OBJECTIVE:To facilitate the construction of Chinese pharmaceutical profession associations. METHODS: We analyzed the current situation and problems existing in Chinese pharmaceutical profession association as well as the developmental experience of foreign pharmaceutical associations then put forward suggestions for the development of pharmaceutical profession associations in China. RESULTS & CONCLUSIONS: The sound development of pharmaceutical profession associations calls for the cooperated efforts of government, profession association and pharmaceutical enterprises, meanwhile its function as bridge and tie between pharmaceutical enterprises and government should be brought into full play.

OBJECTIVE:To provide references for Chinese drug distribution reform.METHODS:The drug distribution model in USA was briefly introduced and compared with that in China.The difficulties and orientations in Chinese drug distribution reform were put forward.RESULTS &CONCLUSIONS:Drug distribution reform should be carried out cautiously.Our government should deal well with the relationships between different interested parties and set up a reimbursement mechanism in medical institutions in order to facilitate the reform.

OBJECTIVE:To further perfect the discipline theory of pharmaceutical administration in China.METHODS:The processes and methods of the discipline theory construction of pharmaceutical administration was studied by deductive theory and‘taking root’theory.RESULTS&CONCLUSION:The pharmaceutical administration theory is characterized by diverse and empirical,to make it improved,more research work needs to be done.

OBJECTIVE:To study the consistency policies of generic drugs in China,America and Japan comparatively,and provide reference for perfecting quality and efficacy consistency evaluation of generic drugs in China. METHODS:Generic drugConsistency evaluationQuality evaluationDESIwere used as keywords to search the related literatures or information of ge-neric drugs published or reported in CNKI,Web of Science,Elsevier,Springer database and USA FDA website during Jan. 1st, 1950-Jun. 30th,2016. And comparative analysis was conducted for the historical background,evaluation methods and policy influ-ences of consistency policies of generic drugs in China,America and Japan. RESULTS:There were differences in the historical background,evaluation methods,major participants and policy influences of consistency policies of generic drugs in China,Ameri-ca and Japan. The evaluation for generic drugs in USA was reevaluation of the drugs effectiveness under the history of drug registra-tion regulation was imperfect. With experts'review,it was evaluated based on FDA,enterprises,scientific literature evidence and experts review. Main evaluation method was in vitro dissolution test in Japan. The consistency evaluation of generic drug in China focused on the generic drug marketing authorization,mainly using in vivo bioequivalence. And the standards of reference prepara-tions were from the basically similar drugs to the original drugs. CONCLUSIONS:Compared with innovation-based countries like America and Japan,the availability of reference preparations in China is low,and policy environment is more complex. China should further improve the laws and regulations,giving reasonable buffer period,considering the diversity of evaluation methods, exemptions in special circumstances and current situation of pharmaceutical industry,paying attention to the balance between techni-cal supervision and system supervision.

MicroRNA-451 (miR-451) is significantly lowly expressed in glioma,gastric cancer,colorectal cancer,liver cancer and other tumor tissues.Upregulation of miR-451 can significantly inhibit tumor cell proliferation,invasion and metastasis as well as increasing tumor cell apoptosis and improving radiotherapy and chemotherapy sensitivity and other biological effects.

Objective To optimize the formulation of self-microemulsifying drug delivery systems containing tanshinone ⅡA(tanshinone ⅡA-SMEDDS) and assess the quality of tanshinone ⅡA-SMEDDS. Methods Pseudoternary phase diagrams were used to choose the oil,emulsifier,co-emulsifier,and their proportion in the formulation on the basis of the ability to form emulsions and regions. Then the self-emulsifying time,droplet and morphology,size distribution,?-potential,stability,and other aspects of the quality were evaluated. Results The formulation of tanshinone ⅡA-SMEDDS was as follows:ethyl oleate-Labrasol-PEG 400=10%:45%:45%,drug loading ratio was 2.25 mg/g. The self-microemulsifying time of tanshinone ⅡA-SMEDDS in 0.1 mol/L hydrochloric acid solution was less than 1 min,the emulsion drops were spherical shape with average particle size of (84.9?2.1) nm and the average ?-potential (-24.0?1.15) mV (n=3). So tanshinone ⅡA-SMEDDS was stable. Conclusion In this paper,the tanshinone ⅡA-SMEDDS has a good self-emulsifying performance. It is expected to further stabilize the preparation of tanshinone ⅡA self-microemulsifying agents.

