This proficiency testing program is established to evaluate the pharmaceutical preparation analysis capacity of laboratories recommended by 18 countries and economies. It was authorized by Asia Pacific Laboratory Accreditation Cooperation (APLAC), and organized by Shanghai Institute for Food and Drug Control (SIFDC) and China National Accreditation Service for Conformity Assessment (CNAS). The 0.3sigma test is used to evaluate the homogeneity and stability of the proficiency testing sample. The results of the laboratories were assessed by Z-score. The robust average and the robust standard deviation of the participants' results were calculated as assigned value and standard deviation for performance assessment of hydrochlorothiazide and captopril using robust statistics. Thirty-three of 38 laboratories recommended by 18 countries and economies sent their results back. Twenty-four laboratories' results were observed as satisfactory. Five laboratories were identified as having reported at least one questionable result. Four laboratories were identified as having reported at least one unsatisfactory result.

Objective:To establish an HPLC coupled with post column derivatization method for the determination of gentamicin C components and the related substances based on the latest European Pharmacopeia and compare with the electrochemical method. Methods:A Hydrophilic C18(250 mm ×4.6 mm, 5 μm)column was used with acetonitrile-50 mmol·L-1 sodium hydroxide solution ( pH 2. 6) containing 0. 7% trifluoroacetic acid and 0. 025% pentafluoropropanoic acid (1. 5∶98. 5) as the mobile phase. The temper-ature of post-column reaction was set at 30℃, and the samples were detected by a fluorescence detector withλex of 340nm andλem of 430nm. A pulsed amperometric detector (PAD) was applied in the electrochemical method with golden working electrode in a four-po-tential working mode. Results: According to the results of the two detection methods, the linear range of C1a , C2 , C2a and C1 was 5.82-233.00,6.92-277.00,4.00-160.00and6.23-249.00 μg·ml-1(r >0.9993) , respectively. The limit of detection and quantization were 0. 92-3. 28ng and 1. 37-5. 19ng, respectively. Conclusion:There is no significant difference between the determina-tion results of the two methods.

Objective:To establish a method for the determination of sodion in cefalotin sodium by ion chromatography and investi-gate the salt-forming rate of the products. Methods: A TSKgelSuper IC-CR cation exchange column (150 mm × 4. 6 mm, 3. 0 μm) was used. The mobile phase was the mixture of 2. 2 mmol·L-1 methanesulfonic acid and 1 mmol·L-1 18-crown-6-ether with the flow rate of 0. 8 ml·min-1 . The column temperature was 40℃ and the injection volume was 20μl. The detector was an electric conductiv-ity detector. Results:The linear correlation of sodion was good within the range of 3. 0-60. 0μg·ml-1(r=0. 999 9). The average re-covery was 99. 8%(RSD=0. 8%, n=9). The mole number ratio of sodion to cefalotin was within the range of 0. 97-1. 03. Conclu-sion:The method is specific, precise and accurate, and can be used in the determination of sodion in cefalotin sodium. The salt-form-ing rate of the 8 batches of samples is promising.

OBJECTIVETo explore the effect of ouabain on intracellular Ca(2+) concentration ([Ca(2+)]i) in thoracic aorta vascular smooth muscle cells (VSMCs) in vitro.

METHODSPrimary SD rat thoracic aorta VSMCs were cultured by tissue adherent method and identified by immunochemistry. The binding ability between ouabain and VSMCs was detected by autoradiography, and fluo 3-AM (a Ca(2+) fluorescent probe) was employed to investigate whether ouabain affected VSMCs within a short period of time. The effect of a truncated fragment of the sodium pump α2 subunit was assayed in antagonizing the effect of ouabain on [Ca(2+)]i in the VSMCs.

RESULTSWithin the concentration range of 0.1-100 nmol/L, ouabain was found to dose-dependently bind to the VSMCs. Different concentrations of ouabain (0-3200 nmol/L) caused a transient, dose-dependent increase in [Ca(2+)]i in the VSMCs, which was antagonized by the application of the truncated fragment of sodium pump α2 subunit.

CONCLUSIONSElevations in [Ca(2+)]i in the VSMCs can be the cytological basis of high ouabain-induced hypertension. The truncated fragment of the sodium pump α2 subunit can antagonize ouabain-induced increase of [Ca(2+)]i in the VSMCs, which provides a clue for understanding the pathogenesis of and devising a therapeutic strategy for high ouabain-induced hypertension.

