[1]高帅鑫,周晓鹰.基于UPLC-PDA指纹图谱评价白蒲黄不同复方制剂的质量[J].常州大学学报(自然科学版),2019,31(06):82-87,93.
　GAO Shuaixin,ZHOU Xiaoying.Quality Evaluation of Baipuhuang's Dosage Formulations by UPLC-PDA Fingerprint[J].Journal of Changzhou University(Natural Science Edition),2019,31(06):82-87,93.
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基于UPLC-PDA指纹图谱评价白蒲黄不同复方制剂的质量()
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常州大学学报(自然科学版)[ISSN:2095-0411/CN:32-1822/N]

卷:
第31卷
期数:
2019年06期
页码:
82-87,93
栏目:
生物医学工程
出版日期:
2019-11-28

文章信息/Info

Title:
Quality Evaluation of Baipuhuang's Dosage Formulations by UPLC-PDA Fingerprint
文章编号:
2095-0411(2019)06-0082-06
作者:
高帅鑫; 周晓鹰
(常州大学 制药与生命科学学院,江苏 常州 213164)
Author(s):
GAO Shuaixin;  ZHOU Xiaoying
(School of Pharmaceutical Engineering & Life Sciences, Changzhou University, Changzhou, 213164,China)
关键词:
白蒲黄复方制剂;  指纹图谱;  UPLC-PDA;  质量控制
Keywords:
Baipuhuang dosage formulation;  fingerprint;  UPLC-PDA;  quality control
分类号:
R 562.1
文献标志码:
A
摘要:
建立白蒲黄复方制剂(配方颗粒、片剂及胶囊)的超高效液相色谱-二极管阵列检测(UPLC-PDA)指纹图谱,为全面控制白蒲黄复方制剂提供参考。将白蒲黄不同复方制剂加70%甲醇超声60 min; 提取物的分析采用Agilent Poroshell 120 EC-C18柱(直径2.1 mm×长度150 mm, C18粒径2.7 μm),流速1.0 mL·min-1,柱温40 ℃,检测波长254 nm,流动相为甲醇(B)-0.1%甲酸水溶液(A),采用梯度洗脱0～15 min:5% ～40% B; 15～35 min:40% B; 35～50 min:40% ～70% B; 50～55 min:70% B; 55～62 min:70% ～100% B; 62～75 min:100% B。分别对不同厂家、剂型、批次的白蒲黄复方制剂进行相似度拟合,标定了白蒲黄不同复方制剂指纹图谱的24个共有峰,并对白蒲黄制剂的色谱条件及提取方法进行优化,其精密度、稳定性、重复性的变异系数(RSD)值均小于2%; 测得的10批次样品与拟合指纹图谱相似度均大于0.95。所建立的指纹图谱可为规范白蒲黄不同复方制剂的均一性和稳定性的质量控制提供参考依据。
Abstract:
The UPLC-PDA fingerprint of Baipuhuang's different dosage formulations for granules, tablets and capsules is established to provide a reference for the quality control of Baipuhuang compound preparation. Baipuhuang's different dosage formulations are extracted with 70% methanol by sonicating for 60 min. Agilent Poroshell 120 EC-C18 column(2.1 mm×50 mm, 2.7 μm)was used to analyze the extracted liquid. The column temperature was maintained at 40 ℃, the flow rate was 1.0 mL·min-1 and the detector was utilized to monitor under wavelength 254 nm. The mobile phase was methanol(B)-0.1% formic acid water(A)with the elution gradient 0—15 min: 5%—40% B, 15—35 min: 40% B, 35—50 min: 40%—70% B, 50—55 min: 70% B, 55—62 min: 70%—100% B, 62—75 min: 100% B. Comparing and fitting. The peaks of different batches of Baipuhuang's different dosage formulations were compared and fitted. The extraction and chromatographic conditions of Baipuhuang were optimized. The accuracy, stability and repeatability RSD were less than 2% respectively and the values of fingerprint similarity were greater than 0.95. The fingerprint can provide a reference for the quality control of the standard uniformity and stability of Baipuhuang's different dosage formulations.

