In order to further s tandardize the clinical application of proton pump inhibitors and provide reference for prescription suitability review ，under the guidance of Guiding Principles for Clinical Use of Proton Pump Inhibitor which was promulgated by the General Office of National Health Commission of the People ’s Republic of China ，Pharmaceutical Admini- stration Committee of Chongqing Hospital Association initiates “the formulation Project on Prescription Review Rules for Proton Pump Inhibitors ”. The First Affiliated Hospital of the Army Medical University takes the lead and cooperates with clinical experts ， pharmaceutical experts and evidence-based experts from many domestic medical institutions to discuss the indications ，usage and dosage，medication for special groups and drug interactions of proton pump inhibitors ，and finally forms this consensus. The main contents of the consensus include the basic prescription review rules of omeprazole ，esmeprazole，pantoprazole，rabeprazole， lansoprazole and iprazole （including injection and oral preparations ，calculated by common name ），and 12 prescription review recommendations for some clinical applications not covered on the basic prescription review rules ，in order to provide reference for medical institutions at all levels.

Modern Chinese medicine is the combination of traditional Chinese medicine (TCM) theory and modern pharmaceutical technology, and is an important carrier to realize the scientification, standardization, and internationalization of TCM. Since the founding of the People's Republic of China, the modern Chinese medicine has made outstanding achievements, but there are still many problems to be solved. This paper focuses on the resources of Chinese medicine, treatment principle, quality markers, health industry, and other issues, analyzes several key aspects of research and development in the process of modern Chinese medicine, and puts forward some solutions. It is willing to discuss with partners, and jointly promote the healthy development of the industry.

OBJECTIVE: To investigate FDA issued lists and guidance on Bioequivalence Recommendations for Specific Products related with Narrow Therapeutic Index Drugs.METHODS: FDA issued lists and Bioequivalence Recommendations for Specific Products related with Narrow Therapeutic Index Drugs was investigated in multiple aspects, including detailed drugs lists, bioequivalence study designs, selection of bioequivalence subjects,analytes to measure,bioequivalence waiver, selection of reference products.RESULTS: Keeping updated lists and Bioequivalence Recommendations for Specific Products relative with Narrow Therapeutic Index Issued by FDA are to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment.CONCLUSION: Narrow therapeutic index list and Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since CFDA have not released similar list and guidance on specific narrow therapeutic index.

OBJECTIVE To investigate the effect of TiO2 nanoparticles on overcoming cancer multidrug resistance(MDR). METHODS: Doxorubicin-TiO2 nanoparticles(DTN) were prepared, the K562/DOX cells were chosen as the model cells. And doxorubicin solution(F-DOX) and doxorubicin liposomes(DOX-L) were also prepared as the control. The MTT assay were measured, and the amount of doxorubicin in the K562/DOX cells at different time were determined by HPLC. The P-gp expression were detected by flow cytometry. RESULTS: The MTT assay shows that IC50 of group DTN were lower than that of group F-DOX. The uptake test shows that amount of doxorubicin in K562/DOX cells of group DTN was 1.23 times of group DOX-L when in 4 h, and the efflux test shows that amount of doxorubicin in K562/DOX cells was 1.18 times of group DOX-L. The flow cytometry result revealed that the effect of TiO2 nanoparticles on overcoming MDR maybe through down-regulating the expression of P-gp in K562/DOX cells. CONCLUSION: The TiO2 nanoparticles are a new inorganic materials-based nanoparticles which promising approach to overcome MDR.

OBJECTIVE: To investigate the influence of tripterygium glucoside tablet on the pharmacokinetics of atorvastatin in rats. METHODS: Twelve rats were equally randomized to two groups (six rats in each group), including the atorvastatin-only group (A) and the tripterygium glucoside tablet and atorvastatin group (B). Animals in group A were administered according the oral dose of 2 mg·kg-1; and animals in group B were administered at an oral dose of atorvastatin (2 mg·kg-1)and tripterygium glucoside tablet (2 mg·kg-1). Blood samples were collected into a heparinized tube via the oculi chorioideae vein at different time points after drug administration, and the plasma concentration of atorvastatin were determined using HPLC-UV. Finally, the pharmacokinetic profiles of atorvastatin were calculated and compared. RESULTS: Compared with the atorvastatin-only group(A), the pharmacokinetic parameters of the tripterygium glucoside tablet and atorvastatin group(B) have changed greatly. ρmax of atorvastatin increased from (4.77±0.64) to (7.79±0.61) mg·L-1, and AUC0-t increased from (12.82± 3.50) to (27.39±5.76) mg·h·L-1, at the same time, tmax was extended from (0.25±0.03) to (0.52±0.07) h, t1/2 was prolonged from (2.39±0.19) to (5.09±1.35) h, MRT was extended from (2.93±0.23) to (4.36±0.44)h. It indicates that the metabolism of atorvastatin may be suppressed. CONCLUSION: The RESULTS indicate that tripterygium glucoside tablet could influence the pharmacokinetics of atorvastatin when atorvastatin and tripterygium glucoside tablet are used concomitantly. This study could be used for clinical medication guidance of tripterygium glucoside tablet and atorvastatin to avoid the occurrence of adverse reactions.

