Objective: To prevent and control the risk of excipients in intrathecal drugs and strengthen their management. Methods: Information of excipients in approved intrathecal drugs abroad was collected, the quality requirements of regulatory agencies for intrathecal drugs in various countries were listed, literature on the safety of excipients in intrathecal drugs was searched and sorted out, and the impact of intrathecal drugs on medication safety was analyzed. Results: The quality requirements for intrathecal drugs are stricter than those for ordinary injections, with fewer types and quantities of excipients. Regulatory agencies in various countries specified that intrathecal drugs must not contain preservatives, and the threshold of bacterial endotoxin per kg of body mass in a single hour period is much lower than that for ordinary injections. The information on excipients for intrathecal drugs in the US “Inactive Ingredient Search for Approved Drug Products” is an important reference for excipient selection during formulation development. Conclusion: The safety and regulation of excipients in intrathecal injections are critical to ensuring the clinical safety of these high-risk formulations. It is recommended that drug regulatory agencies, research and development departments, and manufacturing enterprises collectively enhance their attention to the excipients used in intrathecal injections. By improving the regulatory framework, promoting safety research, and strengthening lifecycle management, the risk associated with excipients can be systematically assessed and controlled, thereby better safeguarding patient medication safety.

Traditional 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.

Objective: 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. Methods: 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. Conclusion: 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.

Objective: 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. Methods: 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. Results: 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. Conclusion: 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.

Objective: 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. Methods: 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. Results: 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. Conclusion: 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.

Objective: To prepare lasmiditan tablets and study the in vitro dissolution and pharmacokinetics. Methods: 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. Results: 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 C_max of the self-made tablets and Reyow^® were 189 and 188 ng·L^－1, the T_max was 3 h. The oral relative bioavailability of homemade tablets was 93.32%. Conclusion: 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.

Objective: To evaluate the uncertainty of the determination of polysaccharide content in Haemophilus influenzae type b (Hib) conjugate vaccine by ultraviolet-visible (UV) spectrophotometry. Methods: According to the General Rule 3421 of the Chinese Pharmacopoeia, the polysaccharide content in Haemophilus influenzae type b conjugate vaccine was determined. Based on the experimental process, the Evaluation and Representation of Measurement Uncertainty, and the Guidelines for the Evaluation of Uncertainty in Chemical Analysis, the uncertainties of the measurement results were systematically evaluated. Results: The sources of uncertainty mainly included the preparation of standard solution u(P), sample processing u(S), standard curve fitting u(C), measurement repeatability u(rep), UV spectrophotometry u(I), and method bias u(B). The combined standard uncertainty (u_c) was 1.109 0 μg·mL^－1, and the expanded uncertainty (U) was 2.218 0 μg·mL^－1 (coverage factor k=2, 95% confidence probability). Conclusion: The dominant contributors to measurement uncertainty were standard curve fitting, sample processing, and method bias. The fitting of the control standard curve significantly reduces measurement uncertainty, with this effect being particularly pronounced. The uncertainty introduced during sample processing primarily stems from pipette operations, which necessitate rigorous metrological verification. While standard curve preparation is time-consuming, optimized workflow efficiency can be achieved by employing pipettes for sample processing volumes of 1 mL or greater and utilizing micropipettes for standard curve preparation when the volumes are 1 mL or less. Method bias-related uncertainty requires strict compliance with standardized testing protocols, with particular attention to meticulous control of experimental parameters. Furthermore, maintaining appropriate laboratory temperature conditions, implementing regular instrument calibration, and performing systematic equipment maintenance all contribute substantially to uncertainty mitigation. This study can provide references for uncertainty assessment of drug quality control based on UV spectrophotometry.

