Latest ArticlesTo investigate the effect and mechanism of Qianggu Tongbi capsules on oxidative stress in rats with osteoarthritis.
Twenty-four SD rats were randomly divided into two groups, 6 of which were used for control group and 18 were used for modeling. After modeling, the 18 rats were randomly divided into model group, Qianggutongbi capsules group, and glucosamine group. Hematoxylin eosin staining (HE) was used to observe the changes of cartilage. Superoxide dismutase (SOD) kit, malondialdehyde (MDA) kit, and nitric oxide (NO) kit were applied to detect the levels of SOD, MDA and NO in serum, respectively. Real time-polymerase chain reaction (RT-PCR) was applied to detect the expressions of nuclear factorerythroid 2-relaxed factor (Nrf2), Kelch-like ECH-associated protein 1 (Keap1), macrophage activation factor (Maf), heme oxygenase-1 (HO-1), and NADPH quinone oxidoreductase 1 (NQO1) in each group. Western blot was used to detect the expressions of Nrf2, Keap1, Maf, HO-1, and NQO1 in each group.
HE staining results showed that there was obvious infiltration of dense inflammatory cells in the cartilage tissue of the model group, while the inflammatory cells in the Qianggu Tongbi capsules group and glucosamine group were significantly reduced compared with the blank control group. Compared with the model group, the levels of antioxidant indexes of Qianggu Tongbi capsules group and glucosamine group increased significantly, while the free radical concentrations decreased significantly (P<0.05). Compared with the model group, the mRNA and protein expression levels of Nrf2, Maf, HO-1, and NQO1 in Qianggu Tongbi capsules group and glucosamine group were significantly up-regulated (P<0.05), while the mRNA and protein expression levels of Keap1 were down-regulated (P<0.05).
Qianggu Tongbi capsules can change the antioxidant indexes in serum by activating the expression of Nrf2-Keap1/ARE pathway-related proteins and mRNA, so as to restore the function of antioxidant stress in rats with osteoarthritis.
To study the mechanism of action of DL-3-N-butylphthalide (NBP) on cerebral small vessel disease in diabetic rats based on Nrf2/HO-1 signaling pathway.
The successfully modeled diabetes rats with cerebrovascular disease were randomly divided into NBP treatment group and model group. The water maze test was carried out. After taking the materials, paraffin sections were stained, dehydrated and sealed. The histological structure of the rat cerebral cortex and the histopathological changes of neurons in this area were observed under a microscope. The expressions of Nrf2 and HO-1 protein in Nrf2/HO-1 signal pathway of brain tissue were detected by Western blot.
Compared with the model group, the escape latency of the rats in the NBP-treated group was shortened gradually on the 1st-4th day in the water maze test. Compared with the model group, the cells of brain tissue in the NBP-treated group were arranged regularly, the nuclei were full and round, and the pyknosis was decreased. Western blot analysis showed that Nrf2 and HO-1 protein expression in the brain tissue of rats treated with NBP was higher than that of the model group.
Nrf2 and HO-1 were increased in the brain tissue of NBP-treated rats, and NBP may play a protective role in the brain by up-regulating the expression of anti-oxidative stress protein.
Patient engagement in drug development is a vital part of patient-centered drug development, and its value and implementation have been recognized and actively explored by leading countries or regions in the field of medicine all over the world. Since November 2021, the Center for Drug Evaluation has issued six guidelines or drafts for patient-centered drug development. Patients provide suggestions and feedback in time through deep participating in the drug development, while collecting and analyzing the information require scientific research methods to ensure the quality of patient data and the rigor and transparency of reports. Qualitative or mixed-methods research is a scientific research method suitable for patients open information collection, analysis, and reporting. However, these two methods may not be widely recognized in the field of drug development. Therefore, this paper briefly introduces these two methods and their application in patient involvement in drug development, aiming to improve the quality of related research.
Corporate venture capital (CVC) plays a huge role as a tool for parent companies to seek external innovation and obtain return on investment. The biopharmaceutical industry itself has high requirements for knowledge and innovation, and is in a stage of rapid development around the world. Therefore, CVC in the biopharmaceutical industry ecosystem is increasingly important. This paper analyzes the CVC development and trends of American pharmaceutical companies, and summarizes the investment data of well-known American pharmaceutical companies CVC in recent years. Fosun Health Capital, as a CVC of Fosun Pharma, is analyzed in this paper as a leading example of Chinese pharmaceutical company CVC. Finally, this paper summarizes the advantages and disadvantages of CVC in the biopharmaceutical industry and expects Chinese pharmaceutical companies to seize the opportunity during the rapid development of the industry and make CVC to become an important part of the Chinese biopharmaceutical industry ecosystem.
Inflammation is a self-defense mechanism which is started when the body is infected or injured. As a common defense mechanism, inflammation is very common in clinic. If not treated in time, it may lead to a variety of more serious diseases. At present, most of the anti-inflammatory drugs used in clinic are chemically synthesized, but their side effects cannot be ignored, which has become an urgent clinical problem to be solved. Plant essential oil is extracted from aromatic plants, which has anti-inflammatory effect. This paper expounds the effective components, mechanism of action, synergy, and safety of plant essential oil for inflammatory pathogens, which can be used for reference for the future direction of scientific research on plant essential oil.
To explore the adverse reactions of risdiplam based on Public Data Open Project of the US Food and Drug Administration (OpenFDA) in order to provide reference for clinical drug safety.
The relevant data of risdiplam were searched and extracted from the OpenFDA database from August 7, 2020 to May 31, 2022. And the report odds ratio (ROR) and proportional report odds ratio (PRR) were applied for signal detection.
