Objective To study the construction of market credit supervision systems for pharmaceutical enterprises in Liaoning Province and to provide suggestions for improving the integrity awareness and production activities.M...Objective To study the construction of market credit supervision systems for pharmaceutical enterprises in Liaoning Province and to provide suggestions for improving the integrity awareness and production activities.Methods Based on the market credit supervision experience of National Medical Products Administration and some other provinces,the construction of supervision laws and regulations system for pharmaceutical enterprises in Liaoning Province was investigated from the perspectives of daily supervision and inspection,joint punishment of illegal acts,sampling results,information communication and publicity.Results and Conclusion In recent years,Liaoning Provincial Party Committee and the People’s Government of Liaoning Province has attached great importance to the construction of social credit system by issuing a series of local regulations and local government rules.However,the laws and regulations on the market credit supervision of pharmaceutical enterprises are not perfect,and there is a lack of legal documents such as the credit rating method.Besides,some regulatory documents are slightly outdated and they should be revised in time according to the development of the pharmaceutical industry.The Food and Drug Administration of Liaoning Province should promulgate some relevant laws and regulations on the market credit supervision of pharmaceutical enterprises as soon as possible.Firstly,Liaoning Drug Administration should formulate the“Measures for the Administration of Drug Safety Credit of Pharmaceutical Enterprises”,including the establishment of credit information management system,which can clarify the main responsibility of pharmaceutical enterprises and key personnel,and standardize drug advertising and advertising endorsement.Secondly,Liaoning Drug Administration should introduce the“Credit Rating Methods for Pharmaceutical Enterprises”,and divide the credit rating of pharmaceutical enterprises into four grades from high to low.Besides,differentiated credit supervision measures must be implemented.Finally,the Pharmaceutical Industry Association of Liaoning Province should issue the industry norms that regard drug quality as life so as to improve the integrity awareness of pharmaceutical enterprises and promote the production activities.展开更多
To evaluate the impact of GMP on Chinese pharmaceutical industry in a quantitative system, we referred to theories on policy evaluation and industrial organization, and conducted literature review, key person intervie...To evaluate the impact of GMP on Chinese pharmaceutical industry in a quantitative system, we referred to theories on policy evaluation and industrial organization, and conducted literature review, key person interview, multi-round Delphi and field investigation. We set up the principles to construct our indicator system, reviewed based on the policy objectives of the new GMP for drugs systematically, and analysed the influence path of the new GMP for pharmaceutical manufacturers. We proposed a three-dimensional ＂structure-conduct-performance＂ evaluation indicator system. Our evaluation indicator system is accepted by experts and relevant personnel, indicating the three-dimensional evaluation indicator system is feasible to evaluate the impact of the new GMP in Chinese pharmaceutical industry.展开更多
A simple and sensitive flow injection spectrophotometric method is reported for the determination of vitamin E using potassium ferricyanide-Fe(Ⅲ) detection system.In the presence of vitamin E,Fe(Ⅲ)/ferricyanide redu...A simple and sensitive flow injection spectrophotometric method is reported for the determination of vitamin E using potassium ferricyanide-Fe(Ⅲ) detection system.In the presence of vitamin E,Fe(Ⅲ)/ferricyanide reduces.The in situ reduced ions are then reacted with unreduced portion of ferricyanide/Fe(Ⅲ) to make soluble Prussian blue,which is monitored at absorption wavelength of 735 nm.Linear calibration graph was obtained in the concentration range of 0.1-40μg mL^(-1).The relative standard deviations (n=4) were in the range of 1.1-3.6%,with limits of detection(3 s blank) of 0.04μg mL^(-1).The proposed method allowed 12 injections h^(-1).The method is applied to determine vitamin E in pharmaceuticals,infant milk and blood serum samples using hexane extraction with the recoveries in the range of 93±3 to 97.5±4%.The method is validated using certified reference materials SRM 968c for blood serum samples.展开更多
A simple flow injection spectrophotometric method is reported for the determination of cysteine,N-acetyl cysteine and glutathione based on the reduction of Fe（Ⅲ）/ferricyanide,the in situ reduced ions are reacted wi...A simple flow injection spectrophotometric method is reported for the determination of cysteine,N-acetyl cysteine and glutathione based on the reduction of Fe（Ⅲ）/ferricyanide,the in situ reduced ions are reacted with unreduced portion of ferricyanide/Fe（Ⅲ） to form soluble Prussian blue,which is monitored at 735 nm.The calibration graphs are linear in the concentration ranges of（1―100）×10-6 mol/L for cysteine and N-acetyl cysteine,and（1―50）×10-6 mol/L for glutathione.The relative standard deviations of 1.8%,2.5% and 1.9% were found for eleven replicate analyses of 5×10-6 mol/L cysteine,N-acetyl cysteine and glutathione.The limits of detection（3σ blank） at 5×10-7 mol/L for cysteine,and 3×10-7 mol/L for N-acetyl cysteine and glutathione were obtained.The proposed method allowed 60 injections/h.The effects of common substances present in pharmaceuticals and human physiological fluids were examined.The method was applied to determining cysteine in pharmaceutical formulations with the recoveries in a range of 97% to 106% and the results obtained are agreed well with labeled values.展开更多
