基于HPLC指纹图谱及多成分含量测定评价制备过程对强心合剂质量的影响  

Preparation process evaluation on the quality of Qiangxin Mixture based upon HPLC fingerprint and multi-component content determination

作　　者：高紫薇 林欣荣 陈晓虎[2,3] 吴磊 GAO Ziwei;LIN Xinrong;CHEN Xiaohu;WU Lei(Department of Pharmacy,Affiliated Hospital,Nanjing University of Chinese Medicine,Jiangsu Province Hospital of Chinese Medicine,Jiangsu Nanjing 210029,China;First College of Clinical Medicine,Nanjing University of Chinese Medicine,Jiangsu Nanjing 210029,China;Department of Cardiology,Affiliated Hospital,Nanjing University of Chinese Medicine,Jiangsu Province Hospital of Chinese Medicine,Jiangsu Nanjing 210029,China)

机构地区：[1]南京中医药大学附属医院江苏省中医院药学部,江苏南京210029 [2]南京中医药大学第一临床医学院,江苏南京210029 [3]南京中医药大学附属医院江苏省中医院心血管内科,江苏南京210029

出　　处：《中国医院药学杂志》2024年第7期781-790,共10页Chinese Journal of Hospital Pharmacy

基　　金：国家自然科学基金面上项目(编号:81973824);江苏省中医药科技发展计划一般项目(编号:YB2020014);江苏省研究生科研与实践创新计划项目(编号:SJCX230757);江苏省中药骨干人才高级研修项目(苏中医科教[2022]11号)。

摘　　要：目的:建立强心合剂HPLC指纹图谱并进行多成分含量测定,考察制备过程提取、浓缩、离心、灭菌工艺对强心合剂质量的影响。方法:以强心合剂的提取液、浓缩液、离心液、合剂(灭菌后)为供试品,采用HPLC法建立强心合剂制备过程4个不同工艺阶段的指纹图谱,并进行相似度评价与色谱峰指认,测定方中槲皮素-3-O-β-D葡萄糖7-O-β-D龙胆双糖苷、芥子碱硫氰酸盐、芥子酸、大车前苷、毛蕊异黄酮葡萄糖苷、车前草苷D 6个成分的含量。结果:10批强心合剂制备过程中不同工艺阶段的图谱与对照指纹图谱相比,相似度均大于0.90,表明生产工艺较稳定,提取液中标定18个共有峰,而浓缩、离心、灭菌后增至21个;含量测定结果显示制备过程不同工艺阶段对强心合剂质量均有不同程度的影响,其中浓缩过程影响最大。结论:该研究针对不同制备过程对强心合剂质量的影响进行探讨分析,可为中药制备过程中整体质量评价的共性技术提供数据依据和理论参考。OBJECTIVE To establish the high performance liquid chromatography(HPLC)fingerprint of Qiangxin Mixture(QM)and determine the multi-component content and examine the effects of extraction,concentration,centrifugation and sterilization on the quality of QM during preparation process.METHODS Extract,concentrate,centrifuge and mixture(after sterilization)of QM were used as test products.And the fingerprints of four different process stages of preparation process of QM were established by HPLC and similarity evaluation and chromatographic peak identification performed.The contents of six components of quercetin-3-O-β-D glucose 7-O-β-D gentiandiglycoside,glucosine thiocyanate,glucosinoic acid,psyllin,isoflavone glucoside and psyllin D were determined.RESULTS As compared with control fingerprint,the similarity of different process stages in the preparation of 10 batches of QM was greater than 0.90.It indicated that the production process was relatively stable and 18 common peaks in the extract increased to 21 after concentration,centrifugation and sterilization.The content determination results showed that different process stages of preparation process had varying degrees of influence on the quality of QM and concentration process had the greatest impact.CONCLUSION This study examined the effects of different preparation processes on the quality of QM and provided data and theoretical rationales for common techniques of overall quality evaluation during preparation processes of traditional Chinese medicines.

关 键 词：强心合剂 浓缩 离心 灭菌 高效液相色谱 

分 类 号：R286.0[医药卫生—中药学]