中国科技论文统计源期刊 中文核心期刊
美国《化学文摘》《国际药学文摘》
《乌利希期刊指南》
WHO《西太平洋地区医学索引》来源期刊
日本科学技术振兴机构数据库（JST）
第七届湖北十大名刊提名奖
美国《化学文摘》《国际药学文摘》
《乌利希期刊指南》
WHO《西太平洋地区医学索引》来源期刊
日本科学技术振兴机构数据库（JST）
第七届湖北十大名刊提名奖
The American Heart Association (AHA) / American Stroke Association (ASA) published the “2024 Guidelines for Primary Stroke Prevention” in the Stroke journal on October 21, 2024. This document summarized the clinical research and epidemiological data since the publication of the previous version of the guidelines in 2014, providing strategies and recommendations for stroke prevention across the entire lifecycle. The guidelines emphasized the importance of pharmacological treatment, routine screenings, and lifestyle changes, with updated and refined recommendations. This article dissects the newly revised sections of the guidelines, with a special focus on the management of blood pressure, blood glucose, and blood lipids levels, as well as customized advice for particular populations and patient subgroups. Furthermore, it explores health behavior management strategies, including diet and exercise, by intergarting the knowledge from the previous version of the primary stroke prevention guidelines with pertinent domestic and international materials. The ultimate objective is to offer valuable insights and guidance to China in advancing primary stroke prevention efforts and formulating coherent guidelines and consensuses within this critical domain.
Objective To study the pharmacokinetic profile of zidovudine and lamivudine tablets (ZL) in Chinese healthy subjects and to evaluate its bioequivalence and safety. Methods A randomized, open, single-dose, two-sequence, four-cycle and fully replicated crossover bioequivalence trial was conducted in 32 healthy subjects both fasting and postprandial, and two preparations of ZL tablets were administered orally in each cycle, with a washout period of 5 days. The concentrations of zidovudine and lamivudine in plasma were determined using high performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic evaluation index parameters were statistically analyzed using Phoenix WinNonlin version 8.1 data statistical software to evaluate bioequivalence. Results The Cmax of zidovudine under fasting and postprandial conditions between ZL and the reference drugs after a single dose were (3 782.499±1 921.649)vs.(3 543.164±1 946.076) ng·mL-1 and (1 585.827±914.246)vs.(1 667.595±862.945) ng·mL-1, respectively. And the AUC0-t for fasting and postprandial conditions of zidovudine was (3 177.091±819.538)vs. (3 071.375±972.145) h·ng·mL-1 and (2 437.999±478.147)vs. (2 402.725 ± 477.792) h·ng·mL-1, respectively; while the AUC0-∞ were (3 225.674±825.131)vs.(3 093.448±972.340) h·ng·mL-1 and (2 464.310±480.790)vs.(2 427.693±477.933) h·ng·mL-1, respectively. The Cmax of a single dose of lamivudine under fasting and postprandial conditions between ZL and the reference drugs were (1 923.329±490.572)vs.(1 830.570±476.947) ng·mL-1 and (1 922.711±589.130)vs.(1 881.857±527.577) ng·mL-1, respectively. The AUC0-t for preprandial and postprandial lamivudine was (7 598.265±1 376.774)vs.(7 283.422±1 356.146) h·ng·mL-1 and (7 554.169±958.379)vs.(7 329.376±924.075) h·ng·mL-1, respectively, whereas the AUC0-∞ were (7 734.038±1 326.907)vs.(7 405.088±1 340.036) h·ng·mL-1 and (7 660.916±958.694)vs.(7 435.102±930.448) h·ng·mL-1, in fasting and fed tests, the 90% confidence intervals (CI) of the geometric mean ratios of the main pharmacokinetic parameters between test and reference preparations were all within the range of 80%-125%, respectively. A total of 37 adverse events occurred during the trial period, including 21 in the fasting group and 16 in the postprandial group, and no serious adverse events occurred. Conclusion The test formulations of zidovudine and lamivudine tablets were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions compared to the reference tablets.
Objective This study aims to comprehensively analyze the overall framework and key quality attributes of the proposed standard system for prefilled syringes through key clause analysis. Methods Based on a thorough understanding of market product conditions and the current status of domestic and international standards; the critical quality attributes of pre-filled syringe container systems were identified. Results A new standard system for prefilled syringes was constructed to meet the regulatory and industry development needs of China. Conclusions The proposed standard system for prefilled syringes is designed with both rigidity and flexibility, meeting regulatory needs and facilitating industry development.
Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system. Methods A thorough review of the framework, scope, and quality control key points of the 2015 national pharmaceutical packaging material standards (abbreviated as YBB standards), the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted. Comparative analysis was employed to reveal the similarities and differences among the three, thereby uncovering the unique characteristics of each. Results The YBB standards emphasize quality control for prefilled syringes, offering clear and operational guidelines that provide companies with precise directives for production and testing. However, the scope of these standards is relatively limited. ISO standards apply to a wide range of products, featuring comprehensive coverage and a degree of flexibility. They emphasize the universality of products and compatibility with other international standards, which facilitates global production and trade. USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach. Conclusion By thoroughly studying and drawing upon the quality control philosophies, standard frameworks, and key control points of prefilled syringes from both domestic and international standards, we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.
Objective Interpret the method of determining the shading property for colored glass containers in the Chinese Pharmacopoeia (2025 edition) in detail,and provide theoretical guidance and technical support for the implementation of standards. Methods By summarizing and analyzing the related abroad standards for shading property of colored glass containers, combining with the results of experimental verification, the method for determining the shading property of colored glass containers was established in accordance with the requirements of the construction of the pharmaceutical packaging material system in the Chinese Pharmacopoeia. An explanation was provided for the selection of instruments and equipment, the requirements for the preparation of the samples, and the way of expressing the results. Results The method of determining the shading property for colored glass containers, formulated in conjunction with international standards, proposed scientifically reasonable operational requirements based on solid experimental verification data, and solved the problem of having no “method” to follow in the domestic shading property measurement. Conclusion The proposal of the method for determining the shading property of colored glass containers filled the industry gap, improved the pharmaceutical packaging material standard system, standardized the method operation, and was conducive to promoting industrial development and ensuring the safety of formulations.
Objective To introduce the general testing methods for glass materials and containers for pharmaceutical packaging within the packaging material standard system in the 2025 Edition of the Chinese Pharmacopoeia, aiming to provide assistance for the implementation of these standards. Methods Introduce the general situation of the revision of general testing methods for glass materials and containers for pharmaceutical use. The improvement of new general testing method standards is summarized by contrasting the new version of the general testing methods for pharmaceutical glass materials and containers with the current standards. Results The general testing methods for pharmaceutical glass materials and containers in the Chinese Pharmacopoeia 2025 Edition are more scientific in structure, more rational and operational. Conclusion The 11 general testing methods will control the quality of pharmaceutical glass materials and containers, which could contribute to the enhancement of the quality and efficacy of drugs in our country.
Objective To assist drug and pharmaceutical packaging material manufacturers in understanding and utilizing the functionality evaluation methods for prefilled syringe with Luer conical fittings, thereby scientifically specifying product quality. Methods By comparing the standards status both domestically and internationally, and in conjunction with the product characteristics, production, and actual usage situation of prefilled syringe with Luer conical fittings, the test contents and key points of related functionality evaluation methods were analyzed. Results The functionality evaluation methods for prefilled syringe with Luer conical fittings represent improvements and supplements to domestic standard, appropriate methods should be selected based on the product type. Conclusion Developing functionality evaluation methods for prefilled syringe with Luer conical fittings will provide guidance to standardized quality control for drug and pharmaceutical packaging material manufacturers. It will also better meet the requirements for market regulation, and is an effective way to promote the overall development of the industry.
Objective The aim of this study was to develop a method for the determination of nine vulcanizing agents and accelerators in pharmaceutical rubber stoppers by headspace gas chromatography with sulfur chemiluminescence detector (HS-GC-SCD). Methods A DB-1 capillary column (30 m×0.32 mm×0.25 μm) was used with He as the carrier gas. The injection port temperature was 220 ℃, the split ratio was 10∶1, and the carrier gas flow rate was 1.5 mL·min-1. The temperature program was as follows: the starting temperature was 40 ℃, and it was increased to 60 ℃ at a rate of 5 ℃ per minute, and then to 260 ℃ at a rate of 15 ℃ per minute. SCD detector parameters: base temperature was 280 ℃, combustion chamber temperature was 800 ℃, air flow rate was 60 mL·min-1, and hydrogen flow rate was 40 mL·min-1. Results The sample pretreatment method was simple and convenient, and it effectively reduced the extraction loss. The methodological results showed that all sulfides showed good linear relationships within the concentration range (r2≥0.990). The RSD was less than 2%; and the average recovery rate was 86.4%-97.5%. From the analysis of the sample test results, free sulfur is commonly found in rubber stoppers. Among all the samples of the vulcanization system, the free sulfur detected in the sulfur vulcanization system is higher than the free sulfur produced by degradation of other vulcanization systems. Conclusions This method is simple to operate, compared with other existing detection methods. HS-GC-SCD has a smaller matrix effect, higher sensitivity and selectivity, and is appropriate for quantifying the concentrations of sulfide present in various rubber stoppers.