A total of 844 adverse event (ADE) reports with risdiplam as a primary suspicious drug were retrieved, and 68 adverse drug reactions (ADR) risk signals were detected, including positional vertigo, decreased oxygen saturation, tachycardia, and accelerated heart rate, which were not labeled in package insert. Top 5 ADE reports were product storage errors, gastrointestinal dysfunction, muscle weakness, diarrhea and weakness. Top 5 ADES in signal strength included diaper dermatitis, positional vertigo, respiratory tract infection virus, product temperature drift, and skin contact exposure.
It is helpful to use real-world data for assessing the potential adverse reactions of risdiplam, suggesting clinicians to monitor specific adverse events and conduct further drug safety evaluations. The signal strength of positional vertigo is high and is not mentioned in the instruction manual, thus it is necessary for clinicians to pay close attention.
In recent years, the use of N-acetylgalactosamine (GalNAc) conjugates to target asialoglycoprotein receptors and further deliver oligonucleotides to hepatocytes has become a breakthrough approach in the field of therapeutic oligonucleotides. Compared with traditional delivery methods of nucleic acid drugs, GalNAc-nucleic acid conjugation is a simple method of liver delivery. It exhibits liver targeting specificity, high efficiency, high safety, large-scale preparation and many other advantages, thus has research value of in-depth development and broad prospects for clinical application. Givosiran, developed using GalNAc conjugation, has been approved by FDA for the treatment of acute hepatic porphyria, and there are 7 other conjugates are in registration review or phase III clinical trials, and at least 21 GalNAc nucleic acid conjugates are in the early stages of clinical development. However, the relevant research foundation of GalNAc conjugation in China is relatively weak, and no related products are on the market, making it a neck-stuck technology in China. Therefore, this review focuses on GalNAc and its derivatives as nucleic acid drug delivery vehicles and their application progress in small interfering RNA (siRNA) and antisense oligonucleotides (ASO). This review provides reference for the development of domestic GalNAc conjugates.
To investigate the effect of agarwood line incense (ALI) burning on anxiety and depression and its mechanism.
Chronic unforeseeable mild stress (CUMS) was applied to induce depression-like model and M-chloropheniperazine (MCPP) was applied to induce anxiety model. By using open field test (OFT), light-dark transtition test (LDT), tail suspension test (TST) and forced swim test (FST), changes of activity after inhaling the incense were measured to evaluate its effects of anti-anxiety and anti-depression. To investigate the mechanism, monoamine neurotransmitters in brain, such as 5-HT, Glu, and GABAA, were observed by ELISA. The protein expression levels of GRN2B, GRM5, GluR1, VGluT1 were evaluated by Western Blot.
Compared with the anxiety model group, the total distance and average velocity significantly reduced (P<0.05), the rest time increased (P<0.05), and the distance and average velocity in the black box reduced (P<0.05) in ALI inhalation group. Compared with the depression model group, the total distance and average velocity significantly increased (P<0.05), the rest time decreased (P<0.05), and the immobile time of TST and FST decreased (P<0.05) in the ALI group. The ALI inhalation increased the levels of 5-HT and GABA (P<0.05), decreased the level of Glu (P<0.05) in the brain tissues of the anxiety model group. ALI decreased the level of GABA (P<0.05), and increased the levels of 5-HT and Glu (P<0.05). ALI increased the protein expression levels of GRN2B, GRM5, GluR1, and VGluT1 in hypothalamus of the rats in anxiety model group. ALI decreased the protein expression of GRM5 and increased the protein expressions of GRN2B, GluR1, and VGluT1 in hypothalamus of the rats in depression model group.
ALI has a significant anxiolytic and anti-depression effects, and the mechanism may be related to the regulation of the levels of 5-HT, Glu, GABAA, and the protein expression of GRN2B, GluR1, and VGluT1 in hypothalamus.
To provide reference for improving the management of innovative drug clinical trial in China.
From the perspective of the project whole life cycle, this paper analyzes the complex project system of innovative drug clinical trials, discusses the measures and regulatory experience in promoting the development of innovative drug clinical trials in the United States, hoping the suggestions were useful for China.
The process of innovative drug clinical trial projects is complex and the interests of different subjects are different, therefore certain regulatory difficulties exist. Through timely promulgation of various modern regulatory program and clinical trial guidance documents, the United States has promoted the rigor and efficiency of innovative drug clinical trials in the whole life cycle process of protocol design, review and approval, study start-up, ethical review, and data sharing. It is suggested that China should optimize the management path of innovative drug clinical trials from the following aspects, and explore the "master protocol" trial design model to provide further guarantee for clinical trials of new therapies: initiating operation procedures based on optimized trial, applying parallel mechanism of independent review and specialized ethical review, and using diversified data sharing models, in order to ensure efficient clinical trials. The review information disclosure and stakeholder communication mechanism should be constantly improved to strengthen the guidance of innovative drug clinical trial project.
Visible particulates in injectable products directly jeopardize patient safety, and it is a critical quality attributes of injectable products. In recent years, unqualified products and recall events related to injectable products caused by visible particulates occurred frequently. Therefore, it is necessary to conduct the risk assessment, production process control and product detection of visible particulates in injectable products. Referring to the U.S. FDA Inspection of Injectable Products for Visible Particulates Guidance for Industry (draft guidance) and relevant guidelines and manufacturing and controls (CMC) review experience, this article mainly introduces and discusses the ideas of visible particulate control in chemical injections from the aspects like concept of visible particulates, quality risk assessment, production process and sample inspection control, life cycle management, etc., hoping to provide reference for the control and evaluation of visible particulates in injections.
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62199257
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