The presence of emerging pharmaceutical pollutants at low concentration levels in the surface and ground water has caused a potential threat to the marine and human lives.The emerging pharmaceutical pollutants general...The presence of emerging pharmaceutical pollutants at low concentration levels in the surface and ground water has caused a potential threat to the marine and human lives.The emerging pharmaceutical pollutants generally include analgesics and anti-inflammatories,lipid-lowering drugs,antiepileptics,antibiotics,and β-blockers compounds.In recent years,various processes have been developed and advanced oxidation process is the most effective for decontamination of emerging pharmaceutical pollutants till date.Semiconductor based photocatalysis technology has recently received a great interest for the removal of new emerging pharmaceutical pollutants.This review article highlights the removal of emerging pharmaceutical pollutants especially through photocatalysis as well as recent progress using different nanostructures.Additional focus has been given over fundamental key dynamics processes of nanomaterials and degradation pathways of emerging pharmaceutical pollutants.Finally,this review concludes with the perspectives and outlook over future developments in photocatalysis technology for the degradation of emerging pharmaceutical pollutants leading to a solution for realworld in near future.展开更多
The China Basic Medical Insurance Program was created in 1999 with three objectives:equal accessibility,affordability,and quality.Today,it has become the biggest medical insurance program in the world,covering 95%of C...The China Basic Medical Insurance Program was created in 1999 with three objectives:equal accessibility,affordability,and quality.Today,it has become the biggest medical insurance program in the world,covering 95%of China's population.Since 2015,China's healthcare ecosystem has been reshaped by increasing innovation,which has in turn been driven by regulatory reform,enhancement of research and development capability,and capital market development.There has also been improved regulatory efficiency to reduce lags in launching drugs.In 2022,nearly 20%of novel active substances launched globally were from China.China has also risen to become the second biggest contributor to innovation in terms of pipelines.Using a“fast-follow”strategy,many locally developed innovative drugs can compete with products from multinational companies in their quality and pricing.However,China's pharmaceutical and biotechnology industry will continue to face challenges in pricing and reimbursement,as well as a shortened product lifecycle with rapid price erosion.The government has already accelerated the timeline for updating the drug reimbursement list and is willing to create a high-quality medical insurance program.However,some obstacles are hard to overcome,including reimbursement for advanced therapies,limited funding and an increasing burden of disease due to an aging population.This article reviews the trajectory of medical innovation in China,including the challenges.Looking forward,balancing affordability and innovation will be critical for China to continue the trajectory of growth.The article also offers some suggestions for future policy reform,including optimizing reimbursement efficiency with a focus on highquality solutions,enhancing the value assessment framework,payer repositioning from“value buyer”to“strategic buyer”,and developing alternative market access pathways for innovative drugs.展开更多
This study investigated the degradation of clofibric acid(CFA),bezafibrate(BZF),and sulfamethoxazole(SMX)in synthetic human urine using a novel mesoporous iron powderactivated persulfate system(mFe-PS system),and iden...This study investigated the degradation of clofibric acid(CFA),bezafibrate(BZF),and sulfamethoxazole(SMX)in synthetic human urine using a novel mesoporous iron powderactivated persulfate system(mFe-PS system),and identified the factors limiting their degradation in synthetic human urine.A kinetic model was established to expose the radical production in various reaction conditions,and experiments were conducted to verify the modeling results.In the phosphate-containing mFe-PS system,the 120 min removal efficiency of CFA decreased from 95.1%to 76.6%as the phosphate concentration increased from 0.32 to 6.45 mmol/L,but recovered to 90.5%when phosphate concentration increased to 16.10 mmol/L.Meanwhile,the increased concentration of phosphate from 0.32 to 16.10mmol/L reduced the BZF degradation efficacy from 91.5%to 79.0%,whereas SMX removal improved from 37.3%to 62.9%.The m Fe-PS system containing(bi)carbonate,from 4.20 to166.70 mmol/L,reduced CFA and BZF removal efficiencies from 100%to 76.8%and 80.4%,respectively,and SMX from 83.5%to 56.7%within a 120-min reaction time.In addition,alkaline conditions(pH≥8.0)inhibited CFA and BZF degradations,while nonacidic pH(pH≥7.0)remarkably inhibited SMX degradation.Results of the kinetic model indicated the formation of phosphate(H_(2)PO_(4)^(·)/HPO_(4)^(·-))and/or carbonate radicals(CO_(3)^(·-))could limit pharmaceutical removal.The transformation products(TPs)of the pharmaceuticals revealed more incompletely oxidized TPs occurred in the phosphate-and(bi)carbonate-containing m Fe-PS systems,and indicated that H_(2)PO_(4)^(·)/HPO_(4)^(·-)mainly degraded pharmaceuticals via a benzene ring-opening reaction while CO_(3)^(·-)preferentially oxidized pharmaceuticals via a hydroxylation reaction.展开更多