Objective: To conduct a comprehensive analysis of proprotein convertase subtilisin kexin 9（PCSK9） monoclonal antibodies based on a multi-dimensional evaluation method, providing a reference for clinical medication selection and drug selection in medical institutions. Methods: Referring to the evaluation system in the Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions (the 2nd edition), with appropriate adjustments to some scoring criteria, a quantitative assessment was conducted on six PCSK9 monoclonal antibodies available in the domestic market from five aspects: pharmaceutical characteristics, efficacy, safety, economy, and other attributes. The recommendation grades were determined based on the scoring results. Results: The quantitative scoring results, ranked from high to low, were as follows: evolocumab (79.31 points), alirocumab (74.85 points), tolersimab (73.86 points), recaticimab (71.95 points), ongericimab (70.9 points), and ebronucimab (70.88 points). Conclusion: All six PCSK9 monoclonal antibodies demonstrated good lipid-lowering efficacy. Among them, evolocumab, alirocumab, and tolersimab are strongly recommended, while the others are weakly recommended.

Objective: To analyze the efficacy and safety of sugemalimab as first-line treatment for non-small cell lung cancer (NSCLC) based on real-world data and provide guidance for its rational clinical application. Methods: The clinical data of NSCLC patients hospitalized at a specialized cancer hospital from June 2022 to December 2024 and receiving first-line sugemalimab treatment were retrospectively collected. Statistical analyses were performed on efficacy, safety profiles, and influencing factors. Results: Among 81 NSCLC patients treated with sugemalimab, the median progression-free survival (PFS) was 13.6 months (10.6-NA, 95%CI), with an objective response rate (ORR) of 58.0% and a disease control rate (DCR) of 95.0%. Patients with lung adenocarcinoma exhibited longer PFS compared to those with squamous cell carcinoma (17.2 vs 11.3 months, P=0.036). The incidence of all-grade adverse drug reactions (ADRs) was 33.3%, with grade 3~4 ADRs occurring in 7.6% of patients. No grade 5 ADRs were observed. Myelosuppression was the most common ADR across all grades and severe cases. COX regression analysis identified pathological type, metastatic sites, and pre-treatment albumin levels as potential prognostic factors. Conclusion: Sugemalimab demonstrates favorable efficacy and safety as a first-line treatment for NSCLC in real-world clinical practice.

Objective: To evaluate the economy of different doses of tirzepatide and semaglutide in the treatment of adult patients with type 2 diabetes mellitus (T2DM) in China, thus to provide a reference for medical insurance decision-making. Methods: The Markov model was adopted to simulate the long-term health outputs and economic benefits of the four treatment regimens. Taking quality-adjusted life years (QALYs) as the indicator of health output and three times China's per capita GDP in 2024 as the willingness to pay threshold (WTP), the health output and medical costs of patients after 30 years of treatment with four treatment regimens were simulated. The incremental cost-effectiveness ratio (ICER) was used as the evaluation index to evaluate the economy of the four treatment regimens. The key assumptions were verified through univariate and probabilistic sensitivity analyses to ensure the robustness of the model. Results: Compared with the 1 mg semaglutide treatment regimen, the incremental costs of the 5, 10, 15 mg tirzepatide treatment regimens were 333 108.30,  699 163.50, 968 283.70 yuan, respectively; the incremental effects were 0.063 1, 0.140 5, and 0.165 5 QALYs respectively; the ICERs were 5 278 151.00, 4 977 303.00, and 5 852 089.70 yuan·QALY^-1, respectively. When the WTP was 287 247 yuan·QALY^－1, the 5, 10, 15 mg tirzepatide treatment regimens were not economically viable. The results of the sensitivity analysis showed that the results of the basic analysis were relatively robust. The results of the situation analysis showed that at the WTP of 287 247 yuan·QALY^－1, when the unit prices of 5, 10, 15 mg tirzepatide decrease by 68.4%, 79.6%, and 77.3% respectively, the probabilities of economic viability of tirzepatide compared with semaglutide were comparable. Conclusion: For T2DM patients with poor blood glucose control treated with metformin monotherapy, compared with the 1 mg semaglutide regimen, the 5, 10, 15 mg tirzepatide treatment regimens have a lower probability of being economically viable at the current price. Appropriate price reduction can make tirzepatide become a safer, more effective, and economical treatment regimen.