基于传统煎药工艺的野菊花饮片标准汤剂制备及其质量评价方法分析
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摘要
目的:制备5个产地15批次野菊花饮片标准汤剂并确立其质量评价方法,研究其出膏率、指标成分含量及转移率、指纹图谱等数据,为野菊花饮片标准汤剂及其配方颗粒的制备提供参考。方法:参照传统煎药工艺制备标准汤剂,采用超高效液相色谱-二极管阵列检测器(UPLC-DAD)测定指标成分蒙花苷的含量,计算该成分的转移率,绘制指纹图谱,采用真空干燥法制备浸膏粉,计算出膏率。结果:15批野菊花饮片标准汤剂中蒙花苷质量浓度0. 19～0. 74 g·L~(-1),转移率21. 95%～66. 23%,平均转移率37. 12%(RSD 11. 8%); p H 5. 1～5. 5;出膏率24. 7%～32. 5%,平均出膏率27. 87%(RSD 2. 4%)。指纹图谱共有峰有9个,确认其中2个色谱峰(2号和9号)分别为绿原酸和蒙花苷。结论:建立的制备工艺符合传统汤剂制备方法且稳定可行,可用于野菊花饮片标准汤剂的制备及质量评价。
Objective: To study the dry extract rate, determination and transfer rate of maker compounds,fingerprint and others of standard decoction of Chrysanthemi Indici Flos and provide basic data for the preparation of this standard decoction and its dispensing granules by establishing 15 batches of standard decoction of Chrysanthemi Indici Flos from 5 different places. Method: The standard decoction of Chrysanthemi Indici Flos was prepared based on the traditional decoction process,the content of linarin was determined by UPLC-DAD,the transfer rate of this composition was calculated,the fingerprint was drawn,the extract powder was prepared by vacuum drying,and the dry extract rate was calculated. Result: The concentration of linarin in 15 batches of standard decoction of Chrysanthemi Indici Flos was 0. 19-0. 74 g·L~(-1),the transfer rate of linarin was 21. 95%-66. 23%,its average transfer rate was 37. 12% with RSD of 11. 8%,the pH value was 5. 1-5. 5,the range of dry extract rate was 24. 7%-32. 5%,the average dry extract rate was 27. 87% with RSD of 2. 4%. There were 9 major common peaks in the fingerprint and 2 peaks( No. 2 and No. 9) were confirmed,such as chlorogenic acid and linarin. Conclusion: The preparation method in this research conforms to the traditional decoction method and is stable and feasible. It can be used for the preparation and quality evaluation of standard decoction of Chrysanthemi Indici Flos.
Objective: To study the dry extract rate, determination and transfer rate of maker compounds,fingerprint and others of standard decoction of Chrysanthemi Indici Flos and provide basic data for the preparation of this standard decoction and its dispensing granules by establishing 15 batches of standard decoction of Chrysanthemi Indici Flos from 5 different places. Method: The standard decoction of Chrysanthemi Indici Flos was prepared based on the traditional decoction process,the content of linarin was determined by UPLC-DAD,the transfer rate of this composition was calculated,the fingerprint was drawn,the extract powder was prepared by vacuum drying,and the dry extract rate was calculated. Result: The concentration of linarin in 15 batches of standard decoction of Chrysanthemi Indici Flos was 0. 19-0. 74 g·L~(-1),the transfer rate of linarin was 21. 95%-66. 23%,its average transfer rate was 37. 12% with RSD of 11. 8%,the pH value was 5. 1-5. 5,the range of dry extract rate was 24. 7%-32. 5%,the average dry extract rate was 27. 87% with RSD of 2. 4%. There were 9 major common peaks in the fingerprint and 2 peaks( No. 2 and No. 9) were confirmed,such as chlorogenic acid and linarin. Conclusion: The preparation method in this research conforms to the traditional decoction method and is stable and feasible. It can be used for the preparation and quality evaluation of standard decoction of Chrysanthemi Indici Flos.
