复方腰背痛颗粒的质量标准研究  

Study on the quality standard of compound lumbar and back pain granules

作　　者：赵文萃 赵庆兰 吴艳云 张巍 王国兴 ZHAO Wencui;ZHAO Qinglan;WU Yanyun;ZHANG Wei;WANG Guoxing(The 964th hospital of the Joint Logistices Support Force,Changchun 130062,China;Changchun People’s Hospital,Changchun 130051,China)

机构地区：[1]联勤保障部队第九六四医院,长春130062 [2]长春市人民医院,长春130051

出　　处：《长春中医药大学学报》2025年第3期284-287,共4页Journal of Changchun University of Chinese Medicine

基　　金：吉林省科技发展计划项目(20210204012YY);联勤保障部队第九六四医院新业务新技术项目。

摘　　要：目的 建立一种有效的质量控制方法,以确保复方腰背痛颗粒的质量稳定性和疗效的可靠性。方法 采用高效液相色谱法(HPLC)对复方腰背痛颗粒中的主要成分当归和川芎进行定量分析,测定两种药材中阿魏酸的含量,并利用薄层色谱法(TLC)对本方剂中当归、地龙进行鉴别。结果 鉴别和含量测定方法均显示出良好的专属性。在HPLC测定中,阿魏酸的浓度在2.50~30.00 μg·mL^(-1)范围内呈现出良好的线性关系(r=0.999 7),平均加样回收率为97.93%(RSD=0.62%)。结论 采用TLC鉴别与HPLC法含量测定相结合的方法,不仅能够有效地控制复方腰背痛颗粒的质量,而且为该药物的质量控制提供了一种科学、准确的手段。Objective To establish an effective quality control method to ensure the quality stability and reliability of efficacy for compound lumbar and back pain granules.Methods The main components of Angelica sinensis and Ligusticum chuanxiong in compound lumbar and back pain granules were determined by HPLC,and the content of ferulic acid in two medicinal materials was determined.Angelica sinensis and Earthworm in this prescription were identified by thin-layer chromatography(TLC).Results The identification and determination methods showed good specificity.In HPLC determination,the concentration of ferulic acid showed a good linear relationship within the range of 2.50-30.00μg·mL^(-1)(r=0.9997),with an average recovery rate of 97.93%(RSD=0.62%).Conclusion The combination of TLC identification and HPLC content determination method can not only effectively control the quality of compound lumbar and back pain granules,but also provide a scientific and accurate means for the quality control of the drug.

关 键 词：薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R681.5[医药卫生—骨科学]