Latest ArticlesTo develop the national reference standards of 1,1,1,2-tetrafluoroethane as the excipient of medicinal aerosol and its impurities thus to improve the standard of quality control.
The national reference standards of 1,1,1,2-tetrafluoroethane and its main impurities 1,1,2,2-tetrafluoroethane, pentafluoroethane, pentafluorochloroethane and 1,1,1-trifluoroethane were sub-packaged in liquid state directly. The structures were confirmed by IR, MS and MR spectroscopy, the moisture was determined by Coulomb method, the tightness of the package was confirmed by immersion in water. The content of each substance was calculated by mass balance method．Homogeneity and stability were investigated by F test and linear fitting respectively, and the content of 1,1,1,2-tetrafluoroethane was confirmed by multiple laboratories simultaneously.
The contents of 1,1,1,2-tetrafluoroethane, 1,1,2,2-tetrafluoroethane, pentafluoroethane, pentafluorochloroethane and 1,1,1-trifluoroethane were 100.0%, 99.9%, 99.7%, 99.2%, and 99.9%, respectively, with good homogeneity and stability.
In this study, the national reference standards of 1,1,1,2-tetrafluoroethane and its main impurities were developed for the first time, where 1,1,1,2-tetrafluoroethane can be applied for content determination, and the other substances can be applied for the inspection of related substances.
To investigate the status of clinical trials registered on ClinicalTrials.gov on diseases in the list of rare diseases in China and analyze the registration characteristics.
All clinical trials involved in the list of rare diseases in China were searched on ClinicalTrials.gov from inception to April 5th, 2022. The relevant information of clinical trial registration was collected, and WPS Office was used for data analysis.
A total of 12 904 rare disease-related clinical trials were screened out, and the overall trend was increasing year by year. The information of clinical trial stages was missing a lot, and the sample size was mainly 0~100 cases. The types of trials were mainly interventional studies (9 042 trials, 70.1%) and observational studies (3 760 trials, 29.1%). There were three main statuses of trials: completed (6 467 trials, 50.1%), recruiting (2 388 trials, 18.5%), and unknown status (1 207 trials, 9.4%). The number of drug therapy trials was the largest (5 992 trials, 46.3%). The countries/regions participating in clinical trials were mainly developed countries in Europe and the United States. All of the top three single/multi-center rare disease-related clinical trials were conducted in European and American countries. There were a small percentage of clinical trials conducted in China (460 trials, 3.6%), but the proportion of single center-clinical trials was the highest (260 trials, 56.5%). The research institutions were mainly universities and medical institutions, and in China they were mainly medical institutions (358 trials, 77.8%). The sponsoring institutions were mainly European and American countries. The design of rare disease-related clinical trials was mainly non-randomized, open label and parallel allocation of therapeutic regimens. The outcome indicators were mainly related to safety and efficacy.
The development of clinical trials of rare diseases in China is on the rise, but there is a big gap with European and American countries. We should establish a systematic research and development incentive mechanism and introduce relevant laws and regulations as soon as possible to promote the high-quality development of clinical trials of rare diseases.
To screen potential small-molecule inhibitors of monkeypox virus thymidylate kinase from traditional Chinese medicine databases using virtual screening technology.
Based on the published monkeypox virus thymidylate kinase sequence, the three-dimensional structure of monkeypox virus thymidylate kinase was constructed using homology modeling technology, and multiple rounds of screening were performed using docking-based virtual screening technology, including high-throughput virtual screening, standard precision virtual screening, high precision virtual screening and Prime MMGBSA.
Fifteen compounds with potential inhibitory activity against monkeypox virus thymidylate kinase were obtained by screening. The binding modes of compounds MOL002468, MOL009538, MOL000416 and MOL009237 with thymidylate kinase were analyzed for receptor-ligand interactions including hydrogen bonding, hydrophobic interactions, conjugation and salt bridges.
A virtual screening strategy for monkeypox virus thymidylate kinase was successfully constructed in order to discover new drugs that can be used to prevent and treat monkeypox virus, promoting further development and utilization of traditional Chinese medicine databases.
Photodynamic therapy (PDT) is a tumor treatment method that uses photosensitizers to convert oxygen into reactive oxygen species and stimulate multiple pathways to kill cells. PDT can break through some limitations in tumor treatment with the help of nano-drug delivery system, but it still cannot solve the key problem of poor biocompatibility of photosensitizers. The cell membrane-modified biomimetic nano-drug delivery system formed by introducing natural cell membrane into nano-drug delivery system can give full play to the low immunogenicity of the cell membrane, improve the biocompatibility of photosensitizers, and enhance the anti-tumor effect of PDT. This review focuses on the progress of nanoparticles modified with cancer cell membrane, red blood cell membrane, leukocyte membrane and hybrid cell membrane, and their applications in PDT against tumors. The advantages and disadvantages of every type of cell membrane-modified nanoparticles based on PDT have been summarized to provide reference for its clinical application.
