Qualitative analysis of Xinyue Capsules (心悦胶囊) by high-performance liquid chromatography: Preliminary evaluation of drug quality in a Sino-Austrian joint study

Mei Xue; Lin Yang; Da-zhuo Shi; Christian Radauer; Heimo Breiteneder; Yan Ma

doi:10.1007/s11655-015-2311-2

Your Location：

Home >

Browse articles >

Qualitative analysis of Xinyue Capsules (心悦胶囊) by high-performance liquid chromatography: Preliminary evaluation of drug quality in a Sino-Austrian joint study

OriginalPaper | Updated：2021-08-27

- Qualitative analysis of Xinyue Capsules (心悦胶囊) by high-performance liquid chromatography: Preliminary evaluation of drug quality in a Sino-Austrian joint study
- Qualitative analysis of Xinyue Capsules (心悦胶囊) by high-performance liquid chromatography: Preliminary evaluation of drug quality in a Sino-Austrian joint study
- 中国结合医学杂志（英文版） 2015年21卷第10期页码：772-777
- Affiliations：
  
  1. Center of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences,Beijing,China
  2. Molecular Research in Traditional Chinese Medicine Group, Department of Pathophysiology and Allergy Research, Center of Pathophysiology, Infectiology & Immunology, Medical University of Vienna,Vienna,Austria
- Author bio：
- Funds：
  
  Supported by the National Natural Scientific Fund of China (No. 81273933, 81102722), the International Science and Technology Cooperative Project from the Ministry of Science and Technology of China (No. 2010DFA31690) and the Austrian Federal Ministry of Science and Research and the Austrian Federal Ministry of Health (No. GZBMWF-402.000/3-IV6b/2008)
- DOI：10.1007/s11655-015-2311-2
  中图分类号：
- 纸质出版日期：2015，
  
  网络出版日期：2015-11-3，
Scan for full text
Xue, M., Yang, L., Shi, Dz. et al. Qualitative analysis of Xinyue Capsules (心悦胶囊) by high-performance liquid chromatography: Preliminary evaluation of drug quality in a Sino-Austrian joint study., Chin. J. Integr. Med. 21, 772–777 (2015). https://doi.org/10.1007/s11655-015-2311-2

Mei Xue, Lin Yang, Da-zhuo Shi, et al. Qualitative analysis of Xinyue Capsules (心悦胶囊) by high-performance liquid chromatography: Preliminary evaluation of drug quality in a Sino-Austrian joint study[J]. Chinese Journal of Integrative Medicine, 2015,21(10):772-777.
Xue, M., Yang, L., Shi, Dz. et al. Qualitative analysis of Xinyue Capsules (心悦胶囊) by high-performance liquid chromatography: Preliminary evaluation of drug quality in a Sino-Austrian joint study., Chin. J. Integr. Med. 21, 772–777 (2015). https://doi.org/10.1007/s11655-015-2311-2 DOI：

Mei Xue, Lin Yang, Da-zhuo Shi, et al. Qualitative analysis of Xinyue Capsules (心悦胶囊) by high-performance liquid chromatography: Preliminary evaluation of drug quality in a Sino-Austrian joint study[J]. Chinese Journal of Integrative Medicine, 2015,21(10):772-777. DOI： 10.1007/s11655-015-2311-2.

摘要

To develop a reliable method to assess the stability of Xinyue Capsules (心悦胶囊) containing Panax quinquefolius saponins according to European quality standards. An efficient high-performance liquid chromatography ultraviolet (HPLC-UV) method was established to analyse six main ginsenosides (Rb1

Rb2

Re and Rg1) in six different batches (120 capsules/batch) from the same lot of Xinyue Capsules and in one batch measured six times within one day. The six ginsenosides were separated on a Hypersil BDS-C18 column (3 μm

100 mm×3 mm) at a flow rate of 0.5 mL/min. Gradient elution was performed using a mobile phase gradient of acetonitrile-water modified with 0.01% formic acid. The HPLC chromatograms were analyzed with "LC data comparison" using Lab Solutions software. The HPLC peaks were identified by comparing their retention times (Rg1: 23.44 min

Re: 23.77 min

Rb1: 35.24 min

Rc: 36.18 min

Rb2: 38.55 min and Rd: 40.88 min) with those of the standards under the same chromatographic conditions

which showed similar results among the samples of six different batches and among the samples from one batch detected six times within one day. Xinyue Capsules have good drug intra-day consistency at room temperature and exhibit a consistent quality between different batches. This study established a reliable method to assess the stability of Xinyue Capsules

which is suitable for further qualitative analysis and may assist in promoting the safe and effective use of Chinese herbal medicine.

