Abstract：OBJECTIVE To establish a method combining triterpenoids fingerprint with chemometric analysis based on reference drug, and determine 89 batches of samples to evaluate the quality of Ganoderma preparations. METHODS The samples were extracted by ultrasonic with methanol, chromatography was performed on Agilent TC C18(2) column (4.6 mm×250 mm, 5 μm) with gradient elution with acetonitrile and 0.02% phosphoric acid aqueous solution. The detection wavelength was set at 254 nm. Principal component analysis and HCA heatmap were used for data analysis. RESULTS The chromatographic fingerprint has 56 characteristic peaks. By comparing the samples with the reference drug, it was found that Ganoderma preparations were produced using Ganoderma lucidum by almost all manufacturers. Principal component analysis, HCA heatmap analysis and similarity analysis divided the samples into three categories. The first type had characteristic peaks and peak areas which were consistent with the reference drug, and the quality was better. The second type had characteristic peaks which consistent with the reference drug, but the peak areas were smaller and the quality was medium. And the third type was different from the reference drug, which was the problem sample. The strong characteristic peaks for classification of different samples were peak 26, peak 31, peak 24, peak 32 and peak 18. CONCLUSION The method is comprehensive, accurate and specific, and it can be used for comprehensive quality evaluation of triterpenoids in Ganoderma preparations.
于新兰, 王雪, 严丽, 孙磊. 基于对照制剂的灵芝制剂HPLC三萜指纹图谱化学计量学分析[J]. 中国药学杂志, 2020, 55(4): 298-304.
YU Xin-lan, WANG Xue, YAN Li, SUN Lei. Chemometric Analysis of HPLC Fingerprint of Triterpenoids in Different Ganoderma Preparations Based on Reference Drug. Chinese Pharmaceutical Journal, 2020, 55(4): 298-304.
YE P F,ZHANG M P,WANG K Y,et al. The research progress on the components and pharmacological effects of Ganoderma lucidum [J]. Edib Med Mushrooms(食药用菌),2013(3):158-161.
ZHANG R T, ZHOU T, SONG X X, et al. Research progress on active ingredients and pharmacological action of Ganoderma lucidum [J]. J Anhui Agric Sci(安徽农业科学),2018,46(3):18-19.
LU X H, MA A H, WANG N, et al. Study on polysaccharide content and stability of Ganoderma capsules [J]. Chin J New Drugs(中国新药杂志),2003,12(6):451-453.
JIANG W, ZHOU G S, CHEN X P, et al. Content determination of polysaccharides, triterpenoids and sterols of Ganoderma Lucidum Pieces by ultraviolet-visible spectrophotometry [J]. China Pharm(中国药业),2018,27(14):9-11.
ZHONG S F, LIU Y P, LI Y P, et al. Study on the monosaccharide content of polysaccharide in Ganoderma Lucidum capsule by HPLCESI-MS [J]. Chin J Anal Lab(分析试验室),2016,35(11):1285-1289.
JIANG L Z, HU D L, XI J F, et al. Determination of adenosine in Ganoderma lucidum capsules by RP-HPLC [J]. Chin Tradit Pat Med(中成药),2012,34(2):377-379.
YAN H, ZHANG Y M, SONG J C, et al. Idenitifcation of adenosine and adeinne, and determination of adenosine in Ganoderma capsules [J]. Chin J Pharm Anal(药物分析杂志),2008,28(11):1800-1803.
QIU W W, WENG X P. Quality standard research and quality evaluation of Ganoderma lucidum capsules [J]. J Chin Med Mater(中药材),2005,28(9):827-828.
LI B M, GU H F, LI Y, et al. Determination of nine triterpenoid acids from Ganoderma lucidum of different producting areas by HPLC [J]. China J Chin Mater Med(中国中药杂志),2012,37(23):3599-3603.
JIA H Y, WANG Y T, ZHANG H Z, et al. Determination of triterpenoids in Ganoderma lingzhi from different areas and species by HPLC [J]. Microbiol China(微生物学通报),2017,44(1):238-244.
GU Z Y, WENG X C. RP-HPLC Fingerprint for quality assessment of Ganoderma lucidum [J]. J Shanghai Univ (Nat Sci)(上海大学学报:自然科学版),2008,14(6):652-655.
XIE P S, YAN Y Z. Chromatographic Fingerprints for the Detailed Illustration of the Quality of Herbal Medicines(中药色谱指纹图谱精细分析图集)[M]. Fujian:Science and Technology Press,2015.
DING P, QIU J Y, LIANG Y J, et al. Study on fingerprint of chemical components of Ganoderma lucidum [J]. China J Chin Mater Med(中国中药杂志),2009,34(18):2356-2358.
MA H X, LIN F L, LIU Y L, et al. Quantitative and fingerprint of Ilex pubescens Slices [J]. Chin J Exp Tradit Med Form(中国实验方剂学杂志),2019,25(13):140-150.
WANG Y Y, WANG X F, LIU J, et al. Fingerprint of epimedium wushanense based on principal component, factor and cluster analysis [J]. Chin J Exp Tradit Med Form(中国实验方剂学杂志), 2019, 25(7):165-172.
ZHOU M N, WANG Y J, ZHANG Y, et al. Investigation of compatible stability of Xingnaojing Injection based on HPLC fingerprint and principal component analysis [J]. Chin J Exp Tradit Med Form(中国实验方剂学杂志),2019,25(19):80-86.
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.
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]. Chin Tradit Herb Drugs(中草药),2018,49(22):5320-5327.
SUN G X, HOU Z F, ZHANG C L, et al. Comparison between the qualitative similarity and the quantitative similarity of chromatographic fingerprints of traditional Chinese medicines [J]. Acta Pharm Sin(药学学报),2007,42(1):75-80.
YU X L, BAO R, CAI L, et al. Multiwavelength detection and multivariate analysis for Tongzhi Surunjiang Preparation with substitute reference substance method by high performance liquid chromatography [J]. Chin Pharm J(中国药学杂志),2018,53(18):1592-1602.