1.Roles of adenosine receptors in Alzheimer's disease.
Rong YAN ; Zengyao HU ; Wenxia ZHOU ; Qi WANG ; Yongxiang ZHANG
Acta Pharmaceutica Sinica 2014;49(6):751-6
As an important neurotransmitter, adenosine displays its functions by acting on the adenosine receptors. Recent studies have shown that the distribution, expression and balance among subtypes of adenosine receptors are closely related with cognitive activities, and changes of adenosine receptors play key roles in neurodegenerative disorders including Alzheimer's disease. It has been pointed out that prolonged activation of adenosine receptors by high level adenosine may lead to the disturbance of balance among adenosine receptor subtypes. This imbalance mainly performed as increased expression of A2a receptor and decreased expression of A1 receptor, and enhancement of the excitatory signals mediated by A2a receptor and weakened inhibitory signals mediated by A1 receptor. Changes of these two subtypes of adenosine receptors may lead to a lot of disorders of neurological activities which developed into dysfunction of cognition to the end. These findings imply that the potential of maintaining the balance among adenosine receptors on the treatment of AD would facilitate both the revealing of the mechanism and the cure of AD.
2.Analytical Study of the Quality Status of National Drug Sampling and Testing in 2022
Jialiang ZHU ; Ting SUN ; Bilian CHEN ; Nana RONG ; Chong WANG ; Zengyao HU
Herald of Medicine 2024;43(10):1706-1710,后插1
Objective To understand and assess the quality status of national drug sampling inspection in 2022 and the possible risks of drug quality.Methods With the aim of identifying issues and preventing risks,a sampling model of"dispersed sampling,centralized inspection,exploratory research,and comprehensive evaluation"was used to review the historical inspection data of national drug sampling.The overall quality and potential risks of national drug sampling in 2022 were analyzed,with a focus on identifying and examining the main quality problems and risks.Results The average pass rate of the sampling inspection in 2022 was 99.4% .The overall safety situation of China's post-marketing drug quality is stable and manageable,indicating that the drug quality is at a high level.Conclusions By carrying out exploratory studies related to drug safety,authenticity,and efficacy,national sampling plays an important role in comprehensively evaluating the quality status of drugs.It aids in improving the quality control level of drug varieties and industry standards,strengthening quality and safety supervision,combating illegal practices such as adulteration and falsification,and providing public warnings about drug safety.
3.Discussion on the Quality Risk Reminder Mechanism of Drug Sampling and Testing in China
Wen LIU ; Chong WANG ; Jiong ZHU ; Zengyao HU
China Pharmacy 2021;32(21):2575-2580
OBJECTIVE:To provide a reference for further improvi ng the quality risk reminder mechanism of the drug sampling and testing (called“the Reminder ”as for short )in China ,and strengthening the drug quality management. METHODS : The quality risk management situation of the drug sampling and testing were summarized ,and the legal nature ,main content and working procedures of the Reminder were analyzed. The latest data of the Reminder in 2020 were taken as an example to analyze the role of the Reminder in the investigation of potential drug quality risks ,and made the suggestions for existing problems. RESULTS & CONCLUSIONS :Based on legal standards ,China’s drug regulatory departments had carried out exploratory research on drugs that may have quality and safety risks due to drug quality control blind spots or deviations of manufacturing enterprises , and divided them into serious risks and general risks according to the severity of the problems found ,and implemented hierarchical management. The Reminder was an administrative measure for general drug quality risks based on the principle of persuasion first , and did not have sanctions. Its main content covered all the information required for risk investigation and rectification (basic drug information, suggested risk information , contact information , risk discovery methods , troubleshooting and rectification requirements,and responsibilities of local provincial drug regulatory departments ). It involved five responsible parties ,ie. the inspection institution ,China Institute for Food and Drug Control ,National Medical Products Administration ,the provincial food and drug administration of the relevant manufacturing enterprises and the relevant manufacturing enterprises. Through the mode of closed-loop management ,the benign interaction between regulatory authorities and manufacturing enterprises could been realized. In 2020,National Medical Products Administration issued 312 reminders to 286 manufacturers,with an accuracy of 87.91%,which was scientific and targeted. The manufacturer had carried out a series of rectification measures for the contents of the Reminder , including carrying out process verification ,revising internal control standards and strengthening production process control. However, there were also some problems , such as the rationality of the prompt contents being questioned by the manufacturer and the i nsufficient investigation of the manufacturer. It is suggested that the manufacturers correctly understand the nature and value of the Reminder. The inspection agency should further improve the scientific pertinence of the problems found ,while the drug regulatory department should focus on the troubleshooting of the problems found ,so as to jointly promote the improvement of drug quality.
