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Research on the Impact of the Centralized Drug Procurement Policy on China’s Pharmaceutical Enterprises
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作者 Miao Li Tian Lijuan 《Asian Journal of Social Pharmacy》 2024年第4期351-360,共10页
Objective To analyze the impact of the centralized drug procurement policy on pharmaceutical enterprises,and put forward some suggestions for improving China’s centralized drug procurement policy.Methods Through lite... Objective To analyze the impact of the centralized drug procurement policy on pharmaceutical enterprises,and put forward some suggestions for improving China’s centralized drug procurement policy.Methods Through literature analysis and comparative research,the relevant policies and implementation effects from the“4+7”drug procurement pilot to the seventh batch of volume procurement were sorted out,and the impact of the procurement policy on pharmaceutical enterprises was analyzed.Results and Conclusion The centralized drug procurement policy has continuously improved the enthusiasm of enterprises to participate in bidding,and the consistency evaluation work has been carried out well.However,there are also some problems,such as the reduction of enterprise profits,the difficulty of enterprise operation,the decline in the quality of winning drugs,and the insufficient innovation ability and the supply capacity of enterprises.In this regard,enterprises should reasonably control the cost of drugs to ensure the stable supply of winning drugs.Besides,enterprises should create brand effect for their timely transformation and development.While strengthening pharmaceutical innovation,they can change from low-level generic drug production to R&D innovation.The government should pay close attention to the impact of centralized procurement on the quality and efficiency of enterprise drugs.For instance,the government should improve the pricing rules for drug procurement and increase supervision of drug quality and supply.At the same time,it should give certain policy and financial support to enterprises’technological innovation and talent introduction. 展开更多
关键词 pharmaceutical collection purchase of pharmaceutical products in quantity procurement policy
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Potentials of ribosomopathy gene as pharmaceutical targets for cancer treatment
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作者 Mengxin Wang Stephen Vulcano +7 位作者 Changlu Xu Renjian Xie Weijie Peng Jie Wang Qiaojun Liu Lee Jia Zhi Li Yumei Li 《Journal of Pharmaceutical Analysis》 SCIE CAS CSCD 2024年第3期308-320,共13页
Ribosomopathies encompass a spectrum of disorders arising from impaired ribosome biogenesis and reduced functionality.Mutation or dysexpression of the genes that disturb any finely regulated steps of ribosome biogenes... Ribosomopathies encompass a spectrum of disorders arising from impaired ribosome biogenesis and reduced functionality.Mutation or dysexpression of the genes that disturb any finely regulated steps of ribosome biogenesis can result in different types of ribosomopathies in clinic,collectively known as ribosomopathy genes.Emerging data suggest that ribosomopathy patients exhibit a significantly heightened susceptibility to cancer.Abnormal ribosome biogenesis and dysregulation of some ribosomopathy genes have also been found to be intimately associated with cancer development.The correlation between ribosome biogenesis or ribosomopathy and the development of malignancies has been well established.This work aims to review the recent advances in the research of ribosomopathy genes among human cancers and meanwhile,to excavate the potential role of these genes,which have not or rarely been reported in cancer,in the disease development across cancers.We plan to establish a theoretical framework between the ribosomopathy gene and cancer development,to further facilitate the potential of these genes as diagnostic biomarker as well as pharmaceutical targets for cancer treatment. 展开更多
关键词 Ribosome biogenesis Ribosomopathy gene Cancer treatment target pharmaceutical target
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Digital Transformation Trend of the Pharmaceutical Distribution Industry in the Context of New Infrastructure in China
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作者 Gan Xingzhi 《Asian Journal of Social Pharmacy》 2024年第2期159-167,共9页
Objective To study the pharmaceutical distribution industry against the background of new infrastructure construction since it is vital to the health and life of the public,and to offer some suggestions to further imp... Objective To study the pharmaceutical distribution industry against the background of new infrastructure construction since it is vital to the health and life of the public,and to offer some suggestions to further improve the industry quality and achieve industry upgrading.Methods The national strategies for new infrastructure as well as the underlying logic for enterprise digital transformation were analyzed to provide the outlook on the digital transformation trend of the pharmaceutical distribution industry.Results and Conclusion In the future,the pharmaceutical distribution industry shall transform the pattern,channel,management and control,and experience in the entire business chain in a digital way by focusing on connection efficiency,data efficiency and decision-making efficiency. 展开更多
