经典名方芍药甘草汤的物质基准量值传递分析
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摘要
目的:建立同时适用于芍药甘草汤药材、饮片与物质基准的HPLC指纹图谱检测方法,进行药材-饮片-物质基准制备过程中的物质群量值传递研究,并结合出膏率和有效成分转移率等技术经济指标,评价芍药甘草汤物质基准制备工艺流程的科学性和合理性。方法:依据古代医籍记载的方法制备芍药甘草汤物质基准;采用HPLC对15批药材、饮片、物质基准进行指纹图谱检测和有效成分含量测定,流动相乙腈-0. 05%磷酸水溶液梯度洗脱,检测波长237 nm;同时,结合出膏率和有效成分转移率,进行物质基准制备过程中物质群的量值传递相关性分析。结果:建立的HPLC指纹图谱检测方法精密度、重复性和稳定性均良好,能同时适用于药材、饮片、物质基准指纹图谱的检测。在物质基准指纹图谱中,以甘草苷为参照峰,确定了共有峰16个,其中6个色谱峰归属于白芍,11个色谱峰归属于甘草,指认了7个主要色谱峰。15批药材、饮片及芍药甘草汤物质基准指纹图谱与各自对照指纹图谱的相似度均良好(≥0. 90); 15批物质基准的平均出膏率24. 81%,芍药苷、甘草苷、甘草酸从饮片到物质基准的平均转移率分别为79. 68%,63. 70%和51. 20%,且均未出现离散数据。结论:采用整体物质群控制的指纹图谱方法、制备工艺过程中物质群量值传递研究思路与技术经济指标评价相结合的模式,建立了科学合理的芍药甘草汤物质基准制备工艺评价方法,可为其他经典名方物质基准的评价研究提供参考。
Objective: To establish the HPLC fingerprint test method for the medicinal materials,decoction pieces and substance benchmarks of Shaoyao Gancaotang for investigating the quality transmitting of substance group in preparation process of the medicinal materials-decoction pieces-substance benchmarks,then to evaluate the scientificity and rationality of preparation process of substance benchmarks of Shaoyao Gancaotang by combining with yields of dry extract,transfer rates of effective components and other indexes. Method: Substance benchmarks of Shaoyao Gancaotang was prepared according to the method recorded in ancient medical books,fingerprints of 15 batches of medicinal materials,decoction pieces and substance benchmarks were detected by HPLC,and the contents of effective ingredients were determined. At the same time,the correlation analysis of quality transmitting of substance group during the preparation of substance benchmarks was carried out by combining the yields of dry extract and transfer rates of effective components. Result: The established HPLC fingerprint method has good precision,repeatability and stability,it can be used for the simultaneous determination of fingerprint of medicinal materials,decoction pieces and substance benchmarks. In the fingerprint of substance benchmarks,16 common peaks were determined by taking liquiritin as the reference peak, of which 6 chromatographic peaks belong to Paeoniae Radix Alba and 11 chromatographic peaks belong to Glycyrrhizae Radix et Rhizoma,7 major chromatographic peaks were identified. The similarities of fingerprints of 15 batches of medicinal materials,decoction pieces and substance benchmarks of Shaoyao Gancaotang were good by comparing with their respective reference fingerprints( ≥0. 90),the average dry extract rate of 15 batches of substance benchmarks was 24. 81%,and no discrete data were found; the average transfer rates of paeoniflorin,liquiritin and glycyrrhizic acid from decoction pieces to substance benchmarks were 79. 68%, 63. 70% and 51. 20%,respectively,and no discrete data were found. Conclusion: In this paper,a scientific and reasonable method for evaluating the process of substance benchmarks of Shaoyao Gancaotang is established by means of the fingerprint method controlled by the whole substance group,the research idea of quality transmitting of substance group in the preparation process,and the evaluation of technical and economic indicators. It can be used as a reference for the evaluation and research of material benchmarks in other famous classical formulas.