Objective: To evaluate the feasibility of performing muscle-sparing thoracotomy and intercostal sutures in the treatment of upper and/or middle thoracic esophageal cancer for the purpose of tumor control and postoperative quality of life improvement.Methods: Seven patients with esophageal cancer were treated with vertical muscle-sparing thoracotomy and Mckeown esophagectomy.Detailed clinic data were summarized and analyzed with patient follow-up information.Results: Of the 7 patients,five were still alive with a 71.4% five-year survival rate.There were no deaths resulting from the operation in this group.The mean length of thoracic incision was 11 cm.The range of hospital stays was 14 to 25 days,with a mean length of 18 days.No patients complained of impaired shoulder action,and the incision pain was hardly perceived without external stimulation 1 month after operation.Conclusion: Performing the muscle-sparing thoracotomy in the treatment of early-stage esophageal cancer located in the upper and /or middle thoracic segment yields a satisfactory long-term survival rate with an improved life quality in terms of incision pain relief and shoulder function.

Objective To investigate the methods of preoperation diagnosis and treatment of primary gastric lymphoma of mucosa-associated lymphoid tissue(MALT).Methods To analyze retrospectively the diagnosis and treatment of 54 cases of MALT lymphoma diagnosed surgically and pathologically.Results The most common symptoms were stomachache or discomfort.Of the patients with MALT lymphoma,85.2%(46/54)cases were diagnosed by preoperation gastroscopy with biopsy.Helicobacter pylori was found in 48 cases(88.9%).The overall resection rate for MALT lymphoma was 87%(47/54).The 5-year and 10-year survival were 77.1% and 72.9%,respectively.Conclusions It is obvious that MALT lymphoma is associated with Helicobacter pylori.Since no specific symptoms in gastric MALT lymphoma,the preoperative diagnosis is relied upon the application of gastrointestinal image,gastroscopy and repeated biopsy.The use of curative resection with the post-operative chemotherapy and/or radiotherapy to treat MALT lymphoma is reasonable.

OBJECTIVE:To put forward some suggestion to improve drug bidding system in China.METHODS:The process of drug bidding system reform and its common problems were analyzed.Game theory and information asymmetry theory were adopted to analyze the root of the problems and to put forward suggestions.RESULTS:Governments indiscriminately expanded the goals of bidding policy and strengthen price factor.They neglected important steps such as logistics distribution.Current single evaluation system can not count the medication order exactly.Delayed received payment of medical institution resulted in many problems of drug purchase.CONCLUSION:Centralized drug bidding system should be improved and enhanced.It also should be connected with relevant medical system reform to standardize drug circulation channels,reduce drug price and reduce the burden of patient.

OBJECTIVE:To provide suggestions for the revision of regulations on drug import and export stated in Pharmaceutical Management Law.METHODS:The Federal Food,Drug and Cosmetic Act(FD&CA) and regulations and procedures on drug import & export were reviewed.Then literature analysis and comparison research were adopted in study.RESULTS:Complete legal system for drug import and exports were established in USA.With multiple revision and supplement,items in FD&CA were comprehensive and explicit,which standardized the behavior of import and export and increased sales.CONCLUSIONS:The management for drug import and export should further be strengthened in China with a focus on improving Pharmaceutical Management Law.The most important thing is to implement full supervision on drug imports with flexible import procedure and regulations,and enhance the management for exporting drugs and specific medicines.