Quality grade evaluation of Nvjin Pills based on traditional Chinese medicine reference drug and network pharmacology of target-focused compounds.

To improve the effectiveness of marketed drugs related to active ingredients, it is necessary to designate a more unified quality evaluation standard. Taking Nvjin Pills as an example, this study reported the development of a novel principle of analysis in traditional Chinese medicine. The core of the experiment is to prepare three batches of traditional Chinese medicine reference drugs by high-quality Chinese materia medica. The active ingredients identified in the herbal formula including glycyrrhizic acid, cinnamaldehyde, paeonol, baicalin, hesperidin, paeoniflorin, and ferulic acid were analyzed in traditional Chinese medicine reference drugs by the high-performance liquid chromatography method combined with wavelength switching. The simple prediction results of network pharmacological analysis verified the feasibility and reliability of the established quantitative analysis method for seven target-focused compounds in Nvjin Pills, which were recommended as candidate indicators for quality evaluation ultimately. Using the seven target-focused compounds as the scientific ruler, quality grade specifications of Nvjin Pills were proposed by comprehensive analysis. Accordingly, 16, 47, and 13 batches of samples were primarily graded as first grade, second grade, and unqualified grade, respectively. This study will provide a chemical basis for quality control of Nvjin Pills, which is necessary for the production process of pharmaceutical development.

Preparation and Characterization of PLGA-PEG-PLGA Nanoparticles Containing Salidroside and Tamoxifen for Breast Cancer Therapy.

Nanoparticles (NPs) containing the hydrophilic drug salidroside (Sal) and the hydrophobic drug tamoxifen (Tam) were prepared using a triblock copolymer poly(lactic-co-glycolic acid) (PLGA)-poly(ethylene glycol) (PEG)-PLGA to achieve synergism in the treatment of breast cancer. The double emulsion (w/o/w) method was used to prepare Sal-Tam NPs with an average particle size of 275.3 ± 44.0 nm, a polydispersity index of 0.302 ± 0.102, and a zeta potential of - 6.98 ± 2.99. The entrapment efficiency of the hydrophilic and hydrophobic components was 32.63% ± 0.73% and 49.18% ± 3.04%, respectively. On differential scanning calorimetry, the NPs showed the amorphous nature of both Sal and Tam. The sustained release of Sal and Tam from the NPs was significantly prolonged under physiological conditions (pH 7.4). The CCK-8 assay using the 4T1 cell line revealed a 1.7-fold decrease in the IC50 value for Sal-Tam NPs when compared with free Tam. The in vivo anti-tumor effect was assessed in BALB/c mice, and the results demonstrated that these NPs decreased the tumor volume compared with saline and showed high anti-tumor activity. A pharmacokinetic study showed significant enhancement of the bioavailability of Tam in Sal-Tam NPs compared with free Tam in suspension. The intracellular and mitochondrial anti-oxidative effect of Sal was thought to be attributed to the promising anti-tumor effect of drug co-delivery. This study confirmed that the use of Sal-Tam NPs may be a promising approach in breast cancer therapy.

Compatible stability study of panax notoginseng saponin injection (xueshuantong®) in combination with 47 different injectables.

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.

[Research progress of adverse reactions of traditional Chinese medicine injections].

Traditional Chinese medicine injections (TCMIs) originated in china, which was fast-acting with high bioavailability. TCMI is applied widely in clinic since it plays an important role for therapy severe and acute disease, such as cardiovascular diseases (CVD), infectious diseases, malignancy, and etc. However, the adverse reactions reported of TCMIs are increasing in recent years. For this, the review summarized systematically the reports and researches of adverse drug reactions (ADRs) of TCMIs according to about 100 literatures in the nearly five years. The ADR of TCMIs mainly includes allergic reaction, respiratory damage, digestive system damage, cardiovascular system damage and urinary system damage, and etc. The main causes are relative with complexity, uncertainty and instability of the drug material. Influence of excipients, pharmaceutical technologies, drug combination and application method was also discussed. There are many methods on adverse reactions of TCMIs, including descriptive studies, analytical epidemiology and experimental studies. This article provided necessary information for reasonable application of TCMIs in clinical practice.