藿香正气丸的质量标准研究
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摘要
目的建立藿香正气丸的薄层鉴别和含量测定方法。方法采用TLC法定性鉴别藿香正气丸中的广藿香、厚朴、陈皮、白芷、甘草及白术;采用HPLC法测定制剂中橙皮苷、厚朴酚及和厚朴酚的含量。结果藿香正气丸中广藿香、厚朴、陈皮、白芷、甘草及白术的TLC图谱斑点清晰、重复性好、专属性强、分离较好、方法简便。制剂中橙皮苷、和厚朴酚及厚朴酚的线性范围分别为0.95～9.46,0.32～3.16和0.89～8.90μg,水丸平均加样回收率分别为100.63%,101.41%和100.17%,RSD值分别为0.94%,1.23%和0.45%;浓缩丸平均加样回收率分别为100.87%,101.30%和100.40%,RSD值分别为1.28%,1.14%和1.22%;2个指标测定的精密度、重复性、稳定性和准确度RSD值均低于3.00%。结论该方法简便、快捷,结果准确、可靠,可作为该制剂的质量控制标准。
Objective To establish the methods of TLC identification and content determination for Huoxiang Zhengqi Pills.Methods Herba pogostemonis,Magnolia officinalis Cortex,Angelicae dahuricae Radix,Pericarpium citri Reticulatae,Glycyrrhizae Radix et Rhizoma and Rhizoma atractylodis Macrocephalae were identified by TLC.The contents of aurantiamarin,magnolol and honokiol were determined by HPLC.Results The TLC spots were clear and showed good repeatability.Aurantiamarin showed a linear relationship in the range of 0.95-9.46μg with an average recovery of 100.63%(RSD was 0.94%)in water pills and an average recovery of 100.87%(RSD was 1.28%)in concentrated pills;magnolol showed a linear relationship in the range of 0.32-3.16μg with an average recovery of 101.41%(RSD was 1.23%)in water pills and an average recovery of 101.30%(RSD was1.14%)in concentrated pills;honokiol showed a linear relationship in the range of 0.89-8.90μg with an average recovery of100.17%(RSD was 0.45%)in water pills and an average recovery of 100.40%(RSD was 1.22%)in concentrated pills.The RSDs of precision,reproducibility,stability and accuracy were all less than 3.00%.Conclusion The methods are easy,fast and reliable,and could be used as a quality control method for Huoxiang Zhengqi Pills.
Objective To establish the methods of TLC identification and content determination for Huoxiang Zhengqi Pills.Methods Herba pogostemonis,Magnolia officinalis Cortex,Angelicae dahuricae Radix,Pericarpium citri Reticulatae,Glycyrrhizae Radix et Rhizoma and Rhizoma atractylodis Macrocephalae were identified by TLC.The contents of aurantiamarin,magnolol and honokiol were determined by HPLC.Results The TLC spots were clear and showed good repeatability.Aurantiamarin showed a linear relationship in the range of 0.95-9.46μg with an average recovery of 100.63%(RSD was 0.94%)in water pills and an average recovery of 100.87%(RSD was 1.28%)in concentrated pills;magnolol showed a linear relationship in the range of 0.32-3.16μg with an average recovery of 101.41%(RSD was 1.23%)in water pills and an average recovery of 101.30%(RSD was1.14%)in concentrated pills;honokiol showed a linear relationship in the range of 0.89-8.90μg with an average recovery of100.17%(RSD was 0.45%)in water pills and an average recovery of 100.40%(RSD was 1.22%)in concentrated pills.The RSDs of precision,reproducibility,stability and accuracy were all less than 3.00%.Conclusion The methods are easy,fast and reliable,and could be used as a quality control method for Huoxiang Zhengqi Pills.
引文
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[3]石起璘,马晓慧,颜璐璐,等.藿香正气滴丸治疗功能性消化不良的网络药理学研究[J].中国新药杂志,2014,23(12):1371-1377,1422.