Objective To enhance the efficiency and accuracy of post-marketing safety monitoring and evaluation of drugs in China by studying large language models-based patient medical record pharmacovigilance profiling techniques, providing scientific methods and technical support to ensure the safe use of drugs for patients. Methods This study constructs a pharmacovigilance profile that includes individual patient differences, medication details, and adverse reaction manifestations. It enhances a large language model with a knowledge graph in the field of pharmacovigilance and designs targeted prompts to guide the model to output pharmacovigilance profiles. Results Large language models demonstrate significant advantages in active monitoring, effectively processing and analyzing medical text data, and improving the monitoring and prediction capabilities of drug adverse reactions. Through the design of prompts, the model can more accurately depict patient pharmacovigilance profiles, providing decision support for medical professionals. Conclusions The study of large language model-based patient medical record pharmacovigilance profiling technology provides scientific evidence and technical support for the early detection and prevention of drug adverse reactions, helping to reduce medical costs, improve medical outcome prognoses, and opens new paths to ensure patient drug safety.
Objective Pharmacovigilance, as an essential component of post-marketing drug regulation, plays a crucial role in ensuring the safety of public medication use. In recent years, Artificial intelligence (AI) technology, with its powerful data processing and analysis capabilities, has shown tremendous potential in the field of Pharmacovigilance. This article introduced and analyzed the application background of AI technology in Pharmacovigilance, its exploration and current status both internationally and within China, highlighted its application in the country, as well as the associated problems and challenges from the perspective of post-marketing regulation. It aims to provide reference for post-marketing regulation in China. Currently, China's exploration and application of AI in pharmacovigilance have just begun, and efforts should be intensified and the pace accelerated. Regulatory agencies should actively develop and implement regulatory standards or relevant guidelines for AI technologies throughout the product lifecycle, strengthen personnel training, talent cultivation, and introduction, actively promote close cooperation among regulatory agencies, pharmaceutical companies, research institutes, and universities, and jointly promote the innovative application of AI technology in the field of drug regulation.
Objective In view of the potential threat of adverse drug reaction (ADR) to patients' health and the limitations of traditional monitoring methods, this study investigates the construction method of an ADR knowledge graph based on a knowledge-driven technology path to promote the intelligent upgrading of pharmacovigilance field. Methods In this study, an adverse drug reaction knowledge base was established, and the data within the knowledge base were preprocessed. The BERT-CRF model was utilized to identify and extract the relevant entities, relationships and attribute information, and knowledge alignment was carried out by combining the rule method and statistical method. The knowledge fusion data was stored in the Neo4j graph database to construct the knowledge graph. Results Based on the established knowledge base, this study explored the method of constructing knowledge graph of adverse drug reaction by knowledge-driven technology, laying the groundwork for data mining and the development of intelligent auxiliary system tools based on knowledge graph. Conclusions The study on the construction method of an ADR knowledge graph based on a knowledge-driven technology path provides a new perspective and technical path for the intelligent upgrading of pharmacovigilance field. It holds important theoretical and practical significance for improving drug safety, protecting patients' health, and promoting the healthy development of pharmaceutical industry.