关键词 pharmaceutical distribution digital transformation new infrastructure TREND
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Research on the Improvement of Incentive Mechanism for Pharmaceutical Sales Personnel - Taking Company A as an Example
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作者 Jia Fan Tian Lijuan 《Asian Journal of Social Pharmacy》 2024年第3期272-278,共7页
Objective To analyze the improvement of the incentive mechanism of sales personnel in pharmaceutical company A,and to promote the smooth operation and further development of the company in a long term.Methods Compensa... Objective To analyze the improvement of the incentive mechanism of sales personnel in pharmaceutical company A,and to promote the smooth operation and further development of the company in a long term.Methods Compensation incentive,performance appraisal,welfare benefit,training incentive,promotion motivation and enterprise cultural inspiration were explored through questionnaires,telephone interviews and in-person interviews.Results and Conclusion This company’s incentive mechanism has problems in two aspects:Material incentives and spiritual incentives.As to the company’s characteristics and strategic development,the optimization countermeasures of incentive mechanism are proposed from the following three aspects:constructing a reasonable incentive system,establishing an efficient spiritual incentive mechanism,and implementing the dynamic incentive and differentiated incentive simultaneously. 展开更多
关键词 pharmaceutical company sales personnel incentive mechanism STRATEGY
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Countermeasures and Suggestions for Strengthening Human Resource Management in China’s Pharmaceutical Industry
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作者 Sun Yuyuan Wang Shuling 《Asian Journal of Social Pharmacy》 2024年第2期202-207,共6页
Objective To provide reference and enlightenment for the development of human resource management in China’s pharmaceutical industry and to put forward some suggestions to promote the further development of pharmaceu... Objective To provide reference and enlightenment for the development of human resource management in China’s pharmaceutical industry and to put forward some suggestions to promote the further development of pharmaceutical industry.Methods The method of literature review was used to analyze the current situation and existing problems of human resource management in China’s pharmaceutical industry.Results and Conclusion Only by continuously improving the human resource management skills and innovating management methods can pharmaceutical enterprises achieve long-term benefits with sustainable development.The formulation of human resource management strategy in pharmaceutical industry must be conducive to the realization of the business goals of enterprises.To achieve this overall goal,the human resources management department of enterprises must make the plan from a strategic perspective,formulate talent strategic planning which serves the overall strategic goal of the enterprise.As a result,human resource management will play an important role in the development of China’s pharmaceutical industry. 展开更多
关键词 pharmaceutical industry human resource management COUNTERMEASURE
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Comparative Analysis of Profit Model of Typical Pharmaceutical O2O Enterprises in China
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作者 Qu Simeng Wang Shuling 《Asian Journal of Social Pharmacy》 2024年第1期81-88,共8页
Objective To study the profit model of Chinese pharmaceutical O2O enterprises.Methods A case study of three typical pharmaceutical O2O enterprises was conducted,and their profit models were compared.Results and Conclu... Objective To study the profit model of Chinese pharmaceutical O2O enterprises.Methods A case study of three typical pharmaceutical O2O enterprises was conducted,and their profit models were compared.Results and Conclusion The pharmaceutical O2O enterprises in China are divided into three categories according to the profit models.It is found that the current pharmaceutical O2O enterprises have problems such as simple profit model and low corporate profits.Based on these problems,it is recommended that relevant enterprises develop various business models to increase profit channels.Besides,they should establish and improve internal cost control systems. 展开更多
关键词 pharmaceutical O2O profit model case analysis
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Research on the Threshold Effect of China’s Pharmaceutical Export Trade on Internal and External R&D Investment
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作者 Qiao Jiahui Song Yu +1 位作者 Gong Jingran Chen Yuwen 《Asian Journal of Social Pharmacy》 2024年第2期135-146,共12页
