Objective To evaluate the quality of cisatracurium besilate injection produced by domestic manufacturers.Methods A comprehensive evaluation of 104 batches of samples was carried out using statutory testing methods combined withexploratory research,including related substances,1,5-pentanediol diacrylate,residual solvents,genotoxic impurities of benzenesulfonate esters,infrared spectrum,and endotoxin examination.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results According to the statutory tests,the qualified rate of 104 batches of samples was 100.0％.The exploratory research showed that the results of related substances in the samples produced by 6 manufacturers were far below the limit,and no genotoxic impurities of benzenesulfonate esters were detected.However,the results showed that there was variability in 1,5-pentanediol diacrylate,as well as residual solvents.Conclusions The quality of the cisatracurium besilate injection is good,and the current specifications should be further improved and unified.It was proposed that the infrared spectrum,related substance,and 1,5-pentanediol diacrylate method be added or revised,and the limit of endotoxin strictly controlled.It was proposed that manufacturers pay attention to the quality of API and control injection production.

Objective Based on the sampling test of national drugs,the quality of Huatan Pingchuan tablets was systematically evaluated,and the quality problems were analyzed to provide references and suggestions for the quality control of this variety and to improve its quality standard.Methods A total of 157 batches of samples were tested according to the statutory standard,and based on the testing results and prescription characteristics,microscopic identification and comprehensive analysis of its quality using thin-layer chromatography,high-performance liquid chromatography,and other methods were subsequently established or improved for the exploratory research.Results The established thin-layer chromatography identification for Radix Scutellariae,as well as the content determination methods for Radix Scutellariae,Syringae Cortex,and promethazine hydrochloride,are easy to operate and have good durability and specificity and can be applied to the quality control and evaluation of Huatan Pingchuan tablets.Conclusions The overall quality of the tablets is average;some enterprises should strengthen the quality control of raw medicinal materials(decoction pieces);individual enterprises have significant differences in the quality of samples from different batches,so they need to pay attention to the quality of raw materials and the stability of production processes;the inspection items of the current standards cannot fully reflect the key quality attributes of drugs,and standards improvement work needs to be carried out.

Objective To evaluate the quality of Uncaria Hook(UH)in the market.Methods Twenty-nine batches of UH were tested by legal standards(character,identification,inspection,and extract detection).The TLC method was used to explore the identification of the control herbs,pilocarcinine,dehydropilocarcinine,pilocarcinine and isocarcinine.The HPLC method was used to establish the characteristic spectrum of UH.Then cluster analysis,PCA-X,and OPLS-DA analysis methods were used to perform statistical analysis on the common peak area of unguttine,and determine the contents of heicoside,iso-dehydrounguttine,iso-unguttine,iso-unguttine,and unguttine,to screen out the key quality control components of UH and evaluate their quality.Results Among the 29 batches of samples,23 batches were qualified,and the qualified rate was 79.31％.The results of the TLC analysis showed that the chemical constituents of different base sources were very different.No pilocarcinine was detected in Uncaria macrophylla no hydropilocarcinine was detected in Uncaria sinensis,and four components were not detected in Uncaria hirsuta.Only the samples with the base source of the plant showed corresponding spots in the chromatographic position with the control drug and the control substance.The results of HPLC showed that the chemical composition and content of different base sources of UH were very different.No hydrouncinine and pilocarcinine were detected in Uncaria macrophylla.No iso-dehydrouncinine,dehydrouncinine,and dehydropilocarcinine were detected in Uncaria sinensis.And only heicoside was detected in Uncaria sinensis,and the content of heicoside was low.Based on statistical analysis,there were differences among different batches of UH,and three key quality control ingredients,iso-dehydrounguocarcinoma,dehydrounguocarcinoma,and iso-unguocarcinoma that may lead to quality differences of unguocarcinoma were found.Conclusions Overall,the UH is of poor quality,the current processing standards and testing standards can not ensure the quality of the product,affecting the safety and effectiveness of clinic use.The chemical composition categories and contents of different base sources of UH are very different,which increases the difficulty of formulating a unified quality standard.

Based on the results of the National Drug Sampling and Inspection Programme,we summarized the history,the standard collection,the production enterprises and the dosage form specifications,the quality standard study,the pharmacological and pharmacodynamic study,and the clinical application study of Wuwei Qingzhuo preparation of Mongolian medicine and Shiliu Jianwei preparation of Zang medicine,to provide the basis for improved quality standards for both preparations.The development of these two preparations was searched and analyzed through literature.The available information shows that there is very little research on the two preparations and insufficient pharmacological experimental and clinical experimental data.The two preparations are basically the same in prescription and efficacy.However,the quality standards are very different,which are not conducive to the quality control of the two and their related dosage forms.And it is suggested that the Chinese Pharmacopoeia should take the situation of this category into comprehensive consideration,and unify the quality standards of the two preparations.

Objective To summarize the potential risk factors that may arise in the national drug sampling and testing inspection process in recent years,to focuse on the operation of the quality management system,and to put forward proposals on how to do a good job under the new drug regulatory model of sampling and testing work.Methods Focusing on the investigation of data integrity and authenticity,the analysis focuses on the analysis of risk points such as reagent management,standard substance management,instrument,and facility management,electronic data management and other issues,and carries out a comprehensive verification of the effectiveness of the operation of the quality management system and so on.Results National drug sampling and testing institutes should strengthen the overall quality management,according to the operation of the laboratory,combined with their respective risk characteristics,reagent management,standard substance management,instrument and facility management,electronic data management and other aspects of the risk of systematic sorting and the establishment of the risk alert function,the development of risk warning lists,and the implementation of the corresponding risk control strategy.Conclusion National drug sampling and testing institutes must strengthen the operation of the process of influencing factors in the effective control of the emphasis on the testing of the work of the key control points and continue to standardize and improve the inspection process of the quality system to ensure that the quality of the various activities in a controlled state.

