Latest ArticlesAs critical biological products related to public health security, vaccines require specialized quality regulation with strategic significance. Against the backdrop of the implementation of the Vaccine Administration Law of the People's Republic of China, this study focuses on China's resident vaccine inspector system. Through in-depth interviews with 19 stakeholders from regulatory agencies and vaccine enterprises, combined with policy text analysis, the research systematically examines the operational mechanisms and implementation outcomes of the system. It was revealed that the resident inspector system, underpinned by a preventive regulatory model of "on-site facility supervision, risk early warning, and rectification closed-loop", demonstrates significant efficacy in controlling quality risks at the source and enhancing corporate compliance. However, there exist structural challenges, including discontinuities in talent echelons, fragmented training systems, insufficient incentive mechanisms, lagging digital capabilities, and immature coordination mechanisms between dispatched inspections and daily supervision. To address these issues, the study proposes a five-in-one optimization framework integrating "professional talent selection, systematic training, quantitative evaluation, technological empowerment, and mechanism linkage”. Specific recommendations include establishing cross-regional talent-sharing mechanisms to alleviate workforce shortages, adopting a combined training model of "theoretical learning, practical drills, and simulated inspections" to enhance competency, develop a KPI assessment system based on risk detection metrics and corporate satisfaction, strengthen digital system operation training and information and intelligent terminal equipment, enhance the coordinated development of dispatched inspection and daily supervision. The research provides theoretical support for improving the vaccine lifecycle regulatory system, offers practical insights for enhancing regulatory precision and mitigating systemic quality risks.
In the past two decades, the technology of compression-coated tablets has developed and progressed rapidly. Particularly, for the stepwise compression-coating technology, both the machine production capacity and the tablets quality have been greatly improved. And because the application of new excipients and new pharmaceutical technology, the prescription design ideas have been much optimized. Zero-order release tablets, pulsatile drug delivery tablets, floating drug delivery tablets, and colonic drug delivery tablets can be produced by compression coating technology, which can make blood drug concentrations more stable, improve the bioavailability of drugs or reduce adverse drug reactions, so the treatment of some diseases can be improved by these drug delivery tablets.
Hemifacial spasm (HFS) is a movement disorder characterized by involuntary, paroxysmal contractions of the facial muscles, typically caused by compression or demyelination of the facial nerve. It is often associated with facial distortion and twitching, significantly affecting the patient's quality of life. Traditional pharmacological treatments, such as anticonvulsants, benzodiazepines, and muscle relaxants, can provide some symptom relief, but their efficacy is limited, and side effects are prominent. In recent years, botulinum toxin type A (BTX-A) has emerged as the first-line clinical treatment for HFS. BTX-A works by inhibiting acetylcholine release at the nerve terminal, blocking the signal transmission at the neuromuscular junction, and reducing muscle overactivity. Additionally, it modulates the excitability of the central nervous system and improves neural plasticity, facilitating the recovery of facial nerve function and further alleviating HFS symptoms. This article systematically reviews the mechanism of action and clinical research of BTX-A in the treatment of HFS, analyzes current challenges in its use, and explores its future prospects in the treatment of HFS, aiming to provide safer, more effective, and personalized treatment options for HFS patients.
This study employs cryo-electron microscopy (Cryo-EM) to precisely evaluate the physical stability of liposomes in situ. Cryo-EM eliminates the need for drying and staining, thereby preserving the native morphology of liposomes to the greatest extent. It clearly reveals the bilayer membrane structure and the spatial distribution of encapsulated substances, overcoming issues such as deformation, hydration layer interference, and probe convolution effects associated with traditional characterization methods. Cryo-EM enables efficient and intuitive assessment of liposome morphology, particle size, size distribution, and the state of encapsulated materials. Cryo-EM provides reliable scientific evidence and quality control standards for the development and optimization of liposomal formulations. Ultimately, it enhances the consistency and comparability of drug development and production, meeting the growing clinical demands.
To systematically investigate the dynamic tissue distribution and tumor-targeting characteristics of memory T cells in non-tumor-bearing and tumor-bearing NCG mouse models using validated qPCR and in vivo imaging techniques.
A total of 144 NCG mice were randomly divided into non-tumor-bearing control, tumor-bearing control, non-tumor-bearing treatment, and tumor-bearing treatment groups. The treatment groups received a single intravenous injection of 1×107 memory T cells per mouse, while the control groups received vehicle only. In vivo imaging was performed on days 1, 3, 7, 14, 21, and 28 post-administration. Tissues and body fluids were collected at the same time points, and the genomic distribution of memory T cells was quantified by qPCR.
In non-tumor-bearing mice, memory T cells were initially (day 1~3) distributed mainly in highly perfused organs such as the lung, spleen, and liver, followed by a rapid decline and near clearance by day 14. In tumor-bearing mice, the early distribution pattern resembled that in non-tumor-bearing animals; however, starting from day 14 onward, significant tumor enrichment was observed and persisted until day 28, accompanied by a concurrent decrease in cell concentrations in non-target tissues.
Memory T cells demonstrate a trend of rapid clearance in the absence of antigenic stimulation, whereas in the presence of tumor, they exhibit antigen-driven tumor homing and long-term persistence capabilities.
To establish the identification and content determination methods of Qi Feng Er Teng Granules.