Objective: To establish the HPLC fingerprint test method for the medicinal materials,decoction pieces and substance benchmarks of Shaoyao Gancaotang for investigating the quality transmitting of substance group in preparation process of the medicinal materials-decoction pieces-substance benchmarks,then to evaluate the scientificity and rationality of preparation process of substance benchmarks of Shaoyao Gancaotang by combining with yields of dry extract,transfer rates of effective components and other indexes. Method: Substance benchmarks of Shaoyao Gancaotang was prepared according to the method recorded in ancient medical books,fingerprints of 15 batches of medicinal materials,decoction pieces and substance benchmarks were detected by HPLC,and the contents of effective ingredients were determined. At the same time,the correlation analysis of quality transmitting of substance group during the preparation of substance benchmarks was carried out by combining the yields of dry extract and transfer rates of effective components. Result: The established HPLC fingerprint method has good precision,repeatability and stability,it can be used for the simultaneous determination of fingerprint of medicinal materials,decoction pieces and substance benchmarks. In the fingerprint of substance benchmarks,16 common peaks were determined by taking liquiritin as the reference peak, of which 6 chromatographic peaks belong to Paeoniae Radix Alba and 11 chromatographic peaks belong to Glycyrrhizae Radix et Rhizoma,7 major chromatographic peaks were identified. The similarities of fingerprints of 15 batches of medicinal materials,decoction pieces and substance benchmarks of Shaoyao Gancaotang were good by comparing with their respective reference fingerprints( ≥0. 90),the average dry extract rate of 15 batches of substance benchmarks was 24. 81%,and no discrete data were found; the average transfer rates of paeoniflorin,liquiritin and glycyrrhizic acid from decoction pieces to substance benchmarks were 79. 68%, 63. 70% and 51. 20%,respectively,and no discrete data were found. Conclusion: In this paper,a scientific and reasonable method for evaluating the process of substance benchmarks of Shaoyao Gancaotang is established by means of the fingerprint method controlled by the whole substance group,the research idea of quality transmitting of substance group in the preparation process,and the evaluation of technical and economic indicators. It can be used as a reference for the evaluation and research of material benchmarks in other famous classical formulas.
引文
[1]朱广伟,张贵君,汪萌,等.中药芍药甘草汤基原及药效组分和药理作用研究概况[J].中华中医药杂志,2015,30(8):2865-2869.
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[9]邓哲,刘德文,杜杰,等.经典名方研发建议的梳理和探讨[J].中国实验方剂学杂志,2018,doi:10. 13422/j. cnki. syfjx. 20190554.
[10]周萃,杨燕云,顾颖杰,等.甘草饮片及其四种炮制品的HPLC指纹图谱研究[J/OL].辽宁中医杂志,http://kns. cnki. net/kcms/detail/21. 1128. r.20181120. 1545. 048. html,2018-11-27/2018-12-04.
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[12]汪萌,闫永红,邹慧琴,等.芍药甘草汤功能与药效组分对应性研究[J].国际药学研究杂志,2015,42(1):101-106.
[13]余佳丽,唐晓章,周菲,等.三七药材-三七二醇皂苷指纹图谱及其物质群量值传递分析[J].中国实验方剂学杂志,2018,24(7):18-22.
[14]北京药品监督管理局.北京市中药饮片炮制规范.上册[M].北京:化学工业出版社,2015:64,78.
[15]浙江省食品药品监督管理局.浙江省中药炮制规范[M].北京:中国医药科技出版社,2015:23.
[16]吴世强,种月荣,石勇强.甘草的多法炮制及历史考证[J].时珍国医国药,2005,16(1):36-36.
[17]刘渡舟.伤寒论校注.卷二[M].北京:人民卫生出版社,1991:98.
[18]国家药典委员会.中华人民共和国药典.一部[M].北京:中国医药科技出版社,2015:86-87,105.
[19]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.
[20]李越峰,边甜甜,司昕雷,等.不同采收期对甘草中甘草苷、甘草酸及甘草多糖含量的影响[J].中兽医医药杂志,2016,35(5):47-50.