Objective To study the threshold effect of export trade on internal and external R&D investment in China’s pharmaceutical industry,and to provide reference for some pharmaceutical enterprises to improve the inves... Objective To study the threshold effect of export trade on internal and external R&D investment in China’s pharmaceutical industry,and to provide reference for some pharmaceutical enterprises to improve the investment.Methods The panel data of pharmaceutical industry in 25 provinces and cities in China from 2009 to 2019 were selected to conduct empirical analysis by establishing a threshold regression model,and a better export trade interval was obtained.Results and Conclusion There is a threshold value for the effect of new product export on both internal and external R&D expenditures,and the threshold values are 845.2788 million yuan and 318.4198 million yuan,respectively.There is a single threshold effect of export trade on both internal and external R&D investment in China’s pharmaceutical industry,and the effect of export trade on internal and external R&D investment changes from negative to positive as the export trade develops from low to high. 展开更多
关键词 pharmaceutical industry threshold effect export trade R&D investment
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Research on the Status Quo and Countermeasures of Human Resource Management Outsourcing in China’s Pharmaceutical Enterprises
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作者 Wang Jianing Wang Shuling 《Asian Journal of Social Pharmacy》 2024年第1期64-71,共8页
Objective To explore the current situation of human resource management outsourcing in China’s pharmaceutical enterprises,and to put forward some suggestions for enterprises and the government.Methods The current sit... Objective To explore the current situation of human resource management outsourcing in China’s pharmaceutical enterprises,and to put forward some suggestions for enterprises and the government.Methods The current situation of human resource management outsourcing in China’s pharmaceutical enterprises was analyzed through the method of literature research.Results and Conclusion At present,the status of human resource management outsourcing in China’s pharmaceutical companies is that the level of human resource outsourcing companies is not high,and there are no relevant industry norms and laws.The information asymmetry between pharmaceutical enterprises and outsourcing companies results in adverse selection and moral hazard.Besides,the different culture of pharmaceutical enterprises and outsourcing companies leads to inefficient communication between enterprises and employee.To solve these problems,the government should promote and improve industry norms and laws to regulate the market.In addition,enterprises should clarify the motivation for outsourcing and make good decision on the outsourcing content.Meanwhile,enterprises should strengthen communication with employees to eliminate employees’concerns. 展开更多
关键词 pharmaceutical enterprise human resource management outsourcing countermeasure research
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The Development and Experience of American Pharmaceutical Industry Associations and Its Enlightenment to China
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作者 Zhang Yuanyuan Tian Lijuan 《Asian Journal of Social Pharmacy》 2024年第3期237-243,共7页
Objective To study the development history and current situation of pharmaceutical industry associations in the United State and to provide reference for China’s pharmaceutical industry associations.Methods Literatur... Objective To study the development history and current situation of pharmaceutical industry associations in the United State and to provide reference for China’s pharmaceutical industry associations.Methods Literature research and comparative study were used to investigate the development history and current situation of pharmaceutical associations in the United States.Then,their characteristics and experiences were summarized.Some countermeasures and suggestions were put forward for the existing problems of pharmaceutical associations in China.Results and Conclusion The institutional environment of pharmaceutical associations in the United States is relatively good,reflecting the characteristics of emphasizing process management and neglecting entrance management with and the help of public supervision.At the same time,the government advocates market competition by adhering to the market-oriented services for the public.American pharmaceutical industry associations have strong innovation capacity and perfect credit system.Drawing on the experience of pharmaceutical industry associations in the United States,China should strengthen the construction of pharmaceutical industry associations.Firstly,the supervision mechanism should be improved.Secondly,these associations should have good partnerships with the government and offer the public the best services.Finally,the fund-raising mechanism of pharmaceutical industry associations should be optimized to ensure the innovative development of the pharmaceutical industry. 展开更多
关键词 pharmaceutical industry association development history social co-governance
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Research on the Influence of Government R&D Funding and Enterprise R&D Investment on the Innovation Efficiency of Pharmaceutical Industry
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作者 Zhang Xuefeng Jia Zheng +2 位作者 Fu Shuyong Zhang Dawei Xing Hua 《Asian Journal of Social Pharmacy》 2024年第4期361-370,共10页
