枳实饮片标准汤剂的质量控制
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摘要
目的:建立枳实饮片标准汤剂的质量控制方法,为枳实配方颗粒及其他枳实相关产品的质量评价提供参考。方法:从市场上收集了不同品质的16批枳实饮片,其中包括13批酸橙枳实和3批甜橙枳实,按标准化煎煮工艺制备枳实饮片标准汤剂,以辛弗林转移率、标准汤剂的出膏率和pH等为综合评价指标,建立枳实饮片标准汤剂的质量控制体系。结果:13批酸橙枳实饮片标准汤剂中辛弗林转移率处于35. 7%～92. 7%,平均转移率61. 9%; 3批甜橙枳实饮片标准汤剂中辛弗林转移率处于53. 1.%～84. 4%,平均转移率73. 2%。13批酸橙枳实饮片标准汤剂的出膏率处于20. 7%～43. 8%,平均出膏率28. 4%; 3批甜橙枳实饮片标准汤剂的出膏率范围为13. 8%～17. 6%,平均出膏率15. 4%。说明酸橙枳实饮片标准汤剂的出膏率高于甜橙枳实饮片标准汤剂的出膏率。13批酸橙枳实饮片标准汤剂的pH 4. 48～5. 32,平均pH 4. 99; 3批甜橙枳实饮片标准汤剂的pH 4. 77～5. 38,平均pH 5. 06。与相应的对照指纹图谱相比,13批酸橙枳实饮片标准汤剂的HPLC指纹图谱相似度均> 0. 9,找到6个共有峰,其中3个指认为柚皮苷、橙皮苷和新橙皮苷; 3批甜橙枳实饮片标准汤剂的HPLC指纹图谱相似度均> 0. 9,找到2个共有峰,其中1个指认为橙皮苷。酸橙枳实饮片标准汤剂图谱中的色谱峰数量明显多于甜橙枳实饮片标准汤剂。结论:建立的质量评价方法精密度、重复性、稳定性良好,适用于枳实相关产品的质量评价。酸橙和甜橙的枳实饮片标准汤剂应该作为2个品种,不同基原枳实饮片标准汤剂应该分别进行研究。以枳实为例,建议多基原的中药配方颗粒以"种名+中药饮片+配方颗粒"的形式命名。
Objective: To establish a quality control method of standard decoction of Aurantti Fructus Immaturus( AFI),and to provide reference for quality evaluation of AFI dispensing granules and other related products of AFI. Method: A total of 16 batches of AFI pieces with different quality were collected from the market,including 13 batches of Citrus aurantium and 3 batches of C. sinensis,and the standard decoction of AFI was prepared according to the standard decoction process. Transfer rate of synephrine,dry extract rate and others of the standard decoction were regarded as evaluation indicators and relative assessment are conducted. Result:Transfer rates of synephrine in 13 batches of standard decoction of AFI( C. aurantium) were ranged from 35. 7%to 92. 7% with the average value was 61. 9%; dry extract rates were varied from 20. 7% to 43. 8% and the average value was 28. 4%; pH values were 4. 48-5. 32 with the average value was 4. 99; the HPLC fingerprint similarities were > 0. 9 by comparing with the corresponding control fingerprint,6 common peaks were found and 3 of them were identified as naringin,hesperidin and neohesperidin. Transfer rates of synephrine in 3 batches of standard decoction of AFI( C. sinensis) were changed from 53. 1% to 84. 4%, and the average value was73. 2%; dry extract rates were shifted from 13. 8% to 17. 6% and the average value was 15. 4%; pH values were4. 77-5. 38 with the average value was 5. 06; the HPLC fingerprint similarities were > 0. 9 by comparing with the corresponding control fingerprint,2 common peaks were found and one of them were identified as hesperidin.Conclusion: From the HPLC fingerprint of standard decoction of AFI,we can easily understand that the number of peaks in C. aurantium is obviously more than that of C. sinensis. This method has good precision,reproducibility and stability,it is suitable for quality evaluation for related products of AFI. Simultaneously,the research provides a good reference for identifying sources of AFI.
