骨奇泰搽剂质量标准提升研究  

Improvement of Quality Standard of Guqitai Liniment

作　　者：林奕沁 秦银燕 陈贞伶 何成章[1] 陆华[1] LIN Yiqin;QIN Yinyan;CHEN Zhenling;HE Chengzhang;LU Hua(The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi,China 530021)

机构地区：[1]广西医科大学第一附属医院,广西南宁530021

出　　处：《中国药业》2024年第4期72-76,共5页China Pharmaceuticals

基　　金：广西壮族自治区中医药管理局自筹经费科研课题[GXZYZ20210007]。

摘　　要：目的提升骨奇泰搽剂的质量标准。方法采用薄层色谱(TLC)法对制剂中徐长卿、细辛、威灵仙进行定性鉴别;采用高效液相色谱法同时测定三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Re的含量,色谱柱为Shimadzu WondaSil Superb C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(梯度洗脱),流速为1.0 mL/min,检测波长为203 nm,柱温为25℃,进样量为20μL。结果徐长卿、细辛、威灵仙的TLC图斑点清晰,阴性对照无干扰。三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Re的进样量分别在0.2810~5.4652μg(R^(2)=1.0000)、0.4795~9.2077μg(R^(2)=0.9998)、0.0732~1.4858μg(R^(2)=0.9999)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于2.0%;平均加样回收率分别为98.44%,97.34%,103.51%,RSD分别为0.81%,1.69%,0.58%(n=6);4批样品中,三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Re的平均含量分别为0.2476,1.0388,0.1102 mg/mL。结论所建立的方法专属性较强,重复性好,可用于控制骨奇泰搽剂的质量。Objective To improve the quality standard of Guqitai Liniment.Methods Thin-layer chromatography(TLC)method was used to qualitatively identify Cynanchi Paniculati Radix et Rhizoma,Asari Radix et Rhizoma and Clematidis Radix et Rhizoma in the preparation.The high-performance liquid chromatography(HPLC)method was used to determine the contents of notoginsenoside R_(1),ginsenoside Rg_(1) and ginsenoside Re simultaneously;the chromatographic column was Shimadzu WondaSil Superb C18 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-water(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 203 nm,the column temperature was 25℃,and the injection volume was 20μL.Results The TLC chromatograms of Cynanchi Paniculati Radix et Rhizoma,Asari Radix et Rhizoma and Clematidis Radix et Rhizoma had clear spots,and there was no interference from the negative reference.The linear ranges of notoginsenoside R_(1),ginsenoside Rg_(1) and ginsenoside Re were 0.2810-5.4652μg(R^(2)=1.0000),0.4795-9.2077μg(R^(2)=0.9998)and 0.0732-1.4858μg(R^(2)=0.9999)respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above three ingredients were 98.44%,97.34%,and 103.51%,with the RSDs of 0.81%,1.69%and 0.58%(n=6)respectively.The average contents of notoginsenoside R_(1),ginsenoside Rg_(1) and ginsenoside Re in four batches of samples were 0.2476,1.0388,0.1102 mg/mL,respectively.Conclusion The established method is specific and repeatable,which can be used for the quality control of Guqitai Liniment.

关 键 词：骨奇泰搽剂 质量标准 高效液相色谱法 薄层色谱法 三七皂苷R1 人参皂苷RG1 人参皂苷RE 细辛 

分 类 号：R917[医药卫生—药物分析学] R927.1[医药卫生—药学]