消风止痒颗粒质量标准研究  

Quality standard of Xiaofeng Zhiyang Keli(消风止痒颗粒)

作　　者：张锐 马天翔 顾志荣[3] 许爱霞[3] 马转霞 祁梅[3] 孙岚萍 葛斌[3] ZHANG Rui;MA Tianxiang;GU Zhirong;XU Aixia;MA Zhuanxia;QI Mei;SUN Lanping;GE Bin(School of Pharmacy,Gansu University of Chinese Medicine,Lanzhou,Gansu,730101,China;Pharmaceutical Preparation Section,Jiuquan Hospital of TCM,Jiuquan,Gansu,735000,China;Pharmaceutical Preparation Section,Gansu Provincial the People's Hospital,Lanzhou,Gansu,730000,China)

机构地区：[1]甘肃中医药大学药学院,甘肃兰州730101 [2]酒泉市中医院药剂科,甘肃酒泉735000 [3]甘肃省人民医院药剂科,甘肃兰州730000

出　　处：《甘肃中医药大学学报》2021年第6期33-40,共8页Journal of Gansu University of Chinese Medicine

基　　金：甘肃省中医药管理局科研项目(GZK-2019-41);甘肃省人民医院研发攻关项目(18GSSY2-3)。

摘　　要：目的建立消风止痒颗粒的质量标准。方法采用薄层色谱(TLC)法对消风止痒颗粒方中的荆芥、防风、苦参、白茅根、当归进行定性鉴别,采用高效液相色谱(HPLC)法测定该方中5-O-甲基维斯阿米醇苷、橙皮苷的含量,并建立消风止痒颗粒的HPLC指纹图谱。结果TLC斑点清晰,阴性无干扰;5-O-甲基维斯阿米醇苷和橙皮苷的回归方程分别为Y=6568037.86X+2207.56(r=1.0000)、Y=36797094.53X-6789.79(r=0.9999),分别在0.008~0.320,0.002~0.080 mg范围内呈良好的线性关系,平均回收率分别为100.09%,98.78%,RSD分别为2.88%,2.53%;消风止痒颗粒HPLC指纹图谱相似度均大于0.99,10批样品中确定了27个共有峰,并指认了其中6个共有峰。结论本法简便可行、重现性好、专属性强,可用于消风止痒颗粒的质量控制。Objective To establish the quality standard of Xiaofeng Zhiyang Keli(消风止痒颗粒,XZK).Methods Thin-layer chromatography(TLC)method was used in the qualitative determination of Schizonepetae herba,Saposhnikoviae radix,Sophorae flavescentis radix,Imperatae rhizome and Angelicae sinensis radix.High performance liquid chromatography(HPLC)was used for the content determination of 5-O-methylvisammioside and hesperidin.HPLC fingerprint of XZK was established.Results TLC spots were clear and negative without interference.The regression equations of 5-O-methylvisammioside and hesperidin were Y=6568037.86X+2207.56(r=1.0000)and Y=36797094.53X-6789.79(r=0.9999),respectively.They had a good linear relationship in the range of 0.008 to 0.320 and 0.002 to 0.080 mg respectively,with average recoveries of 100.09%and 98.78%,respectively,and RSD of 2.88%and 2.53%,respectively.The similarity degree of HPLC fingerprint of XZK was greater than 0.99.Twenty-seven common peaks were determined in 10 batches of samples,and 6 of them were identified.Conclusion This method is simple,feasible,reproducible and specific,which can be used for the quality control of XZK.

关 键 词：消风止痒颗粒 5-O-甲基维斯阿米醇苷 橙皮苷 薄层色谱 高效液相色谱 指纹图谱 质量标准 

分 类 号：R284.2[医药卫生—中药学]