首页|清肝合剂的质量控制研究

清肝合剂的质量控制研究

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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。125~258 μg/mL时与峰面响应值呈现良好的线性关系(A峰面响应值=22655 ρμg/mL-99737,r2=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。20 μg/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。
Research on Quality Control of Qinggan Mixture
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 16.125-258 μg/mL,it exhibited a good linear relationship with the peak response value(Apeak responsevalue=22655 ρμg/mL-99737,r2=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 1.20 μg/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.

Qinggan Mixturequality controlcortex moutanradix scutellariaefructus gardeniaebaicalinthin-layer chromatographyhigh performance liquid chromatographyassay

王玉、陈彤、王慧

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徐州市中医院药学部,江苏 徐州 221009

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

徐州市重点研发计划(社会发展)项目

KC22189

2024

抗感染药学
江苏省苏州市第五人民医院

抗感染药学

影响因子:0.505
ISSN:1672-7878
年,卷(期):2024.21(4)
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