Objective To establish an evaluation indicator system for pharmacovigilance (PV) work in medical institutions of Fujian province, and provide a reference for the PV work in healthcare facilities. Methods Based on literature analysis and interpretation of policies and regulations, combined with the practical pharmacovigilance work in Fujian province, a preliminary indicator system was constructed. Following this, three rounds of expert consultation were conducted, including two rounds of the Delphi method to determine the content of the index system, and one round of the Analytic Hierarchy Process (AHP) to determine the weights of each index. Results A total of 9 primary indicators, 23 secondary indicators, and 59 tertiary indicators were selected for the evaluation of pharmacovigilance work in health facilities of Fujian province, including pharmacovigilance organizational structure, human resources, equipment resources, development and documentation of the quality management system's procedural documents, Performance indicators for monitoring and reporting, risk identification, assessment, control and research capabilities. The consensus coefficients for three rounds of consultation with experts were 100%, 100%, and 100%. The average authority coefficient of the experts was 0.878, and the expert coordination coefficients for the two rounds of Delphi method were 0.081 and 0.343, respectively (P<0.001). In the AHP, the weight vector for primary indicators ranged from 0.023 to 0.263, with a maximum eigenvalue of 9.195. The weight vector values of the secondary indicators were from0.096 to 1.000, and the maximum eigenvalues were 3.018-4.061; The weight vectors of the tertiary indicators were 0.143 to 1.000, and the maximum eigenvalues were from3.000 to 5.078. The consistency ratio (CR) of each judgment matrix was between 0 and 0.051. Conclusions The constructed indicator of capability assessment model, integrating regulatory functions and the practical situation of medical institutions, can be used by regulatory authorities to assess pharmacovigilance work in medical institutions. It provides a solid reference for improving the pharmacovigilance capabilities of medical institutions in Fujian province.
Objective To analyze signals of adverse events (AEs) related to macrolide antibiotic in children from the US FDA Adverse Event Reporting System (FAERS), and provide a reference for clinical safe medication in children. Methods The AEs reports of children (less than 18 years old) were extracted from FAERS during January 2004 to March 2024, and the reports of odds ratio (ROR) and information component of Bayesian confidence propagation neural network (IC) were used to analyze the signals of macrolide antibiotics in children. Results There were 2 133 648 reports of children from FAERS, including azithromycin (7 589 cases), clarithromycin (3 673 cases), and erythromycin (820 cases). The significant signals of system organ class (SOC) were 16 in total, such as skin disorders, ear and labyrinth disorders, gastrointestinal disorders, nervous system, immune system disorders, etc. A proportional imbalance analysis was performed on macrolide antibiotics (azithromycin and clarithromycin), and obtained relevant positive signals, including azithromycin (232) and clarithromycin (194). The most frequently reported AEs included rash, vomiting, diarrhea, hypersensitivity and so on. The strongest signals of azithromycin were Stevens-Johnson syndrome (SJS), hypersensitivity reactions, drug-induced liver injury, etc., while the strongest signals of clarithromycin were dysgeusia, lip swelling, toxic epidermal necrolysis (TEN), nightmare, psychotic disorder, etc. 17 unlisted signals of azithromycin and 21 of clarithromycin were found. The same PT of azithromycin and clarithromycin had significant difference, such as dyspnea, hypersensitivity, rash, SJS, vomiting, and more. Conclusions To ensure the safety of children's treatment, children using macrolide should pay attention to skin, gastrointestinal, ear and other toxicity and hypersensitivity reactions, especially serious skin reactions, unlisted suspicious AEs and psychiatric disorders.
Objective To evaluate the effectiveness, safety and economy of generic venlafaxine sustained-release capsules and the original drug in clinical practice based on real world clinical data. Methods This is a multicenter, retrospective real-world study. The information of outpatients who used venlafaxine sustained-release capsules in 7 hospitals from October 2021 to October 2022 was collected, including prescription data and laboratory data. They were divided into generic drug group and original drug group. After the baseline level was corrected by propensity score match method, the prescription daily dose, plasma concentration, medication possession ratio, the continuous medication rate for 3, 6 and 9 months, dressing change rate, the incidence of adverse reactions, the frequency of drug use, the average daily cost, the annual cost per capita and the proportion of the average annual cost of drugs were compared between the two groups. Results After the baseline level was corrected by propensity score matching method, the prescription daily dose and medication possession ratio (MPR≥0.8) in the generic drug group were higher than that of the original drug group (P<0.05). There was no statistically difference in plasma concentration between the two groups (P=0.294). The continuous medication rate for 3, 6 and 9 months in the generic drug group were statistically higher than those in the original drug group (P < 0.01). The single dressing change rate of the generic drug group was lower than that of the original drug group (P=0.032). There was no significant difference in the rate of secondary dressing change between the two groups (P=1.000). There were no significant differences in the incidence of abnormal ALT, AST, TC, Na, APTT, and PLC between two groups (P>0.05). The average daily cost of the generic drug group was lower than that of the original drug group. The per capita annual cost of drugs and the proportion of average annual cost of drugs in the generic drug group were significantly lower than those in the original drug group (P<0.01). Conclusion In the actual clinical diagnosis and treatment, no clinically significant differences in effectiveness and safety were found between the generic venlafaxine sustained-release capsule and the original-patented, while the economic advantages of the generic drug were better than that of the original-patented drug.