Animals ; Aorta, Thoracic ; cytology ; Calcium ; metabolism ; Cells, Cultured ; Cytoplasm ; metabolism ; Muscle, Smooth, Vascular ; cytology ; Myocytes, Smooth Muscle ; drug effects ; metabolism ; Ouabain ; pharmacology ; Rats ; Rats, Sprague-Dawley ; Sodium-Potassium-Exchanging ATPase

Objective To enhance the understanding of the quality control of rubber closures and to promote pharmaceutical manufacturers'reasonable selection and effective management of rubber closures.Methods According to the performance needs of drug products for rubber closures,the impacts of the ingredients and manufacturing processes of rubber closures with other possible influence on drug products were analyzed.Complied with the requirements of pharmaceutical lifecycle management,the processes of selection and utilization of rubber closures were divided into three periods,including screening,validation and maintenance,and suggestions on the tasks and goals for these three periods were given.Results Though the actual performance of rubber closures was affected by multiple factors,the processability in the pharmaceutical manufacturing processes and the suitability in the periods of storage,transportation and clinical application could be confirmed by reasonable screening and scientific validation of rubber closures.And by the effective quality control of rubber closures,the suitability could be maintained across the lifecycle of drug products.Conclusion By means of the reasonable selection and effective quality control of rubber closures,it would be benefit for keeping drug safety,efficacy and quality controllability throughout the lifecycle.

Objective To interpret the guideline for rubber closures for pharmaceutical packaging in the Chinese Pharmacopoeia(2025 Edition)for relative parties to facilitate their better understanding and reasonable application of the guideline.Methods Based on the considerations of lifecycle risk management and combined with the developing requirements for the quality management of rubber closures,the necessity of establishing the guideline was explained and the relevant contents of quality control were interpreted,and suggestions of the reasonable utilization of rubber closures were given.Results According to the rubber closures'properties and their actual application,relative parties should establish the enterprise standards or the quality agreements of the rubber closures,in line with the general baseline requirements settled by the guideline.Conclusion Based on the risk management concept in the whole process,the established guideline defining the quality control requirements of rubber closures and their critical quality attributes would be helpful to promote the quality control of rubber closures.

Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

Objective To explore the effect of ouabain on intracellular Ca2+ concentration ([Ca2+]i) in thoracic aorta vascular smooth muscle cells (VSMCs) in vitro. Methods Primary SD rat thoracic aorta VSMCs were cultured by tissue adherent method and identified by immunochemistry. The binding ability between ouabain and VSMCs was detected by autoradiography, and fluo 3-AM (a Ca2+fluorescent probe) was employed to investigate whether ouabain affected VSMCs within a short period of time. The effect of a truncated fragment of the sodium pumpα2 subunit was assayed in antagonizing the effect of ouabain on [Ca2+]i in the VSMCs. Results Within the concentration range of 0.1-100 nmol/L, ouabain was found to dose-dependently bind to the VSMCs. Different concentrations of ouabain (0-3200 nmol/L) caused a transient, dose-dependent increase in [Ca2+]i in the VSMCs, which was antagonized by the application of the truncated fragment of sodium pump α2 subunit. Conclusions Elevations in [Ca2+]i in the VSMCs can be the cytological basis of high ouabain-induced hypertension. The truncated fragment of the sodium pumpα2 subunit can antagonize ouabain-induced increase of [Ca2+]i in the VSMCs, which provides a clue for understanding the pathogenesis of and devising a therapeutic strategy for high ouabain-induced hypertension.

Objective To explore the effect of ouabain on intracellular Ca2+ concentration ([Ca2+]i) in thoracic aorta vascular smooth muscle cells (VSMCs) in vitro. Methods Primary SD rat thoracic aorta VSMCs were cultured by tissue adherent method and identified by immunochemistry. The binding ability between ouabain and VSMCs was detected by autoradiography, and fluo 3-AM (a Ca2+fluorescent probe) was employed to investigate whether ouabain affected VSMCs within a short period of time. The effect of a truncated fragment of the sodium pumpα2 subunit was assayed in antagonizing the effect of ouabain on [Ca2+]i in the VSMCs. Results Within the concentration range of 0.1-100 nmol/L, ouabain was found to dose-dependently bind to the VSMCs. Different concentrations of ouabain (0-3200 nmol/L) caused a transient, dose-dependent increase in [Ca2+]i in the VSMCs, which was antagonized by the application of the truncated fragment of sodium pump α2 subunit. Conclusions Elevations in [Ca2+]i in the VSMCs can be the cytological basis of high ouabain-induced hypertension. The truncated fragment of the sodium pumpα2 subunit can antagonize ouabain-induced increase of [Ca2+]i in the VSMCs, which provides a clue for understanding the pathogenesis of and devising a therapeutic strategy for high ouabain-induced hypertension.

ObjectiveTo evaluate the proficiency and consistency of domestic and foreign testing institutions in the field of veterinary drug residue detection in food， and to promote international cooperation and mutual recognition of testing results among these institutions. MethodsA robust statistical analysis was conducted on the testing results of 20 laboratories in eight countries and regions across North America， Europe， and Asia. The laboratories’ testing capabilities were evaluated using Z-score comparison. ResultsAmong the 20 participating laboratories， 18 achieved satisfactory results， resulting in a satisfaction rate of 90%， while 2 laboratories （10%） failed to meet the requirements. The satisfaction rate of domestic laboratories （100%） was higher than that of foreign laboratories （81.8%）. ConclusionDomestic laboratories perform better than overseas laboratories in determining veterinary drug residues in food. To enhance testing capabilities， these overseas laboratories with unsatisfactory evaluation results should strengthen their daily quality control and ensure traceability of original records.