Latest ArticlesTo isolate and prepare iridin monomer from traditional Chinese medicine Iridis tectori Rhizoma, and to explore the regulatory effect of iridin on the isolated intestinal muscle in vitro.
The multi-solvent extraction method was used to prepare Iridin. The effect of iridin on acetylcholinesterase (AChE) activity was studied by modified Ellman colorimetry. The isolated intestinal muscle experiment was used for in vitro evaluation. In this study, the mouse small intestinal smooth muscle was obtained, from which the small intestinal smooth muscle ring was prepared in K-H solution. The change of the tension was measured by the BL-420S biological function experimental system. The resting tension and its effects on the contraction of small intestinal smooth muscle induced by neostigmine and pralidoxime iodide were investigated.
The iridin monomer obtained by the multi-solvent extraction method has a purity of over 98% calculated by the HPLC peak area normalization method. Iridin had inhibitory effect on AChE activity with a dose-dependent manner, and its half-inhibitory concentration (IC50) is 4.09 mg·mL-1. Iridin (0.014~4.604 mg·mL-1) had obvious excitatory effect on the contraction of isolated small intestine in normal mice, and the inhibitory effect was dose-dependent. Iridin had a significant antagonistic effect on the inhibition of small intestinal contraction caused by the cholinesterase revitalizer iodopyridine (P<0.05), but had no significant synergistic effect on promoting the small intestinal motility by the cholinesterase inhibitor neostigmine (P>0.05).
Multi-solvent extraction method is a simple and efficient method for the isolation and preparation of iridin in Iridis tectori Rhizoma, and iridin has the cholinergic effect on inhibiting AChE. It can promote the contraction of the small intestine, and is expected to be a candidate for ache inhibitor.
To analyze the situation and clinical characteristics of adverse drug reactions induced by brentuximab vedotin, so as to provide reference for clinical safe and rational drug use.
By searching the literature in CNKI, Wanfang, database, VIP, CBM, Embase, and PubMed, the adverse drug reaction cases after the marketing of brentuximab vedotin were collected and statistically analyzed.
A total of 24 literatures were involved and 254 patients were included. Adverse drug reactions induced by brentuximab vedotin mainly involved nervous system damage (30.13%), blood system damage (26.50%), immune dysfunction (9.62%), skin and subcutaneous tissue disorders (8.97%), systemic reaction (8.33%), with the specific performance of peripheral neuropathy, neutropenia, infections, infusion reaction, elevated transaminase levels, thrombocytopenia, rashes, and so on. Most of the patients with adverse reactions had good prognosis. Nine cases of death were reported, including interstitial lung disease (n=3), pneumonia (n=2), progressive multifocal leukoencephalopathy (n=2), heart failure (n=1) and acute liver injury (n=1).
The doctors and pharmacists should pay attention to the adverse drug reactions by brentuximab vedotin. The adverse drug reaction monitoring should be strengthened, with the adverse drug reactions detected and dealt in time, so as to ensure the medication safety of patients.
Biopharmaceutical industry is an important part of the national economy. Drug safety is directly related to people's life and health, which is an important guarantee for social stability and economic development. In order to effectively ensure drug safety and promote the innovative development, transformation and upgrading of the biomedical industry, the national level and provincial (autonomous region, province-level municipality) governments have successively formulated and issued the "14th Five-Year Plan" for drug safety supervision and promoting high-quality development. This paper introduces the national "14th Five-Year Plan" for drug safety and promoting high-quality development at the national level. It also analyzes and compares the common measures and characteristic measures of different provinces (autonomous regions and province-level municipalities).
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.
The run-in period is a specific stage after enrollment and before randomization. It is an important design element of many landmark drug clinical trials and plays an important role in drug development. However, the status quo includes non-standard design of run-in period in research protocols and inadequate reporting of run-in period in results. The author summarize the definition, type, duration, significance, advantages and disadvantages of the run-in period, and list clinical application cases, in order to provide reference for the clinical trial design and the application of the run-in period.