4.Analysis and Suggestions on National Drug Quality Disclosure System
Wen LIU ; Jiong ZHU ; Chong WANG ; Zengyao HU
China Pharmacy 2021;32(23):2817-2821
OBJECTIVE:To provide reference for further improving the national drug quality disclosure system. METHODS : The national drug quality disclosure system was analyzed in respects of general information ,implementation procedure , implementation situation and effects ,and existing problems. The improvement suggestions were put forward. RESULTS & CONCLUSIONS:The national drug quality disclosure system had gone through the bulletin stage ,notice stage and announcement stage. At present ,it had become drug regulatory measure with timely release ,rigorous procedures and sanctions. The process of national drug quality disclosure included five steps ,ie. informing the sampling enterprises of the fact that the drugs were unqualified,controlling the risk of unqualified drugs ,providing legal relief to the notified units ,preparing the contents of the national drug quality notice ,and releasing the national drug quality notice to the public. In recent years ,National Medical Products Administration had made greater efforts to release the national drug quality notice. The release of the national drug quality notice has played an important role on forcing drug manufacturers to improve drug quality and enhance the credibility of drug regulatory departments. However ,there are also some problems ,such as the non-conforming report is not delivered in time ,the tracing time for suspected counterfeit TCM pieces is too long ,and the provincial drug regulatory bureau does not strictly control the first trial of complaints. It is suggested that National Medical Products Administration strengthen the training ,review and punishment of provincial drug regulatory departments ;at the same time ,provincial drug regulatory departments also need to strengthen responsibility and business capacity-building ,pay attention to relevant work and strengthen daily supervision.
5.Comparative Analysis of Test and Retest Contents between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality Sampling and Testing
Wen LIU ; Jiong ZHU ; Jun HU ; Chong WANG ; Zengyao HU
China Pharmacy 2020;31(14):1665-1670
OBJECTIVE:To provide re ference for the relevant personnel of drug quality sampling and testing to understand and implement the new requirements in the Management of Drug Quality Sampling and Testing . METHODS :The test and retest requirements were compared between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality Sampling and Testing. The revised and newly added contents were analyzed ,and the recommendations for implementation were put forward. RESULTS & CONCLUSIONS :Referring to drug regulation need ,related requirements of test and retest in the Management of Drug Quality Sampling and Testing were modified and supplemented on the basis of the Regulation of Drug Quality Sampling and Testing . In the requirements for test ,the requirements for test items were revised ,the requirements for test time limit were confirmed ,the requirements for test report ,original record and quality management system ,the definition of “serious risk ” and its reporting requirements were added newly. The requirements for exploratory research were put forward for test institutions, as well as new requirements for test institutions and inspectors ’behaviors. In the requirements for retest ,the materials to be submitted for retest were revised ,and the identity certificate of the manager and time limit certificate were added ;the situation of no-retest were revised ,and the treatment method were added when obviously visible foreign matters were detected ;transfer requirements for retest report were added newly. It is suggested that the relevant personnel should pay more attention to the above changes,strengthen the construction of test capacity a nd the management of tes t time and quality ,attach importance to serious quality risks ,actively carry out exploratory research ,and mind their own test behaviors ;strictly review retest materials , pay attention to the newly revised no-test and comprehensively transfer the retest report according to the requir ements and actual situation ,conduct and implement the Management of Drug Quality Sampling and Testing actively.