养胃颗粒质量标准研究  

Quality Standard of Yangwei Granules

作　　者：赵娜娜 陈晴 朱斌 江兴松 洪倩 庄子赫 杨阳 ZHAO Nana;CHEN Qing;ZHU Bin;JIANG Xingsong;HONG Qian;ZHUANG Zihe;YANG Yang(The Affiliated Huaihai Hospital of Xuzhou Medical University·The 71st Group Army Hospital of the Chinese PLA,Xuzhou,Jiangsu,China 221004)

机构地区：[1]徐州医科大学附属淮海医院·中国人民解放军陆军第七十一集团军医院,江苏徐州221004

出　　处：《中国药业》2024年第15期61-65,共5页China Pharmaceuticals

基　　金：中国人民解放军陆军第七十一集团军医院院内科研项目[YNMS-2022016,YN2011004,YN2011005]。

摘　　要：目的 建立养胃颗粒的质量标准。方法 采用薄层色谱法定性鉴别制剂中的黄芪、延胡索、威灵仙、连翘、枳实、甘草;采用高效液相色谱法测定芍药苷的含量,色谱柱为Dikma Diamonsil C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(梯度洗脱),流速为1.0 mL/min,柱温为30℃,检测波长为230 nm,进样量为10μL。结果 薄层色谱分离效果良好,特征斑点显色清晰,且阴性对照无干扰。芍药苷色谱峰分离完全,保留时间为12.204 min;质量浓度在5~100μg/mL范围内与峰面积线性关系良好(r=0.999 7,n=6);精密度、稳定性、重复性试验结果的RSD均低于2.0%;平均加样回收率为98.16%,RSD为0.67%(n=6)。结论 所建立的方法简便灵敏、专属性强、重复性好、结果准确,可用于养胃颗粒的质量控制。Objective To establish the quality standard of Yangwei Granules.MethodsAstragali Radix,Corydalis Rhizoma,Clematidis Radix et Rhizoma,Forsythiae Fructus,Aurantii Immaturus Fructus,and Glycyrrhizae Radix et Rhizoma were identified by the thin-layer chromatography(TLC) method.The content of paeoniflorin was determined by the high-performance liquid chromatography(HPLC) method,the chromatographic column was Dikma Diamonsil C_(18) column(250 mm × 4.6 mm,5 μm),the mobile phase consisted of a mixed solution of acetonitrile-0.1% phosphoric acid solution(gradient elution),the flow rate was1.0 mL/min,the column temperature was 30 ℃,the detection wavelength was 230 nm,and the injection volume was 10 μL.ResultsThe TLC chromatograms had good separation,with clear color of characteristic spots,and no interference from negative samples.The chromatographic peak of paeoniflorin was completely separated with a retention time of 12.204 min.The linear range of paeoniflorin was 5-100 μg/mL(r = 0.999 7,n = 6),and the RSDs of precision,stability,and repeatability test results were all lower than 2.0%.The average recovery of paeoniflorin was 98.16% with an RSD of 0.67%(n = 6).ConclusionThe established methods are simple,sensitive,highly specific,and reproducible,which can be used for the quality control of Yangwei Granules.

关 键 词：养胃颗粒 薄层色谱法 高效液相色谱法 质量标准 定性鉴别 含量测定 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0