药学研究2025，Vol.44Issue(6)：547-552,6.DOI:10.13506/j.cnki.jpr.2025.06.005
二值法评价金松止痒洗液质量研究
Evaluating the quality of Jinsong Zhiyang Lotion using the Bi-value method
摘要
Abstract
Objective To establish a Bi-value method for the quality of traditional Chinese medicine(TCM),using the first value macro qualitative similarity(Sm)to identify TCM species,addressing the qualitative question of"whether it is or not,"and using the second macro quantitative similarity(Pm)to comprehensively evaluate the overall content of the finger-print chemicals,thereby addressing the issue of controlling the total amount of pharmacologically active substances.Methods High-performance liquid chromatography(HPLC)was employed to establish the HPLC fingerprint of Jinsong Zhiyang Lotion at a wavelength of 234 nm.Using peak No.20(baicalin)as the reference peak,a total of 30 common fingerprint peaks were identified.The reference fingerprint(RFP)was generated using the average method.Based on the RFP,the quality of 41 batches of Jinsong Zhiyang Lotion was evaluated using the Bi-Value method.Simultaneously,the contents of seven com-ponents—gallic acid,chlorogenic acid,isochlorogenic acid C,baicalin,wogonoside,osthole,and fraxinellone—were deter-mined.Results The quality of the 41 batches of Jinsong Zhiyang Lotion was classified as follows:Grade 1(2 batches:S33,S35);Grade 2(5 batches:S5,S14,S18,S19,S25);Grade 3(9 batches:S3,S7,S9,S15,S16,S17,S23,S26,S30);Grade 4(9 batches:S2,S4,S21,S27,S28,S31,S32,S36,S41);Grade 5(8 batches:S6,S10,S11,S22,S24,S29,S34,S37);Grade 6(5 batches:S1,S8,S12,S20,S40);Grade7(3 batches:S13,S38,S39).Conclusion Based on the HPLC fingerprint of 30 peaks,the macro qualitative similarity(Sm)was used to identify Jinsong Zhiyang Lotion.All Sm val-ues were greater than 0.90,indicating that all 41 batches were indeed Jinsong Zhiyang Lotion,thus resolving the qualitative identification issue.The macro quantitative similarity(Pm)was used to comprehensively evaluate the overall content of the 30 fingerprint components.The Pm values ranged from 56.1％to 140.2％,effectively distinguishing the total content of phar-macologically active substances in the 41 batches of Jinsong Zhiyang Lotion.Therefore,using these two numerical indicators,the quality of TCM can be evaluated holistically.This method is simple,convenient,easy to interpret,and facilitates the judg-ment of TCM quality characteristics.关键词
二值法/高效液相色谱指纹图谱/金松止痒洗液/质量控制/含量测定Key words
Bi-value method(BVM)/High-performance liquid chromatography(HPLC)/Jinsong Zhiyang Lotion/Quality control/Content determination分类
医药卫生引用本文复制引用
李文颖,兰丽丽,孙万阳,阳永彤,孙国祥..二值法评价金松止痒洗液质量研究[J].药学研究,2025,44(6):547-552,6.基金项目
国家自然科学基金项目(No.81573586) （No.81573586）