Objective To study the effect of government R&D funding and enterprise R&D input on innovation efficiency of China’s pharmaceutical industry.Methods Based on the inter-provincial panel data of China’s pharma... Objective To study the effect of government R&D funding and enterprise R&D input on innovation efficiency of China’s pharmaceutical industry.Methods Based on the inter-provincial panel data of China’s pharmaceutical industry from 2009 to 2019,the stochastic frontier analysis method was used to study the influence of government R&D funding and enterprise R&D input on the innovation efficiency.Results and Conclusion With 1%increase in government R&D funding,the innovation efficiency of enterprises will increase by 0.122%.When R&D investment increases by 1%,innovation efficiency will increase by 0.169%.Both government R&D funding and enterprise R&D investment promote the innovation efficiency of pharmaceutical enterprises,but the increase of enterprise R&D investment contributes more to the improvement of pharmaceutical innovation efficiency. 展开更多
关键词 government R&D funding enterprise R&D investment pharmaceutical industry enterprise innovation efficiency stochastic frontier analysis
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《Asian Journal of Pharmaceutical Sciences》刊物简介
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《沈阳药科大学学报》 CAS CSCD 北大核心 2020年第5期F0002-F0002,共1页
《亚洲药物制剂科学》杂志,即Asian Journal of Pharmaceutical Sciences(AJPS,ISSN 1818-0876,CN 21-1608/R)创刊于2006年,为亚洲药学联盟(AFPS)的官方杂志,是由沈阳药科大学主办,Elsevier出版的全英文双月刊,是中国第一个被SCIE收录... 《亚洲药物制剂科学》杂志,即Asian Journal of Pharmaceutical Sciences(AJPS,ISSN 1818-0876,CN 21-1608/R)创刊于2006年,为亚洲药学联盟(AFPS)的官方杂志,是由沈阳药科大学主办,Elsevier出版的全英文双月刊,是中国第一个被SCIE收录的药剂学学术期刊。名誉主编为日本东京永井基金会Tsuneji Nagai教授、日本愛知学院大学Yoshiaki Kawashima教授和沈阳药科大学崔福德教授。 展开更多
关键词 Asian Journal of pharmaceutical Sciences 《Asian Journal of pharmaceutical Sciences》
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Association Between Independent Auditor Fees and Firm Value: A Study of Brazilian Public Companies
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作者 Antonio Lopo Martinez Arquimedes de Jesus Moraes 《Journal of Modern Accounting and Auditing》 2014年第4期442-450,共9页
This article investigates the relationship between fees for audit and non-audit services with Tobin's Q. Using a sample of Brazilian public companies in the period from 2009 to 2011, we estimate the association betwe... This article investigates the relationship between fees for audit and non-audit services with Tobin's Q. Using a sample of Brazilian public companies in the period from 2009 to 2011, we estimate the association between Tobin's Q and the auditors' remuneration scaled by total assets. Additionally, to strengthen the conclusions, we present a second model with the remuneration of the auditors in absolute terms. The results suggest a significant relationship between Tobin's Q and audit and non-audit fees, positive and negative, respectively. Specifically, increases in audit fees and non-audit fees respectively increase and decrease the Tobin's Q of the audited company. The results of this study have important implications for those interested in good corporate governance practices. Managers and board members concerned with value carefully evaluate the remuneration and nature of services creation, when engaging independent auditors, should provided. 展开更多
关键词 audit fees non-audit fees Tobin's Q
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Research and Prospect of Quality Development of Pharmaceutical Technology in Drug Research and Development
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作者 Bei Zhang Zongchao Ning 《Journal of Advances in Medicine Science》 2021年第1期48-52,共5页
Pharmaceutical technology is an indispensable and important link in drug research and development,which plays a key role in drug research and development quality.In the background of science and technology development... Pharmaceutical technology is an indispensable and important link in drug research and development,which plays a key role in drug research and development quality.In the background of science and technology development,pharmaceutical technology has been greatly developed,but also to promote the quality of drug research and development,to provide more guarantee for people’s health.In the new era,how to achieve pharmaceutical technology innovation,so as to further improve the quality of drug research and development,is an important research topic in the current related industries.This paper mainly revolves around quality of pharmaceutical technology development of a series of exploration,in the traditional drug development based on a better control of drug quality,the future of smart pharmaceutical green pharmaceutical development direction,aims to further enhance the pharmaceutical technology,promote the quality of research and development to promote the comprehensive,promote the steady development of the pharmaceutical industry as a whole. 展开更多
关键词 Drug research and development pharmaceutical process Quality development Intelligent pharmaceutical Green pharmaceutical
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Study on the Genetic and Physiological Toxicity of Wastewater from a Pharmaceutical Factory Using Root Tip Micronucleus Technology of Vicia faba 被引量:1
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作者 陈枫 朱铁钢 《Agricultural Science & Technology》 CAS 2013年第7期1041-1043,共3页