Objective Through molecular genetics analysis of a calculi family lineage, this study aims to explore its pathogenesis and the association between genotypes and phenotypes. Methods A retrospective analysis was conducted on a calculi family lineage admitted to Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology. Clinical data and peripheral blood samples of the affected children and some family members were collected. Whole exome sequencing was performed, followed by Sanger sequencing to validate the candidate variants. Results Among the 38 family members across four generations, 10 members were diagnosed with calculi disease. The second generation, member 2 (Ⅱ-2), third generation, member 2 (Ⅲ-2), and third generation, member 4 (Ⅲ-4) suffered from recurrent multiple kidney stones and gallstones. The second generation, member 6 (Ⅱ-6), second generation, member 13 (Ⅱ-13), and third generation, member 5 (Ⅲ-5) had recurrent multiple kidney stones alone, while first generation, member 2 (Ⅰ-2), second generation, member 4 (Ⅱ-4), second generation, member 8 (Ⅱ-8), and second generation, member 11 (Ⅱ-11) only had gallstones. No other family members exhibited any signs of kidney or gallbladder involvement. II-2 was diagnosed in 2018 with end-stage renal disease stage 5, grade 3 hypertension and gallstones, urinary amino acid high-performance liquid chromatography analysis indicated elevated urinary cystine. This member had a history of recurrent multiple kidney stones and recurrent urinary tract infections for over 30 years, with multiple histories of ureteroscopic stone removal.Genetic analysis revealed that Ⅱ-2, Ⅲ-2, Ⅲ-4, Ⅲ-5 and Ⅳ-1 all carry a heterozygous mutation in exon 10 of the solute carrier family 3 member 1 (SLC3A1)gene, c.1889G>A (p.Gly630Asp). The third generation, member 1 (Ⅲ-1), and fourth generation, member 2 (Ⅳ-2), are wild type. This mutation shows a phenomenon of family co-segregation. Conclusions The heterozygous mutation of SLC3A1 gene, c.1889G>A, may be the genetic cause of calculi disease in multiple members of this family lineage. Recurrent multiple kidney stones and/or gallstones require high attention to genetic etiology. It is recommended to perform genetic analysis on calculi family lineages and patients with early-onset calculi disease.
There are a large number of drug transporters widely distributed in various tissues and organs in the human body. They are involved in the membrane transport of numerous endogenous substances, toxins, and drugs. The transmembrane transport mediated by transporters not only plays an important role in maintaining the homeostasis of the internal environment, but also closely related to drug absorption, distribution, metabolism, and excretion processes. In clinical practice, drug-drug and drug-endogenous molecule interactions based on drug transporters may affect therapeutic efficacy or lead to toxic side effects. Therefore, it is particularly important to closely monitor and evaluate the risks of transporters mediated drug-drug interactions in the drug development and marketing process. This review summarized the classification, functions, tissue distribution and substrate specificity of typical drug transporters in new drug development. Subsequently, the research progress regarding drug-drug interactions involving 24 drug transporters for 55 newly approved drugs by the US Food and Drug Administration in 2023 is comprehensively reviewed. The aim is to provide reference for further drug-drug interaction research together with its scientific significance during new drug development stage.
As common drug delivery materials, polymers possess the advantages of a simple preparation method, adjustable chemical structure, and excellent biocompatibility. They are widely used in the responsive drug delivery for various diseases, especially in drug delivery of colon diseases. Utilizing the adjustable characteristics of polymers, drug delivery systems based on pH response, microbial enzyme response, reactive oxygen species response, and bio-adhesion have been constructed, showing excellent efficacy in the treatment of colitis. This article reviews the research progress of polymer-based targeted drug delivery systems in the treatment of colitis and discusses its research and application prospects.
Diabetic chronic wounds are one of the significant complications among diabetic patients, with an incidence that is rising annually. Given the substantial societal burden and complex pathophysiology of diabetic chronic wounds. There is an urgent need to develop new and more effective treatment modalities. Recently, cell-free therapies, particularly those involving extracellular vesicles such as exosomes, have gained prominence. This paper summarizes the therapeutic application of extracellular vesicles in the treatment of delayed wound healing in diabetes, explores the potential molecular mechanisms involved, and discusses the clinical value of extracellular vesicles in preventing and treating delayed wound healing in diabetes.
