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OBJECTIVE:To put forward suggestions for improving the supervision of phase Ⅳ clinical trials in China. METH-ODS:According to summarizing the post-marketing research in America,FDA's supervision(including key elements,supervision flow,auxiliary supervision system and enforcement measures)for drug post-marketing research in America was analyzed,and sug-gestions for the supervision of phaseⅣclinical trials in China was put forward. RESULTS&CONCLUSIONS:The drug post-mar-keting research in America included post-marketing commitment research(PMR)and post-marketing requirement research(PMC). The key elements included supervision subjects(dealt by Office of New Drugs affiliated to Drug Evaluation and Research Center), key document (including the documents helping FDA and applicants reached a research agreement,and documents for process tracking and supervision in identified studies)and important time node. The supervision flow included developing drafts and review-ing reports. FDA had established PMC/PMR database,which was used as auxiliary supervision system,and relevant enforcement measures were respectively developed for PMC and PMR. Relevant supervision departments in China should converse the supervi-sion ideas,give full play to the government's guidance and supervision,enhance the connection of supervision between pre- and post-marketing,specially develop phase Ⅳ clinical program,establish system for phase Ⅳ clinical trial data,enhance whole pro-cess supervision,draw lessons from"pre-process plan,dynamic tracking in the process,and post-process decision according to law"of FDA to improve the supervision of phaseⅣclinical trials in China.
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OBJECTIVE:To improve the effectiveness of experimental teaching and independent hands-on ability of the students.METHODS:Combined with teaching characteristics of newly established universities,the characteristics of instrumental analytical experiment teaching and the characteristics of pharmaceutical students,flipped classroom and project modular design were applied to instrumental analytical experiment teaching together.The instrumental analytical experiment teaching was expounded and integrated in respects of curriculum content design,teaching implementation and curriculum assessment.RESULTS&CONCLUSIONS:The students achieve the knowledge learning after classroom,and complete the knowledge absorption and mastering in class with the help of video and audio information.It also improved independent learning ability of the students,strengthened the ability of interactive learning and cooperative leafing between teachers and students and among students.It is feasible to apply the flipped classroom and the experimental project modular design in the instrument analytical chemistry experiment teaching reform.This method also can provide some references for the reform of instrument analytical chemistry experiment teaching.
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OBJECTIVE:To provide reference for improving the policies and countermeasures for national essential medicines. METHODS:The existing problems of medicine distribution under essential medicine system were analyzed and countermeasures were put forward. RESULTS:Due to the regional economic environment and industry development level differences,local policy had conflict with national laws and regulations,lacking of systembasis in regulatory process and drug centralized bidding and pur-chasing department weakened responsibility in terms of administrative supervision when performing national essential medicine sys-tem;distribution distribution capability had weakened,distribution enterprise internal management was not standard,the essential medicine storage and distribution process quality showed safety hidden risks in terms of marketization. It is suggested to establish and improve the national essential medicine system overall implementation programs and regional implementation programs,inte-grate medicine distribution market,explore and establish modernized pharmaceutical logistics system,intensify supervision and management of distribution,support distvibution transformation development to reduce social risk and further improve bidding and purchasing mechanism to reduce distribution costs. CONCLUSIONS:The existing problems in distribution can be gradually solved only by further promoting the medical and health system and improving the national essential medicine system.
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This article believed that natural medicine resources in the Three Gorges Reservoir Area are abundant and with modern industrialization development basis through analysis of condition, distribution features and development prospect of natural medicine resources. It argued that natural medicine resources can be the industry with the most sustainable development potential in the Three Gorges Reservoir Area and the efficient path to solve industrial hollowing and surplus labors after immigrants of the area, which can greatly improve and optimize environment of the area. It proposed that the development of natural medicine resources should be closely combined with strong pharmaceutical enterprises;innovation and research centers for natural medicine resources in the area should be established;professional wholesale markets should be built;strong varieties should be developed;standardized quality control system should be set up. All the above mentioned are with the purpose to promote industry standardization and science, and provide references for government rational development and utilization of natural medicine resources.
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OBJECTIVE:To establish a method for the identification of Chongqing local medicinal material Heracleum hemsley-anum. METHODS:The original plant morphology,morphological characteristics,microscopic characteristics (transverse section and powder),were identified. RESULTS:H. hemsleyanum had cone shape root,brown,many-branched with special fragrance;the microscopic characteristics of taproot a transverse showed no differences with lateral root transverse section,primary xylem was di-arch,secondary phloem was more developed than secondary xylem,secondary phloem was rich in the oil chamber. Vascular tissues contained a large number of parenchyma cells. In TLC chromatrogram,the test sample showed the same color fluorescent spots with-the substance reference of osthole and columbianadin in the corresponding locations. CONCLUSIONS:The established method is simple with high accuracy,and can be used as the basis for identification of H. hemsleyanum.
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OBJECTIVE:To compare the contents of osthole and columbianadin in Argelica. pubescens in Wushan county, Wuxi county in Chongqing and other domestic areas in china. METHODS:HPLC was performed on the column of Shiseido Cap-cell Pak C18 with mobile phase of acetonitrile-water(gradient elution) at flow rate of 1.0 ml/min,detection wavelength was 330 nm,column temperature was 30 ℃ and volume injection was 10 μl. RESULTS:The linear range was 0.015 1-0.301 6 mg/ml(r=0.999 9) for osthole and 0.016 7-0.334 4 mg/ml(r=0.999 9) for columbianadin;RSDs of precision,stability and reproducibility tests were lower than 2.0%;recoveries were 98.46%-106.11%(RSD=2.34%,n=9)and 98.24%-102.69%(RSD=1.29%,n=9), respectively. CONCLUSIONS:The method is simple and good reproducibility,and and can be used for the contents determination of osthole and columbianadin in A. pubescens. The contents of osthole and columbianadin in A. pubescens of Wushan county in Chongqing are obviously higher than Wuxi county and other domestic areas in China.