225Ac is one of the most promising radionuclides in alpha particle targeting therapy (targeted alpha therapy, TAT). The alpha particles produced by 225Ac decay have the characteristics of higher linear energy transfer, shorter tissue action distance, less side effects and so on. Therefore, TAT drugs such as small molecules and antibodies labeled with 225Ac have good application prospects in tumor treatment. This paper introduces the decay properties and sources of 225Ac, summarizes the commonly used chelating agents for 225Ac labeling, exemplifies the process of 225Ac labeling, and summarizes the application of 225Ac-labeled compounds in non-clinical and clinical research in the past three years. Finally, the challenges and prospects of 225Ac-labeled TAT drugs are analyzed, which provides a basis for the follow-up development of TAT drugs.
Compared with other administration methods such as intravenous injection, oral administration is simple and feasible with low medical cost and high safety, and can relieve the pain of patients and enhance humanistic care. However, due to the harsh gastrointestinal environment, many oral drugs cannot reach their target sites with effective concentrations to exert therapeutic effects. Therefore, there are many challenges in developing oral drugs. Exosomes are extracellular vesicles secreted by cells, which transport proteins, nucleic acids, miRNA and other bioactive substances to receptor cells for intercellular communication. Recently, a number of researchers have reported that vesicles with structures similar to those secreted by mammalian cells can be extracted from vegetables, fruits and dairy products, and named them as food-derived exosomes (FDEs). FDEs have attracted wide attention due to their low immunogenicity, high biocompatibility, non-toxic and environmental properties. This review summarizes the medical application of FDEs as oral preparations, hoping to provide theoretical reference for the development and application of oral preparations based on FDEs.
Excel and Cite Space were used to perform bibliometrics and knowledge map study of relevant literature from 1983 to 2021 in the field of drug regulatory science of CNKI in China. Research status and development trends are analyzed from the annual amount of articles, literature sources, foundation, research hotspots and research subjects. The study finds that by 2021, drug regulatory science research in China has reached a certain scale, with the number of articles increased rapidly. The number of publications in core journals have began to increase, and 33.89% of the articles were supported by the fund. Research hotspots focused on two aspects: pharmacovigilance with its related systems, and new methods and technologies of drug regulation. A network of collaboration has been formed among major researchers and research institutions, with close cooperation among universities, medical institutions, and government agencies. However, a certain geographical restriction existed in the cooperation. To promote the healthy and rapid development of drug regulatory science research in China, it is necessary to improve the quality of published research results, deeply dig the frontier research directions, and encourage international-domestic exchanges and collaboration. At the same time, it is also important to break the regional cooperation barriers in current research network, mobilize the enthusiasm of medical enterprises, and widen the cooperation among medical enterprises, universities, medical institutions, and government agencies.
To 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.
With the reform of China's pharmaceutical system going deeper, reorganization of mergers and acquisitions of the pharmaceutical industry is becoming increasingly active. It is not only in accordance with the objective laws, but also has strong vitality and good development prospects. This paper analyzes the present situation, characteristics, development opportunities and risks of domestic and foreign mergers and acquisitions in the pharmaceutical industry in the last ten years, and puts forward some suggestions to optimize the merger strategy, so as to provide reference for the domestic and foreign mergers and acquisitions of Chinese pharmaceutical enterprises and the formulation of relevant national policies.
To investigate the clinical efficacy and safety of apatinib in advanced gastric cancer with different blood supply.
The clinical data of 45 patients with advanced gastric cancer with different blood supply treated with apatinib were analyzed retrospectively. The patients with the difference of CT values between arterial phase and plain scan at the same level ≥40 HU were included in group A, ≥20 HU and <40 HU in group B, and <20 HU in group C. The therapeutic effects, serum carcinoembryonic antigen (CEA), carbohydrate antigen199 (CA199), survival and safety of the three groups were compared.
The objective remission rate and disease control rate of group A were significantly higher than those of group B and group C (P<0.05). After treatment, the CEA and CA199 of the three groups decreased significantly, and through pairwise comparison, the CEA and CA199 of the three groups ranked C, B and A from high to low. There was significant difference in PFS among the three groups (P<0.05). After pairwise comparison, the PFS of the three groups ranked A, B and C from high to low. The difference of adverse events among the three groups was not statistically significant (P>0.05).
The clinical efficacy of apatinib in rich blood supply advanced gastric cancer is better than that in lack of blood supply advanced gastric cancer. It has the same safety in rich blood supply advanced gastric cancer and lack of blood supply advanced gastric cancer.
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