The recent GMP （good medical practice） rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and techno...The recent GMP （good medical practice） rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and technology transfer. This requires the technology transfer process to be regulated as the part of pharmaceutical quality system and the following development of corresponding written procedures. The following publication is dedicated to the development of TTP （technology transfer process） and its accessible graphic formalisation alongside the definition of main stages and possible procedures limited by the offered model. According to the actualized GMP rules, the technology transfer is an essential part of pharmaceutical quality system at a modem pharmaceutical company.展开更多
The microstructures of pharmaceutical preparations play a pivotal role in determining their critical quality attributes(CQAs),such as drug release,content uniformity,and stability,which greatly impact the safety and e...The microstructures of pharmaceutical preparations play a pivotal role in determining their critical quality attributes(CQAs),such as drug release,content uniformity,and stability,which greatly impact the safety and efficacy of drugs.Unlike the inherent molecular structures of active pharmaceutical ingredients(APIs)and excipients,the microstructures of pharmaceutical preparations are developed during the formulation process,presenting unique analytical challenges.In this review,we primarily focus on presenting the research methods used to elucidate the microstructures of pharmaceutical preparations,including X-ray imaging(XRI),scanning electron microscopy(SEM),atomic force microscopy(AFM),Raman spectroscopy,infrared(IR)spectroscopy,and rheometer technology.Subsequently,we highlight the applications,advantages,and limitations of these methods.Finally,we discuss the current challenges and future perspectives in this field.This review aims to provide a comprehensive reference for understanding the microstructures of pharmaceutical preparations,offering new insights and potential advancements in their development.展开更多
Membrane technology holds significant potential for augmenting or partially substituting conventional separation techniques,such as heatdriven distillation,thereby reducing energy consumption.Organic solvent nanofiltr...Membrane technology holds significant potential for augmenting or partially substituting conventional separation techniques,such as heatdriven distillation,thereby reducing energy consumption.Organic solvent nanofiltration represents an advanced membrane separation technology capable of discerning molecules within a molecular weight range of approximately 100-1000 Da in organic solvents,offering low energy requirements and minimal carbon footprints.Molecular separation in non-polar solvent system,such as toluene,n-hexane,and n-heptane,has gained paramount importance due to their extensive use in the pharmaceutical,biochemical,and petrochemical industries.In this review,we presented recent advancements in membrane materials,membrane fabrication techniques and their promising applications for separation in nonpolar solvent system,encompassing hydrocarbon separation,bioactive molecule purification and organic solvent recovery.Furthermore,this review highlighted the challenges and opportunities associated with membrane scale-up strategies and the direct translation of this promising technology into industrial applications.展开更多
Infrared(IR)spectroscopy,a technique within the realm of molecular vibrational spectroscopy,furnishes distinctive chemical signatures pivotal for both structural analysis and compound identification.A notable challeng...Infrared(IR)spectroscopy,a technique within the realm of molecular vibrational spectroscopy,furnishes distinctive chemical signatures pivotal for both structural analysis and compound identification.A notable challenge emerges from the misalignment between the mid-IR light wavelength range and molecular dimensions,culminating in a constrained absorption cross-section and diminished vibrational absorption coefficients(Supplementary data).展开更多
Objective To provide some suggestions and countermeasures for improving the patent evaluation system in pharmaceutical enterprises.Methods Literature research method was used to collect the relevant documents of pharm...Objective To provide some suggestions and countermeasures for improving the patent evaluation system in pharmaceutical enterprises.Methods Literature research method was used to collect the relevant documents of pharmaceutical enterprises and patent evaluation system,and then the problems of traditional patent evaluation methods for pharmaceutical patents were studied.Results and Conclusion The evaluation of pharmaceutical patents plays an important role for pharmaceutical enterprises.However,it is urgent to improve the pharmaceutical patent evaluation system because there are many difficulties in evaluating pharmaceutical patents,such as large fluctuation of patent value,strong subjective interference,the incomplete pharmaceutical information,unapplicable traditional evaluation method,and the insufficient role of evaluation agencies.Therefore,some suggestions are put forward:(1)The application of the real option method;(2)Developing evaluation institutions and training evaluation personnel;(3)Improving the laws and policies related to the evaluation of pharmaceutical patents;(4)Building a pharmaceutical patent evaluation database.展开更多
Drugs are related to the public's life and health. The "Drug Administration Law of the People's Republic of China" implemented on December 1, 2019 officially specifies that the state establishes a ph...Drugs are related to the public's life and health. The "Drug Administration Law of the People's Republic of China" implemented on December 1, 2019 officially specifies that the state establishes a pharmacovigilance system. This paper analyzes and considers the current situation and main problems of developing the pharmacovigilance system from the perspective of pharmaceutical manufacturing enterprises, expounds the significance of constructing the pharmacovigilance system, and discusses the important contents related to the construction of the pharmacovigilance system combining with the practical experience of enterprises.展开更多