Objective: To establish a quality control method of standard decoction of Aurantti Fructus Immaturus( AFI),and to provide reference for quality evaluation of AFI dispensing granules and other related products of AFI. Method: A total of 16 batches of AFI pieces with different quality were collected from the market,including 13 batches of Citrus aurantium and 3 batches of C. sinensis,and the standard decoction of AFI was prepared according to the standard decoction process. Transfer rate of synephrine,dry extract rate and others of the standard decoction were regarded as evaluation indicators and relative assessment are conducted. Result:Transfer rates of synephrine in 13 batches of standard decoction of AFI( C. aurantium) were ranged from 35. 7%to 92. 7% with the average value was 61. 9%; dry extract rates were varied from 20. 7% to 43. 8% and the average value was 28. 4%; pH values were 4. 48-5. 32 with the average value was 4. 99; the HPLC fingerprint similarities were > 0. 9 by comparing with the corresponding control fingerprint,6 common peaks were found and 3 of them were identified as naringin,hesperidin and neohesperidin. Transfer rates of synephrine in 3 batches of standard decoction of AFI( C. sinensis) were changed from 53. 1% to 84. 4%, and the average value was73. 2%; dry extract rates were shifted from 13. 8% to 17. 6% and the average value was 15. 4%; pH values were4. 77-5. 38 with the average value was 5. 06; the HPLC fingerprint similarities were > 0. 9 by comparing with the corresponding control fingerprint,2 common peaks were found and one of them were identified as hesperidin.Conclusion: From the HPLC fingerprint of standard decoction of AFI,we can easily understand that the number of peaks in C. aurantium is obviously more than that of C. sinensis. This method has good precision,reproducibility and stability,it is suitable for quality evaluation for related products of AFI. Simultaneously,the research provides a good reference for identifying sources of AFI.
引文
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[13]刘振丽,王跃生,宋志前,等.枳实配方颗粒高效液相色谱特征图谱分析[J].中国实验方剂学杂志,2006,12(10):8-9.
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[15]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.
[16]曹静亚,李晓,宋梦娇,等.连翘标准汤剂质量评价体系的建立[J].中国实验方剂学杂志,2018,24(7):7-12.
[17]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.
[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]张振霞,郑玉忠,梁丽娟,等.酸橙和甜橙2种枳实药材HPLC指纹图谱研究及柚皮苷和辛弗林含量分析[J].中国药房,2011,22(39):3711-3714.
[20]曾洪莲,刘振丽,宋志前,等.不同品种枳实HPLC指纹图谱及成分含量差异性研究[J].中国中药杂志,2016,41(17):3272-3278.
[21]廖茂梁,胡静,尚海花,等.正交试验优选枳实中辛弗林提取工艺[J].中国实验方剂学杂志,2011,17(13):23-25.
[22]崔文金,焦梦姣,邓哲,等.黄连饮片标准汤剂的制备及质量标准分析[J].中国实验方剂学杂志,2017,23(19):40-45.
[23] LIU X M,GU Z X,GUO Y,et al. Rapid analysis of Aurantii Frutus Immaturus(Zhishi)using paper spray ionization mass spectrometry[J]. J Pharm Biomed Anal,2017,137:2014-212.
[24] LI P,ZENG S L,DUAN L,et al. Comparison of Aurantii Fructus Immaturus and Aurantii Fructus based on multiple chromatographic analysis and chemometrics methods[J]. J Chromatogr A,2016,1469:96-107.
[25] LIU W Y,ZHOU C,YAN C M,et al. Characterization and simultaneous quantification of multiple constituents in Aurantii Fructus Immature extracts by HPLC-DADESI-MS/MS[J]. Chin J Nat Medicines,2012,10(6):456-463.
[26] CHUANG C C,WEN W C,Sheu S J. Classification of Aurantii Fructus samples by multivariate analysis[J]. J Sep Sci,2007,30(12):1827-1832.
[27]胡源祥,陈海芳,宋玉鹏,等.枳实及其主要活性成分促进脾虚模型大鼠胃肠运动的机制研究[J].中国药房,2017,28(13):1747-1750.
[28] WANG S Y,LIU Y P,FAN Y H,et al. Mechanism of aqueous fructus aurantii immaturus extracts in neuroplexus of cathartic colons[J]. World J Gastroenterol,2015,21(31):9358-9366.
[2]张艳丽,梁茂新.枳实潜在功用的发掘和利用[J].中华中医药杂志,2016,31(7):2789-2792.
