目的 建立指纹图谱和多指标定量与化学计量学相结合的宁心宝胶囊质量评价方法。方法 采用HPLC建立宁心宝胶囊的指纹图谱,共标定 6个共有峰,通过对照品比对指认分别为尿嘧啶、次黄嘌呤、尿苷、腺嘌呤、鸟苷和腺苷,并同时测6个共有峰的含量。基于指纹图谱和含量测定结果,采用聚类热图分析和主成分分析等化学计量学方法对不同厂家生产的宁心宝胶囊进行质量评价。结果 27个厂家产品指纹图谱相似度为0.656~0.997。聚类热图分析和主成分分析表明,27个厂家产品明显分成两类,影响因素主要是尿苷、鸟苷、核苷总量和指纹图谱相似度。原料来源不同是导致不同厂家产品质量差异主要原因,而原料药菌种纯度是影响宁心宝胶囊质量的关键因素。结论 该方法准确可靠,可用于宁心宝胶囊的质量控制和综合评价。
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.
关键词
宁心宝胶囊 /
指纹图谱 /
含量测定 /
聚类热图 /
主成分分析 /
质量评价
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Key words
ningxinbao capsules /
fingerprint /
quantitative analysis /
hierarchical clustering heat map /
principal components analysis /
quality evaluation
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中图分类号：
R284
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参考文献
[1] Drug Specifications Promulgated by the Ministry of Public Health,PR China(卫生部药品标准).Vol 11(第十一册)[S]. 1996:55.
[2] ZENG J H. Clinical studies of trimetazidine combined with Ningxinbao in the treatment of arrhythmias induced by acute inferior wall myocardial infarction[J]. Chin Med Pharm(中国医药科学), 2015, 5(8):51-54.
[3] TAO Y Z, ZHAO X Q, LIU J H, et al. Clinical application of Ningxinbao capsule combined with amiodarone in unstable angina pectoris with ventricular arrhythmia[J]. Hainan Med J(海南医学), 2014, 25(15):2266-2268.
[4] YOU M L. Fermentation Cordyceps fungal substance and the main natural Cordyceps activity ingredients comparative study[J]. Biothchnol Bull(生物技术通报),2009,25(2):129-131.
[5] ZHAO J, XIE J, WANG L Y, et al. Advanced development in chemical analysis of Cordyceps[J]. J Pharm Biomed Anal, 2014, 87:271-289.
[6] XIAO X Y, LI Y K, ZHANG P, et al. RIP-HIPLC Determination of nucleosides in ningxingbao capsules[J]. Chin J Pharm Anal(药物分析杂志), 2007, 27(10):1592-1597.
[7] CHEN W, HUANG K H, FU T, et al. Research on analytic methods of nucleotides in cordyceps preparation [J]. Tianjin Agri Sci(天津农业科学), 2011,17(1):37-39.
[8] HUANG X D, LIU W, XU X Y, et al. Study on HPLC fingerprint and simultaneous determination of four nucleosines in Ningxinbao capsules[J]. Chin Pharm(中国药师), 2016,19 (3):488-491.
[9] SUN L, ZHANG C, TIAN R T, et al. A holistic strategy of identification and quality evaluation of frankincense by chromatographic fingerprint combined with chemometrics[J]. Chin Pharm J(中国药学杂志), 2015, 50(2):140-146.
[10] YU X L, BAO R, CAI L, et al. Multiwavelength detection and multivariate analysis for Tongzhi Sunrunjiang Preparation with substitute reference substance method by high performance liquid chromatography[J]. Chin Pharm J(中国药学杂志), 2018, 53(18):71-79.
[11] ZHONG C C, FENG Y L.HPLC Fingerprint analysis of caulis of Chimonanthus nitens combined with chemometrics method[J]. Chin Pharm J(中国药学杂志), 2017, 52(21):1944-1947.
[12] CHEN C J, XIA R, CHEN H, et al. TB tools, a Toolkit for Biologists integrating various HTS-data handling tools with a user-friendly interface [J]. Biorxiv, 2018,doi: https://doi.org/10.1101/289660.
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脚注
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基金
国家药典委员会药品医疗器械审评审批制度改革子课题资助(ZG2016-2-04)
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