Fresh air system is the air circulation system of air conditioning, which plays a role in purifying air and circulating indoor air and outdoor air. The fresh air system mainly exhausts the indoor low quality air to th...Fresh air system is the air circulation system of air conditioning, which plays a role in purifying air and circulating indoor air and outdoor air. The fresh air system mainly exhausts the indoor low quality air to the outside through the pipe, so as to make the indoor air fresh. With the continuous development of production technology, people have higher and higher requirements for clean air conditioning technology. Based on this, this paper briefly analyzes the application of clean air conditioning fresh air system in pharmaceutical factory.展开更多
China-Cameroon pharmaceutical cooperation is expected to bring benefits beyond its borders A new chapter in Sino-Cameroonian cooperation is being written.The $948.7 million Yicheng Pharmaceutical Group Fabrication Co....China-Cameroon pharmaceutical cooperation is expected to bring benefits beyond its borders A new chapter in Sino-Cameroonian cooperation is being written.The $948.7 million Yicheng Pharmaceutical Group Fabrication Co.Ltd.plant is set to reshape Cameroon’s pharmaceutical landscape.展开更多
AI is revolutionizing the current paradigm of pharmaceutical research,addressing the challenges encountered at all stages of the process.AI driven drug discovery is based on biomedical big data and new algorithms to i...AI is revolutionizing the current paradigm of pharmaceutical research,addressing the challenges encountered at all stages of the process.AI driven drug discovery is based on biomedical big data and new algorithms to identify drug targets,screen and optimize active compounds,analyze drug properties,and facilitate drug production and quality control.On this basis,we organized this special issue entitled"Innovative Pharmaceutical Research Driven by AI",and collected Original research articles,Reviewpapers.展开更多
Microorganisms,abundant in nature,are prolific producers of a diverse array of natural products(NPs)that are fundamental in the development of innovative therapeutics.Despite their significant potential,the field face...Microorganisms,abundant in nature,are prolific producers of a diverse array of natural products(NPs)that are fundamental in the development of innovative therapeutics.Despite their significant potential,the field faces considerable challenges,including the continuous emergence of potential health threats,as well as novel pathogen strains and viruses.The advent and implementation of advanced technologies,such as culture strategies,genomics mining,and artificial intelligence(AI),are facilitating a paradigm shift in pharmaceutical research,introducing innovative methodologies and perspectives.The development and maturation of these technologies have enhanced the exploration of microbial-derived NPs,thereby advancing pharmaceutical research and development.This review synthesizes recent developments in this context,emphasizing their applications in pharmaceutical discovery and development.Through systematic analysis and synthesis,it provides objective insights into the promising prospects and future direction of this essential field.展开更多
Yeast-based models have become a powerful platform in pharmaceutical research,offering significant potential for producing complex drugs,vaccines,and therapeutic agents.While many current drugs were discovered before ...Yeast-based models have become a powerful platform in pharmaceutical research,offering significant potential for producing complex drugs,vaccines,and therapeutic agents.While many current drugs were discovered before fully understanding their molecular mechanisms,yeast systems now provide valuable insights for drug discovery and personalized medicine.Recent advancements in genetic engineering,metabolic engineering,and synthetic biology have improved the efficiency and scalability of yeast-based production systems,enabling more sustainable and cost-effective manufacturing processes.This paper reviews the latest developments in yeast-based technologies,focusing on their use as model organisms to study disease mechanisms,identify drug targets,and develop novel therapies.We highlight key platforms such as the yeast two-hybrid system,surface display technologies,and optimized expression systems.Additionally,we explore the future integration of yeast engineering with artificial intelligence(AI),machine learning(ML),and advanced genome editing technologies like CRISPR/Cas9,which are expected to accelerate drug discovery and enable personalized therapies.Furthermore,yeast-based systems are increasingly employed in largescale drug production,vaccine development,and therapeutic protein expression,offering promising applications in clinical and industrial settings.This paper discusses the practical implications of these systems and their potential to revolutionize drug development,paving the way for safer,more effective therapies.展开更多