[3]何英杰,刘东波,唐其,等.酸橙类中药材枳实和枳壳化学成分研究进展[J].中药材,2017,40(6):1488-1494.
[4]张霄潇,李振勇,马玉玲,等.中药枳实的研究进展[J].中国中药杂志,2015,40(2):185-190.
[5]张红,孙明江,王凌.枳实的化学成分及药理作用研究进展[J].中药材,2009,32(11):1787-1790.
[6]邓敏芝,邓可众,陈虹,等.不同采收期枳实促胃肠动力作用及其辛弗林含量的比较研究[J].中国民族民间医药,2016,25(17):14-17.
[7]刘伟,袁洪燕,张群,等.柑橘类生物碱辛弗林的研究进展[J].湖南农业科学,2016(9):101-106.
[8]张文娟,陶缘,王亚军,等.柑橘属中生物碱辛弗林生理活性的研究进展[J].食品工业科技,2013,34(22):331-334.
[9]闫晗,丁之恩,董敏,等.柑橘皮中辛弗林对营养型肥胖大鼠的减肥效果研究[J].食品与生物技术学报,2017,36(8):890-895.
[10] Roh K B,Kim I H,Kim Y S,et al. Synephrine inhibits eotaxin-1 expression via the STAT6 signaling pathway[J]. Molecules,2014,19(8):11883-11895.
[11]张玲,刘振丽,宋志前,等.枳实配方颗粒、相应饮片及汤剂HPLC图谱对比分析[J].中国中医信息杂志,2007,14(10):38-39.
[12]刘振丽,宋志前,张玲,等.枳实配方颗粒与水煎剂主要化学成分含量比较[J].中国药房,2007,18(6):438-440.
[13]刘振丽,王跃生,宋志前,等.枳实配方颗粒高效液相色谱特征图谱分析[J].中国实验方剂学杂志,2006,12(10):8-9.
[14]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.
[15]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.
[16]曹静亚,李晓,宋梦娇,等.连翘标准汤剂质量评价体系的建立[J].中国实验方剂学杂志,2018,24(7):7-12.
[17]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.
[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]张振霞,郑玉忠,梁丽娟,等.酸橙和甜橙2种枳实药材HPLC指纹图谱研究及柚皮苷和辛弗林含量分析[J].中国药房,2011,22(39):3711-3714.
[20]曾洪莲,刘振丽,宋志前,等.不同品种枳实HPLC指纹图谱及成分含量差异性研究[J].中国中药杂志,2016,41(17):3272-3278.
[21]廖茂梁,胡静,尚海花,等.正交试验优选枳实中辛弗林提取工艺[J].中国实验方剂学杂志,2011,17(13):23-25.
[22]崔文金,焦梦姣,邓哲,等.黄连饮片标准汤剂的制备及质量标准分析[J].中国实验方剂学杂志,2017,23(19):40-45.
[23] LIU X M,GU Z X,GUO Y,et al. Rapid analysis of Aurantii Frutus Immaturus(Zhishi)using paper spray ionization mass spectrometry[J]. J Pharm Biomed Anal,2017,137:2014-212.
[24] LI P,ZENG S L,DUAN L,et al. Comparison of Aurantii Fructus Immaturus and Aurantii Fructus based on multiple chromatographic analysis and chemometrics methods[J]. J Chromatogr A,2016,1469:96-107.
[25] LIU W Y,ZHOU C,YAN C M,et al. Characterization and simultaneous quantification of multiple constituents in Aurantii Fructus Immature extracts by HPLC-DADESI-MS/MS[J]. Chin J Nat Medicines,2012,10(6):456-463.
[26] CHUANG C C,WEN W C,Sheu S J. Classification of Aurantii Fructus samples by multivariate analysis[J]. J Sep Sci,2007,30(12):1827-1832.
[27]胡源祥,陈海芳,宋玉鹏,等.枳实及其主要活性成分促进脾虚模型大鼠胃肠运动的机制研究[J].中国药房,2017,28(13):1747-1750.
[28] WANG S Y,LIU Y P,FAN Y H,et al. Mechanism of aqueous fructus aurantii immaturus extracts in neuroplexus of cathartic colons[J]. World J Gastroenterol,2015,21(31):9358-9366.