Latest ArticlesTraditional Chinese medicine preparations in medical institutions are unique and valuable resources in our country, which have important medical value and economic value. However, in recent years, the development scale of traditional Chinese medicine preparations in medical institutions in Beijing has continued to shrink due to various factors such as policy, funding, and mechanism. At present, achievement translation has become the inevitable way to inspire the potential of hospital preparations and achieve wide application. Taking Beijing as an example, this paper systematically reviewed the current status of the preservation and use of traditional Chinese medicine preparations in medical institutions. On this basis, it analyzed the causes and problems of the low translation rate, and combined with the latest policy guidance, put forward diversified and operational conversion paths, in order to provide solutions for the revitalization of traditional Chinese medicine preparations in medical institutions, and inject new momentum into the inheritance and innovation of traditional Chinese medicine.
To develop a practical methodology for risk identification and quality improvement in the quality management system of non-clinical drug safety research institutions, i.e., Good Laboratory Practice (GLP) institutions, by identifying and analyzing the distribution of key factors in the operation and management of GLP institutions.
Certain inspection fundings from different inspection types, including initial certification inspections, renewal certification inspections, and inspections for newly added test items, were used as analyzing items. Based on the demo data, key factors are identified and categorized, and the Pareto principle was applied to determine the main risk factors in the quality management of GLP institutions. Based on this, a risk identification model was constructed using externally identified inspection findings to enhance the level of quality management.
By identifying and categorizing key factors, and utilizing findings from external inspections as the data foundation, this model serves as a tool for semi-quantitative analysis of quality management risk factors. It provides a reference framework for the digital transformation of quality management and facilitates risk management.
To conduct a comprehensive investigation on the developmental trajectory, current status, and research hotspots in gene therapy drugs both domestically and internationally, thus to provide references for promoting technological innovation and facilitating the translation of research outcomes.
This study retrieved data from the CNKI, Web of Science Core Collection, and ClinicalTrials.gov databases, incorporating 1 890 Chinese articles, 7 598 English articles, and 1 806 clinical trial records. Visualization analysis of the current landscape and trends in the field of gene therapy drugs was conducted using VOSviewer and CiteSpace.
Research in this field has demonstrated sustained growth. Domestic research hotspots are primarily focused on the application of CRISPR-Cas9 technology, the development of nanocarriers, and targeted cancer therapies. In recent years, international research has shown heightened interest in exploratory technologies such as gene editing, rare disease treatments, and artificial intelligence. These findings provide a theoretical basis for understanding the evolution of the gene therapy drug field.
Gene therapy drug research has entered a phase of rapid development. Emerging hotspots include AI-enabled vector design and the optimization of off-target effects. Future research holds great potential through the deep integration of molecular biology, materials science, and information technology. Nevertheless, challenges such as vector delivery efficiency, immunogenicity control, and scalable production processes remain the central to current research efforts and represent key areas for ongoing investigation.
To conduct a systematic analysis of patent infringement litigation involving traditional Chinese medicine (TCM), summarize its common problems, explore the underlying causes, and propose targeted improvement strategies.
The research primarily adopted an empirical analysis approach, supplemented by case studies. By integrating statistical data and relevant legislation, TCM patent infringement cases were examined from multiple dimensions, including judicial levels, final judgment reversal rates, litigation parties, and litigation patterns.
Several characteristics of TCM patent infringement litigation were indicated: first, in terms of judicial hierarchy, cases tended to reach higher levels of adjudication, with most undergoing second-instance or retrial procedures; second, the reversal rate in final judgments was relatively high; third, regarding party structure, both plaintiffs and defendants were predominantly legal entities; and fourth, in terms of litigation patterns, TCM patent infringement cases were often accompanied by administrative litigation, showing an intertwined relationship between civil and administrative proceedings.
TCM patent infringement litigation faces several challenges, including incomplete legislation, prolonged judicial processes, and difficulties in determining infringement. To address these issues, efforts should be made to strengthen administrative-judicial coordination mechanisms, promote local legislation, establish platforms for innovation and transformation of TCM achievements, apply the drug patent linkage system flexibly, develop strategic patent layout planning for enterprises, and cultivate specialized legal professionals in the TCM field, thereby fostering the sustainable development of China's TCM industry.
Peritoneal dialysis fluids are an indispensable and crucial component of peritoneal dialysis treatment. As a combination of drugs and medical devices, peritoneal dialysis fluids have a relatively complex drug delivery connection system. They present certain complexities in design, production, quality control, transportation and distribution, as well as treatment process. The quality of peritoneal dialysis fluids directly affects the quality of life of patients. This article, based on the experience of review work, discusses the prescription process, quality research and control, stability and packaging system of peritoneal dialysis fluids, in order to provide valuable references and lessons for the research and development of such products and continuously improve product quality.
