益胃活络合剂质量标准研究  

Study on quality standards for Yiwei Huoluo Mixture

作　　者：邵旭红 李玉华 李阳 车妍荷 刘静 常智 曾丽雯 SHAO Xuhong;LI Yuhua;LI Yang;CHE Yanhe;LIU Jing;CHANG Zhi;ZENG Liwen(Department of Pharmacy,Zhongwei City Hospital of Traditional Chinese Medicine,Ningxia,Zhongwei 755000,China)

机构地区：[1]宁夏回族自治区中卫市中医医院药学部,宁夏中卫755000

出　　处：《中国医药科学》2025年第3期61-65,共5页China Medicine And Pharmacy

基　　金：宁夏回族自治区青年科技托举人才培养项目(宁科协发组字[2024]6号)。

摘　　要：目的 建立益胃活络合剂的薄层色谱鉴别和含量测定方法,并制订益胃活络合剂的质量标准。方法 采用薄层色谱法(TLC)和高效液相色谱法(HPLC)进行质量评价并进行微生物检测;采用《中华人民共和国药典》(2020年版)4部通则进行装量、相对密度和pH值测定。结果 TLC法显示益胃活络合剂中党参、白术、三七粉、皂角刺在色谱图相应位置上显相同颜色的斑点;有效性、安全性、微生物限度检查均符合标准;定量检测中党参炔苷在15~200μg/ml区间内呈良好的线性关系(线性回归方程为y=27 950x+53 301,R=0.9999),加样回收率为102.85%(RSD为1.43%)。结论 以上检验方法的建立为益胃活络合剂的规范化生产提供了有力的质量控制依据,为患者临床用药安全、有效、稳定提供了科学保障。Objective To establish a thin layer chromatography identification and assay method for Yiwei Huoluo Mixture,and to develop quality standards for Yiwei Huoluo Mixture.Methods Thin layer chromatography(TLC)and high-performance liquid chromatography(HPLC)were used for quality evaluation and microbial detection.The general rules of the"Pharmacopoeia of the People’s Republic of China VolumeⅣ"(2020 edition)were used for the determination of loading,relative density and pH.Results The TLC method showed that Codonopsis pilosula,Atractylodes macrocephala,Panax notoginseng powder,and Sophora saponins in the Yiwei Huoluo Mixture showed spots of the same color at the corresponding positions on the chromatogram.The effectiveness,safety,and microbial limit tests all met the standards.In quantitative detection,there was a good linear relationship(linear regression equation was y=27950x+53301,R=0.9999)in the range of 15-200µg/ml for Codonopsis pilosula glycosides,and the recovery rate of the spiked sample was 102.85%(RSD of 1.43%).Conclusion The establishment of the above testing methods provides a strong quality control basis for the standardized production of Yiwei Huoluo Mixture,and provides scientific guarantee for the safety,effectiveness,and stability of clinical medication for patients.

关 键 词：益胃活络合剂 质量标准研究 薄层色谱法 含量测定 高效液相色谱法 

分 类 号：R288[医药卫生—中药学]