灰茅根鼻渊丸质量标准研究  

Study on the Quality Standard of Huimaogen Biyuan Pills

作　　者：周轲 李文伟 杨鹏伟 陈朝晖 姚世霞 朱旭江 杨光远 ZHOU Ke;LI Wenwei;YANG Pengwei;CHEN Zhaohui;YAO Shixia;ZHU Xujiang;YANG Guangyuan(Gansu Institute for Drug Control,Lanzhou 730070,China;Gansu Province Longnan City Hui County People's Hospital,Longnan 742300,China)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730070 [2]甘肃省陇南市徽县人民医院,陇南742300

出　　处：《中国民族民间医药》2024年第11期35-39,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：甘肃省药品科研项目(2022GSMPA0032)。

摘　　要：目的:建立灰茅根鼻渊丸质量标准。方法:采用TLC法对处方中黄芩、浙贝母进行定性鉴别;利用HPLC法,Kromasil 100-5 C_(18)(4.6 mm×250 mm,5μm)色谱柱分离,甲醇-0.2%磷酸(40∶60)流动相洗脱,检测波长280 nm,流速1.0 mL·min^(-1),柱温30℃,进样量10μL,测定灰茅根鼻渊丸中的黄芩苷含量。结果:薄层色谱斑点显色清晰,分离效果好,阴性无干扰,专属性强,重现性较好;黄芩苷在19.11~764.40μg/mL浓度范围内,与峰面积呈良好的线性关系(r=0.9999),平均加样回收率为97.37%,RSD为2.44%(n=9)。结论:所建立的质量控制方法符合质量标准要求,专属性强、重现性好,可用于灰茅根鼻渊丸的质量控制。Objective To set upthe quality standard of huimaogen biyuan pills.Methods TLC was used for the identification of Radix Scutellariae and Thunberg Fritillary Bulbinin prescription;The content ofbaicalin was determined by HPLC.Thechromatographic condition was as follows:Kromasil 100-5 C_(18)column(4.6 mm×250 mm,5μm),using mobile phase with Methanol-0.2%phosphoric acid(40∶60),the detective wavelength was set at 280 nm,with a flow rate of 1.0 mL·min^(-1),the column temperature was 30℃and injection volume was 10μL.Results TLC identification has clear spots,good separation effects and reproducibility,strong specificity,negative control without interference.HPLC determined that baicalin was in range from 19.11 to 764.40μg/mL,which presented a good linear relationship with the peak area,r=0.9999,the average recovery was 97.37%,RSD was 2.44%(n=9).Conclusion The established quality control method has good specificity and reproducibility,which meet the quality standard requirements and can be used for the quality control of huimaogen biyuan pills.

关 键 词：灰茅根鼻渊丸 质量标准 TLC HPLC 黄芩苷 

分 类 号：R284.1[医药卫生—中药学]