A collaborative inter-laboratory validation was carried out using a reporter gene assay to measure the bioactivity of anti-PD-1 monoclonal antibody, in order to study the applicability and transferability of the method. In this study, two collaborative schemes were designed to measure the precision, linearity and accuracy of the method. The results showed that the 95% confidence interval (CI) of the intra-assay precision was (1.72-16.89)%, inter-assay precision was (2.63-17.67)%, inter-laboratory precision was (9.00-14.26)%, all linear correlation coefficients were greater than 0.99, and the 95% CI for the accuracy at different potency levels was (91.83-104.40)% at 50%, (90.40-101.40)% at 75%, (94.71-105.60)% at 100%, (94.00-102.00)% at 125%, and (96.73-104.30)% at 150%. The collaborative validation results proved that the reporter gene assay for the bioactivity determination of anti-PD-1 monoclonal antibody has good precision, linearity and accuracy, and could be applied to the release and stability analysis of anti-PD-1 monoclonal antibodies in different laboratories.

The alveolar capillary endothelial barrier is mainly composed of alveolar capillary endothelial cells and alveolar epithelial cells. The destruction of this barrier and the continuous infiltration of inflammatory cells have been considered to play an important role in the development of chronic obstructive pulmonary disease, acute lung injury, and idiopathic pulmonary fibrosis. Therefore, it is of great significance to understand the mechanism of alveolar capillary endothelial barrier regulation. Sphingosine 1-phosphate (S1P) is a bioactive sphingolipid metabolite produced by sphingosine kinase. A large number of studies have shown that S1P not only regulates immune cell transport, but also plays important roles in regulating cell apoptosis, vascular endothelial barrier, and alveolar epithelial barrier. S1P exerts different regulatory effects on alveolar capillary endothelial barrier by activating S1P1 and S1P3. Activation of S1P1 on the alveolar capillary endothelial cells by S1P mediates barrier protection, while the barrier can be broken when S1P3 is stimulated by S1P. S1P can also regulate alveolar epithelial barrier. By activating S1P3 on the alveolar epithelial cells, S1P leads to epithelial barrier damage, which makes interstitial proteins and body fluids infiltrate into alveolar space and causes pulmonary edema. Therefore, it may be a target for the treatment of lots of lung diseases by regulating the homeostasis of alveolar capillary endothelial barrier. This paper reviews the research advancement of S1P in alveolar capillary endothelial barrier regulation.

Long noncoding RNAs (lncRNAs) are a class of RNAs that are more than 200 nucleotides in length with no protein coding property. LncRNAs are involved in almost every cellular process through multiple mechanisms. LncRNAs can directly bind to molecules in cells such as proteins, RNA, and DNA, to regulate cellular functions by influencing processes including transcription, translation, and molecular transporting. Recent researches showed lncRNAs are key regulators of serious cardiac diseases, especially in development and progression of cardiac ischemia, arrhythmia, cardiac fibrosis, and heart failure. This article mainly summarizes the function and mechanism of lncRNAs in cardiac diseases and gives reasonable prospect of lncRNAs in the future.

Qualitative and relatively quantitative methods were used to study the quality of cultivated Epimedium sagittatum (Sieb. et Zucc.) Maxim., Epimedium myrianthum Stearn, and Epimedium pubescens Maxim by ultra high-performance liquid chromatography coupled with photo-diode array and quadrupole time-of-flight mass spectrometry (UHPLC-PDA-Q-TOF/MS^E). Thirty-two compounds in cultivated and wild samples of E. sagittatum, E. myrianthum and E. pubescens were identified using UHPLC-Q-TOF/MS^E combined with the UNIFI data analysis platform. Principal component analysis (PCA) was used to compare the cultivated and wild samples of these three species. The results show that the chemical compositions of cultivated samples were consistent with the corresponding wild samples. UHPLC-PDA was used to determine the relative content of 12 flavonoids as well as total flavonoids in all samples. The results show that the relative chemical content of these flavonoids in cultivated and wild samples is similar and the quality of cultivated Epimedium is more stable. These qualitative and relatively quantitative methods using UHPLC-PDA-Q-TOF/MS^E combined with the UNIFI data analysis platform and PCA can be used to study the quality of cultivated Herba Epimedii. This research provides a scientific basis for the cultivation and rational development and utilization of Epimedium medicinal materials.

We obtained 332 coding sequences from the Polyporus umbellatus transcriptome based on the BLASTx and ESTScan analyses. The codon usage patterns of P. umbellatus were calculated and statistically analyzed using CodonW. The results showed that the average GC content of genes was 53.57% and the average GC3 content was 57.98%, suggesting that genes favored codons ending with G or C. The effective number of codons (ENC) value range from 38.46 to 61, which indicates that these genes have low codon usage bias. The neutrality plot and ENC-plot analysis revealed that many factors such as mutation and selective pressure play an important role in shaping codon usage bias in P. umbellatus genes. Twenty-two optimal codons were identified as being biased toward codons ending with G or C using the high expression superior codon analysis method. This study will lay a foundation for future research on genetic engineering and molecular evolution in P. umbellatus.

