Abstract：OBJECTIVE To apply reference drug in the fingerprint study of Niuhuang qingwei pills, and perform primary evaluation of the quality grade of the samples. METHODS Ultra performance liquid chromatography (UPLC) separation was performed on an AQUITY UPLC BEH C18 column with gradient elution using acetonitrile (containing 0.5% formic acid)-0.5% formic acid at a flow rate of 0.2 mL·min-1. The injection volume was 2 μL and the column temperature was maintained at 40 ℃. The detection wavelength was set at 254 nm. By comparing with reference substances and the reference herbal materials, characteristic peaks and their ascriptions were investigated. Using Niuhuang qingwei pills reference drug as the accompanying physical control, the similarities of the fingerprints of 49 batches of samples from 18 manufacturers were calculated, and the quality grades were evaluated. RESULTS The similarities of all samples fell within the range of 0.76-0.98. The similarities of 49 samples were above 0.75 and met the second-grade limit. The similarity of 24 samples were above 0.90 and met the first-grade limit. CONCLUSION The method is simple, accurate and rapid. It can be used for the quality control and grade evaluation of Niuhuang qingwei pills, which provides reference for the quality grade research of Chinese patent medicines.
查祎凡, 聂黎行, 于健东, 戴忠, 马双成. 基于超高效液相色谱法和对照制剂的牛黄清胃丸指纹图谱研究和质量等级初评价[J]. 中国药学杂志, 2019, 54(17): 1438-1441.
ZHA Yi-fan, NIE Li-xing, YU Jian-dong, DAI Zhong, MA Shuang-cheng. Fingerprint Study and Primary Quality Evaluation of Niuhuang Qingwei Pills Based on UPLC and Reference Drug. Chinese Pharmaceutical Journal, 2019, 54(17): 1438-1441.
Drug specifications promulgated by the ministry of public health, PR China.Traditional Chinese Medicine Prescription Preparation.Vol Ⅰ(中药成方制剂第一册)[S] . 1988:38.
[2]
YUE C Q, WANG Y H, LI C L, et al. Experimental study on primary pharmacodynamics of Niuhuang Qingweiwan[J]. China J Chin Mater Med(中国中药杂志),2007,32(10):957-960.
[3]
WANG Y H ,ZHENG Y, FU L J, et al. Study on pharmacodynamics of Niuhuang Qingwei Pills[J]. J Chin Med Pharmacol(中医药学报),2007,35(3):15-18.
[4]
ZENG F Y. Clinical study on Niuhuang Qingwei Pills combined with periocline in treatment of peri-implantitis[J]. Drugs Clin(现代药物与临床),2016,31(5):667-672.
[5]
NIE L X, ZHA Y F, HU X R, et al. Whole-ingredient identification and primary grade evaluation of Niuhuang Qingwei Pills based on reference drug[J]. China Tradit Herb Drugs(中草药),2018,49(22):5320-5327.
[6]
NIE L X, ZHA Y F, ZUO T T, et al. Determination and risk assessment of heavy metals and harmful elements residues in Niuhuang Qingwei Pills based on ICP-MS[J]. China J Chin Mater Med(中国中药杂志),2019,44(1):82-87.
[7]
NIE L X, ZHA Y F, CHEN Y H, et al. Quality evaluation of gypsum fibrosum in Niuhuang Qingwei Pills based on ICP-MS and reference drug[J]. Environ Chem(环境化学),2018,37(10):2322-2325.
[8]
YAO L W, LIU Y, ZHENG X W, et al. Application of the fingerprint and characteristic fingerprint technology in traditional Chinese medicinal materials and Chinese patent medicine[J]. Chin New Drugs J(中国新药杂志),2018,27(8):934-939.
[9]
ZOU C C, YAN H Y. Research progress on chromatographic fingerprint similarity evaluation method for traditional Chinese medicine in the past 30 years 1988-2017 and its prospect[J]. China J Chin Mater Med(中国中药杂志),2018,43(10):1969-1977.
[10]
XU S, SHANG M Y, LIU G X, et al. High-performance liquid chromatography fingerprint analysis of Smilacis Glabrae Rhizoma and its adulterants[J]. Chin Pharm J(中国药学杂志),2017,52(12):1011-1017.
[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]
ZHOU W X, LIU T, LIU Q, et al. HPLC and physical fingerprint of Chuanxiong Rhizoma standard decoction[J]. China Tradit Herb Drugs(中草药),2018,49(21):5107-5115.
[13]
MA L Y, MA S C. Development and prospect of TCM reference standards[J]. Chin Pharm Aff(中国药事),2010,24(12):1232-1235.
[14]
NIE L X, DAI Z, MA S C. Guideline principle and technical requirement for preparing traditional Chinese medicine reference drug[J]. China J Chin Mater Med(中国中药杂志),2017,42(19):3672-3675.
[15]
GENG T, ZHANG Z J, LI Y J. Quality evaluation of Guizhi Fuling capsule using self-control method of reference Chinese medicine preparation[J]. China J Chin Mater Med(中国中药杂志),2014,39(21):4127-4132.
[16]
SUN G X, ZHANG Y, GAO J Y, et al. Selection of Guanxin Suhe Pill reference preparation by internal standard quantified fingerprints method[J]. China Tradit Herb Drugs(中草药),2014,45(5):642-647.
2019, Vol. 54 