OBJECTIVE: To investigate similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. METHODS: The comparisons of these bioequivalence recommendations were performed and based on bioequivalence study designs, selection of bioequivalence subjects,dosage, selection of reference products, method of pharmacokinetic calculations and bioequivalence acceptance limits, bioequivalence waiver on multiple-strength products and and implementation of the Biopharmaceutics Classification System, which are issued by Australia, the European Medicines Association, Japan,the USA, and the World Health Organization. RESULTS: There were lots of differences were found in bioequivalence approaches among the regulatory authorities surveyed, although there are more similarities. CONCLUSION: Discussion of the similarities and differences among bioequivalence approaches used by international regulatory authorities would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China.

OBJECTIVE: To investigate Guidance for Industry Bioequivalence Recommendations for specific products issued by FDA. METHOD: Combination with FDA and CFDA issued guidance related to Bioequivalence (up to May 20th, 2016), 185 FDA issued Guidance for Bioequivalence Recommendations for Specific Products were discussed, which are involved in the CFDA announced initial list of the equivalence assessment of quality and curative effect for generic products. RESULTS: Bioequivalence Recommendations for Specific Products issued by FDA is to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment, as an extension and implement to the guideline involved in the aspect of bioequivalence. CONCLUSION: Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since CFDA haven't released similar guidance on specific products yet.

Objective: Exhaustive search is the basis for meta-analysis and evidence based medicine (EBM). The validity of searches can be confirmed by evaluating the core journals included in the search results. Core journals also exert significant influence because they serve as the hub of each discipline. However, the qualitative relationship between core journals and published articles has not been fully evaluated; therefore, core journals were selected for clinical articles on respiratory infectious diseases and were evaluated for their quality.Methods: We searched PubMed for clinical articles in three areas: drugs for respiratory infections, drug resistance, and vaccines. The core journals were selected based on Bradford’s Law. The quality of the selected articles was further assessed using the double-blind and randomized controlled trial (RCT) methods.Results: The Bradford curve that was created displayed a high R2 accuracy of 0.9971, 0.9981, and 0.9953 at the linear portion. Evaluation of the research quality of selected core journals revealed a statistically high quality in the field of respiratory infections and vaccines; however, no statistically significant difference was observed in the field of resistant bacteria.Conclusion: With exceptions in some areas, the quality of publications tended to be higher when core journals were selected based on Bradford’s Law. Different evaluation methods are required for fields unsuitable for randomization or blinding. In the future, it will be vital to consider evaluation methods for core journals according to the characteristics of the studies.

Objective To investigate the current situation and existing problems of community chronic disease management in China and provide a theoretical basis for community chronic disease management to reduce the mortality and economic burden. Methods Research papers on community chronic disease management published in Chinese academic journal network from January 2010 to January 2020 were selected. Literature co-occurrence analysis system software, Bicomb2.0, and SPSS were used for data extraction and analysis based on publication years, geographical distribution, funding sources, etc. Results 1 427 papers were included. Most papers were published in the recent three years (2017—2019), with an average of 206.7 papers per year. 1 347 papers in Chinese (94.4%) and 80 in English (5.6%) were published in 436 journals, and 24.5% were funded. Hot topics are community health services, health management, diabetes and hypertension management, influencing factors. Conclusion Community chronic disease management has drawn a lot of attention in China. Economically well-developed provinces invested more on community chronic disease management. Universities are the main research institutions. Most researches are still at the exploratory stage.

The purpose of this study is to investigate whether regular visits to community pharmacies to take medications contributes to the prevention of frailty in the elderly and whether it also contributes to the improvement of leftover medications. The patients showed a significant increase in the number of steps taken after interventions, and the frailty index using J-CHS criteria also showed a significant improvement after interventions. In addition, two patients were found to have leftover medications, but improvement was observed after interventions. In the post-intervention patient satisfaction survey, all seven patients responded positively to the following questions: “Effectiveness of medication management,” “Improvement in medication adherence,” “Improvement in physical condition,” “Increase in the number of outings,” “Increase in the amount of exercise,” and “Appropriateness of the number of visits.” On the other hand, two patients responded negatively to the following questions: “Improvement of sleep,” and “Improvement of diet.” As a result, it can be inferred that this initiative is beneficial for the prevention of frailty in elderly patients.