We evaluate the therapeutic effects of baicalein on chemotherapy-induced intestinal mucositis (CIM) in mice. The role of gut microflora regulation in the therapeutic effects of baicalein was investigated meanwhile. Male Balb/c mice were randomly divided into three groups including normal control group, model group and experimental group. Except for normal control group, mice were injected with 5-fluorouracil and irinotecan to induce CIM. Animal welfare and experimental procedures comply follow the rules of the Animal Ethics Committee of the Institute of Materia Medica, Chinese Academy of Medical Sciences. Baicalein significantly reduced disease activity index (DAI) of CIM mice and decreased the content of interleukin 6 (IL-6) and tumor necrosis factor α (TNF-α) in serum. There were significant differences in the composition of the gut microbiota among groups according to the analysis of α diversity, β diversity, and the species differences. Compared with the normal control group, the Ruminococcaceae_UCG_014 and unclassified_f_Lachnospiraceae in mice of model group were significantly decreased while Bacteroides, Escherichia_Shigella, Enterococcus, Parabacteroides, Clostridium_sensu_stricto_1, and Lactococcus were significantly increased. Baicalein significantly decreased the abundance of Bacteroides, Escherichia_Shigella, Parabacteroides, Enterococcus, Clostridium_sensu_stricto_1, and Lactococcus. Meantime, norank_f_Muribaculaceae was notably increased by baicalein. The content of IL-6 and TNF-α in the serum of the three groups were positively correlated with the abundance of Clostridium_sensu_stricto_1, Lactococcus, Bacteroides, and Enterococcus according to correlation analysis. This study suggested the potential therapeutic effect of baicalein on CIM in mice. Regulation of gut microbiota probably plays a critical role in the therapeutic effects of baicalein.

Nervous system drugs play an important role in the drug research and development, and the cognition related drug become the urgent needs of social development. However, drugs which can regulate cognitive function are seriously inadequate in clinical supply, and faced frustration in research and development process. In this paper, a brief overview of the two types of cognition related drugs (drugs affecting normal cognitive function and improving cognitive dysfunction) were discussed based on the current research status of cognitive pharmacology. The current research and development of new cognition related drugs focuses on regulating neurotransmitters, targeting Aβ and Tau proteins, neuroprotection and vascularization, and still requires new research methods and ideas. In this article, we summed up the research strategies based on the clinical and development of cognition related drugs, especially for the Alzheimer's disease, then we put forward the task and challenge of cognitive pharmacology development. We aimed at providing new ideas for researchers to promote the development of cognitive drugs.

During the process of consistency evaluation, it was found that the consistency of drug release between generic and original brands in vitro was not sufficient to demonstrate their same release in vivo. The disintegration of tablets, as a premise for the release of tablet drugs, greatly affects the release of drugs, depending on the structure and properties of disintegrants. Hence the systematic research on disintegrants would be very important for the evaluation of generic consistency. In this experiment, the physicochemical properties and application of 11 different sodium carboxymethyl starch (CMS-Na) from 9 manufacturers were investigated. This provides the reference for selection of excipients for consistency evaluation. The particle morphology of CMS-Na was observed by scanning electron microscope. The particle size distribution was determined by dry particle size analyzer. The determination of pH and loss on drying was carried out according to the 2015 edition of Chinese pharmacopoeia method. The powder fluidity was evaluated with Carr's index, Hausner ratio and angle of repose. The disintegration performance of CMS-Na was evaluated through determining the water absorption and swelling. The disintegration effect of CMS-Na tablets was studied using lactose and microcrystalline cellulose as fillers. The results showed that pH values and weight loss on drying of all samples met the requirements, whereas the particle morphology, fluidity, water swell-ability and disintegration time had a large variation, which leads to the large differences the properties of CMS-Na depending on the sources. Therefore in order to ensure that the reproducibility of generic drugs from their name brand, our studies indicate that only a sizable choice of disintegrants could ensure good inter batch reproducibility.

ACK1 (activated Cdc42-associated kinase) is a non-receptor tyrosine kinase, originally identified by its binding to the GTP-binding small GTPase Cdc42. It is widely expressed in human tissues and activated by various extracellular growth factors such as EGF, PDGF and TGF-β. The activated ACK1 mediates the signaling cascade by interacting with downstream effectors followed by their phosphorylation. In recent years, researchers have investigated the biological functions of ACK1 and its roles in cancer research. The gene amplification and overexpression of ACK1 is associated with a poor prognosis and metastasis in a variety of cancers including lung, ovarian and prostate cancers. Therefore, the development of small molecule inhibitors of ACK1 provides promising opportunities for cancer-targeted therapy. In this review, we briefly describe recent advances in understanding the activation and biological function of ACK1 and introduce its novel inhibitors with potential therapeutic activities in preclinical studies.

Oligosaccharides play important roles in many biological processes and have great medicinal potential. The structure-activity study of oligosaccharides is complicated by the diversity and complexity of their structures. This review summarizes the state of oligosaccharide structural analysis in recent years. The ionization methods and dissociation rule of acid oligosaccharides, neutral oligosaccharides and glycopeptides in mass spectrometry are discussed and the methods of extraction and purification of oligosaccharides, the suitable mass spectrometry models for different types of oligosaccharides, and the advantages and disadvantages of different mass spectrometry models are introduced. We believe that this review will be helpful for the further investigation of these important biological substances.