引文
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[11]段晓颖,马秋莹,闫艳仓,等.野菊花总黄酮生物黏附双层缓释贴片中蒙花苷体外释放与黏膜渗透考察[J].中国实验方剂学杂志,2014,20(19):22-24.
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[14]邓海欣,潘红烨,陈周全,等. 999感冒灵浓缩过程蒙花苷热降解规律研究[J].中国中药杂志,2016,41(8):1380-1382.
[15]刘承萍,曾元儿,高峰.野菊花中蒙花苷的热稳定性研究[J].今日药学,2011,21(2):88-90.
[16]仰铁锤,韩正洲,陈贝贝,等.不同花期及不同炮制的野菊花中蒙花苷含量测定[C]//中国自然资源学会.海峡两岸暨CSNR全国中药及天然药物资源学术研讨会论文集:2012年卷.北京:中国学术期刊(光盘版)电子杂志社,2012:503-504.
[17]涂兴明,刘淦华,刘承萍,等.不同来源野菊花的质量研究[J].中药新药与临床药理,2010,21(4):425-428.
[2]袁慧杰,赖志辉,管艳艳,等.野菊花主要活性成分的药理作用研究进展[J].中华中医药学刊,2018,63(3):651-653.
[3]吴雪松,许浚,张铁军,等.野菊的化学成分及质量评价研究进展[J].中草药,2015,46(3):443-452.
[4]陈士林,刘安,李琦,等.中药饮片标准汤剂研究策略[J].中国中药杂志,2016,41(8):1367-1375.
[5]杨立伟,王海南,耿莲,等.基于标准汤剂的中药整体质量控制模式探讨[J].中国实验方剂学杂志,2018,24(8):1-6.
[6]朱广伟,李西文,邬兰,等.赤芍饮片标准汤剂制备及质量标准研究[J].世界科学技术—中医药现代化,2016,18(12):2062-2069.
[7]朱广伟,李西文,陈士林,等.白芍饮片标准汤剂质量标准研究[J].世界中医药,2016,11(5):753-757.
[8]朱广伟,李西文,李琦,等.基于传统煎药工艺的龙胆饮片标准汤剂制备及质量评价方法研究[J].中草药,2017,40(20):4253-4260.
[9]张鹏,邬兰,李西文,等.人参饮片标准汤剂的评价及应用探讨[J].中国实验方剂学杂志,2017,23(7):2-11.
[10]于小红,赵嵘,代云桃,等.党参标准汤剂质量评价的建立[J].中国实验方剂学杂志,2017,23(7):24-29.
[11]段晓颖,马秋莹,闫艳仓,等.野菊花总黄酮生物黏附双层缓释贴片中蒙花苷体外释放与黏膜渗透考察[J].中国实验方剂学杂志,2014,20(19):22-24.
[12]李秀兰,孙光洁,戴树培,等.密蒙花/结香有效成分的抑菌作用[J].西北药学杂志,1996,11(4):165-166.
[13]陈慧芳.植物活性成分辞典[M].北京:中国医药科技出版社,2001:12-13.
[14]邓海欣,潘红烨,陈周全,等. 999感冒灵浓缩过程蒙花苷热降解规律研究[J].中国中药杂志,2016,41(8):1380-1382.
[15]刘承萍,曾元儿,高峰.野菊花中蒙花苷的热稳定性研究[J].今日药学,2011,21(2):88-90.
[16]仰铁锤,韩正洲,陈贝贝,等.不同花期及不同炮制的野菊花中蒙花苷含量测定[C]//中国自然资源学会.海峡两岸暨CSNR全国中药及天然药物资源学术研讨会论文集:2012年卷.北京:中国学术期刊(光盘版)电子杂志社,2012:503-504.
[17]涂兴明,刘淦华,刘承萍,等.不同来源野菊花的质量研究[J].中药新药与临床药理,2010,21(4):425-428.