Abstract

Rb2

Re: 23.77 min

Rb1: 35.24 min

Rc: 36.18 min

Rb2: 38.55 min and Rd: 40.88 min) with those of the standards under the same chromatographic conditions

which is suitable for further qualitative analysis and may assist in promoting the safe and effective use of Chinese herbal medicine.

关键词

Panax quinquefolius saponinsGinsenosideshigh-performance liquid chromatographyultravioletstabilityChinese Medicine

Keywords

Panax quinquefolius saponinsGinsenosideshigh-performance liquid chromatographyultravioletstabilityChinese Medicine

references

Williamson EM, Lorenc A, Booker A, Robinson N. The rise of traditional Chinese medicine and its materia medica: a comparison of the frequency and safety of materials and species used in Europe and China. J Ethnopharmacol 2013;149:453–462.

Coghlan ML, Haile J, Houston J, Murray DC, White NE, Moolhuijzen P, et al. Deep sequencing of plant and animal DNA contained within traditional Chinese medicines reveals legality issues and health safety concerns. PLoS Genet 2012;8:1–11.

European Directorate for Quality Medicines. Symposium on traditional Chinese medicines (TCMs). Press Release. Available at http://www.edqm.eu/en/proceedingsinternational-conference-83.html. Accessed on November 14, 2013.

Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004. Official J Europ Union 2004;L-136,85–90. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000208.jsp. Accessed on March31, 2004.

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use. Europ Parliam Council Official J 2001;L-311:67–128. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000208.jsp, Accessed on November 6, 2001.

Chang TK, Chen J, Benetton SA. In vitro effect of standardized ginseng extracts and individual ginsenosides on the catalytic activity of human CYP1A1, CYP1A2, and CYP1B1. Drug Metab Dispos 2002;30:378–384.

Liu H, Shi D, Wang W, Zhang C, Fu M, Ge J. Panax quinquefolium saponins inhibited immune maturation of human monocyte-derived dendritic cells via blocking nuclear factor-?B pathway. J Ethnopharmacol 2012;141:982–988.

Zhang DW, Zhang L, Liu JG, Wang CL, Shi DZ, Chen KJ. Mechanisms of Chinese herbs combined with ischemic postconditioning in protecting myocardium of rats from ischemia-reperfusion injury. J Chin Integr Med (Chin) 2010;8:465–471.

Liu HY, Wang W, Shi DZ, Ge JB, Zhang L, Peng J, et al. Protective effect of Chinese herbs for supplementing qi, nourishing yin and activating blood circulation on heart function of patients with acute coronary syndrome after percutaneous coronary intervention. Chin J Integr Med 2012;18:423–430.

Wang C, Shi DZ. Research of cardiovascular effects and mechanism of Panax quinquefolius saponin. Chin J Integr Tradit West Med (Chin) 2011;31:825–831.

Liu R, Zhang J, Liu W, Kimura Y, Zheng Y. Antiobesity effects of protopanaxdiol types of ginsenosides isolated from the leaves of American ginseng (Panax quinquefolius L. ) in mice fed with a high-fat diet. Fitoterapia 2010;81:1079–1087.

Wang C, Li YZ, Wang XR, Lu ZR, Shi DZ, Liu XH. Panax quinquefolium saponins reduce myocardial hypoxiareoxygenation injury by inhibiting excessive endoplasmic reticulum stress. Shock 2012;37:228–233.

Li H, Cui L, Zhou W. Clinical observation of the effect of Shuxinsu Capsule in treating angina pectoris. Chin J Integr Tradit West Med (Chin) 1999;19:656–659.

Li YQ, Jin M, Qiu SL, Wang PL, Zhu TG, Wang CL, et al. Effect of Chinese drugs for supplementing qi, nourishing yin and activating blood circulation on myocardial perfusion in patients with acute myocardial infarction after revascularization. Chin J Integr Med 2009;15:19–25.