[21]周义峰,汤兴利,杭悦宇,等.产地及生长年限对白芍根中芍药苷含量的影响[J].江苏农业科学,2007(1):149-150,183.
[22]王智民,刘菊妍,刘晓谦,等.谈经典名方的化学、生产和质量控制研发和监管[J].中国中药杂志,2017,42(10):1819-1824.
[2]国家中医药管理局.关于发布《古代经典名方目录(第一批)》的通知[EB/OL]. http://kjs. satcm. gov.cn/zhengcewenjian/2018-04-16/7107. html, 2018-04-13/2018-09-18.
[3]曾永青,李立新,王洋洋.芍药甘草汤加减联合氟桂利嗪治疗神经性头痛的临床疗效观察[J].世界中医药,2015,10(1):60-62.
[4]姚伟光,陈青,江春燕.芍药甘草汤治疗儿童功能性腹痛的疗效观察[J].浙江中医药大学学报,2015,39(6):470-472.
[5]褚桂克.芍药甘草汤治疗类风湿性关节炎60例[J].中国中医药现代远程教育,2012,10(1):72-73.
[6]赵丹.国家食药监总局发布经典名方简化注册审批管理规定征求意见稿[J].中医药管理杂志,2017,25(20):190.
[7]国家药品监督管理局.关于发布古代经典名方中药复方制剂简化注册审批管理的规定的公告[EB/OL]. http://cnda. cfda. gov. cn/WS04/CL2050/228247. html,2018-05-29/2018-06-01.
[8]陈畅,程锦堂,刘安.经典名方研发策略[J].中国中药杂志,2017,42(9):1814-1818.
[9]邓哲,刘德文,杜杰,等.经典名方研发建议的梳理和探讨[J].中国实验方剂学杂志,2018,doi:10. 13422/j. cnki. syfjx. 20190554.
[10]周萃,杨燕云,顾颖杰,等.甘草饮片及其四种炮制品的HPLC指纹图谱研究[J/OL].辽宁中医杂志,http://kns. cnki. net/kcms/detail/21. 1128. r.20181120. 1545. 048. html,2018-11-27/2018-12-04.
[11]张娟,刘美,肖炯昌,等.白芍不同提取方法及指纹图谱的研究[J].中国现代中药,2018,doi:10. 13313/j.issn. 1673-4890. 20180725005.
[12]汪萌,闫永红,邹慧琴,等.芍药甘草汤功能与药效组分对应性研究[J].国际药学研究杂志,2015,42(1):101-106.
[13]余佳丽,唐晓章,周菲,等.三七药材-三七二醇皂苷指纹图谱及其物质群量值传递分析[J].中国实验方剂学杂志,2018,24(7):18-22.
[14]北京药品监督管理局.北京市中药饮片炮制规范.上册[M].北京:化学工业出版社,2015:64,78.
[15]浙江省食品药品监督管理局.浙江省中药炮制规范[M].北京:中国医药科技出版社,2015:23.
[16]吴世强,种月荣,石勇强.甘草的多法炮制及历史考证[J].时珍国医国药,2005,16(1):36-36.
[17]刘渡舟.伤寒论校注.卷二[M].北京:人民卫生出版社,1991:98.
[18]国家药典委员会.中华人民共和国药典.一部[M].北京:中国医药科技出版社,2015:86-87,105.
[19]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.
[20]李越峰,边甜甜,司昕雷,等.不同采收期对甘草中甘草苷、甘草酸及甘草多糖含量的影响[J].中兽医医药杂志,2016,35(5):47-50.
[21]周义峰,汤兴利,杭悦宇,等.产地及生长年限对白芍根中芍药苷含量的影响[J].江苏农业科学,2007(1):149-150,183.
[22]王智民,刘菊妍,刘晓谦,等.谈经典名方的化学、生产和质量控制研发和监管[J].中国中药杂志,2017,42(10):1819-1824.