白芥子散的质量标准研究  

Study on Quality Standard for Baijiezi San

作　　者：范晓良 张纯 郭志丽 阮伟峰 方瑞华 FAN Xiaoliang;ZHANG Chun;GUO Zhili;RUAN Weifeng;FANG Ruihua(Department of Pharmacy,Jiaxing Traditional Chinese Medicine Hospital,Zhejiang Chinese Medical University,Jiaxing 314001,China;Jiaxing Key Laboratory of Infectious Diseases and Bacterial Drug Resistance,Jiaxing 314001,China;Department of Traditional Chinese Medicine,Jiaxing Institute for Food,Drug and Product Quality Control,Jiaxing 314001,China)

机构地区：[1]浙江中医药大学附属嘉兴中医院药学部,嘉兴314001 [2]嘉兴市感染性疾病及细菌耐药研究重点实验室,嘉兴314001 [3]嘉兴市食品药品与产品质量检验检测院中药室,嘉兴314001

出　　处：《医药导报》2022年第5期698-703,共6页Herald of Medicine

基　　金：浙江省基础公益计划项目(LGC21H300003);浙江省中医药科技计划项目(2020ZB255);嘉兴市科技计划项目(2018AD32152)。

摘　　要：目的建立白芥子散的质量标准。方法除对白芥子散水分、总灰分进行测定外,采用显微及薄层色谱法(TLC)对白芥子散中的白芥子、延胡索、细辛、甘遂进行定性鉴别,并利用高效液相色谱法(HPLC)同时测定芥子碱硫氰酸盐、细辛脂素两种主要成分的含量。结果12批次白芥子散的水分含量为9.9%~14.8%;总灰分为2.5%~3.7%;粉末显微中各药材的组织特征明显;TLC鉴别专属性强,斑点清晰,分离度良好;芥子碱硫氰酸盐、细辛脂素分别在4.99~498.82μg·mL^(-1)(r=0.9998)及3.951~395.14μg·mL^(-1)(r=0.9999)浓度范围内线性关系良好,平均加样回收率分别为99.58%,101.92%,RSD分别为1.17%,1.55%;12批白芥子散中芥子碱硫氰酸盐、细辛脂素平均含量分别为2.51,0.77 mg·g^(-1)。结论该方法稳定可靠,重复性好,可用于白芥子散的质量控制。Objective To establish the quality standard of Baijiezi San.Methods In addition to the determination of water content and total ash,microscopic identification,and thin layer chromatography(TLC)were used to qualitatively identify Semen Sinapis Albae,Corydalis Rhizoma,Asari Radix et Rhizoma and Kansui Radix.Simultaneously,sinapine thiocyanate and asarinin were determined by high-performance liquid chromatography(HPLC).Results The range for the water content,total ash of 12 batches were 9.9%-14.8%and 2.5%-3.7%,respectively.The tissue characteristics of each herbal material in the powder are obvious;TLC has strong specificity for identification,clear spots and good resolution;Sinapine thiocyanate and asarinin showed a good linear relationship in the linear range of 4.99-498.82μg·mL^(-1)(r=0.9998)and 3.951-395.14μg·mL^(-1)(r=0.9999),respectively.The average recoveries were 99.58%and 101.92%,with RSD 1.17%and 1.55%,respectively.The contents of sinapine thiocyanate,asaridin in 12 batches were 2.51 and 0.77 mg·g^(-1).Conclusion These methods were stable,reliable,repeatable and they could be used for quality control of Baijiezi San.

关 键 词：白芥子散 显微 色谱法 薄层 色谱法 高效液相 质量标准 

分 类 号：R286[医药卫生—中药学] R927.11[医药卫生—中医学]