Hot melt extrusion(HME)technology employs thermodynamic and kinetic principles to mix pharmaceutical polymers with crystalline drugs at high temperatures and extrude them,embedding drug molecules within the polymer matrix to form solid dispersions.Due to its solvent-free nature,capability for one-step processing,and support for continuous operation,HME has garnered significant attention in the pharmaceutical industry in recent years.This article introduced the basic principles and development history of HME technology and its marketed drugs.It reviewed the research progress of HME technology in improving drug solubility,masking taste,controlled release,targeted release,oral dispersible films,implant formulations,semi-solid formulations,and 3D printed formulations.Additionally,the article summarized the advantages and limitations of HME technology and provided an outlook on its future development.

A patient with anti-MDA5-positive dermatomyositis complicated by hepatic dysfunction developed rhabdomyolysis after an intravenous injection of gadopentetate dimeglumine for magnetic resonance imaging.Analysis of clinical manifestations and medication correlation confirmed gadopentetate dimeglumineinduced rhabdomyolysis.Gadopentetate dimeglumine can cause rhabdomyolysis in dermatomyositis patients.Clinical conditions should be closely monitored when using gadopentetate dimeglumine to guard against adverse reactions.

Objective To analyze the policy texts related to pediatric medications in China over the past decade,to explore the deficiencies in existing policy formulation from the perspective of stakeholders,and to propose reasonable optimization suggestions based on the current situation.Methods Collecting national-level policies related to pediatric drugs in China from 2013 to 2023,a two-dimensional policy analysis framework of"Policy tools-Stakeholder"were established.And the content analysis method was used to code,categorize,and statistically analyze the policy texts.Results A total of 54 pediatric drug policies were included in the analysis.In terms of policy tools,a total of 197 policy codes were formed,with environmental tools being the most prevalent with 92 codes(46.70％),primarily consisting of regulatory management tools(28 codes,30.43％).This was followed by supply-oriented tools with 53 codes(26.90％),mainly focused on the issuance of technical guidelines(21 codes,39.62％).Demand-oriented tools accounted for the least with 52 codes(26.40％),with inter-departmental collaboration tools having the highest proportion(17 codes,32.69％).In the dimension of stakeholders,a total of 223 policy codes were formed,with the government having the highest number of codes at 133(59.64％),followed by medical institutions with 56 codes(25.11％).The proportions for medical personnel,pharmaceutical companies,and patients were similar,with 14 codes(6.28％),11 codes(4.93％),and 9 codes(4.04％),respectively.Conclusions Pediatric drugs face challenges with policy tools where supply-oriented tools,particularly those providing financial support,suffer from insufficient policy depth and customization.The demand-oriented tools have a low proportion,leading to structural imbalance and underutilized effectiveness;the environment-oriented tools focus more on regulation than incentives,restricting the accessibility of pediatric drugs;the potential of multiple stakeholders is not fully activated,and there is a lack of policies centered around pediatric patients.To address these issues,supply-oriented policy tools need to establish a diversified financial support model and clearly define the scope of coverage.Demand-oriented policy tools require further adjustments to the catalog,procurement upgrades,and international collaborative research to reshape the pediatric drug security system.Environmental policy tools should enhance economic support,strengthen intellectual property rights,and implement targeted education to build a development ecosystem for pediatric drugs.Regarding stakeholders,it is essential to strengthen multi-stakeholder collaboration and optimize pediatric drug policy tools with a patient-centered approach.

The drug therapy pathway is an important part of the clinical pathway,aiming to enhance the efficiency and quality of healthcare services,optimize the allocation of healthcare resources,enhance patients' adherence to treatment,reduce the rate of medical errors,and ultimately improve patients' treatment outcomes through clear steps of drug therapy.The drug therapy pathway in the United States emphasizes multidisciplinary teamwork,and pharmacists play a key role in the formulation and implementation of the pathway;the drug therapy pathway in the United Kingdom is jointly formulated by the National Health Service of the United Kingdom and the National Institute for Health and Clinical Excellence of the United Kingdom,and pharmacists provide professional advice in the formulation and implementation of the pathway;and the management of the drug therapy pathway in Japan is the responsibility of the Japan Clinical Pathway Society,and pharmacists play an important role in the promotion and implementation of the pathway.Pharmacists play an important role in the promotion and implementation of pathways.This article analyzes the experiences and models of the United States,the United Kingdom,and Japan in the development of drug therapy pathways,to provide a reference for the development of drug therapy pathways in China.

Objective To formulate the 2025 edition of the Pharmacopoeia of the People's Republic of China of prefilled syringe silicone oil determination method,and to interpret the method content.Methods The prefilled syringe was added silicone solvent ethyl acetate to the roll edge of the sleeve and let it stand for extraction for 5 minutes,then put the silicon solvent in the evaporating dish dried at 105 ℃ to constant weight,then add 1mL ethyl acetate into the sleeve for rinsing and placing in the same evaporating dish,and then dry in a water bath at 105℃ to constant weight.The content of silicone oil in the sleeve of the prefilled syringe was calculated according to the quality difference.Results The reliability of the experimental method was verified by the ultimate extraction test,standard recovery test,and precision investigation.The results showed that the ultimate extraction could be achieved after 5 minutes of extraction with ethyl acetate.The recovery rate of the method was 100.0％-101.6％,and the precision was 3.5％.Conclusion The formulation of the determination method refers to the measurement method of silicone oil content in relevant standards at home and abroad,combined with the problems existing in the measurement of silicone oil content in daily tests,to further improve the operability of the detection method,the method is simple,efficient,feasible and reliable.