To establish an ultra-performance liquid chromatography-tandem triple quadrupole mass spectrometry (UPLC-TQ-MS/MS) method for simultaneous quantification of 10 components in rat plasma samples and investigate the pharmacokinetic characteristics of the main components after oral administration of Sanjie Zhentong Capsules (SZC).

Healthy SD rats were administered the contents of SZC at single doses of 1.73, 2.59, and 3.89 g·kg^－1 by oral gavage. Plasma concentrations of 10 components were measured at different time points and pharmacokinetic parameters were analyzed by using non-compartmental model.

After systematic method validation, the 10 components exhibited good linearity (r>0.99). The intra-batch and inter-batch accuracy ranged from 85.3% to 113.8% and 91.6% to 109.9%, respectively. The relative standard deviations (RSDs) of extraction recovery and matrix effects were both below 15%. These results met the requirements of biological sample analysis, demonstrating that the method is specific, sensitive, accurate, and stable, thus suitable for quantifying the target components in plasma. Pharmacokinetic analysis revealed that the plasma exposure of loureirin D and pterostilbene was higher than that of other components, and five components (loureirin C, loureirin D, 7,4′-dihydroxyflavone, resveratrol, and pterostilbene) exhibited strong positive correlations (R²>0.91) between dosage and both AUC_(0-t) and C_max. Except for ginsenoside Rd, which exhibited prolonged retention in vivo, the other nine components demonstrated rapid absorption and fast elimination.

This study established a quantitative analysis method for 10 components of SZC in rat plasma. Within the dose range of 1.73~3.89 g·kg^－1, five components of SZC exhibited linear pharmacokinetic characteristics in rats. These findings further clarify the pharmacodynamic material basis of this preparation and support its clinical use, providing data to improve the quality standards.

To establish a quantitative fluorine nuclear magnetic resonance (qFNMR) method for the determination the content of reference standards of moxifloxacin hydrochloride and its three impurities.

The fluorine nuclear magnetic resonance spectra of the reference standards of moxifloxacin hydrochloride and its three impurities (Impurity Ⅰ, Impurity Ⅲ, and Impurity Ⅳ) were collected using a Bruker Avance NEO 600 MHz spectrometer with 4,4′-difluorobenzophenone as the internal standard and DMSO-d₆ as the solvent. The spectra were acquired with the zgig pulse program, 32 scans (NS), an acquisition time of 2.88 s, and a relaxation delay time (D1) of 10 s, and quantitative analysis was performed.

The quantitative peaks of moxifloxacin hydrochloride and its three impurities were well separated from that of the internal standard 4,4′-difluorobenzophenone on the fluorine NMR spectra. Good linear relationships were obtained for moxifloxacin hydrochloride, Impurity Ⅰ, Impurity Ⅲ and Impurity Ⅳ in the ranges of 2.988~14.70, 3.012~15.17, 3.149~15.26, 2.857~14.58 mg·mL^－1, respectively (r>0.999 4). The precision and repeatability of the method were good. The content results determined by the qFNMR method were basically consistent with those obtained from the mass balance method.

The established qFNMR method for the content determination of reference standards of moxifloxacin hydrochloride and its three impurities is simple, rapid, and highly accurate, thus providing a reference for the establishment and content determination of these reference standards.

This study successfully developed the first batch of national reference standards of caspofungin acetate to ensure quality control of related raw materials and finished products.

The structure of the caspofungin acetate reference standard was confirmed by comprehensive analytical techniques including high-resolution mass spectrometry (HRMS), nuclear magnetic resonance (NMR), and infrared spectroscopy (IR), and the NMR signals of the compound were assigned. The content of caspofungin acetate was determined by the mass balance method (MBM), and the results were corroborated by quantitative nuclear magnetic resonance (qNMR) and the external standard method (ESM).

The content of this batch of caspofungin acetate reference standard, calculated as C₅₂H₈₈N₁₀O₁₅·2CH₃COOH, was 97.0%.

The first batch of national reference standards of caspofungin acetate was successfully developed.

To establish a risk assessment and control system for nitrosamine impurities in chemical drugs and apply it to the study of nitrosamine impurities in propranolol hydrochloride tablets.