Simulation technology is an effective tool to improve the success rate of clinical studies, with applications at all stages of clinical research. This paper illustrated the content, requirements, and issues in three parts: simulation plan, implementation, summary, and evaluation. In the case practice of survival analysis, the article assumed a scenario where time-to-event data does not meet the proportional hazards assumption, using an exponential cure rate function model with a delayed effect. The simulation aimed to study trial design factors such as the average hazards ratio, sample size, and number of events. The results demonstrated that non-proportional hazards assumptions significantly impact the trial hypothesis, follow-up time, and analysis time. Using normal trial design methods based on the proportional hazards assumption could lead to reduced test power and unreliable interim analysis results. Simulation technology could better support the design and implementation of clinical trials. Finally, the paper discussed the importance and impact of scenario assumption in simulation implementation and execution. Also, it is pointed out that the complexity of simulation should be considered to improve the feasibility of simulation execution.
Taste masking is one of the key issues to improve drug compliance in children during the development of oral liquid preparations of traditional Chinese medicine (TCM). Because different families of TCM contain different odors, and TCMs are generally used as compound preparations in clinical practice, the taste usually presents a complex blend phenomenon. At present, the main methods to improve the taste of TCM oral liquids are medicinal materials processing, pre-treatment, preparation technology modification, adding auxiliary materials and so on. but the masking effect and application range of various masking methods are different. In practical application, the masking methods should be selected according to the drug type, dosage form and equipment needs. This paper summarizes the classification, application and new taste masking technology of TCM oral liquid preparations for children by sorting and analyzing relevant journals and patents, so as to provide reference for the research on this kind of pharmaceutical preparations.
To establish a method for determining the biological activity of adalimumab based on tumor necrosis factor-α (TNF-α) neutralization activity to provide technical means for parallel comparison of biological activities of similar biotherapeutic products of adalimumab.
The mouse fibroblast cell line L929 was used as target cell and the key reagents such as TNF-α and actinomycin D (Act-D) were standardized, then the experiment parameters including cell inoculation density, concentrations of key reagents, dilution gradient of adalimumab and incubation time were optimized. Then, the optimized method was validated by the methodology verification in the laboratory and the joint validation between laboratories to evaluate the performance of the method and its applicability to adalimumab reference products and similar biotherapeutic products.
There was a dose-response relationship between adalimumab concentrations and signal values in this method. The optimized concentrations of TNF-α and Act-D were 1 ng·mL-1 and 400 ng·mL-1 respectively, the optimized seeded cell number was 2×104 cells per well, the optimized initial antibody concentration was 1 000 ng·mL-1, the dilution ratio was 1∶2.5, and the optimized seeding time and incubation time were 18 h and 24 h. Methodological validation showed that this method was specific, reproducible and accurate. The results of joint validation were satisfactory.
This method is applicable to the five listed adalimumab products and can be used as a platform quality control method for the biological activity of adalimumab, which is convenient for the national sampling work and the parallel comparison between the products. It also provides an optional evaluation method for the establishment of national adalimumab standards and technical support for the inclusion of adalimumab monograph in Chinese Pharmacopoeia in the future.
In recent years, with the change of people's living standards and the increasingly serious aging phenomenon, the incidence of degenerative diseases of the central nervous system is increasing. Due to the unknown etiology, such diseases seriously affect the quality of life of patients and increase the economic burden of the society and patients' families. Therefore, finding a new drug to treat this kind of disease has become a research hotspot. Procyanidins (PCs) have antioxidant, anti-apoptotic, anti-inflammatory, anticancer and neuroprotective effects, suggesting that PCs have multi-target pharmacological effects. Because of this, PCs have attracted extensive attention as natural antioxidants and have been applied in the treatment of animal models of nervous system diseases. Based on the current status of research on the pharmacological effects of PCs by domestic and foreign scholars, this paper reviews the research progress in the role and mechanism of PCs in the prevention and treatment of degenerative diseases of central nervous system and puts forward the view that PCs may be related to the inhibition of iron death in the treatment of degenerative diseases of central nervous system.
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62662699(Operation and Technical Support)
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
