茜草炭的质量标准提升研究  

Improvement of quality standards for carbonized rubiae radix et rhizoma

作　　者：张明童 张艳慧[2] 马潇 宋平顺 王娟弟 杨玲霞 李冬华 ZHANG Mingtong;ZHANG Yanhui;MA Xiao;SONG Pingshun;WANG Juandi;YANG Lingxia;LI Donghua(Gansu Institute for Drug Control,Gansu Inspection and Testing Technical Engineering Laboratory for Chinese Herbal and Tibetan Medicine,NMPA Key Laboratory for Quality Control of TCM,Lanzhou,Gansu 730070,China;Baoding Institute for Food and Drug Control,Baoding,Hebei 071000,China)

机构地区：[1]甘肃省药品检验研究院、甘肃省中藏药检验检测技术工程实验室、国家药品监督管理局中药材及饮片质量控制重点实验室,甘肃兰州730070 [2]保定市食品药品检验所,河北保定071000

出　　处：《安徽医药》2024年第4期672-675,I0002,共5页Anhui Medical and Pharmaceutical Journal

基　　金：甘肃省药品科研项目(2022GSMPA0017,2022GSMPA0020);兰州市科技计划项目资助(2022-3-41);河北省市场监督管理局科技项目(2020ZD36);中药材及饮片质量控制重点实验室项目(2022GSMPA-KL12,2022GSMPA-KL10)。

摘　　要：目的 在现行中国药典中茜草炭标准的基础上增加薄层鉴别和含量测定。方法 该研究于2022年6—8月以10批茜草和相应的茜草炭为研究对象,鉴别研究采用薄层色谱法,含量测定采用液相色谱法。结果 茜草炭薄层色谱中,在与异茜草素对照品色谱相应的位置上,显相同颜色的荧光斑点,可明显区分茜草和茜草炭;含量测定以异茜草素为指标,在8.2~820.0mg/L范围内与峰面积呈线性关系(r=0.999 9),精密度、稳定性和重复性良好(RSD分别为0.6%、1.8%和2.4%),平均加样回收率99.1%。结论 建立的薄层鉴别和含量测定方法简便可行,可为茜草炭的生产及质量控制提供依据。Objective To add thin-layer identification and content determination to the current carbonized rubiae radix et rhizoma stan-dard in the Chinese Pharmacopoeia.Methods The study was conducted from June to August 2022 with ten batches of rubiae radix et rhi-zoma and its carbon as research subjects.The thin-layer chromatography was used for identification,and high performance liquid chroma-tography for content determination.Results In the thin-layer chromatography,the fluorescence spots of the same color were found in the corresponding position to the chromatographic reference of xanthopurpurin,which could clearly distinguish the rubiae radix et rhizoma and its carbon.After carbonization,the content of xanthopurpurin was measured in the range of 8.2-820.0 mg/L and the peak area showed a linear relationship(r=0.9999).The precision,stability and repeatability were good(RSD was 0.6%,1.8%and 2.4%,respectively),and the average recovery rate was 99.1%.Conclusion The established methods for thin-layer identification and content determination are simple and feasible,which can provide reference for the production and quality control of carbonized rubiae radix et rhizoma.

关 键 词：茜草属 茜草炭 异茜草素 含量测定 质量标准 

分 类 号：R284.1[医药卫生—中药学]