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刘丽琴,王莹,陈红斌,徐建兵,张洪军.新加玉屏风合剂的制备工艺与质量控制研究[J].浙江中西医结合杂志,2026,36(1):
新加玉屏风合剂的制备工艺与质量控制研究
Study on the Preparation Process and Quality Control of Xinjiayupingfeng Mixture
投稿时间:2025-02-20  修订日期:2025-07-08
DOI:
中文关键词:  新加玉屏风合剂  正交试验  提取工艺  TLC鉴别  甘草苷  甘草酸  含量测定
英文关键词:Xinjiayupingfeng Mixture  Orthogonal test  Extraction process  Identification by thin layer chromatography  Liquiritin  Glycyrrhizic acid  Content determination
基金项目:杭州市生物医药和健康产业发展扶持科技专项(No.2022WJCY175)
作者单位E-mail
刘丽琴 杭州市红十字会医院 1367146576@qq.com 
王莹   
陈红斌   
徐建兵* 浙江惠松制药有限公司 584902221@qq.com 
张洪军   
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中文摘要:
      目的:确定新加玉屏风合剂的制备工艺,建立质量控制方法。方法:以甘草苷、甘草酸总量为指标,正交试验优化新加玉屏风合剂的制备工艺,采用TLC法对处方中甘草、防风药味进行定性鉴别,HPLC法测定新加玉屏风合剂中甘草苷、甘草酸含量。结果:确定的最佳提取工艺条件为提取3次,分别以12倍量水、10倍量水、10倍量水,提取1.5h、0.5h、0.5h;建立的甘草、防风TLC鉴别方法专属性、重现性均较好,甘草苷在进样量0.0234μg~0.2343μg范围线性关系良好,平均加样回收率为98.31%,RSD为0.58%,甘草酸在进样量0.1719μg~1.7193μg范围线性关系良好,平均加样回收率为101.73%,RSD为2.42%,精密度、稳定性等符合要求。结论:新加玉屏风合剂制备工艺简便易行,建立的TLC定性和HPLC定量方法可用于新加玉屏风合剂的质量控制。
英文摘要:
      Objective: To determine the preparation process of Xinjiayupingfeng Mixture and establish a quality control method. Methods: Taking the total amount of liquiritin and glycyrrhizic acid as the index, orthogonal test was used to optimize the preparation technology of Xinjiayupingli mixture. TLC method was used to qualitatively identify the flavors of licorice and antiwind medicine in the prescription, and HPLC method was used to determine the contents of liquiritin and glycyrrhizic acid in Xinjiayupingli mixture. Results: The optimum extraction conditions were 3 times of extraction, with 12 times, 10 times, and 10 times the amount of water extracted for 1.5h, 0.5h, and 0.5h, respectively; The established TLC identification method for Glycyrrhiza and Saposhnikovia divaricata has good specificity and reproducibility. Liquiritin has a good linear relationship in the range of injection amount of 0.0234 μ g to 0.2343 μ g, with an average recovery rate of 98.31% and RSD of 0.58%. Glycyrrhizic acid has a good linear relationship in the range of injection amount of 0.1719 μg to 1.7193 μg, with an average recovery rate of 101.73% and RSD of 2.42%. The precision and stability meet the requirements. Conclusion: The preparation process of Xinjiayupingfeng Mixture is simple and feasible, and the established TLC qualitative and HPLC quantitative methods can be used for quality control of Xinjiayupingfeng Mixture.
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