nine batches of samples were identified by systematic fingerprinting. The content of four batches of batches was significantly lower than that of the first batches. The batches of batches of batches of batches of batches of batches of batches were unqualified. Conclusions The results of systematic fingerprinting quantitative assessment of 5-wavelength HVDC and principal component analysis showed that the quality of 12 indexes was basically the same. It was proved that the system fingerprinting quantitative method has the characteristics of authenticity, reliability and accuracy.