Wang CL, Shi DZ, Yin HJ. Effect of Panax quinquefolius saponin on angiogenesis and expressions of VEGF and bFGF in myocardium of rats with acute myocardial infarction. Chin J Integr Tradit West Med (Chin) 2007;27:331–334.

Zhang Y, Chen KJ, Yang LH. Effects of Panax quinquefolius saponin of stem and leaf on glucose-lipid metabolism and insulin signal transduction in insulin resistant model adipocytes. Chin J Integr Tradit West Med (Chin) 2010;30:748–751.

Wang H, Peng D, Xie J. Ginseng leaf-stem: bioactive constituents and pharmacological functions. Chin Med 2009;4:20.

Fuzzati N. Analysis methods of ginsenosides. J Chromatogr B Analyt Technol Biomed Life Sci 2004;812:119–133.

Kwona SW, Hanb SB, Parka IH, Kimc JM, Parka MK, Park JH. Liquid chromatographic determination of less polar ginsenosides in processed ginseng. J Chromatography A 2001;921:335–339.

Yang SO, Lee SW, Kim YO, Sohn SH, Kim YC, Hyun DY, et al. HPLC-based metabolic profiling and quality control of leaves of different Panax species. J Ginseng Res 2013;37:248–253.

Sun J, Chen P. Differentiation of Panax quinquefolius grown in the USA and China using LC/MS-based chromatographic fingerprinting and chemometric approaches. Anal Bioanal Chem 2011;399:1877–1889.

Yang WZ, Ye M, Qiao X, Liu CF, Miao WJ, Bo T, et al. A strategy for efficient discovery of new natural compounds by integrating orthogonal column chromatography and liquid chromatography/mass spectrometry analysis: its application in Panax ginseng, Panax quinquefolium and Panax notoginseng to characterize 437 potential new ginsenosides. Anal Chim Acta 2012;739:56–66.

Yang L, Miao Y, Yin HJ, Shi DZ, Chen KJ. Identification of ginsenosides from Panax quinquefolius in Xinyue Capsule by LC-ESI-MSn. Chin Tradit Herb Drugs (Chin) 2010;41:1942–1947.

Zhang S, Chen R, Wu H, Wang C. Ginsenoside extraction from Panax quinquefolium L. (American ginseng) root by using ultrahigh pressure. J Pharm Biomed Anal 2006;41:57–63.

Chan K. Chinese medicinal materials and their interface with Western medical concepts. J Ethnopharmacol 2005;96:1–18.

Chan K. Progress in traditional Chinese medicine. Trends Pharmacol Sci 1995;16:182–187.

Qian T, Cai Z, Wong RN, Mak NK, Jiang ZH. In vivo rat metabolism and pharmacokinetic studies of ginsenoside Rg3. J Chromatogr B Analyt Technol Biomed Life Sci 2005;816:223–232.

Wang CQ, Jia XH, Chen J, Xiao XY, Wang X, Cai SQ. Systematic study on QAMS method for quality control of Panax notoginseng. China J Chin Mater Med (Chin) 2012;37:3438–3445.

Brown PN. Determination of ginsenoside content in Asian and North American ginseng raw materials and finished products by high-performance liquid chromatography: singlelaboratory validation. J AOAC Int 2011;94:1391–1399.

Corbit RM, Ferreira JF, Ebbs SD, Murphy LL. Simplified extraction of ginsenosides from American ginseng (Panax quinquefolius L. ) for high-performance liquid chromatographyultraviolet analysis. J Agric Food Chem 2005;53:9867–9873.

FULL TEXT LINK

More>

浏览量

Downloads

CSCD

文章被引用时，请邮件提醒。

Submit

工具集

关联资源

Ginseng-Derived Panaxadiol Saponins Promote Hematopoiesis Recovery in Cyclophosphamide-Induced Myelosuppressive Mice: Potential Novel Treatment of Chemotherapy-Induced Cytopenias

Relationship between Tissue Distributions of Modified Wuzi Yanzong Prescription (加味五子衍宗方) in Rats and Meridian Tropism Theory

Future view and development of immunology: Exploring the immunology based on Chinese medicine and culture

Cost-effectiveness analysis of combined Chinese medicine and Western medicine for ischemic stroke patients

Objective tongue inspection on 142 liver cancer patients with damp-heat syndrome