The legality and certainty of administrative licensing for drug registration are core symbols of the modernization of the country's drug regulatory system. In the context of multiple links and departments participating in drug registration, it is particularly important to balance the right to statement and defense of drug registration applicants with the maintenance of administrative efficiency. This paper sorted out the dispute resolution mechanisms involved in the current drug registration process, analyzed the ambiguous areas in procedure connection and determination of the effect of conclusions, as well as the challenges they pose to the scientificity and authority of administrative licensing decisions. It also proposed preliminary suggestions to improve China's drug registration dispute resolution mechanism from the legislative, institutional and procedural levels, aiming to provide references for building a drug registration dispute resolution mechanism with clear power and responsibilities, fair procedures, smooth connection and efficient operation.
This paper reviews the research progress of sodium zirconium cyclosilicate, a novel potassium binder. Sodium zirconium cyclosilicate is a non-absorbed, insoluble, non-polymer inorganic crystalline powder with a uniform microporous structure, and functions as a highly selective inorganic cation exchanger. When taken orally, it captures potassium ions in the human intestinal tract, which are then excreted in the feces. By reducing potassium ion absorption, it lowers the potassium ion level in the blood, thereby treating hyperkalemia. Sodium zirconium cyclosilicate has a high affinity for potassium ions that is unaffected by other cations. Compared with existing treatments for hyperkalemia, it offers improved selectivity and speed in capturing excess potassium ions, providing a safe and effective option for the long-term management of hyperkalemia. This article describes in detail the chemical structure, mechanism of action, pharmacokinetic characteristics, clinical research progress and pharmaceutical research progress of sodium zirconium cyclosilicate. Studies have shown that sodium zirconium cyclosilicate demonstrates favorable efficacy and safety in the treatment of hyperkalemia, offering a new option for clinical practice.
Tablet in tablet technology, as a new type of drug formulation technology, uses a specific pressing process to wrap the active ingredient or drug containing layer in the middle, and the outer layer is covered with one or more coating layers with different functions such as protection, sustained and controlled release, isolation, etc.. Tablet in tablet technology endows drugs with unique drug release and functional characteristics through special preparation processes and structural design, thereby achieving precise regulation of drug release, enhancing drug stability, and improving other drug properties. In recent years, it has received widespread attention. This article summarizes the development history, principles, and characteristics of tablet in tablet technology through relevant literature research. It also elaborates on the innovative applications of tablet in tablet technology and explores pharmaceutical research, in order to provide some references for the research and development of such formulations.
Malt is a dried product of barley germination, which is widely used in the fields of traditional Chinese medicine and food industry. By combing ancient books and literature, the historical evolution and modern research progress in malt processing methods were summarized. The quality markers of malt were analyzed and predicted by system pharmacology, and finally luteolin, tricin, delphinidin and 5,7-dihydroxy-3′, 4′, 5′-trimethoxyflavon were screened as the quality markers of malt. This study provided theoretical basis and research ideas for the in-depth study of different processed varieties of malt and the establishment of quality standards.
To prepare lasmiditan tablets and study the in vitro dissolution and pharmacokinetics.
Literature and patents were investigated for designing and optimizing the formulation composition and preparation process. Based on the wet granulation preparation process, taking Reyow® as the reference preparation, the optimal excipient ratios of pregelatinized starch, croscarmellose sodium and magnesium stearate were screened out by Box-Behnken experiment. The particle size and tableting hardness of the API before granulation were determined by single factor experiment. The relevant permeation parameters and pharmacokinetic characteristics of the self-developed tablets and reference preparation in the PAMPA (parallel artificial membrane permeability assay) and the pharmacokinetic characteristics in Beagle dogs were further studied.
The particle size of the API was determined to be 220 μm, and the hardness of the tablet was 80 N. The content of pregelatinized starch was 8.77%, and the content of croscarmelase sodium was 4.58%. The magnesium stearate content was 2.67%. The membrane permeability of the self-developed tablets and the reference preparation were 1.125×10-4 and 1.117×10-4 cm·s-1, respectively, and the permeability rates were 0.846 804 and 0.847 113 μg·min-1·cm-2, respectively. The in vivo experiments showed that the Cmax of the self-made tablets and Reyow® were 189 and 188 ng·L-1, the Tmax was 3 h. The oral relative bioavailability of homemade tablets was 93.32%.
The PAMPA permeation and release behavior in Beagle dogs were basically the same between the self-developed tablets and the reference tablets. The self-developed preparation is preliminary bioequivalent to the original product. The process is suitable for the preparation of lasmiditan tablets.
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