Analysis and Suggestions on National Drug Quality Disclosure System / 中国药房

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.

Discussion on the Quality Risk Reminder Mechanism of Drug Sampling and Testing in China / 中国药房

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.

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 / 中国药房

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.

Effect of clioquinol on aggregation ofβ-amyloid in vitro / 国际药学研究杂志

Objective To study whether the metal chelator clioquinol (CQ) can affectβ-amyloid (Aβ) aggregation directly in vitro and whether this effect could be influenced by Zn2+. Methods In the study thioflavin T (Th-T) fluorescence was used to detect the aggregated Aβ. To eliminate the possible false positive results, the absorption spectrum (300 nm to 600 nm) of CQ was scanned, and a competitive binding assay was applied to determine whether Th-T and CQ had the same binding site on Aβ. Circular dichroism spectroscopy was used to detect β-sheet formation of Aβ. Results CQ could decrease the fluorescence intensity, when incubated with monomer Aβor aggregated Aβfor 24 h. Absorption spectra indicated that CQ had no specific absorption peak at 450 nm and 485 nm. Competitive binding assay showed that CQ and Th-T did not bind the same site on Aβ. CD spectra showed that CQ could decrease theβ-sheet formation of Aβ. When incubated with monomer Aβ, CQ decreased the fluorescence intensity in a dose dependent manner, and the IC50 were 6.1μmol/L (without Zn2+) and 4.3μmol/L (with Zn2+);When incubated with aggregated Aβ, CQ decreased the fluorescence intensity in a dose dependent mannerand, and the IC50 was 7.5μmol/L (without Zn2+) and 6.1μmol/L (with Zn2+). Conclusion CQ can inhibit the aggregation of monomer Aβand depolymerize the aggregated Aβdirectly in vitro. Zn2+has little influence on the effect of CQ on Aβ.

Roles of adenosine receptors in Alzheimer's disease / 药学学报

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.