Usnic acid, a secondary metabolite derived from lichens, has been extensively utilized in pharmaceuticals, dietary supplements, and various daily chemical products, including feed, dye, food, perfume and cosmetics, due to its notable pharmacological effects, including anti-tumor, antibacterial, antiviral, and anti-inflammatory properties. Recent studies have shown that usnic acid can inhibit the occurrence and progression of various tumors through inducing apoptosis and autophagy, arresting cell cycle progression, inhibiting cell migration and invasion, and regulating the expression of microRNAs (miRNAs). Furthermore, usnic acid can be combined with clinical anticancer drugs to achieve synergistic anti-cancer effects. Additionally, modified usnic acid analogues also exhibit significant anti-tumor activity. This article will focus on the current research status of usnic acid, examining its physical and chemical properties, the mechanisms underlying its anti-tumor effects, and the anti-tumor activity of its analogues.
Objective To establish a ultrahigh-performance liquid chromatography-orbitrap high-resolution mass spectrometry (UHPLC-Orbitrap HRMS) method for the determination of the genotoxic impurity N-nitroso propranolol (NPPN) in propranolol hydrochloride sustained-release tablets. Methods The test sample was ultrasonically extracted using methanol as the solvent, then centrifuged and filtered before injection analysis. Chromatographic separation was performed using a 2.7 μm particle size C18 UHPLC column with a mobile phase of 0.1% formic acid (A) in water and 0.1% formic acid (B) in acetonitrile, using gradient elution. Mass spectrometry was conducted with an HESI ion source in positive ion parallel reaction monitoring (PRM) scan mode, monitoring the NPPN fragment ion at m/z 72.080 8, and quantification was performed using the standard curve method. Results The calibration curve was in good linearity in the range of 0.51-20.30 ng·mL-1 with excellent correlation coefficient (r) of 0.9999. The recoveries of NPPN at three levels (low, medium, and high) were in the range of 95.4%~98.3%, while the RSDs were from 2.5% to 4.2%. The limit of detection (LOD) was 0.20 ng·mL-1 while the limit of quantitfication (LOQ) was 0.51 ng·mL-1. This analytical method was used to determine NPPN in six batches of propranolol hydrochloride sustained release tablet samples. NPPN was detected in all six samples, among which the detection amount of 3 batches have exceeded the acceptable limit. Conclusion This method is sensitive, accurate, and fast, making it useful for pharmaceutical companies in controlling production processes and providing robust technical support for regulatory authorities.
Objective To establish a reversed-phase HPLC method for determining three stereoisomers in baloxavir marboxil and provide a basis for the quality specification of baloxavir marboxil. Methods The chromatographic column was CHIRALPAK IC-3 (4.6 mm×150 mm,3 μm), The mobile phase was acetonitrile -0.1% formic acid aqueous solution -isopropanol (35∶50∶15). The column temperature was 40 ℃. The flow rate was 0.5 mL·min-1. The injection volume was 10 μL. The detection wavelength was 259 nm. Result The isomer peaks were completely separated from the principal component peak. The detection limits for stereoisomers 1,2 and 3 were 0.024 7,0.038 7,0.038 1 mg·mL-1 respectively. The quantitation limits for stereoisomers 1,2 and 3 were 0.049 4,0.077 3,0.076 1 mg·mL-1 respectively. There were good linear relationships between the concentrations and peak area within the ranges of the study,and the linearity concentration ranges of stereoisomers 1,2 and 3 were 0.049 5-0.989 0 mg·mL-1,0.051 6-1.031 0 mg· mL-1,0.050 8-1.015 0 mg· mL-1 respectively. The linear correlation coefficients were 0.999 4. The recovery was 92.28%-103.90%. The sample solution was stable in 48 h at room temperature. Conclusion The method is accurate and reliable for determining stereoisomers in baloxavir marboxil, and provide a guideline of quality standards of baloxavir marboxil and safety evalution.
