清血解毒合剂的制备工艺及质量标准研究  

Study on preparation technology and quality standard for Qingxue Jiedu Mixture

作　　者：李力[1] 何靓 刘蔚 杨柳[1] LI Li;HE Liang;LIU Wei;YANG Liu(Wuhan Hospital of TCM,Wuhan 430014;Mayinglong Pharmaceutical Group Co.,Ltd.,Wuhan 430060)

机构地区：[1]武汉市中医医院,湖北武汉430014 [2]马应龙药业集团股份有限公司,湖北武汉430060

出　　处：《湖北中医药大学学报》2023年第4期33-37,共5页Journal of Hubei University of Chinese Medicine

基　　金：武汉市卫生健康委2020年度医学科研项目(项目编号:WZ20C22)。

摘　　要：目的 建立清血解毒合剂的制备方法和质量标准。方法 采用L_(9)(3^(4))正交试验设计法,将绿原酸、连翘酯苷A、黄芩苷的含量以及干膏率进行加权综合评分作为考察指标,筛选出最佳制备方法;采用高效液相色谱法对清血解毒合剂进行了定量研究。结果 1日处方量饮片加12倍水,浸泡1.5 h,加热提取3次,每次保持微沸1 h为最佳制备工艺;高效液相色谱法可测定3种成分,RSD值均在2.0%以下(n=6)。结论 本次对清血解毒合剂的实验研究为临床用药提供了安全有效的保障。Objective To optimize the preparation technology and set up the quality standard of Qingxue Jiedu Mixture.Methods Taking the content of chlorogenic acid,forsythiaside A,baicalin and the yield of dry paste as the evaluation index,the best process method was selected by L_(9)(3^(4))orthogonal test;quantitative studies of Qingxue Jiedu Mixture were carried out by high performance liquid chromatography(HPLC).Results Optimum preparation process is as following:soak 1.5 h with12 times the amount of water,extract 3 times for 1 h each time.Three components can be determined by HPLC,and the RSD value is less than 2.0%(n=6).Conclusion The production and operation of Qingxue Jiedu Mixture is simple,and the established quality standard provides a safe and effective guarantee for clinical use.

关 键 词：医院制剂 中药制剂 制备工艺 定量 

分 类 号：R284.2[医药卫生—中药学]