柔肝颗粒的质量标准提高  

Quality Standard Improvement for Rougan Granules

作　　者：董玉娟 李素梅[1] 周敏 DONG Yujuan;LI Sumei;ZHOU Min(Guangdong Second Traditional Chinese Medicine Hospital,Guangzhou Guangdong 510095,China)

机构地区：[1]广东省第二中医院,广东广州510095

出　　处：《药品评价》2022年第5期267-270,共4页Drug Evaluation

基　　金：2021年广东省中医药局科研课题(20212018);2019年广东省中医药局科研课题(20191017)。

摘　　要：目的:在原检验方法基础上,增加检测柔肝颗粒制剂质量的方法,以提高其质量标准来保证临床应用效果。方法:结合薄层色谱法(TLC)与高效液相色谱法(HPLC)对颗粒中所含的药材和有效成分进行定性、定量测定。结果:颗粒中所含的钩藤、白芍、川牛膝三味中药的TLC色谱图斑点清晰可见、RF值与分离度较好、阴性对照无干扰,确定为本制剂的定性鉴别分析方法;有效成分芍药苷的HPLC含量测定具有良好线性回归,且方法学考察结果较好,确定为本制剂的定量分析方法。结论:所建立的检验方法可操作性强、结果重现性好,可为制定柔肝颗粒制剂的质量标准提高提供参考。Objective:Based on the previous quality standard,increase the methods of testing the quality of rougan granules in order to improve its quality standard and ensure the effect of clinical application.Methods:TLC identification method and HPLC method were established to test the medicinal materials and effective components in the granules.Results:The TLC spots of uncaria,paeoniae radix alba and cyathulae radix were clear and well separated without negative interference.It was determined as the qualitative identification method of the preparation.The HPLC content determination of paeoniflorin had good linear regression,and the methodological investigation results were good.It was determined as the quantitative analysis method of the preparation.Conclusion:The methods established in this study has strong operability and good reproducibility,which can provide a reference for formulating the quality standard of rougan granules.

关 键 词：钩藤属 天麻属 柔肝颗粒 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R286.0[医药卫生—中药学]