Objective:To analyze the positive impact of pharmaceutical care in the ophthalmology perioperative period on the rational use of antibiotics.Methods:A total of 115 patients who underwent ophthalmological surgery betwe...Objective:To analyze the positive impact of pharmaceutical care in the ophthalmology perioperative period on the rational use of antibiotics.Methods:A total of 115 patients who underwent ophthalmological surgery between March and June 2023 were selected as the control group,receiving routine medication management.Another 115 patients who underwent ophthalmological surgery between July and October 2023 were selected as the observation group,receiving pharmaceutical care.The rationality of medication use,mastery of medication knowledge,medication compliance,and adverse reaction rates were compared between the two groups.Results:The observation group had higher rationality of medication use,higher scores for mastery of medication knowledge,higher medication compliance,and a lower adverse reaction rate compared to the control group(P<0.05).Conclusion:The combination of antibiotic therapy and pharmaceutical care in the ophthalmology perioperative period can improve the rationality of medication use,enhance patients’mastery of medication knowledge,increase their medication compliance,and prevent adverse reactions to antibiotics.展开更多
文摘Objective To study the construction of market credit supervision systems for pharmaceutical enterprises in Liaoning Province and to provide suggestions for improving the integrity awareness and production activities.Methods Based on the market credit supervision experience of National Medical Products Administration and some other provinces,the construction of supervision laws and regulations system for pharmaceutical enterprises in Liaoning Province was investigated from the perspectives of daily supervision and inspection,joint punishment of illegal acts,sampling results,information communication and publicity.Results and Conclusion In recent years,Liaoning Provincial Party Committee and the People’s Government of Liaoning Province has attached great importance to the construction of social credit system by issuing a series of local regulations and local government rules.However,the laws and regulations on the market credit supervision of pharmaceutical enterprises are not perfect,and there is a lack of legal documents such as the credit rating method.Besides,some regulatory documents are slightly outdated and they should be revised in time according to the development of the pharmaceutical industry.The Food and Drug Administration of Liaoning Province should promulgate some relevant laws and regulations on the market credit supervision of pharmaceutical enterprises as soon as possible.Firstly,Liaoning Drug Administration should formulate the“Measures for the Administration of Drug Safety Credit of Pharmaceutical Enterprises”,including the establishment of credit information management system,which can clarify the main responsibility of pharmaceutical enterprises and key personnel,and standardize drug advertising and advertising endorsement.Secondly,Liaoning Drug Administration should introduce the“Credit Rating Methods for Pharmaceutical Enterprises”,and divide the credit rating of pharmaceutical enterprises into four grades from high to low.Besides,differentiated credit supervision measures must be implemented.Finally,the Pharmaceutical Industry Association of Liaoning Province should issue the industry norms that regard drug quality as life so as to improve the integrity awareness of pharmaceutical enterprises and promote the production activities.
文摘To evaluate the impact of GMP on Chinese pharmaceutical industry in a quantitative system, we referred to theories on policy evaluation and industrial organization, and conducted literature review, key person interview, multi-round Delphi and field investigation. We set up the principles to construct our indicator system, reviewed based on the policy objectives of the new GMP for drugs systematically, and analysed the influence path of the new GMP for pharmaceutical manufacturers. We proposed a three-dimensional ＂structure-conduct-performance＂ evaluation indicator system. Our evaluation indicator system is accepted by experts and relevant personnel, indicating the three-dimensional evaluation indicator system is feasible to evaluate the impact of the new GMP in Chinese pharmaceutical industry.
文摘A simple and sensitive flow injection spectrophotometric method is reported for the determination of vitamin E using potassium ferricyanide-Fe(Ⅲ) detection system.In the presence of vitamin E,Fe(Ⅲ)/ferricyanide reduces.The in situ reduced ions are then reacted with unreduced portion of ferricyanide/Fe(Ⅲ) to make soluble Prussian blue,which is monitored at absorption wavelength of 735 nm.Linear calibration graph was obtained in the concentration range of 0.1-40μg mL^(-1).The relative standard deviations (n=4) were in the range of 1.1-3.6%,with limits of detection(3 s blank) of 0.04μg mL^(-1).The proposed method allowed 12 injections h^(-1).The method is applied to determine vitamin E in pharmaceuticals,infant milk and blood serum samples using hexane extraction with the recoveries in the range of 93±3 to 97.5±4%.The method is validated using certified reference materials SRM 968c for blood serum samples.
文摘A simple flow injection spectrophotometric method is reported for the determination of cysteine,N-acetyl cysteine and glutathione based on the reduction of Fe（Ⅲ）/ferricyanide,the in situ reduced ions are reacted with unreduced portion of ferricyanide/Fe（Ⅲ） to form soluble Prussian blue,which is monitored at 735 nm.The calibration graphs are linear in the concentration ranges of（1―100）×10-6 mol/L for cysteine and N-acetyl cysteine,and（1―50）×10-6 mol/L for glutathione.The relative standard deviations of 1.8%,2.5% and 1.9% were found for eleven replicate analyses of 5×10-6 mol/L cysteine,N-acetyl cysteine and glutathione.The limits of detection（3σ blank） at 5×10-7 mol/L for cysteine,and 3×10-7 mol/L for N-acetyl cysteine and glutathione were obtained.The proposed method allowed 60 injections/h.The effects of common substances present in pharmaceuticals and human physiological fluids were examined.The method was applied to determining cysteine in pharmaceutical formulations with the recoveries in a range of 97% to 106% and the results obtained are agreed well with labeled values.
