川芎饮片标准汤剂的质量分析
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摘要
目的:制备川芎饮片标准汤剂并对其进行质量分析。方法:参照标准汤剂的要求,制备来自3个产地共15批川芎饮片标准汤剂;建立其HPLC指纹图谱,采用聚类分析进行质量分析;建立其指纹图谱共有模式下4种指标成分(阿魏酸,洋川芎内酯Ⅰ,洋川芎内酯A和藁本内酯)的HPLC含量测定方法;计算各批次样品中指标成分转移率、出膏率,并测定样品的pH。结果:对15批川芎饮片标准汤剂采用"中药色谱指纹图谱相似度评价系统"(2012A版)进行指纹图谱分析,确定了22个共有峰,其相似度均>0.92;定性指认出其中11,13,17,18,19,20号峰,分别为阿魏酸,洋川芎内酯Ⅰ,洋川芎内酯A,正丁基苯酞,阿魏酸松柏酯,藁本内酯;通过聚类分析可将3个产地的川芎饮片标准汤剂质量概貌进行区分,说明不同产地的川芎存在质量差异,但同一产地不同批次质量较为稳定。15批川芎饮片标准汤剂共有模式下4种主要成分分别为阿魏酸,洋川芎内酯Ⅰ,洋川芎内酯A和藁本内酯;以洋川芎内酯A(0.176 3~0.249 8 g·L~(-1))和洋川芎内酯Ⅰ(0.065 2~0.103 4 g·L~(-1))在标准汤剂中含量较高,藁本内酯(0.040 0~0.089 8 g·L~(-1))次之,阿魏酸(0.022 0~0.042 3 g·L~(-1))最低,4个成分的转移率依次为6.63%~11.82%,33.32%~55.98%,1.26%~3.73%,16.39%~33.05%;15批川芎饮片标准汤剂的干膏得率12.69%~19.78%,pH 4.54~4.82。结论:该研究建立了各产地多批次川芎饮片标准汤剂的指纹图谱和多成分含量测定方法,适用于川芎饮片标准汤剂的质量控制。
Objective: To prepare standard decoction of Chuanxiong Rhizoma and conduct its quality analysis. Method: According to the requirements of standard decoction,15 batches of standard decoction of Chuanxiong Rhizoma from three producing areas were prepared,the HPLC fingerprint was established and the quality analysis was carried out by cluster analysis; under common pattern of fingerprint, the simultaneous determination of four index components( ferulic acid, senkyunolide Ⅰ, senkyunolide A and ligustilide) was established by HPLC. The transfer rates of main components, dry extract yield, pH value of samples were measured. Result: A total of 15 batches of standard decoctions of Chuanxiong Rhizoma were fingerprinted by Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine( edition of 2012 A).Twenty-two common peaks were identified,and their similarities were all greater than 0. 92,and peak 11,13,17,18,19 and 20 were identified qualitatively as ferulic acid,senkyunolide Ⅰ,senkyunolide A,n-butylphthalide,coniferyl ferulate and ligustilide,respectively. The quality overview of standard decoction of Chuanxiong Rhizoma from three producing areas could be distinguished through cluster analysis, which showed that there were differences in quality of Chuanxiong Rhizoma from different producing areas,but the quality was relatively stable in different batches of samples from the same origin. Under common pattern,there were four major components in 15 batches of standard decoction of Chuanxiong Rhizoma,including ferulic acid,senkyunolide Ⅰ,senkyunolide A and ligustilide. Contents of senkyunolide A( 0. 176 3-0. 249 8 g·L~(-1)) and senkyunolide Ⅰ( 0. 065 2-0. 103 4 g·L~(-1)) was high in the standard decoction,content of ligustilide( 0. 040 0-0. 089 8 g·L~(-1)) followed,and content of ferulic acid( 0. 022 0-0. 042 3 g·L~(-1)) was the lowest,transfer rates of the above four components were 6. 63%-11. 82%, 33. 32%-55. 98%, 1. 26%-3. 73% and 16. 39%-33. 05%, respectively. Dry extract yield of the standard decoction was 12. 69% to 19. 78%,and the pH was 4. 54 to 4. 82. Conclusion: This study establishes the fingerprint and multi-component determination methods of standard decoctions of Chuanxiong Rhizoma from various producing areas,which is suitable for quality control of this standard decoction.
Objective: To prepare standard decoction of Chuanxiong Rhizoma and conduct its quality analysis. Method: According to the requirements of standard decoction,15 batches of standard decoction of Chuanxiong Rhizoma from three producing areas were prepared,the HPLC fingerprint was established and the quality analysis was carried out by cluster analysis; under common pattern of fingerprint, the simultaneous determination of four index components( ferulic acid, senkyunolide Ⅰ, senkyunolide A and ligustilide) was established by HPLC. The transfer rates of main components, dry extract yield, pH value of samples were measured. Result: A total of 15 batches of standard decoctions of Chuanxiong Rhizoma were fingerprinted by Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine( edition of 2012 A).Twenty-two common peaks were identified,and their similarities were all greater than 0. 92,and peak 11,13,17,18,19 and 20 were identified qualitatively as ferulic acid,senkyunolide Ⅰ,senkyunolide A,n-butylphthalide,coniferyl ferulate and ligustilide,respectively. The quality overview of standard decoction of Chuanxiong Rhizoma from three producing areas could be distinguished through cluster analysis, which showed that there were differences in quality of Chuanxiong Rhizoma from different producing areas,but the quality was relatively stable in different batches of samples from the same origin. Under common pattern,there were four major components in 15 batches of standard decoction of Chuanxiong Rhizoma,including ferulic acid,senkyunolide Ⅰ,senkyunolide A and ligustilide. Contents of senkyunolide A( 0. 176 3-0. 249 8 g·L~(-1)) and senkyunolide Ⅰ( 0. 065 2-0. 103 4 g·L~(-1)) was high in the standard decoction,content of ligustilide( 0. 040 0-0. 089 8 g·L~(-1)) followed,and content of ferulic acid( 0. 022 0-0. 042 3 g·L~(-1)) was the lowest,transfer rates of the above four components were 6. 63%-11. 82%, 33. 32%-55. 98%, 1. 26%-3. 73% and 16. 39%-33. 05%, respectively. Dry extract yield of the standard decoction was 12. 69% to 19. 78%,and the pH was 4. 54 to 4. 82. Conclusion: This study establishes the fingerprint and multi-component determination methods of standard decoctions of Chuanxiong Rhizoma from various producing areas,which is suitable for quality control of this standard decoction.