[4]李春苑,周祥羽,巫圣乾,等.藿香正气口服液对湿困脾胃证大鼠尿液代谢组学的影响[J].中药新药与临床药理,2017,28(4):499-503.
[5]赵宏杰,郭利平,杨丰文,等.藿香正气方治疗胃肠型感冒有效性和安全性系统评价[J].中国中药杂志,2017,42(8):1495-1499.
[6]辛可.藿香正气丸在急性肠胃炎治疗中的应用价值探讨[J].中国实用医药,2017,12(7):151-152.
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[8]郭春花.藿香正气丸治疗急性胃肠炎的临床疗效观察[J].当代医学,2016,22(18):122-123.
[9]谢黛.论藿香正气系列制剂的特点与临床选用[J].亚太传统医药,2013,9(10):68-70.
[10]崔红旗.藿香正气丸治疗急性肠胃炎的临床疗效分析[J].中医临床研究,2013,5(8):87,90.
[11]陈德宇,朱玉祥,黄淑芳,等.藿香正气水抗真菌作用实验与临床观察[J].泸州医学院学报,1992,15(3):192-193.
[12]刘永贵,游敏微.不同剂型及厂家藿香正气系列产品抑菌作用比较[J].亚太传统医药,2017,13(1):43-48.
[13]黄雍,胡楚琦,李玉星,等.藿香正气方不同组方及剂型的临床应用[J].中国医药导刊,2017,19(12):1385-1388.
[14]武梅,刘益群,程雯,等.藿香正气散在妇科疾病的应用及探讨[J].辽宁中医杂志,2017,44(2):258-259.
[15]赵现红,李向日,袁永生,等.高效液相色谱法测定藿香正气丸(大蜜丸)中厚朴酚、和厚朴酚含量[J].中国实验方剂学杂志,2005,11(2):13-15.
[16]刘英敏,翁清辉,赖怀恩.高效液相色谱测定加味藿香正气丸中橙皮苷的含量[J].临床和实验医学杂志,2006,5(11):1838.
[17]赵霞,袁梦婕.高效液相色谱法测定加味藿香正气丸中厚朴酚与和厚朴酚的含量[J].现代医药卫生,2014,30(4):499-500,502.
[18]张小兵,任锦文,汤莉,等.加味藿香正气丸的质量标准研究[J].解放军药学学报,2007,23(4):291-293.
[19]刘桂花,帕依曼·亥米提,邢建国,等.莲蒿颗粒的质量标准研究[J].西北药学杂志,2017,32(5):555-559.
[20]张永志,佟玲,李东翔,等.UPLC法同时测定藿香正气滴丸中7个化学成分[J].沈阳药科大学学报,2015,32(11):848-852,881.
[21]林雀跃,张荣林,罗轶,等.藿香正气合剂的HPLC指纹图谱研究[J].中国民族民间医药,2016,25(20):43-47.
[22]周知航,周永刚.不同提取方式对藿香正气方中5种有效成分提取率的影响[J].天津药学,2017,29(1):4-8.
[23]余佳文,邓开英,彭涛,等.UPLC同时测定藿香正气口服液中甘草苷、柚皮芸香苷、橙皮苷、甘草酸铵、厚朴酚、和厚朴酚的含量[J].中国中药杂志,2013,38(14):2314-2317.
[24]王敏,杜守颖,杨冰,等.HPLC法同时测定益气复脉方中3种活性成分的含量[J].西北药学杂志,2017,32(3):260-263.
[25]国家药典委员会.中国药典:2015年版:一部[S].北京:中国医药科技出版社,2015:1728.
[26]王建光,王旭文,王潞娜.HPLC法测定藿香正气胶囊中橙皮苷含量[J].世界中西医结合杂志,2013,8(9):886-888.
[2]肖淑凤.略述藿香正气丸的药理作用及临床应用[J].中国中医药现代远程教育,2014,12(6):100.
[3]石起璘,马晓慧,颜璐璐,等.藿香正气滴丸治疗功能性消化不良的网络药理学研究[J].中国新药杂志,2014,23(12):1371-1377,1422.
