速感宁胶囊的质量标准提升研究  

Study on Improving the Quality Standard of Suganning Capsule

作　　者：王俪颖 张衍旭 王野谌 王茂旭 张雷 董雪莲[1] WANG Liying;ZHANG Yanxu;WANG Yechen;WANG Maoxu;ZHANG Lei;DONG Xuelian(Changchun University of Chinese Medicine,Changchun 130117,China;Jilin Zhongyan Pharmaceutical Co.Ltd,Changchun 130062,China)

机构地区：[1]长春中医药大学药学院,吉林长春130117 [2]吉林省中研药业有限公司,吉林长春130062

出　　处：《中国民族民间医药》2024年第22期31-36,共6页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：吉林省科技发展计划项目(20191102024YY)。

摘　　要：目的:提升速感宁胶囊的质量标准并提供相关参考。方法:建立柴胡、金银花薄层色谱(TLC)鉴别方法,采用高效液相色谱(HPLC)法建立制剂中柴胡皂苷b1和对乙酰氨基酚含量的测定方法。结果:TLC结果显示,速感宁胶囊供试品与柴胡皂苷b1及金银花对照药材在相应位置显相同颜色的荧光斑点,且阴性对照无干扰,专属性良好。对乙酰氨基酚及柴胡皂苷b1检测质量浓度的线性范围分别为0.0099~0.2970 mg/mL、0.1961~1.9619 mg/mL(r均为0.9996),重复性实验的RSD分别为0.45%、1.5%,平均加样回收率分别为100.47%、98.94%,3批样品平均含量分别为0.2906 g/g、0.2061 mg/g。结论:本研究建立了速感宁胶囊中柴胡、金银花的薄层鉴别方法和柴胡皂苷b1、对乙酰氨基酚的含量测定方法,重复性好,薄层鉴别方法专属性较高,可用于速感宁胶囊的质量控制。Objective To provide reference for improving the quality standard of Suganning capsule.Methods To establish a TLC identification method for bupleurum and honeysuckle.HPLC method was used to determine the contents of bupleurum saponin b1 and paracetamol in preparation.Results TLC results showed that Suganning capsule test material showed the same color fluorescence spots with saikosaponin b1 and honeylonicera,and the negative control had no interference,showing good specificity.The linear norms for the mass concentration of acetaminophen and saposide b1 were 0.0099-0.2970 mg/mL and 0.1961-1.9619mg/mL(r=0.9996),respectively.RSD of reproducibility were 0.45%and 1.5%,respectively.The average recoveries were 100.47%,98.94%,and the average contents of three batches of samples were 0.2906g/g and 0.2061 mg/g,respectively.ConclusionIn This study,the thin-layer identification method of bupleurum and honeysuckle and the content determination method of bupleurum saponin b1 and paracetaminophen in Suganning capsules were established.The method has good repeatability and specificity,and can be used for the quality control of Suganning capsules.

关 键 词：速感宁胶囊 含量测定 质量标准提升 

分 类 号：R284.1[医药卫生—中药学]