医院制剂补肾启枢强心颗粒的质量标准研究  

Study on Quality Standard of Hospital Preparation Bushen Qishu Qiangxin Granules

作　　者：李昂 高萌[1,2] 李军茂 罗艺玲 饶小勇 熊磊[4] 姚闽 LI Ang;GAO Meng;LI Junmao;LUO Yiin;RAO Xiaoyong;XIONG Lei;YAO Min(Jiangxi University of Chinese Medicine,Nanchang Jiangxi 330006,China;National Pharmaceutical Engineering Center for Solid Preparation in Chinese Herbal Medicine,Nanchang Jiangxi 330006,China;Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China;Jiangxi Provincial Drug Certification and Evaluation Centre,Nanchang Jiangxi 330006,China.)

机构地区：[1]江西中医药大学,江西南昌330006 [2]中药固体制剂制造技术国家工程研究中心,江西南昌330006 [3]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [4]江西省药品认证审评中心,江西南昌330006

出　　处：《药品评价》2024年第11期1301-1306,共6页Drug Evaluation

基　　金：江西省重点研发计划“揭榜挂帅”项目(No.20223BBG71001);2022年国家青年岐黄学者项目;南昌市高层次科技创新人才“双百计划”(洪科字[2022]321号)。

摘　　要：目的 建立医院制剂补肾启枢强心颗粒的质量标准。方法 采用薄层色谱法(TLC)对补肾启枢强心颗粒中的桂枝、陈皮、炙甘草进行定性鉴别;采用高效液相色谱法(HPLC)同时测定补肾启枢强心颗粒中的淫羊藿苷、橙皮苷的含量。结果 肉桂酸、橙皮苷、甘草苷的薄层色谱斑点清晰,分离度好,阴性对照样品无干扰。淫羊藿苷、橙皮苷分别在浓度0.006 1~0.0983、0.0121~0.1928 mg/mL范围内线性关系良好(r>0.9997);平均加样回收率分别为97.69%、101.83%,RSD分别为0.90%、0.63%(n=9)。结论 本研究建立了补肾启枢强心颗粒的质量标准,该方法专属性强、简便可行、重现性好,可较好地反映其内在质量,为科学评价医院制剂补肾启枢强心颗粒的质量提供参考。Objective To establish the quality standard of hospital preparation bushen qishu qiangxin granules.Methods TLC was used to identify the cinnamomi ramulus,citri reticulatae pericarpium and glycyrrhizae praeparata cum melle radix et rhizoma in bushen qishu qiangxin granules.The contents of icariin and hesperidin in bushen qishu qiangxin granules were determined by HPLC.Results The TLC spots of cinnamic acid,hesperidin and liquiritin were clear,the separation was good,and the negative control samples had no interference.The icariin and hesperidin showed good linear relationships(r>0.9997)within the concentration range of 0.0061~0.0983 and 0.0121~0.1928 mg/mL,respectively;the average recovery rates were 97.69%and 101.83%,with RSDs of 0.90%and 0.63%(n=9),respectively.Conclusion The quality standard of bushen qishu qiangxin granules was established in this study.The method was specific,simple,feasible and reproducible,which could reflect the intrinsic quality of bushen qishu qiangxin granules and provide reference for scientific evaluation of the quality of bushen qishu qiangxin granules.

关 键 词：医院制剂 补肾启枢强心颗粒 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R28[医药卫生—中药学]