清肝颗粒(无糖型)质量标准的建立  

Study on the Quality Standard for Qinggan Granules (Sugar-free Type)

作　　者：庄会芳 谢智军 金凤 庄建林 李倩 范建伟 张贵民 Zhuang Huifang;Xie Zhijun;Jin Feng;Zhuang Jianlin;Li Qian;Fan Jianwei;Zhang Guimin(Lunan Hope Pharmaceutical Co.Ltd.,Shandong Linyi 276006,China;State Key Laboratory of Generic Manufacture Technology of Chinese Traditional Medicine, Lunan Pharmaceutical Group Co.Ltd.)

机构地区：[1]鲁南厚普制药有限公司,山东临沂276006 [2]鲁南制药集团股份有限公司中药制药共性技术国家重点实验室

出　　处：《中国药师》2022年第4期709-713,共5页China Pharmacist

基　　金：山东省重点研发计划(重大科技创新工程)项目(编号:2020CXGC010505);临沂市兰山区科技创新发展计划专项(编号:1942)。

摘　　要：目的:建立清肝颗粒(无糖型)的质量标准。方法:采用TLC法对制剂中板蓝根、茵陈、甘草进行定性鉴别;以茵陈中绿原酸、新绿原酸和隐绿原酸为指标性成分,采用HPLC法测定其含量。色谱柱:Agilent ZORBAX SB C_(18)柱(4.6 mm×250 mm,5μm);流动相:乙腈(A)-0.4%磷酸水溶液(B),梯度洗脱;流速:1.0 ml·min^(-1);检测波长:327 nm;柱温:25℃;进样量:10μl。结果:板蓝根、茵陈、甘草的TLC鉴别特征明显,专属性强,且阴性均无干扰。绿原酸、新绿原酸、隐绿原酸进样量分别在2.33~58.36μg·ml^(-1)(r=0.999 9)、2.37~59.25μg·ml^(-1)(r=0.999 9)、2.02~50.62μg·ml^(-1)(r=0.999 9)范围内线性关系良好,绿原酸、新绿原酸、隐绿原酸的加样回收率分别为99.35%,99.37%,99.35%,其RSD分别为0.58%,0.37%,0.62%(n=6)。结论:建立的清肝颗粒(无糖型)的质量标准操作简单、可靠准确、专属性强、重复性好,可用于制剂的质量控制。Objective:To establish the quality control standard for Qinggan granules(sugar-free type).Methods:TLC was used to identify Isatidis Radix,Artemisiae Scopariae Herba and Glycyrrhizae Radix et Rhizome in the preparation,and HPLC was adopted to determine chlorogenic acid,neochlorogenic acid and cryptochlorogenic acid chosen as the index components in Artemisiae Scopariae Herba.The HPLC analysis was performed on an Agilent ZORBAX SB C_(18) column(4.6 mm×250 mm,5 μm) in a gradient elution mode with the mobile phase of acetonitrile as phase A and 0.4% phosphoric acid solution as phase B.The flow rate was 1.0 ml·min^(-1),the detection wavelength was 327 nm,the column temperature was set at 25℃ and the injection volume was 10 μl.Results:The TLC characteristics of Isatidis Radix,Artemisiae Scopariae Herba and Glycyrrhizae Radix et Rhizome were distinctive with strong specificity and without interference from the negative control.The contents of chlorogenic acid,neochlorogenic acid and cryptochlorogenic acid all showed good linear relationships within the ranges of 2.33-58.36 μg·ml^(-1)(r=0.999 9),2.37-59.25 μg·ml^(-1)(r=0.999 9) and 2.02-50.62 μg·ml^(-1)(r=0.999 9),respectively.The average recoveries of chlorogenic acid,neochlorogenic acid and cryptochlorogenic acid were 99.35%(RSD=0.58%),99.37(RSD=0.37%)and 99.35(RSD=0.62%)(n=6),respectively.Conclusion:The quality established standard for Qinggan granules(sugar-free type) is simple,reliable,accurate,specific and repeatable,and can be used for the quality control of the preparation.

关 键 词：清肝颗粒(无糖型) 薄层色谱法 高效液相色谱法 绿原酸 新绿原酸 隐绿原酸 质量标准 

分 类 号：TQ460.72[医药卫生—药物分析学]