肾康栓中丹酚酸B的含量测定及指纹图谱研究
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摘要
目的建立肾康栓中丹酚酸B的含量测定方法及HPLC指纹图谱。方法采用HPLC法,色谱柱为Agilent Eclipse XDB-C_(18)(250mm×4.6mm,5μm);甲醇-1mL·L~(-1)甲酸溶液为流动相,梯度洗脱;流速为1.0mL·min~(-1);检测波长为286nm;柱温为30℃。结果建立了肾康栓的HPLC指纹图谱,共标定16个共有峰并进行归属,10批样品中丹酚酸B含量在1.925～4.259mg·粒~(-1)之间。结论该方法建立的指纹图谱灵敏度高、稳定性好,为肾康栓的质量控制提供了科学依据。
Objective To establish an HPLC method for the content determination of salvianolic acid B and to establish the chromatographic fingerprint of Shenkang Suppositories.Methods The HPLC method was established by emplying Agilent Eclipse XDB-C_(18)(250mm×4.6mm,5μm)column with methanol-1mL·L~(-1 )formic acid solution as mobile phase in a gradient elution mode.The flow rate was 1.0mL·min~(-1).The detection wavelength was 286nm and the column temperature was 30℃.Results The HPLC chromatographic fingerprint of Shenkang Suppositories was established,and 16common peaks were obtained and assigned.For 10batches of samples,the contents of salvianolic acid B ranged from 1.925to 4.259mg·pellet~(-1).Conclusion This method is sensitive and reliable which can be used for the quality control of Shenkang Suppositories.
Objective To establish an HPLC method for the content determination of salvianolic acid B and to establish the chromatographic fingerprint of Shenkang Suppositories.Methods The HPLC method was established by emplying Agilent Eclipse XDB-C_(18)(250mm×4.6mm,5μm)column with methanol-1mL·L~(-1 )formic acid solution as mobile phase in a gradient elution mode.The flow rate was 1.0mL·min~(-1).The detection wavelength was 286nm and the column temperature was 30℃.Results The HPLC chromatographic fingerprint of Shenkang Suppositories was established,and 16common peaks were obtained and assigned.For 10batches of samples,the contents of salvianolic acid B ranged from 1.925to 4.259mg·pellet~(-1).Conclusion This method is sensitive and reliable which can be used for the quality control of Shenkang Suppositories.
引文
[1]张进珍,宋跃飞.二参益气补肾胶囊联合肾康栓治疗慢性肾脏病临床观察[J].特色疗法,2018,26(4):23-24.
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[15]王紫燕,李春沁,穆敏婕,等.HPLC波长切换法同时测定补肾活血方中丹参素、葛根素、大豆苷和丹酚酸B的含量[J].药物分析杂志,2016,36(6):1020-1026.
[16]梁家红,张水娟,姚立.丹酚酸B对肺上皮细胞和急性肺损伤的影响[J].中国药理学通报,2013,29(4):531-534.
[17]方蕾,杨美娟,蒋玉凤.丹酚酸B对脑缺血再灌注损伤小鼠血管保护作用[J].中华中医药学刊,2016,34(12):3060-3062.
[18]罗红,王春花,赵玲璐,等.丹酚酸B抗心肌纤维化的机制研究[J].中国药房,2017,28(28):3900-3903.
[19]陶善珺,任尤楠,赵梦秋,等.丹酚酸B对糖尿病血糖波动模型大鼠胰岛细胞的保护作用[J].中草药,2016,47(17):3058-3063.
[20]武晓玲,曹成顺.肾康栓质量标准研究[J].基层中药杂志,2002,16(5):27-28.
[2]梁衍,闫晓辉.高位结肠透析联合肾康栓保留灌肠治疗慢性肾脏病的疗效观察[J].临床医学研究与实践,2016,1(15):18-19,29.
[3]黄馨,白瑜,于李汀,等.肾康栓对于慢性肾脏病的治疗效果及临床应用[J].医学与哲学,2017,38(8B):35-37,49.
[4]孔爱丽.肾康栓联合尿毒清颗粒治疗慢性肾功能衰竭的疗效观察[J].中国医药指南,2014,12(7):215-216.
[5]陈莉.肾康栓联合肾衰宁片治疗慢性肾功能衰竭的疗效观察[J].现代药物与临床,2016,31(1):37-40.
[6]吕勇,王亿平,张莉,等.肾康栓剂治疗慢性肾衰竭湿浊血瘀证临床研究[J].中成药,2006,28(7):987-989.
[7]余晓艳,任伍魁.肾康栓治疗慢性肾功能衰竭疗效观察[J].陕西中医,2013,33(12):1594-1595.
[8]汪力,王少清,高芳,等.肾康栓治疗慢性肾脏病30例[J].陕西中医,2014,35(12):1586-1588.
[9]何劲松.肾康栓治疗慢性肾脏病(CKD3~5期)的疗效观察[J].中国中西医结合肾病杂志,2017,18(9):812-813.
[10]温玉玮.肾康栓治疗慢性肾脏病Ⅲ~Ⅳ期(湿浊血瘀证)患者的疗效观察[J].中国新药杂志,2017,26(21):2568-2572.
[11]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,2015:76-77.
[12]曾敏,王雨萌,贾璞,等.HPLC法测定红曲灵芝丹参胶囊中4种成分的含量[J].西北药学杂志,2017,32(6):679-682.
[13]张乐,张强,刘娟,等.参七消痞颗粒中野黄芩苷和丹酚酸B含量测定方法研究[J].北京中医药大学学报,2013,36(8):550-553.
[14]杨道炬,张怀,刘树强,等.HPLC法测定消脂胶囊中丹参酮ⅡA和丹酚酸B的含量[J].中药新药与临床药理,2014,25(6):737-740.
[15]王紫燕,李春沁,穆敏婕,等.HPLC波长切换法同时测定补肾活血方中丹参素、葛根素、大豆苷和丹酚酸B的含量[J].药物分析杂志,2016,36(6):1020-1026.
[16]梁家红,张水娟,姚立.丹酚酸B对肺上皮细胞和急性肺损伤的影响[J].中国药理学通报,2013,29(4):531-534.
[17]方蕾,杨美娟,蒋玉凤.丹酚酸B对脑缺血再灌注损伤小鼠血管保护作用[J].中华中医药学刊,2016,34(12):3060-3062.
[18]罗红,王春花,赵玲璐,等.丹酚酸B抗心肌纤维化的机制研究[J].中国药房,2017,28(28):3900-3903.
[19]陶善珺,任尤楠,赵梦秋,等.丹酚酸B对糖尿病血糖波动模型大鼠胰岛细胞的保护作用[J].中草药,2016,47(17):3058-3063.
[20]武晓玲,曹成顺.肾康栓质量标准研究[J].基层中药杂志,2002,16(5):27-28.