基金RKG acknowledges financial assistance from Department of Science and Technology(DST)India,through the INSPIRE Faculty Award(Project No.IFA-13 ENG-57)Grant No.DST/TM/WTI/2K16/23(G).PK thanks IIT Kanpur for Institute Postdoctoral Fellowship.
文摘The presence of emerging pharmaceutical pollutants at low concentration levels in the surface and ground water has caused a potential threat to the marine and human lives.The emerging pharmaceutical pollutants generally include analgesics and anti-inflammatories,lipid-lowering drugs,antiepileptics,antibiotics,and β-blockers compounds.In recent years,various processes have been developed and advanced oxidation process is the most effective for decontamination of emerging pharmaceutical pollutants till date.Semiconductor based photocatalysis technology has recently received a great interest for the removal of new emerging pharmaceutical pollutants.This review article highlights the removal of emerging pharmaceutical pollutants especially through photocatalysis as well as recent progress using different nanostructures.Additional focus has been given over fundamental key dynamics processes of nanomaterials and degradation pathways of emerging pharmaceutical pollutants.Finally,this review concludes with the perspectives and outlook over future developments in photocatalysis technology for the degradation of emerging pharmaceutical pollutants leading to a solution for realworld in near future.
文摘The China Basic Medical Insurance Program was created in 1999 with three objectives:equal accessibility,affordability,and quality.Today,it has become the biggest medical insurance program in the world,covering 95%of China's population.Since 2015,China's healthcare ecosystem has been reshaped by increasing innovation,which has in turn been driven by regulatory reform,enhancement of research and development capability,and capital market development.There has also been improved regulatory efficiency to reduce lags in launching drugs.In 2022,nearly 20%of novel active substances launched globally were from China.China has also risen to become the second biggest contributor to innovation in terms of pipelines.Using a“fast-follow”strategy,many locally developed innovative drugs can compete with products from multinational companies in their quality and pricing.However,China's pharmaceutical and biotechnology industry will continue to face challenges in pricing and reimbursement,as well as a shortened product lifecycle with rapid price erosion.The government has already accelerated the timeline for updating the drug reimbursement list and is willing to create a high-quality medical insurance program.However,some obstacles are hard to overcome,including reimbursement for advanced therapies,limited funding and an increasing burden of disease due to an aging population.This article reviews the trajectory of medical innovation in China,including the challenges.Looking forward,balancing affordability and innovation will be critical for China to continue the trajectory of growth.The article also offers some suggestions for future policy reform,including optimizing reimbursement efficiency with a focus on highquality solutions,enhancing the value assessment framework,payer repositioning from“value buyer”to“strategic buyer”,and developing alternative market access pathways for innovative drugs.
基金supported by the Hong Kong Innovation and Technology Commission (No.ITC-CNERC14EG03)the Research Grants Council of the Hong Kong SAR (No.T21-604/19R)。
文摘This study investigated the degradation of clofibric acid(CFA),bezafibrate(BZF),and sulfamethoxazole(SMX)in synthetic human urine using a novel mesoporous iron powderactivated persulfate system(mFe-PS system),and identified the factors limiting their degradation in synthetic human urine.A kinetic model was established to expose the radical production in various reaction conditions,and experiments were conducted to verify the modeling results.In the phosphate-containing mFe-PS system,the 120 min removal efficiency of CFA decreased from 95.1%to 76.6%as the phosphate concentration increased from 0.32 to 6.45 mmol/L,but recovered to 90.5%when phosphate concentration increased to 16.10 mmol/L.Meanwhile,the increased concentration of phosphate from 0.32 to 16.10mmol/L reduced the BZF degradation efficacy from 91.5%to 79.0%,whereas SMX removal improved from 37.3%to 62.9%.The m Fe-PS system containing(bi)carbonate,from 4.20 to166.70 mmol/L,reduced CFA and BZF removal efficiencies from 100%to 76.8%and 80.4%,respectively,and SMX from 83.5%to 56.7%within a 120-min reaction time.In addition,alkaline conditions(pH≥8.0)inhibited CFA and BZF degradations,while nonacidic pH(pH≥7.0)remarkably inhibited SMX degradation.Results of the kinetic model indicated the formation of phosphate(H_(2)PO_(4)^(·)/HPO_(4)^(·-))and/or carbonate radicals(CO_(3)^(·-))could limit pharmaceutical removal.The transformation products(TPs)of the pharmaceuticals revealed more incompletely oxidized TPs occurred in the phosphate-and(bi)carbonate-containing m Fe-PS systems,and indicated that H_(2)PO_(4)^(·)/HPO_(4)^(·-)mainly degraded pharmaceuticals via a benzene ring-opening reaction while CO_(3)^(·-)preferentially oxidized pharmaceuticals via a hydroxylation reaction.