ObjectiveThe aim was to assess genetic and physiological toxicity of wastewater from a pharmaceutical factory using root tip micronucleus technology of Vicia faba. MethodThe pollution of wastewater from a pharmaceutic... ObjectiveThe aim was to assess genetic and physiological toxicity of wastewater from a pharmaceutical factory using root tip micronucleus technology of Vicia faba. MethodThe pollution of wastewater from a pharmaceutical factory was detected by using root tip micronucleus technology of Vicia faba, and the genetic and physiological toxicity of the wastewater to Vicia faba was assessed. ResultNon-processed wastewater had an extremely high level of biological toxicity; the cells were unable to live with the wastewater at a high concentration; the cells were able to grow with the wastewater at a low concentration, though the micronucleus ratio was extremely high. The processed wastewater had no significant impact on cell growth, but the micronucleus ratio was extremely high, showing that the processed water also had a high pollution index. ConclusionThe research could provide scientific references for the national treatment of wastewater from a pharmaceutical factory. 展开更多
关键词 Waste water from a pharmaceutical factory Root tip of Vicia faba Micronucleus ratio Pollution index Genetic toxicity
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Effects of Influencing Factors on Fenton Oxidation of Antibiotic Pharmaceutical Wastewater by a Statistical Design Approach 被引量:1
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作者 赵俊杰 祁佩时 +1 位作者 刘云芝 林娜 《Journal of Donghua University(English Edition)》 EI CAS 2013年第1期26-33,共8页
A series of batch-scale experiments were completed to investigate the effects of operational parameters on chemical oxygen demand (COD) removal by Fenton reagent for antibiotic pharmaceutical wastewater (APW). The sig... A series of batch-scale experiments were completed to investigate the effects of operational parameters on chemical oxygen demand (COD) removal by Fenton reagent for antibiotic pharmaceutical wastewater (APW). The significance of five operational factors including the mass ratio of H2O2/COD (g/g), the mole ratio of H2O2/Fe2+ (mol/mol), initial pH, oxidation temperature T, and reaction time t were evaluated statistically by Box-Behnken design (BBD). It was found that the five parameters were all significant to the COD removal efficiency by t-test, as well as the interactions between mass ratio/reaction time and oxidation temperature/reaction. The optimal COD removal efficiency (89.50%) was achieved when the mass ratio of H2O2/COD and the mole ratio of H2O2/Fe2+ were 3.00 and 5.00 respectively, with pH value of 3.68 at 298K for 72min reaction. A quadratic regression model with 0.9907 regression coefficient (R2) was developed which had good agreement to the experimental data. 展开更多
关键词 Fenton oxidation response surface methodology (RSM) Box-Behnken design (BBD) antibiotic pharmaceutical wastewater (APW)
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Online pharmaceutical process analysis of Chinese medicine using a miniature mass spectrometer: Extraction of active ingredients as an example 被引量:1
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作者 Wangmin Hu Junling Hou +4 位作者 Wenjing Liu Xuan Gu Yulei Yang Hongcai Shang Mei Zhang 《Journal of Pharmaceutical Analysis》 SCIE CAS CSCD 2023年第5期535-543,共9页
The automation of traditional Chinese medicine(TCM)pharmaceuticals has driven the development of process analysis from offline to online.Most of common online process analytical technologies are based on spectroscopy,... The automation of traditional Chinese medicine(TCM)pharmaceuticals has driven the development of process analysis from offline to online.Most of common online process analytical technologies are based on spectroscopy,making the identification and quantification of specific ingredients still a challenge.Herein,we developed a quality control(QC)system for monitoring TCM pharmaceuticals based on paper spray ionization miniature mass spectrometry(mini-MS).It enabled real-time online qualitative and quantitative detection of target ingredients in herbal extracts using mini-MS without chromatographic separation for the first time.Dynamic changes of alkaloids in Aconiti Lateralis Radix Praeparata(Fuzi)during decoction were used as examples,and the scientific principle of Fuzi compatibility was also investigated.Finally,the system was verified to work stably at the hourly level for pilot-scale extraction.This mini-MS based online analytical system is expected to be further developed for QC applications in a wider range of pharmaceutical processes. 展开更多
关键词 Process analytical technology TCM pharmaceuticals Miniature mass spectrometry Online analysis
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Treatment of Wastewater from Pharmaceutical Intermittent Production by Fe/C-Fenton-Hydrolysis Acidification-A/O Process 被引量:1
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作者 Zhai Jian Jiang Chunhua +2 位作者 Wang Ya Zhang Jingjing Wang Yina 《Meteorological and Environmental Research》 CAS 2018年第1期71-74,82,共5页
