清肝合剂的质量控制研究  

Research on Quality Control of Qinggan Mixture

作　　者：王玉 陈彤 王慧 WANG Yu;CHEN Tong;WANG Hui(Pharmacy Department of Xuzhou City Hospital of TCM,Xuzhou Jiangsu 221009,China)

机构地区：[1]徐州市中医院药学部,江苏徐州221009

出　　处：《抗感染药学》2024年第4期343-347,共5页Anti-infection Pharmacy

基　　金：徐州市重点研发计划(社会发展)项目(No.KC22189)。

摘　　要：目的:建立清肝合剂的质量标准,为清肝合剂的生产质量控制提供参考。方法:采用薄层色谱法(thin-layer chromatography,TLC)对清肝合剂中的牡丹皮、黄芩和栀子3种药材进行定性鉴别,采用高效液相色谱法(high performance liquid chromatography,HPLC)测定清肝合剂中黄芩苷的含量。结果:牡丹皮、黄芩和栀子的TLC图斑点清晰,分离效果好,专属性强,阴性对照均无干扰;黄芩苷质量浓度为16.125~258μg/mL时与峰面响应值呈现良好的线性关系(A_(峰面响应值)=22655ρ_(μg/mL)-99737,r^(2)=0.9994,n=5);平均加样回收率为100.55%(RSD=1.92%);3批清肝合剂中黄芩苷的平均含量为1.20μg/mL。结论:清肝合剂中牡丹皮、栀子和黄芩可以采用TLC进行定性鉴别;用HPLC定量检测清肝合剂中的黄芩苷,具有较好的专属性、精密度、重复性和稳定性,可用于清肝合剂中黄芩苷定量的质量控制。Objective:To establish the quality standard of Qinggan Mixture,and to provide reference for the quality control of manufacture of Qinggan Mixture.Methods:Three kinds of medicinal materials in Qinggan Mixture,namely,cortex moutan,radix scutellariae and fructus gardeniae,were identified qualitatively by thin-layer chromatography(TLC),and the content of baicalin in Qinggan Mixture was determined by high performance liquid chromatography(HPLC).Results:The TLC map of cortex moutan,radix scutellariae and fructus gardeniae was clear in spots,with good separation effect,and strong specificity,and there was no interference from the negative control.When the mass concentration of baicalin was 16.125-258μg/mL,it exhibited a good linear relationship with the peak response value(A_(peak response value)=22655ρ_(μg/mL)-99737,r^(2)=0.9994,n=5).The average spiked recovery rate was 100.55%(RSD=1.92%);the average content of baicalin in three batches of Qinggan Mixture was 1.20μg/mL.Conclusion:Cortex moutan,radix scutellariae and fructus gardeniae in the Qinggan Mixture can be qualitatively identified by TLC;HPLC has good specificity,precision,repeatability and stability in quantitative determination of baicalin in the Qinggan Mixture,and can be used for quantitative quality control of baicalin in the Qinggan Mixture.

关 键 词：清肝合剂 质量控制 牡丹皮 黄芩 栀子 黄芩苷 薄层色谱法 高效液相色谱法 含量测定 

分 类 号：R284.1[医药卫生—中药学]