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Liu C.,Hebei Medical University | Shi J.,Center for Drug Evaluation of China Food and Drug Administration | Dai Q.,Beijing Normal University | Yin X.,Xuzhou Medical College | And 2 more authors.
Drug Development and Industrial Pharmacy | Year: 2015

Objective: The aim of this study was to investigate the ciprofloxacin liposome of high encapsulation efficiency with optimal physical properties for pulmonary administration and to test its in-vivo potential in rats. Methods: Ciprofloxacin-loaded liposome was prepared by gradient of ammonium sulfate method. The particle size and morphology were determined using a NANOPHOX particle size analyzer and a transmission electron microscope, respectively. Encapsulation efficiency was calculated by UV spectrophotometry. Ciprofloxacin liposome released in vitro was performed using simulated lung fluid. In-vivo studies, pharmacokinetics and pulmonary distribution, HPLC method was established to determine the concentration of ciprofloxacin in rat plasma and lung tissue. The pulmonary pathological section was used to observe the change of pulmonary pathology. Results: The optimized ciprofloxacin liposome, which had a high encapsulation efficiency of 93.96%, and an average particle size of 349.6nm with a span of 0.42, showed sustained in-vitro release. The optimized ciprofloxacin liposome was further examined in the in-vivo study in rats. The concentration of ciprofloxacin in lung and blood was simultaneously determined in each rat. The ratio of the AUClung value between ciprofloxacin liposome and ciprofloxacin solution was 288.33, whereas the relative bioavailability was 72.42%, and the drug targeting efficiency of ciprofloxacin liposome and ciprofloxacin solution by intratracheal administration were 799.71 and 2.01, respectively. Conclusion: Ciprofloxacin liposome for pulmonary administration offered an attractive alternative that was able to deliver high concentrations of antibiotic directly to the chosen target site while minimizing the local irritation. © 2013 Informa Healthcare USA, Inc. Source


Zhang Z.-F.,Center for Drug Evaluation of China Food and Drug Administration
Chinese Pharmaceutical Journal | Year: 2014

METHODS: To collect and retrieve the literature reports, subject summary and case report related to the multiple drug resistance of bacteria both at home and abroad. Summarize, analyze and evaluate the current grim situation for multiple drug resistance in our country as well as analyze the possible reasons, investigate the related successful experience abroad and discuss the basic idea of our country against multiple drug resistance of bacteria.OBJECTIVE: To introduce introduce the basic current status of multiple resistant bacteria in our country, analyze the production and transmission situations of multiple resistant bacteria and discuss the thoughts of our country for the countermeasures for the multiple resistant bacteria.RESULTS: At present, the focus for drug resistance of bacteria in China is still the multiple drug resistance of the methicillin-resistant staphylococcus, streptococcus pneumoniae which is multiple resistant to β-lactams and macrolides and gram-negative bacilli which produce super-broad spectrum β-lactamase and AmpC enzyme and non-fermenting sugar flora. Excessive addition of antibiotics in animal feeding and food fresh keeping, waste residue with high concentration of antibiotics arbitrarily discharged by the manufacturers of antibiotics and long-term, repeated, unprincipled and large dose use of antibiotics in clinical treatment field have resulted in the continuous increasing of antibiotics concentration in human activity space which has become the main reason for the production of drug resistant bacteria as well as promotion of the spread of drug resistance bacteria.CONCLUSION: It is suggested to strengthen the monitoring for multiple resistance bacteria and pay close attention to its development trend, guide and intensify the development for new antibiotics, especially those which are sensitive to gram-negative MDR bacteria. At the same time strengthen the cooperation between each department, establish the production and supply information database of antibiotics for drug resistant bacteria in the country and predict the drug accessibility when sudden drug resistant bacteria infections occur. Establish the contingency plan from the development to production and supply steps of the drug to plan ahead. Source


Huang Q.,Center for Drug Evaluation of China Food and Drug Administration | Wang Y.-Z.,Center for Drug Evaluation of China Food and Drug Administration | Fan Y.,Center for Drug Evaluation of China Food and Drug Administration | Liu X.-Y.,Center for Drug Evaluation of China Food and Drug Administration | Gao R.-X.,Center for Drug Evaluation of China Food and Drug Administration
Chinese Journal of New Drugs | Year: 2014

On September 6th 2013, China Food and Drug Administration(CFDA) issued the 28th notification requiring. It was required that all drug clinical trials approved by CFDA must be registered and made public on the registry and publicity platform. The platform for registry and publicity of drug clinical trials was established by Center for Drug Evaluation. This requirement in accordance with international practice is an important initiative for regulatory agency to enhance the supervision and management of drug clinical trials, promote the openness and transparency of drug clinical trial information, and protect the interests and safety of subjects. The paper will introduce the building process and design thoughts of the platform, and reply the common problems in the registration process, in order to help registrants better understand it and fulfill this work. ©, 2014, Chinese Journal of New Drugs Co. Ltd. All right reserved. Source


Wang Y.-Z.,Center for Drug Evaluation of China Food and Drug Administration | Wang P.,Center for Drug Evaluation of China Food and Drug Administration | Shi J.-F.,Center for Drug Evaluation of China Food and Drug Administration | Liu X.-Y.,Center for Drug Evaluation of China Food and Drug Administration | Huang Q.,Center for Drug Evaluation of China Food and Drug Administration
Chinese Journal of New Drugs | Year: 2015

The registry of clinical trials and publicity of pivotal information are to fulfill not only the ethical requirements of the “Helsinki Declaration”, but also the science and moral obligations of the researchers and regulatory agencies. The China Food and Drug Administration issued the notice in 2013 to require that all the clinical trials conducted in China should be registered and made public of key information on the Platform for Registry and Publicity of Drug Clinical Trials (website: www.chinadrugtrials.org.cn) established by Center for Drug Evaluation to promote and protect the interests of human subject. The publicity significance of clinical trials in respect of ethics, science and morality were introduced in this paper to facilitate and guide the evolving of this work. ©, 2015, Chinese Journal of New Drugs Co. Ltd. All right reserved. Source

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