摘要
目的制备百合地黄汤物质基准,进行制备过程工艺和质量控制分析,评价其科学性和合理性。方法按古籍方法制备15批物质基准,测定制备过程中梓醇和毛蕊花糖苷的含量,计算转移率和出膏率;建立HPLC指纹图谱检测方法,分别检测饮片、煎煮液、浓缩液和物质基准的指纹图谱,进行共有色谱峰归属、指认和相似度评价。结果15批物质基准梓醇和毛蕊花糖苷转移率分别为81.40%~92.88%和28.90%~41.41%,出膏率为36.06%~41.71%,均未出现离散数据;煎煮、浓缩和冻干过程有效成分转移率较稳定。标定物质基准指纹图谱共有峰16个,其中6个归属于百合、9个归属于地黄,指认了3个色谱峰;饮片、煎煮液、浓缩液和物质基准指纹图谱相似度均大于0.9;煎煮液、浓缩液、物质基准3者对照图谱的相似度均大于0.99。结论该指纹图谱检测方法合理可行,能同时适用于饮片、中间体和物质基准;物质基准制备工艺科学合理,不会造成其物质基础明显改变。本实验为百合地黄汤制剂开发奠定了基础,为经典名方物质基准制备过程工艺与质量评价提供了新思路。
Objective To prepare substance benchmarks of Baihe Dihuang Decoction(BDD),and evaluate the scientificity and rationality of preparation process by analyzing the process quality.Methods Fifteen batches of substance benchmarks were prepared according to the ancient method,the content of catalpol and acteoside in the preparation process was determined,and the transfer rate and extractum rate were calculated.Fingerprints of 15 batches of decoction pieces,decoction,concentrate and substance benchmarks were detected by HPLC,and the common peaks of fingerprints were attributed and identified;In addition,the similarity of fingerprints were evaluated.Results In 15 batches of substance benchmarks,the transfer rates of catalpol and acteoside were 81.40%-92.88%and 28.90%-41.41%respectively,the extractum rate was 36.06%-41.71%,and without discrete data.During the process of decoction,concentration and freeze-drying,the transfer rates of effective components were stable.In the fingerprints of substance benchmarks,16 common peaks were determined,of which six peaks belong to Lilii Bulbus,nine peaks belong to Rehmanniae Radix.Three peaks were identified.The similarity of fingerprints of decoction pieces,decoction,concentrate,and substance benchmarks were all over 0.9.The similarity of reference fingerprints of decoction,concentrate,and substance benchmarks were over 0.99.Conclusion The fingerprint method is reasonable and feasible,which can be used for simultaneously determining the fingerprint of decoction pieces,intermediates and substance benchmarks.The preparation process is scientific and reasonable,and will not changes substance basis significantly.The paper establishes a foundation for the development of preparation of BDD,and provides a new idea for the evaluation of process and quality of the substance benchmarks of classical famous prescriptions.
作者
周菲
林美斯
王琳
李锐
张春容
赵丽
林大胜
曹科
ZHOU Fei;LIN Mei-si;WANG Lin;LI Rui;ZHANG Chun-rong;ZHAO Li;LIN Da-sheng;CAO Ke(Key Laboratory of Traditional Chinese Medicine Resources with Southwest Characteristics,School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;Chengdu Taihe Health Technology Group Inc.,Ltd.,Chengdu 611731,China;School of Acupuncture and Moxibustion,Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610097,China)
出处
《中草药》
CAS
CSCD
北大核心
2019年第16期3824-3832,共9页
Chinese Traditional and Herbal Drugs
基金
四川省科技计划项目(2018SZ0008)
关键词
经典名方
百合地黄汤
物质基准
制备工艺
质量控制
指纹图谱
转移率
出膏率
梓醇
毛蕊花糖苷
classical famous prescriptions
Baihe Dihuang Decoction
substance benchmarks
preparation process
quality control
fingerprint
transfer rate
extractum rate
catalpol
acteoside