[4]李春苑,周祥羽,巫圣乾,等.藿香正气口服液对湿困脾胃证大鼠尿液代谢组学的影响[J].中药新药与临床药理,2017,28(4):499-503.
[5]赵宏杰,郭利平,杨丰文,等.藿香正气方治疗胃肠型感冒有效性和安全性系统评价[J].中国中药杂志,2017,42(8):1495-1499.
[6]辛可.藿香正气丸在急性肠胃炎治疗中的应用价值探讨[J].中国实用医药,2017,12(7):151-152.
[7]张云.藿香正气丸治疗急性肠胃炎的临床分析[J].中医临床研究,2015,7(3):76-77.
[8]郭春花.藿香正气丸治疗急性胃肠炎的临床疗效观察[J].当代医学,2016,22(18):122-123.
[9]谢黛.论藿香正气系列制剂的特点与临床选用[J].亚太传统医药,2013,9(10):68-70.
[10]崔红旗.藿香正气丸治疗急性肠胃炎的临床疗效分析[J].中医临床研究,2013,5(8):87,90.
[11]陈德宇,朱玉祥,黄淑芳,等.藿香正气水抗真菌作用实验与临床观察[J].泸州医学院学报,1992,15(3):192-193.
[12]刘永贵,游敏微.不同剂型及厂家藿香正气系列产品抑菌作用比较[J].亚太传统医药,2017,13(1):43-48.
[13]黄雍,胡楚琦,李玉星,等.藿香正气方不同组方及剂型的临床应用[J].中国医药导刊,2017,19(12):1385-1388.
[14]武梅,刘益群,程雯,等.藿香正气散在妇科疾病的应用及探讨[J].辽宁中医杂志,2017,44(2):258-259.
[15]赵现红,李向日,袁永生,等.高效液相色谱法测定藿香正气丸(大蜜丸)中厚朴酚、和厚朴酚含量[J].中国实验方剂学杂志,2005,11(2):13-15.
[16]刘英敏,翁清辉,赖怀恩.高效液相色谱测定加味藿香正气丸中橙皮苷的含量[J].临床和实验医学杂志,2006,5(11):1838.
[17]赵霞,袁梦婕.高效液相色谱法测定加味藿香正气丸中厚朴酚与和厚朴酚的含量[J].现代医药卫生,2014,30(4):499-500,502.
[18]张小兵,任锦文,汤莉,等.加味藿香正气丸的质量标准研究[J].解放军药学学报,2007,23(4):291-293.
[19]刘桂花,帕依曼·亥米提,邢建国,等.莲蒿颗粒的质量标准研究[J].西北药学杂志,2017,32(5):555-559.
[20]张永志,佟玲,李东翔,等.UPLC法同时测定藿香正气滴丸中7个化学成分[J].沈阳药科大学学报,2015,32(11):848-852,881.
[21]林雀跃,张荣林,罗轶,等.藿香正气合剂的HPLC指纹图谱研究[J].中国民族民间医药,2016,25(20):43-47.
[22]周知航,周永刚.不同提取方式对藿香正气方中5种有效成分提取率的影响[J].天津药学,2017,29(1):4-8.
[23]余佳文,邓开英,彭涛,等.UPLC同时测定藿香正气口服液中甘草苷、柚皮芸香苷、橙皮苷、甘草酸铵、厚朴酚、和厚朴酚的含量[J].中国中药杂志,2013,38(14):2314-2317.
[24]王敏,杜守颖,杨冰,等.HPLC法同时测定益气复脉方中3种活性成分的含量[J].西北药学杂志,2017,32(3):260-263.
[25]国家药典委员会.中国药典:2015年版:一部[S].北京:中国医药科技出版社,2015:1728.
[26]王建光,王旭文,王潞娜.HPLC法测定藿香正气胶囊中橙皮苷含量[J].世界中西医结合杂志,2013,8(9):886-888.