引文
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[20]肖作奇,欧阳波,潘涛,等.地肤子高效液相色谱指纹图谱及聚类分析研究[J].中医药导报,2017,23(13):37-39,43.
[21]黄玮,周云庆,杨洪元,等.胆黄润肠丸指纹图谱的聚类分析[J].中国医院药学杂志,2016,36(9):719-723.
[22]蔡晓洋,张思荻,曾俊,等.基于主成分分析和聚类分析的栀子种质资源评价[J].中国实验方剂学杂志,2017,23(14):30-37.
[23]范卫锋,郑兆广,胡琴,等.丁香茄子的HPLC指纹图谱分析[J].中国实验方剂学杂志,2017,23(20):66-70.
[24]仝家羽,赵嵘,代云桃,等.当归标准汤剂质量评价体系的建立[J].中国实验方剂学杂志,2017,23(7):18-23.
[25]焦梦姣,邓哲,章军,等.含挥发性成分中药饮片标准汤剂的制备和质量标准研究——以牡丹皮为例[J].中国中药杂志,2018,43(5):891-896.
[2]郑春松,徐筱杰,叶蕻芝,等.川芎活血化瘀和行气止痛作用的计算机模拟研究[J].中华中医药杂志,2015,30(5):1432-1436.
[3]张晓琳,徐金娣,朱玲英,等.中药川芎研究新进展[J].中药材,2012,35(10):1706-1711.
[4]陈雏,吴燕,李彬,等.UPLC法测定川芎生长过程中6种主要成分的含量变化[J].天然产物研究与开发,2018,doi:10.16333/j.1001-6880.2018.6.014.
[5]RAN X,MA L,PENG C,et al.Ligusticum chuanxiong Hort:a review of chemistry and pharmacology[J].Pharm Biol,2011,49(11):1180-1189.
[6]韦玮,徐嵬,杨秀伟.规范化种植川芎化学成分研究[J].中草药,2017,48(15):3017-3025.
[7]梁乙川,郭换,刘素娟,等.一测多评法测定川芎中7种成分含量[J].中药材,2018,41(1):144-147.
[8]梁军.HPLC测定川芎中5种药效成分的含量[J].解放军预防医学杂志,2015,33(2):224.
[9]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.
[10]林瑞东.川芎配方颗粒生产工艺和质量标准的研究[D].长春:吉林大学,2015.
[11]毛霞,胡久梅.川芎配方颗粒的制备工艺及质量标准研究[J].辽宁农业职业技术学院学报,2015,17(3):11-12,21.
[12]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,2017,48(20):4253-4260.
[13]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.
[14]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.
[15]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.
[16]李琦,章军,崔文金,等.黄芩饮片标准汤剂的制备和质量标准评价[J].中国实验方剂学杂志,2017,23(7):36-40.
[17]董青,赵嵘,代云桃,等.红花标准汤剂的质量评价[J].中国实验方剂学杂志,2017,23(7):12-17.
[18]徐姣,赵嵘,代云桃,等.栀子标准汤剂的质量评价方法考察[J].中国实验方剂学杂志,2017,23(7):30-35.
[19]周蔚昕,刘涛,张佳,等.川芎饮片标准汤剂指纹图谱研究[J].中草药,2018,49(10):2401-2409.
[20]肖作奇,欧阳波,潘涛,等.地肤子高效液相色谱指纹图谱及聚类分析研究[J].中医药导报,2017,23(13):37-39,43.
[21]黄玮,周云庆,杨洪元,等.胆黄润肠丸指纹图谱的聚类分析[J].中国医院药学杂志,2016,36(9):719-723.
[22]蔡晓洋,张思荻,曾俊,等.基于主成分分析和聚类分析的栀子种质资源评价[J].中国实验方剂学杂志,2017,23(14):30-37.
[23]范卫锋,郑兆广,胡琴,等.丁香茄子的HPLC指纹图谱分析[J].中国实验方剂学杂志,2017,23(20):66-70.
[24]仝家羽,赵嵘,代云桃,等.当归标准汤剂质量评价体系的建立[J].中国实验方剂学杂志,2017,23(7):18-23.
[25]焦梦姣,邓哲,章军,等.含挥发性成分中药饮片标准汤剂的制备和质量标准研究——以牡丹皮为例[J].中国中药杂志,2018,43(5):891-896.