Objective The optimum formulation process was selected to prepare the ethosomes of Cortex Dictamni-Fructus Kochiae, and its prescription was verified and its properties were studied. Methods The formulation was optimized by single factor and response surface test. The appearance, particle size, Zeta potential and stability were investigated. The encapsulation rate was used as the evaluation index. Results The optimum preparation process of ethosomes of Cortex Dictamni-Fructus Kochiae is as follows: Using the dosage of lyophilized powder 409.06 mg, soybean lecithin 258.07 mg, cholesterol 90.87 mg, ethanol volume fraction 22.76%, stirred for 2 hours at 700 r·min-1 at 50 ℃ water bath temperature, The appearance of the prepared ethosomes suspension was light yellow, and the particles were nearly spherical in shape. The average particle size was (103.1±0.78) nm, the Zeta potential was (-36.0±3.65) mV, and the average encapsulation rates of Xibutanone, ash, and saponin Ic were (89.25±0.91)%, (80.16±1.52)%, (86.59±0.58)%, respectively. After 14 days of storage at room temperature, the results showed that: The ethosomal suspension is still a light yellow, uniform, and stable liquid, and there is no stratified precipitation phenomenon. Conclusion The method of ethanol injection is easy to operate, high encapsulation rate and good stability, which lays a foundation for further study on the skin administration of this preparation.
Objective To establish the fingerprint of Xuemai Shutong granules by UPLC-ELSD and determine the contents of 9 components in the preparation simultaneously. Methods The UPLC-ELSD was used to establish the fingerprint of Xuemai Shutong granules,and determine the content of its 9 components. The similarity evaluation system, systematic, cluster analysis, principal component analysis and orthogonal partial least squares discriminant analysis were used to evaluate the quality of different batches of preparation. Results The similarity degrees of UPLC-ELSD fingerprints of 11 batches of Xuemai Shutong granules were from 0.929 to 0.978,17 common peaks were calibrated, of which 11 peaks were identified ∶ peak 3 (notoginsenoside R1), peak 4[ginsenoside Rg1(Re)], peak 5 (notoginsenoside R2), peak 6 (ginsenoside Rb1), peak 9 (astragaloside Ⅳ), peak 10 (ginsenoside Rk3), peak 11 (ginsenoside Rh4), peak 12 [20(S)-ginsenoside Rg3], peak 13 [20(R)-ginsenoside Rg3], peak 14 (ginsenoside Rk1), peak 15 (ginsenoside Rg5). The stoichiometric analysis divided 11 batches of samples into 2 classes, and the 2 principal components in PCA analysis reflected the information of 17common peaks, 10 peaks which affected the quality difference are screened out. The linear relationship of the 9 components was good in their respective quality ranges in the content analysis(r>0.999 2),the average recovery rate were between 95.02%-97.78% and the RSD were 0.69%-1.70%(n=6). The contents of notoginsenoside R1, notoginsenoside R2, ginsenoside Rb1, astragaloside Ⅳ, ginsenoside Rh4, 20(S)-ginsenoside Rg3, 20(R)-ginsenoside Rg3, ginsenoside Rk1, ginsenoside Rg5in the 11 batches of Xuemai Shutong granules were 0.087 5-0.187 6,0.494 3-0.688 6,0.448 1-0.705 5,0.192 2-0.270 8,1.492 5-2.077 6,0.316 0-0.463 8,0.254 5-0.382 0,0.117 6-0.163 9,3.407 7-4.706 4 mg·g-1, respectively. Conclusions The established fingerprint and content determination method was accurate and reliable, which can improve the quality standard of Xuemai Shutong granules, and provide reference for its overall quality evaluation.
Objective To evaluate the compatibility of commonly used intravenous drugs in the ICU of Hebei General Hospital and to propose optimization strategies. Methods Data from 35 intravenous drugs used in ICU from January 1 to December 31, 2023 were analyzed using the Micromedex database and relevant literature. Results A compatibility chart for 35 drugs was created. Total 595 combinations, of which 279 (46.9%) were compatible, 22 (3.7%) were incompatible, 28 (4.7%) were uncertain, and 266 (44.7%) were unknown. Conclusion Drug co-administration is common in the ICU, but there is a lack of safety evidence and guidelines. There is an urgent to improve compatibility data and develop comprehensive resources to ensure safer intravenous drug administration.
Objective From the perspective of China’ s health service system, to evaluate the economy of the first-line treatment of advanced squamous non-small cell lung cancer with serplulimab combined with chemotherapy. Methods A three-state partitioned survival model was constructed, and the cost-effectiveness method was used to evaluate the economy of serplulimab combined chemotherapy in the first-line treatment of advanced squamous non-small cell lung cancer. The clinical data were collected from the ASTRUM-004 trial. The quality adjusted life years (QALYs) were used as the output index and the incremental cost-effectiveness ratio (ICER) was calculated. The stability of the model was verified by sensitivity analysis, and the situation analysis was carried out for the decrease of the price of serplulimab. Results The results of basic analysis showed that the cost of the combination group increased by 1 951 442 yuan compared with the placebo combination chemotherapy group, and the ICER was 2 498 816.54 yuan/QALY. Single factor sensitivity analysis showed that PFS state utility value, body weight, and serplulimab price had a greater impact on ICER. Probabilistic sensitivity analysis showed that the basic analysis results are robust. The results of the scenario analysis showed that when the price of serplulimab was reduced by 20% and 80%, it was not economical. Conclusions From the perspective of the China's health service system, currently, the combination therapy of serplulimab with chemotherapy is not cost-effective in the first-line treatment of advanced squamous cell lung cancer compared to placebo combination therapy.
