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Objective:To introduce the construction and practice of the Clinical Research Coordinator(CRC) management system based on the whole process of the clinical trial project in Ninth People′s Hospital of Shanghai Jiao Tong University School of Medicine.Methods:Constructed CRC management system with hospital features, including the management of admission, examination, training, emergency, and evaluation.Results:CRC management system was put into practice, and investigators, sponsors, and drug clinical trial institutions were highly satisfied with clinical trials using this system.Conclusions:With the gradual formation of CRC industry norms and consensus, the standardized management of CRC can promote the development of China′s pharmaceutical industry.
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Objective To provide reference for anti-infection treatment and individual pharmaceutical care in patient on peritoneal dialysis. Methods The plasma concentration of vancomycin in patient on peritoneal dialysis was monitored by clinical pharmacists. The anti-infection treatment plan was evaluated and adjusted according to the bacterial culture and drug sensitivity results of the abdominal dialysis fluid. The adverse reactions of pancytopenia induced by vancomycin were documented. Results Infection in the patient on peritoneal dialysis was effectively controlled. The related indicators of pancytopenia were improved. Conclusion A case of pancytopenia induced by vancomycin in the patient on peritoneal dialysis was analyzed to get clinical staff's attention to this adverse reaction and improve the safety of vancomycin administration.
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Lianhuaqingwen (LHQW) capsule, a herb medicine product, has been clinically proved to be effective in coronavirus disease 2019 (COVID-19) pneumonia treatment. However, human exposure to LHQW components and their pharmacological effects remain largely unknown. Hence, this study aimed to determine human exposure to LHQW components and their anti-COVID-19 pharmacological activities. Analysis of LHQW component profiles in human plasma and urine after repeated therapeutic dosing was conducted using a combination of HRMS and an untargeted data-mining approach, leading to detection of 132 LHQW prototype and metabolite components, which were absorbed
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Objective To prepare the etoposide chitosan micelle, and investigate the effect of chitosan on etoposide intestinal absorption.Methods The etoposide chitosan micelle was prepared by dialysis.The drug encapsulation efficiency and drug loading efficiency were determined by HPLC.The intestine in rats was cannulated for in situ recirculation.The effects of different chitosan doses on the intestinal drug absorption and the effects of chitosan on the drug absorption at different intestinal locations were studied.Results The average particle size of etoposide chitosan micelle was 139.5 nm.The multi-dispersion coefficient was 0.569.The standard curve of etoposide was A =8 436.8 C-4963.8,r=1.0000.The intra-and inter-day precision values meetthe requirement.The drug encapsulation efficiency was (47.3±2.84)% and drug loading efficiency was (1.10±1.27)%.With the increase of the chitosan concentration, the absorption capacity of the unit area in the whole intestine was increased in different degrees.Chitosan exhibits its effects on etoposide absorptionat different intestinal sections in the following order: ileum>jejunum>duodenum.Conclusion Chitosan promoted etoposide absorption induodenum, jejunum and ileum, especially in jejunum and ileum.
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Objective To investigate the effect of Kanglaite injection (KLT) on immunological function of rat models with Lewis lung carcinoma. Methods Forty C57BL/6 mice were used to establish Lewis lung carcinoma models and divided randomly into the high dose(25 mL/kg), middle dose (12.5 mL/kg) and low dose (6.25 mL/kg) of KLT groups and model group(n=10). The mice in the KLT groups were sacrificed after injecting corresponding dose of KLT with intraperitoneal injection for 14 d. No treatment was performed on the rats in model group. The body weight, tumor and spleen weight was weighed, then the ratio of tumor restriction and the index of spleen was calculated. MTT colorimetric method and ELISA were used to detected activity of T cell proliferation and expression of IL-2 in spleen. The expression of NF-κB and IκBα protein was detected by Western blot. Results The ratio of tumor restriction in the high, middle, low dose of KLT groups decreased gradually. The indexes of spleen of the high and middle dose of KLT groups were higher than those in the model group (P<0.05 or P<0.01).Compared with the model group, the activity of T cell proliferation in the high, middle, low dose of KLT groups and the expression of IL-2 in the high and middle dose of KLT groups was increased significantly (P<0.05 or P<0.01). The expression of NF-κB protein in the nuclei of high, middle, low dose of KLT groups increased dose-dependently, and the expression of NF-κB and IκBα protein in the cytoplasm decreased dose-dependently. ConclusionKLT could enhance immunological function by effecting T cell proliferation, expression of IL-2, NF-κB and IκBα, while restricting tumor growth in Lewis lung carcinoma models.
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Objective: To select suitable conditions for prokaryotic expression and purification of rhIL-17. Methods: rhIL-17 was expressed in E. coli host under heat induction. After compared among the expression amounts in different media under different heat induction time, the most suitable conditions was selected. The target protein was present in the form of inclusion body. The precipitate of inclusion was obtained and purified after 6M guanidine solublization or 2% SDS solublization. Results: Either protocol could yield rhIL-17 with high purity and stable activity. The SDS solublization mehthod gives rise to much more higher productivity than the guanidine solublization method. Conclusion: rhIL-17 were expression in E. coli system and purified to homogenicity by SDS solublization methods with high productivity.