基于标准煎液的忘忧安神口服液量值传递相关性研究  

Study on the Correlation of Quality Value Transfer ofWangyou Anshen Oral Liquid Based on Standard Decoction

作　　者：汪莉 贾妙婷 孙天雄 冯慧敏 李玥 何军刚 罗旭东[1] 梁婷婷 强正泽[1] 李成义[1] WANG Li;JIAMiao-ting;SUN Tian-xiong;FENG Hui-min;LI Yue;HE Jun-gang;LUO Xu-dong;LIANG Ting-ting;QIANG Zheng-ze;LI Cheng-yi(Gansu University of Chinese Medicine,Lanzhou 730000,China)

机构地区：[1]甘肃中医药大学,甘肃兰州730000

出　　处：《中国现代中药》2022年第1期134-141,共8页Modern Chinese Medicine

基　　金：甘肃省高等学校科技成果转化项目(2018D-17)。

摘　　要：目的:研究忘忧安神方饮片-标准煎液-口服液的物质群量值传递关系,评价忘忧安神口服液制备工艺的科学性和合理性。方法:制备10批忘忧安神方标准煎液及10批口服液,采用高效液相色谱法(HPLC)对10批忘忧安神方标准煎液及口服液进行指纹图谱检测及有效成分含量测定,并结合出膏率、有效成分转移率进行口服液制备过程中物质群的量值传递规律分析。结果:在饮片-标准煎液各生产环节间栀子苷、甘草苷、甘草酸、槲皮苷的平均转移率分别为77.35%、69.45%、57.95%、48.67%;在标准煎液-口服液中分别为83.60%、75.92%、75.08%、91.69%。10批忘忧安神方标准煎液及口服液与其各自对照指纹图谱的相似度均大于0.94,10批口服液指纹图谱与10批标准煎液对照指纹图谱的相似度均大于0.76。标准煎液-口服液出膏率平均传递率为63.54%。结论:采用指纹图谱、出膏率及指标性成分转移率相结合的模式,对忘忧安神口服液制备过程中的量值传递规律进行分析,建立了科学合理的忘忧安神口服液制备工艺评价方法,为口服液生产工艺过程的实施及复方制剂的质量评价研究提供参考。Objective:To investigate the quality value transfer of a material group composed of the decoction pieces,the standard decoction and the oral liquid based on Wangyou Anshen Prescription and to evaluate the scientificity and rationality of preparation technology of Wangyou Anshen Oral Liquid.Methods:Ten batches of standard decoction and ten batches of oral liquid were prepared.Their high-performance liquid chromatography(HPLC)fingerprints were established and the content of active ingredients was determined.The quality value transfer law of the material group during the preparation of oral liquid was analyzed utilizing the extract rate and the transfer rates of active ingredients.Results:The average transfer rates of geniposide,glycyrrhizin,glycyrrhizic acid and quercitrin were 77.35%,69.45%,57.95%and 48.67%respectively from decoction pieces to standard decoction and 83.60%,75.92%,75.08%and 91.69%respectively from standard decoction to oral liquid.The similarities of the HPLC fingerprints of 10 batches of standard decoction and 10 batches of oral solution to their respective reference fingerprints were all greater than 0.94.The similarities of the HPLC fingerprints of 10 batches of oral liquid to the reference fingerprint of 10 batches of standard decoction were all greater than 0.76.The average transfer rate of extract from standard decoction to oral liquid was 63.54%.Conclusion:Fingerprint,extract rate and transfer rates of index components were used to analyze the law of quality value transfer in the preparation process of Wangyou Anshen Oral Liquid.A scientific and reasonable evaluation method for the preparation process of the oral liquid was established.This study provides a scientific basis for the implementation of the production process of the oral liquid and a reference for the quality evaluation of other compound preparations.

关 键 词：忘忧安神方 标准煎液 口服液 出膏率 转移率 指纹图谱 量值传递 

分 类 号：R286[医药卫生—中药学]