参考文献/References:

[1]XU Q, SHU Z, HE W, et al. Antitumor activity of Pulsatilla chinensis(Bunge)Regel saponins in human liver tumor 7402 cells in vitro and in vivo[J]. Phytomedicine International Journal of Phytotherapy & Phytopharmacology, 2012, 19(3): 293-300.
[2]金苗苗,曹亮,杜英峰,等. HPLC-MS法同时测定白蒲黄片中7种五环三萜皂苷类化学成分[J]. 药物分析杂志, 2015, 35(6): 986-990.
[3]刘爱朋, 郭利霄, 薛紫鲸,等. 基于指纹图谱和多组分含量测定的蒲公英药材质量控制研究[J]. 中国中药杂志, 2018, 43(18): 3715-3721.
[4]李方,曹阳,张清波. 白蒲黄片质量标准的研究[J]. 中医药信息, 2010, 27(3): 60-62.
[5]魏婷婷,金苗苗,甘晓若,等. UPLC-MS/MS法同时测定白蒲黄胶囊中12种有效成分[J]. 河北医科大学学报, 2019, 40(1): 91-95.
[6]唐光明,柯立坚. HPLC法测定蒲黄片中异鼠李素的含量[J]. 中国药事,2008, 22(8): 678-679.
[7]XIE Z, MUI T, SINTARA M,et al. Rapid quantitation of avenanthramides in oat-containing products by high-performance liquid chromatography coupled with triple quadrupole mass spectrometry(HPLC-TQMS)[J]. Food Chemistry, 2017, 224: 280-288.
[8]梁小银,陈少旭,吴垠. 中药制剂质量控制研究的发展趋势[J]. 中国药房, 2014(3): 280-283.
[9]焦宁,杨劼. 中药制剂质量控制方法研究新进展[J]. 河北医科大学学报, 2013, 34(1): 120-123.
[10]李艳娇,杨钒,宋洋,等. 蒲地蓝消炎片的HPLC指纹图谱[J]. 沈阳药科大学学报, 2018, 35(5): 381-389.
[11]STAVRIANIDI A, STEKOLSHCHIKOVA E, POROTOVA A,et al. Combination of HPLC-MS and QAMS as a new analytical approach for determination of saponins in ginseng containing products[J]. Journal of Pharmaceutical and Biomedical Analysis, 2017, 132: 87-92.
[12]WU Y, JIANG X, ZHANG S,et al. Quantification of flavonol glycosides in Camellia sinensis by MRM mode of UPLC-QQQ-MS/MS[J]. Journal of Chromatography B, 2016(1): 10-17.
[13]TOSHMATOV Z O, ESHBAKOVA K A, AISA H A. Glycoside flavonoids from Dracocephalum komarovii[J]. Chem Nat Compd, 2018, 54(2): 358-359.
[14]ZHANG Y J,SUN G X,HOU Z F,et al. Evaluation of the quality consistency of powdered poppy capsule extractive by an averagely linear-quantified fingerprint method in combination with antioxidant activities and two compounds analyses[J]. Journal of Separation Science,2017,40(23):4511-4520.
[15]XUE Y D,ZHU L,YI T. Fingerprint analysis of Resina Draconis by ultra-performance liquid chromatography[J]. Chemistry Central Journal,2017,11(1):67-74.

备注/Memo

备注/Memo:
收稿日期:2018-12-20。
基金项目:常州大学高层次人才引进启动基金(ZMF14020066)。
作者简介:高帅鑫(1986—),男,河南许昌人,硕士生。通信联系人:周晓鹰(1957—),E-mail: xiaoyingzhou@cczu.edu.cn
更新日期/Last Update: 2019-12-02