TLC was used for identification and HPLC was used for content determination.
The TLC method allowed effective identification of all crude drugs in the formulation. The calibration curves of paeoniflorin, prim-O-glucosylcimifugin, calycosin-7-glucoside, 5-O-methylvisammioside, icariin, sinomenine, and astragaloside IV showed good linearity in the range of 9.01~45.1, 1.69~8.44, 1.04~5.20, 1.32~6.59, 4.35~21.7, 13.5~67.5, 101~506 μg·mL-1, respectively. The average recovery rate of sample addition was within the range of 95.0% to 105.0% (RSD<3.2%).
The TLC and HPLC methods established in this study for Qi Feng Er Teng Granules have strong specificity, high sensitivity and good reproducibility, and can be used for the quality control of Qi Feng Er Teng Granules.
To evaluate the efficacy and safety of chamomile tablets in the treatment of pediatric otolaryngological diseases and explore its clinical application characteristics.
A retrospective analysis was conducted on medical records of children aged 1~14 years who were prescribed chamomile tablets at multiple hospitals in Guangdong Province and Xinjiang Uygur Autonomous Region between October 2015 and October 2024. Data including demographic information, clinical diagnoses, medication details (dosage, frequency, and duration), changes in clinical symptoms before and after treatment, and relevant laboratory test results were collected. Statistical analysis was performed using SAS 9.4 software.
A total of 7 485 patients were included, with school-aged and preschool-aged children accounting for 83.7% of the cohort. Xiangju Tablets were primarily used for the treatment of pediatric allergic rhinitis (3 075 cases), pediatric sinusitis (1 291 cases), chronic tonsillitis and adenoid-related diseases (997 cases), as well as chronic rhinitis, nasopharyngitis, and pharyngitis (1 836 cases). The most common regimen was 1~2 tablets administered three times daily. The combination use rate of Xiangju Tablets reached 96.77%, and it is often combined with antihistamines and corticosteroids to enhance therapeutic efficacy. Laboratory findings indicated improvements in liver function and immune parameters. No serious adverse events were observed during the study period.
Xiangju Tablets demonstrate favorable efficacy in the treatment of pediatric otolaryngological diseases. Overall, this drug exhibits a good safety profile and represent an effective therapeutic option for children with otolaryngological conditions, showing promising clinical potential. However, the current data are insufficient to fully confirm its independent efficacy and specific role in combination therapy, and its clinical application value still needs to be further verified by higher-quality studies.
To analyze the priority challenges in vaccine regulation in China and provide reference for the improvement of the national regulatory system.
A list of possible challenges in vaccine regulation in China was generated through literature review and in-depth interviews. Using the Hanlon method, expert consultation was conducted to assess the importance, severity and feasibility of intervention for these potential challenges to screen out priority challenges.
The expert response rate was 83.5%, the expert authority coefficient was 0.772, and the coordination coefficients for expert scoring on the importance, severity, and feasibility of intervention of potential challenges were 0.576, 0.517, and 0.510, respectively (P<0.05). According to the results of the Hanlon's analysis, the top five priority challenges in vaccine regulation in China were: inadequate development of regulatory human resources; an underdeveloped information disclosure and public communication mechanism; an incomplete quality management system within regulatory authorities; weak quality management capabilities in some enterprises; and insufficient coordination in accelerated regulatory processes.
This study suggests that strengthening the development of professional human resources, improving mechanisms for information disclosure and public communication, enhancing quality management system construction, guiding enterprises to implement self-regulation, and coordinating accelerated regulatory mechanisms are five key dimensions for systematically advancing vaccine regulatory capacity and comprehensively improving the level of vaccine regulatory governance in China.
Helicobacter pylori (H.pylori) gastric infection affects approximately 40% of the world's population and is a common cause of chronic gastritis and peptic ulcer, as well as a definite oncogenic factor in 89% of non-cardia gastric cancers. Preclinical research models, such as gastric tumor cell lines, gastric primary cell culture, and animal models of H.pylori infection, are difficult to simulate and cover the characteristics of chronic infection in the human stomach, hindering the elucidation of H.pylori infection pathogenesis. In recent years, with the breakthrough development of gastric organoid technology, the precise modeling of the H.pylori infection process within a three-dimensional human-derived microenvironment has become an important milestone in this field. This review duscusses the progress of gastric organoid platforms in studying the mechanisms of H.pylori infection, including bacterial colonization, host cell lineage-specific responses, the inflammation-to-carcinoma transformation mechanism, as well as target discovery and precison intervention strategies. These advances provide a basis for the eradication of H.pylori infection and the prevention of gastric cancer.
Drug price regulation is a common concern for governments worldwide, and Canada has accumulated extensive experience in this field. Its drug price management model is both representative and valuable for reference. The atented Medicine Prices Review Board (PMPRB), establishded by the Canadian federal government, formulates pricing guidelines and oversees the prices for patented drugs, which are then implemented by provincial governments. In parallel, several provincial governments regulate the prices of generic drugs within their jurisdictions through the pan-Canadian Pharmaceutical Alliance (pCPA) and its established tiered pricing framework. This study reviews the price review process for patented drugs in Canada, the new framework for price review, and the price management mechanisms for generic drug market entry and exit. It summarizes the practical experience of the Canadian drug price management system, aiming to provide reference for drug price management in China.
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