title: Compatible stability study of panax notoginseng saponin injection (xueshuantong®) in combination with 47 different injectables.
abstract: Panax Notoginseng Saponin (PNS) injection (Xueshuantong®, XST) plays an important role in acute and chronic treatment of cardiovascular disease in China. XST, a freeze-dried powder injection of PNS, contains ginsenosides, Rg1, Rb1, Re, Rd. and notoginsenoside, R1. Study of the stability of herbal medicine injections is limited. The degradation products may contribute to adverse drug reactions (ADRs). The stability kinetics and degradation mechanisms of the five ingredients of PNS in XST injection were systematically explored in aqueous solution. The compatible stability of XST injection in combination with 47 injectables was evaluated using biophysical analysis. A principal components analysis model provided a good clustering result after compatibility. The degradation of the five ingredients in aqueous solution was found to be acid, temperature, oxidation and trivalent ion-dependent. All ingredients were much more stable in XST injection than in aqueous solutions. Nine degradation products were identified by adopting LC-Q-TOF/MS. Standards exceeding the osmotic pressure and/or particle size were found to be the probable causes of the ADR, which were related to drug combination. To minimize the risk of ADRs, drug combinations should be avoided until the complicated chemical matrices of the Chinese medicine injections are more clearly understood. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Meng
authors.initials: M
authors.lastname: Wang
authors.affiliation: College of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Huijie
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Ranran
authors.initials: R
authors.lastname: Dong
authors.affiliation: Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Lejun
authors.initials: L
authors.lastname: Tan
authors.affiliation: Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Zhidong
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.|Molecular Cardiology Research Institute, Tufts Medical Center and Tufts University School of Medicine, Boston, USA.
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhu
authors.affiliation: Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Xiumei
authors.initials: X
authors.lastname: Gao
authors.affiliation: College of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Xiaoliang
authors.initials: X
authors.lastname: Ren
mesh_terms: D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D006863:Hydrogen-Ion Concentration; D007267:Injections; D007700:Kinetics; D010084:Oxidation-Reduction; D053723:Panax notoginseng / Q000737:chemistry*; D015203:Reproducibility of Results; D012503:Saponins / Q000008:administration & dosage*; D013696:Temperature
chemical_list: D004365:Drugs, Chinese Herbal; C519374:Panax notoginseng extract; D012503:Saponins
keywords: Panax Notoginseng Saponin (PNS) injection (Xueshuantong®); compatibility; degradation; stability