The design and running effect of treatment of wastewater from pharmaceutical intermittent production by iron-carbon(Fe/C)-Fentonhydrolysis acidification-anoxic/aerobic(A/O)process were introduced.The results of co... The design and running effect of treatment of wastewater from pharmaceutical intermittent production by iron-carbon(Fe/C)-Fentonhydrolysis acidification-anoxic/aerobic(A/O)process were introduced.The results of continuous operation showed that when the flow rate of the influent wastewater was 300 m^3/d,after the influent high-concentration wastewater(CODCrand NH4+-N concentration were 35 000 and 1 000 mg/L,respectively)and medium-concentration wastewater(CODCrand NH4+-N concentration were 1 500 and 100 mg/L,respectively)were treated by the process,CODCrand NH4+-N concentration in the effluent decreased to 360-410 and 20-25 mg/L,respectively,and the quality of the effluent could meet the Grade III standard of Integrated Wastewater Discharge Standard(GB 8978-1996).The combined process was proved to be an effective method to treat wastewater from pharmaceutical intermittent production,and its operation was stable. 展开更多
关键词 Iron-carbon micro-electrolysis Fenton reagent Hydrolysis acidification Anoxic/aerobic Wastewater from pharmaceutical intermittentproduction
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Clinical Application and Pharmaceutical Values of Levant Cotton Root
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作者 郭宝生 王凯辉 +3 位作者 刘素恩 赵存鹏 王兆晓 耿军义 《Agricultural Science & Technology》 CAS 2014年第2期248-250,共3页
Levant cotton root is a folk traditional herb with a long history in China. This article gave a brief introduction on recent research work related to main com- position, pharmacologic effect and clinical application o... Levant cotton root is a folk traditional herb with a long history in China. This article gave a brief introduction on recent research work related to main com- position, pharmacologic effect and clinical application of levant cotton root and pro- posed existing problems and countermeasures for pharmaceutical industrialization. 展开更多
关键词 Levant Cotton Root pharmaceutical values Clinical application
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Viable but Non-culturable Bacteria in Bioreactorbased Pharmaceutical Wastewater
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作者 邹艳艳 付惠玲 +4 位作者 陈雅红 翟竟余 韦彦斐 梅荣武 丁林贤 《Agricultural Science & Technology》 CAS 2014年第8期1299-1303,共5页
We aimed to investigate the composition and phylogenetic rela-tionships of the viable but non-culturable (VBNC) state bacteria in pharmaceutical wastewater. [Method] Soil filter was used for constructing bioreactor.... We aimed to investigate the composition and phylogenetic rela-tionships of the viable but non-culturable (VBNC) state bacteria in pharmaceutical wastewater. [Method] Soil filter was used for constructing bioreactor. Based on the resuscitation- and growth-promoting function of Resuscitation Promoting Factor (Rpf) for VBNC bacteria, VBNC bacteria were isolated by most probable number (MPN) method and dilution-plating method and 16S rRNA gene phylogenetic analysis was carried out. [Result] In MPN culture system, Rpf could promote the resuscitation and growth of some bacteria. There were VBNC advantage floras that sensitive to Rpf in pharmaceutical wastewater. The culturable VBNC bacteria in pharmaceutical wastewater consisted of high-GC gram-positive actinomycetes including genera Mi-crobacterium, Gordonia and Leucobacter, and gram-negative bacteria including gen-era Candidimonas, Xanthobacter and Aminobacter. Four strains (ZYM1, ZYM3, ZYZR4, ZYXR1) could be potential novel species. [Conclusion] This research re-vealed there were VBNC bacteria in pharmaceutical wastewater. These results could provide important ideas and methods for further studies on VBNC bacteria in the pharmaceutical wastewater, especial y the formation mechanism and recovery mech-anism of VBNC bacteria and the advanced degradation process improvement of pharmaceutical wastewater. 展开更多
关键词 pharmaceutical wastewater BIOREACTOR VBNC bacteria Rpf 16S rRNAgene phylogenetic relationship
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A strategy for population pharmaceutical quality assessment based on quality by design 被引量:2
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作者 Yu Zhao Changqin Hu +2 位作者 Shangchen Yao Lihui Yin Xiaomei Ling 《Journal of Pharmaceutical Analysis》 SCIE CAS CSCD 2021年第5期588-595,共8页
From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for populatio... From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distribution,batch-to-batch difference and abnormal quality probability.After that rules for risk assessment were established based on the SPC limitations and parameters.Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality.Finally,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend tracking.The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production processes.In addition,a process risk assessment and population quality trend tracking provide databased information for approval.Not only can this information serve as a further basis for decisionmaking by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse reactions.With continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation. 展开更多
关键词 Population pharmaceutical quality Quality by design(QbD) Crucial evaluation attributes(CEAs) Process indicators(PIs) Improved statistical process control(SPC) Risk assessment
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