文摘The recent GMP （good medical practice） rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and technology transfer. This requires the technology transfer process to be regulated as the part of pharmaceutical quality system and the following development of corresponding written procedures. The following publication is dedicated to the development of TTP （technology transfer process） and its accessible graphic formalisation alongside the definition of main stages and possible procedures limited by the offered model. According to the actualized GMP rules, the technology transfer is an essential part of pharmaceutical quality system at a modem pharmaceutical company.
文摘The microstructures of pharmaceutical preparations play a pivotal role in determining their critical quality attributes(CQAs),such as drug release,content uniformity,and stability,which greatly impact the safety and efficacy of drugs.Unlike the inherent molecular structures of active pharmaceutical ingredients(APIs)and excipients,the microstructures of pharmaceutical preparations are developed during the formulation process,presenting unique analytical challenges.In this review,we primarily focus on presenting the research methods used to elucidate the microstructures of pharmaceutical preparations,including X-ray imaging(XRI),scanning electron microscopy(SEM),atomic force microscopy(AFM),Raman spectroscopy,infrared(IR)spectroscopy,and rheometer technology.Subsequently,we highlight the applications,advantages,and limitations of these methods.Finally,we discuss the current challenges and future perspectives in this field.This review aims to provide a comprehensive reference for understanding the microstructures of pharmaceutical preparations,offering new insights and potential advancements in their development.
基金supported by the National Natural Science Foundation of China(Grant No.2230081973)Shanghai Pilot Program for Basic Research(22TQ1400100-4).
文摘Membrane technology holds significant potential for augmenting or partially substituting conventional separation techniques,such as heatdriven distillation,thereby reducing energy consumption.Organic solvent nanofiltration represents an advanced membrane separation technology capable of discerning molecules within a molecular weight range of approximately 100-1000 Da in organic solvents,offering low energy requirements and minimal carbon footprints.Molecular separation in non-polar solvent system,such as toluene,n-hexane,and n-heptane,has gained paramount importance due to their extensive use in the pharmaceutical,biochemical,and petrochemical industries.In this review,we presented recent advancements in membrane materials,membrane fabrication techniques and their promising applications for separation in nonpolar solvent system,encompassing hydrocarbon separation,bioactive molecule purification and organic solvent recovery.Furthermore,this review highlighted the challenges and opportunities associated with membrane scale-up strategies and the direct translation of this promising technology into industrial applications.
基金supported by National Natural Science Foundation of China(Grant No.:32301161)the Natural Scientific Foundation of Hunan Province,China(Grant No.:2023JJ60052)+3 种基金the Scientific Research Project of Hunan Provincial Health Commission,China(Grant No.:202112062218,20190161)the Scientific Research Project of Hunan Provincial Department of Education,China(Grant No.:22B0455)the Clinical“4310”Project of the University of South China,China(Grant No.:20224310NHYCG02)the Doctoral Scientific Research Foundation of University of South China,China(Grant No.:200XQD042).
文摘Infrared(IR)spectroscopy,a technique within the realm of molecular vibrational spectroscopy,furnishes distinctive chemical signatures pivotal for both structural analysis and compound identification.A notable challenge emerges from the misalignment between the mid-IR light wavelength range and molecular dimensions,culminating in a constrained absorption cross-section and diminished vibrational absorption coefficients(Supplementary data).
文摘Objective To provide some suggestions and countermeasures for improving the patent evaluation system in pharmaceutical enterprises.Methods Literature research method was used to collect the relevant documents of pharmaceutical enterprises and patent evaluation system,and then the problems of traditional patent evaluation methods for pharmaceutical patents were studied.Results and Conclusion The evaluation of pharmaceutical patents plays an important role for pharmaceutical enterprises.However,it is urgent to improve the pharmaceutical patent evaluation system because there are many difficulties in evaluating pharmaceutical patents,such as large fluctuation of patent value,strong subjective interference,the incomplete pharmaceutical information,unapplicable traditional evaluation method,and the insufficient role of evaluation agencies.Therefore,some suggestions are put forward:(1)The application of the real option method;(2)Developing evaluation institutions and training evaluation personnel;(3)Improving the laws and policies related to the evaluation of pharmaceutical patents;(4)Building a pharmaceutical patent evaluation database.
文摘Drugs are related to the public's life and health. The "Drug Administration Law of the People's Republic of China" implemented on December 1, 2019 officially specifies that the state establishes a pharmacovigilance system. This paper analyzes and considers the current situation and main problems of developing the pharmacovigilance system from the perspective of pharmaceutical manufacturing enterprises, expounds the significance of constructing the pharmacovigilance system, and discusses the important contents related to the construction of the pharmacovigilance system combining with the practical experience of enterprises.