Objective To compare the quality of liquids dispensed by intelligent dispensing robot and traditional manual in PIVAS, to ensure the safety of clinical infusion. Methods Using omeprazole and ambroxol as the main drugs and 5% glucose injection and 0.9% sodium chloride solution as the solvent, a number of quality indexes including drug residues and the number of insoluble particles were evaluated in the two modes of manual and robotic dispensing, respectively. Results Under the robot dispensing mode and manual dispensing mode, the residual amount of drugs was less than 5%, the insoluble particles were far less than the limit, the pH value was in line with the human infusion range, and the endotoxin and aseptic culture were negative results, with no statistical significance (P>0.05). Conclusions The quality of liquid dispensed under the robotic dispensing mode is guaranteed, and there is no significant difference in the quality of liquid dispensed with the traditional manual dispensing mode, which provides a reliable guarantee for the large-scale application of robotic dispensing in intravenous admixture service.
Objective To investigate the risk factors and countermeasures of linezolid-induced thrombocytopenia. Methods Clinical pharmacists participated in the pharmacy practice of linezolid-induced thrombocytopenia in a patient with liver cirrhosis. They analyzed the risk factors, took timely countermeasures, and conducted pharmaceutical care. Results The liver cirrhosis, low creatinine clearance and basic platelet values were closely related to linezolid-related thrombocytopenia, platelet recovered after discontinuation. Linezolid (0.3 g,IV,q12h) was used again under serum drug concentration monitoring, and the infection was effectively controlled, no thrombocytopenia occurred. Conclusions Clinical pharmacists should conduct pharmaceutical care for patients, pay close attention to adverse reactions, and timely adjust the treatment plan to better ensure the effectiveness and safety of treatment.
Objective To construct machine learning models to predict the incidence of linezolid-induced thrombocytopenia (LIT). Methods A total of 198 patients treated with linezolid in a hospital between January 2020 and March 2024 were retrospectively included. Firstly, the patients were divided into LIT and non-LIT groups, and the basic characteristics of the two groups were compared. Then, the variables with significant differences between the two groups were selected as potential risk factors to construct models for predicting LIT, including Logistic regression, decision tree and random forest models, and the prediction performance of the models was evaluated and compared. Results There were 52 (26.3%) patients developed LIT during the treatment. The univariate analysis showed significant differences in linezolid trough concentration (Cmin), baseline platelet counts and creatinine clearance, the incidence of cerebrovascular disease, acute respiratory distress syndrome, and abdominal infection in patients with and without LIT. Among the three models built based on these variables, the random forest model has the best predictive performance. The results of variable importance analysis based on random forest model showed that Cmin, baseline platelet count and combined with acute respiratory distress syndrome had higher importance scores. Conclusions The random forest model has high accuracy in predicting the occurrence of LIT, and the risk of LIT is higher in patients with higher levels of linezolid exposure and lower baseline platelets.
Objective To address the current issues of strong subjectivity in drug classification, vague classification standards, and complex influencing factors, this study aims to explore a scientific method for drug classification to reduce inventory costs and improve inventory effectiveness. Methods A total of 700 drugs were randomly selected from the historical data of a tertiary hospital in Beijing from 2021 to 2022 as the research subjects. The classification was conducted using the Principal Component Analysis (PCA) algorithm and the K-means clustering algorithm(K-means). Results The optimal number of classifications was determined to be 4, with a silhouette coefficient of 0.347 0. The 700 drugs were divided into four categories, with 363 in the first category, 186 in the second, 94 in the third, and 57 in the fourth. The drug classification method studied in this paper was simulated and applied to the drug inventory management of a certain tertiary hospital in the second quarter of 2023. The simulation results indicated that the classification method studied in this paper could reduce inventory costs and improve inventory effectiveness. Conclusion The drug classification method based on PCA algorithm and K-means clustering algorithm can provide a reliable basis for the management of drug inventory classification.