Information was retrieved from various national drug regulatory agencies, PubMed, Elsevier and Wiley websites, and the formation mechanisms, toxicity assessment, and control measures of nitrosamine impurities were analyzed and summarized. Guidelines for risk assessment and control of nitrosamine impurities in pharmaceuticals were systematically reviewed.

A risk assessment and control system for nitrosamine impurities was constructed, covering four key aspects: risk assessment elements, determination of impurity limits, confirmatory testing, and process control factors. This system was applied to evaluate nitrosamine impurities in propranolol hydrochloride tablets. Using fishbone diagram analysis, risk factors for nitrosamine impurities were identified from aspects such as active ingredients, excipients, manufacturing processes, and storage conditions of the tablets. Samples from market surveillance and their raw materials were tested. Factors influencing the formation of nitrosamine impurities were preliminarily investigated through excipient compatibility studies, stress testing, and accelerated stability testing, and corresponding control measures were proposed.

The established risk assessment and control system for nitrosamine impurities in pharmaceuticals will aid in the development of strategies for managing these impurities. It also provides technical references for regulatory authorities and pharmaceutical companies to implement precise control of nitrosamine-related risks.

To conduct a comparative analysis of oral dosage forms listed in the Pharmacopoeia of the People's Republic of China 2025 (ChP) and the International Pharmacopoeia 12th edition (Ph.Int.) to generate foundational evidence for optimizing dosage form monographs in the Chinese Pharmacopoeia, facilitating the inclusion of pediatric-appropriate formulations, and enhancing harmonization with international standards.

A systematic literature review and side-by-side comparison were conducted to examine how each compendium names medicinal products and describes oral dosage forms; pediatric suitability was then scored against international and domestic quality criteria for child-appropriate formulations.

Compared with the ChP, the Ph.Int. embeds a formal nomenclature rule for drug products and appends explicit guidance on pediatric-appropriate formulations as well as minimum labelling/package-insert requirements-elements entirely absent from the current ChP. The ChP includes nine first-level categories encompassing 34 secondary oral dosage forms except traditional Chinese medicine preparations, whereas the Ph.Int. includes four first-level categories with 17 secondary oral dosage forms. Harmonization analysis revealed 12 dosage forms with concordant nomenclature and definitions; five with identical names but divergent definitions; 15 exclusively in ChP (7 with Ph.Int. mappings); and four exclusively in Ph.Int. (all mapped to ChP counterparts). When judged against international pediatric-usability criteria, 47% (8/17) of Ph.Int. oral monographs and 44% (15/34) of ChP entries are suitable for pre-school children or younger. Strikingly, three of the four Ph.Int.-only formulations demonstrate good acceptability for infants and toddlers, underscoring a ready opportunity for ChP expansion.

ChP should draw on Ph.Int. experience to expand its general monographs, rationalize dosage-form classification, and expedite the inclusion of pediatric-friendly oral formulations for children under six. It is suggested to establish a joint working group composed of functional departments to enhance harmonization between the Pharmacopoeia and guidance policies/formularies for clinically commonly used medicines, improve public accessibility to drugs, and concurrently strengthen alignment with the International Pharmacopoeia.

To summarize the information-based initiatives for collaborative medical products administration promoted by international organizations, with the aim of further clarifying internationally accepted administration rules, supporting the expansion of openness and cooperation in the pharmaceutical industry, and further advancing the empowerment of regulation through information technology.

A combination of website and literature research was used to review the policies and actions of international medical products administration organizations, including the Identification of Medicinal Products (IDMP) and Pharmaceutical Quality Knowledge Management (PQKM).

Two core initiatives of international collaborative information-based administration for medical products: the IDMP standard and its application scenarios, and the IDMP-based PQKM system, were identified. The implementation progress in the countries and regions such as the United States and the European Union was also summarized, as well as the pilot outcomes of the International Coalition of Medicines Regulatory Authorities (ICMRA).

The study proposes implications and recommendations for the informationization department of national medical products administration, including continuous attention to international development, coordinated management of development and data security.