文摘Fresh air system is the air circulation system of air conditioning, which plays a role in purifying air and circulating indoor air and outdoor air. The fresh air system mainly exhausts the indoor low quality air to the outside through the pipe, so as to make the indoor air fresh. With the continuous development of production technology, people have higher and higher requirements for clean air conditioning technology. Based on this, this paper briefly analyzes the application of clean air conditioning fresh air system in pharmaceutical factory.
文摘China-Cameroon pharmaceutical cooperation is expected to bring benefits beyond its borders A new chapter in Sino-Cameroonian cooperation is being written.The $948.7 million Yicheng Pharmaceutical Group Fabrication Co.Ltd.plant is set to reshape Cameroon’s pharmaceutical landscape.
文摘AI is revolutionizing the current paradigm of pharmaceutical research,addressing the challenges encountered at all stages of the process.AI driven drug discovery is based on biomedical big data and new algorithms to identify drug targets,screen and optimize active compounds,analyze drug properties,and facilitate drug production and quality control.On this basis,we organized this special issue entitled"Innovative Pharmaceutical Research Driven by AI",and collected Original research articles,Reviewpapers.
基金supported by Nanjing Science and Technology Bureau International,Hong Kong,Macao,and Taiwan Science and Technology Cooperation Program(No.202401042)。
文摘Microorganisms,abundant in nature,are prolific producers of a diverse array of natural products(NPs)that are fundamental in the development of innovative therapeutics.Despite their significant potential,the field faces considerable challenges,including the continuous emergence of potential health threats,as well as novel pathogen strains and viruses.The advent and implementation of advanced technologies,such as culture strategies,genomics mining,and artificial intelligence(AI),are facilitating a paradigm shift in pharmaceutical research,introducing innovative methodologies and perspectives.The development and maturation of these technologies have enhanced the exploration of microbial-derived NPs,thereby advancing pharmaceutical research and development.This review synthesizes recent developments in this context,emphasizing their applications in pharmaceutical discovery and development.Through systematic analysis and synthesis,it provides objective insights into the promising prospects and future direction of this essential field.
基金funded by 2024 Scientific Research Project of Chongqing Medical and Pharmaceutical College(No.ygzrc2024101)Chongqing Education Commission Natural Science Foundation(No.KJQN202402821)+2 种基金Chongqing Shapingba District Science and Technology Bureau Project(No.2024071)2024 Chongqing Medical and Pharmaceutical College Innovation Research Group Project(No.ygz2024401)Chongqing Science and Health Joint Medical Research Project(No.2024SQKWLHMS051),respectively.
文摘Yeast-based models have become a powerful platform in pharmaceutical research,offering significant potential for producing complex drugs,vaccines,and therapeutic agents.While many current drugs were discovered before fully understanding their molecular mechanisms,yeast systems now provide valuable insights for drug discovery and personalized medicine.Recent advancements in genetic engineering,metabolic engineering,and synthetic biology have improved the efficiency and scalability of yeast-based production systems,enabling more sustainable and cost-effective manufacturing processes.This paper reviews the latest developments in yeast-based technologies,focusing on their use as model organisms to study disease mechanisms,identify drug targets,and develop novel therapies.We highlight key platforms such as the yeast two-hybrid system,surface display technologies,and optimized expression systems.Additionally,we explore the future integration of yeast engineering with artificial intelligence(AI),machine learning(ML),and advanced genome editing technologies like CRISPR/Cas9,which are expected to accelerate drug discovery and enable personalized therapies.Furthermore,yeast-based systems are increasingly employed in largescale drug production,vaccine development,and therapeutic protein expression,offering promising applications in clinical and industrial settings.This paper discusses the practical implications of these systems and their potential to revolutionize drug development,paving the way for safer,more effective therapies.
文摘Objective:To analyze the positive impact of pharmaceutical care in the ophthalmology perioperative period on the rational use of antibiotics.Methods:A total of 115 patients who underwent ophthalmological surgery between March and June 2023 were selected as the control group,receiving routine medication management.Another 115 patients who underwent ophthalmological surgery between July and October 2023 were selected as the observation group,receiving pharmaceutical care.The rationality of medication use,mastery of medication knowledge,medication compliance,and adverse reaction rates were compared between the two groups.Results:The observation group had higher rationality of medication use,higher scores for mastery of medication knowledge,higher medication compliance,and a lower adverse reaction rate compared to the control group(P<0.05).Conclusion:The combination of antibiotic therapy and pharmaceutical care in the ophthalmology perioperative period can improve the rationality of medication use,enhance patients’mastery of medication knowledge,increase their medication compliance,and prevent adverse reactions to antibiotics.
