基于对照品和对照提取物的2个含玄参复方和制剂定量研究  

Quantitative study of two formulation and preparation containing Scrophulariae Radix based on reference substances and reference extract

作　　者：杨帆[1] 蒋丽娟 高艳艳 孙萌[1] 李想 姜艳艳[1,2] 刘斌 YANG Fan;JIANG Li-juan;GAO Yan-yan;SUN Meng;LI Xiang;JIANG Yan-yan;LIU Bin(School of Chinese Pharmacy,Beijing University of Chinese Medicine,Beijing 102488,China;Key Laboratory of Discovery of Effective Substances in Classical Prescriptions of Traditional Chinese Medicine,State Administration of Traditional Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]国家中医药管理局“中药经典名方有效物质发现”重点研究室,北京102488

出　　处：《药物分析杂志》2022年第10期1838-1849,共12页Chinese Journal of Pharmaceutical Analysis

基　　金：国家自然科学基金资助项目(81774101)。

摘　　要：目的:基于玄参对照提取物和玄参中主成分化学对照品,分别建立四妙勇安汤和玄麦甘桔颗粒含量测定方法,探讨中药对照提取物代替单体对照品在中药复方质量控制中应用的合理性与科学性。方法:采用高效液相色谱法,使用SunFire C_(18)色谱柱(250 mm×4.6 mm,5μm),以甲醇(A)-0.05%磷酸水溶液(B)为流动相,梯度洗脱,流速1.0 mL·min^(-1),检测波长210 nm(检测哈巴苷)、280 nm(检测哈巴俄苷)、330 nm(检测安格洛苷C),柱温35℃,进样量10、20μL。分别以哈巴苷、安格洛苷C、哈巴俄苷3个对照品和已知含量的玄参对照提取物为对照,分别建立四妙勇安汤和玄麦甘桔颗粒的HPLC含量测定方法,测定2种复方制剂中3个成分的含量,采用t检验法对2种方法所得结果进行比较。结果:对照品法测得四妙勇安汤中3个成分的含量分别为0.1329、0.0421、0.0325 mg·mL^(-1),对照提取物法测得的含量分别为0.1331、0.0420、0.0324 mg·mL^(-1),3个成分对应的P值分别为0.665、0.284、0.661;对照品法测得玄麦甘桔颗粒中3个成分的含量分别为0.0351、0.0122、0.0063 mg·mL^(-1),对照提取物法测得的含量分别为0.0353、0.0122、0.0064 mg·mL^(-1),3个成分对应的P值分别为0.173、0.586、0.157。t检验结果显示,P值均>0.05,2种方法无显著性差异。结论:该研究结果为玄参对照提取物替代对照品对四妙勇安汤和玄麦甘桔颗粒进行含量测定提供了科学依据,为中药对照提取物替代单体对照品在中药复方质量控制应用的可行性和实用性奠定了研究基础,为中药复方质量控制研究提供新的研究思路。Objective:To establish the content determination method of Simiao Yongan decoction and Xuanmai Ganjie granules,based on the Scrophulariaceae Radix reference extract(SRRE)and the reference substances of main components in Scrophulariae Radix,so as to explore the feasibility and rationality of the application oftraditional Chinese medicine reference extract in the quality control of Chinese formulations in place of monomer reference substance.Methods:The separation was performed by HPLC using a SunFire C_(18)column(250 mm×4.6 mm,5μm)with methanol(A)and 0.05%phosphoric acid aqueous solution(B)as the mobile phase in gradient elution at a flow rate of 1.0 mL·min^(-1).The detection wavelengths were 210 nm(harpagide),280 nm(harpagoside)and 330 nm(angoroside C).The column temperature was 35℃,and the injection volume was 10 and 20μL.The HPLC methods were established for the determination of the three components in the two compound preparations by using the three reference standards of harpagide,angoroside C and harpagoside and the SRRE at known contents,and the results were compared by t-test.Results:The contents of the three components in Simiao Yongan decoction were 0.1329,0.0421 and 0.0325 mg·mL^(-1),respectively,determined by reference standards,and were 0.1331,0.0420 and 0.0324 mg·mL^(-1),respectively,determined by SRRE.The corresponding P values were 0.665,0.284 and 0.661,respectively.The contents of the three components in Xuanmai Ganjie granules were 0.0351,0.0122 and 0.0063 mg·mL^(-1),respectively,determined by reference standards,and were 0.0353,0.0122 and 0.0064 mg·mL^(-1),respectively,determined by SRRE.The results of t-test showed that the P-values were all above 0.05 and there was no significant difference between the two methods.Conclusion:The results show that the SRRE can replace the corresponding reference substance to determine the contents in Simiao Yongan decoction and Xuanmai Ganju granules.The results of this study provide a scientific basis for the application of reference extracts in rep

关 键 词：玄参 对照提取物 质量控制 四妙勇安汤 玄麦甘桔颗粒 哈巴苷 安格洛苷C 哈巴俄苷 

分 类 号：R917[医药卫生—药物分析学]