Abstract：OBJECTIVE To establish a quality evaluation method of Ningxinbao capsules based on HPLC fingerprint, quantitative analysis of multi-components and chemometrics. METHODS The fingerprint of Ningxinbao capsules was established by HPLC. Six common peaks were identified as uracil, hypoxanthine, uridine, adenine, guanosine, and adenosine by comparison with reference substances, and their contents in samples were simultaneously determined. The chemometrics methods such as hierarchical clustering heat map analysis and principal component analysis were used to evaluate the quality of Ningxinbao capsules from different manufacturers based on the results of fingerprint and content determination. RESULTS The similarity of samples from 27 different manufacturers ranged from 0.656 to 0.997. Hierarchical clustering heat map analysis and principal component analysis showed that the samples from 27 different manufacturers were clearly divided into two categories. The main influencing factors were fingerprint similarity and the contents of uridine, guanosine and total nucleosides. Different sources of raw materials were the main reasons for the quality differences between samples from different manufacturers. The purity of strain in raw materials was the key factor affecting the quality of Ningxinbao capsules. CONCLUSION The method is accurate and reliable, and it can be used to control and comprehensively evaluate the quality of Ningxinbao capsules.
张琳琳, 张文婷, 唐登峰, 马临科, 马双成. 基于指纹图谱、多指标含量测定及化学计量学的宁心宝胶囊质量评价[J]. 中国药学杂志, 2019, 54(17): 1425-1431.
ZHANG Lin-lin, ZHANG Wen-ting, TANG Deng-feng, MA Lin-ke, MA Shuang-cheng. Quality Evaluation of Ningxinbao Capsules Based on Combinative Method of HPLC Fingerprint, Quantitative Analysis of Multi-components and Chemometrics. Chinese Pharmaceutical Journal, 2019, 54(17): 1425-1431.
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