四四固本颗粒质量标准研究  

Study on the Quality Standard for Sisi Guben Granules(四四固本颗粒)

作　　者：李争艳[1] 陈凌云 余晓玲[1] 吴文迪[1] 董月秋[1] 许云姣 姜莉云[1] LI Zheng-yan;CHEN Ling-yun;YU Xiao-ling;WU Wen-di;DONG Yue-qiu;XU Yun-jiao;JIANG Li-yun(Kunming Municipal Hospital of Traditional Chinese medicine,Kunming Yunnan 650051,China;Yunnan University of Traditional Chinese Medicine,Kunming Yunnan 650200,China)

机构地区：[1]昆明市中医医院,云南昆明650051 [2]云南中医药大学,云南昆明650200

出　　处：《中医药导报》2020年第6期23-30,共8页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：2017年云南省卫计委中医药项目(云财社2017-70号);昆明市科技计划项目(2016-1-2-02698);昆明市卫生和计划生育委员会昆明市名中医专家传承工作室建设项目(2018年)—姜莉云名中医专家传承工作室。

摘　　要：目的:建立四四固本颗粒的质量标准。方法:采用薄层色谱法对制剂中吴茱萸、附子、佛手、干姜、甘草、炒白术进行定性鉴别;采用HPLC法对新乌头碱、次乌头碱、乌头碱进行限度检查,对阿魏酸、甘草酸铵进行含量测定。结果:吴茱萸、附子、佛手、干姜、甘草、炒白术的TLC图斑点清晰,分离度好,阴性对照无干扰;双酯型生物碱限量检查符合要求;阿魏酸在0.025~0.750μg(R=0.999,9)范围内呈良好的线性关系,加样回收率为101.37%(RSD=2.99%);甘草酸铵在0.218~2.725μg(R=1)范围内呈良好的线性关系,加样回收率为99.88%(RSD=2.08%)。结论:所建标准可用于四四固本颗粒的质量控制。Objective:To establish the quality standard for Sisi Guben granules.Methods:TLC was used for qualitative identification of Wuzhuyu(Evodia rutaecarpa),Fuzi(aconite),Foshou(Bergamot),Ganjiang(dried ginger),Gancao(Liquorice)and Chaobaizhu(stir fried Atractylodes).HPLC method was adopted to determine the limits of aconitine,hypaconitine and aconitine and the contents offerulic acid and ammonium glycyrrhetate.Results:TLCs of Wuzhuyu(Evodia rutaecarpa),Fuzi(aconite),Foshou(Bergamot),Ganjiang(dried ginger),Gancao(Liquorice)and Chaobaizhu(stir fried Atractylodes)showed clear spots and good separation without interference from negative control.Double ester determination of alkaloid content conformed to the requirements.The linear range was 0.025-0.750μg(R=0.999,9)for ferulic acid,and the recovery was 101.37%(RSD=2.99%).The linear range was 0.218-2.725μg(R=1)for ammonium glycyrrhetate,and the recovery was 99.88%(RSD=2.08%).Conclusions:Estbalished standard can be used for the quality control of Sisi Guben granules.

关 键 词：四四固本颗粒 质量标准 双酯型生物碱 阿魏酸 甘草酸苷 

分 类 号：R284.1[医药卫生—中药学]