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Objective To improve laboratory research of generic drugs in Chinese pharmaceutical enterprises, avoid the defects in the research process, and explore the feasibility of six sigma management (DMAIC) as improvement model in the process of generic drugs laboratory research. Methods The effectiveness of DMAIC implementation was evaluated through the literature search and case study of a generic API’s process with the DMAIC model. Results The DMAIC model was successfully applied in this case. The model made laboratory research more reasonable, helped R&D personnel to pinpoint key quality attributes and process parameters, etc., ensured the authenticity and completeness of experimental data, and provided valuable data for subsequent industrial production as well as meeting registration requirements. Conclusion DMAIC model can solve the problems, such as poor overall arrangement, poor connection with production, and irregular management. It embodied the idea of Quality by Design (QbD) and can be used as good reference for domestic laboratory research of generic drugs.
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Objective To determine the effect of Nuclear factor-erythroid 2-related factor 2 ( Nrf2 ) on acute hephrotoxicity induced by CCl4 in male rat.Methods 20 male Wistar rats were randomly divided into control group and CCl4 group, 10 rats in each group, another 10 male Wistar rats were transgenic rats microinjection through the carrier, obtained the Nrf2-tk gene integration and specific transgenic rats, as the CCl4 +Nrf2 integration group.The groups was given 1%polysorbate 80 for 4 days,Then the CCl4 and CCl4 +Nrf2 integration group were intraperitoneally injected with a single dose of CCl47.5 mg· kg-1 and were killed 24 h after CCl4 injection.The serum chemical parameters including asparate aminotransferase ( AST) ,alanine aminotransferase ( ALT) and lactate dehydrogenase ( LDH) were measured.Also malonaldehyde ( MDA) ,glutathione ( GSH) ,oxidized glutathione ( GSSG) levels in the liver as well as glutathione ( GSH)/oxidized glutathione ( GSSG ) ratios were detected. Histopathologic changes in the liver were examined. Results F1generation TK transgenic rats in liver and testis and other tissues and organs were not detected the transcription of Nrf2-tk, indicating that Nrf2-tk expression in tissues is specific good.Nrf2 significantly reduced serum AST, ALT and LDH levels in a dose-dependent manner.The results of MDA levels and GSH/GSSG ratios in liver and kidney showed that Nrf2 reduced CCl4-induced hepatic lipid peroxidation,and ameliorated glutathione depletion.The histopathologic results showed that Nrf2 restrained liver and kidney damage induced by CCl4 .Conclusion Nrf2 can effectively protect male rat from acute hepatotoxicity and nephrotoxicity induced by CCl4 .
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Objective To know the situation of the water environment in the Eling Lake Area and provide the theoretical basis for protecting the biosystem of this area. Methods The water samples were collected from the sites 0.5 meters below the water surface of input and output water area, the water area near the east and west bank of the Eling Lake, the center of the lake, and also from the sites 0.5 meters above the bottom of the lake .The water sampling was carried out in August 2005, October 2005 and May 2006. Country standard method was used to determine the physical and chemical characteristics of water samples. The sampling, determination and evaluation in the investigation were according to related standard regulations. Results The water temperature was 5.6 ℃, pH value was 8.49, the total amount of Ca2+ and Mg2+, suspended matter, chlorides, sulfate, DO, COD, BOD5, Cu2+ and Zn2+ were 95.4 mg/L, 87.0 mg/L, 45.0 mg/L, 80.0 mg/L, 7.1mg/L, 11.0 mg/L, 2.0 mg/L, 0.002 mg/L and 0.009 mg/L respectively. Conclusion All of the physical and chemical characteristics of the water samples meet the water quality criterion of the class ruled by GB 3838-2002, and the water can be used as source water.
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Objective To investigate the methods and effects of applying choledochoscope in drainage of retroperitoneal abscess.Methods Eighteen cases of retroperitoneal abscess,who underwent open surgical debridement and drainage or PCD but the drainage was ineffective,were selected for use of choledochoscope to irrigate and debride the abscess repeatedly.Results All of the 18 patients had effective choledoscopic treatment;in 17 patients the abscess healed and drainage catheter was successfully removed;but in one patient,who developed pancreatic fistula,was cured by internal drainage operation performed 6 months later.Conclusions Use of choledochoscope as an adjunctive treatment after drainage operation of retroperitoneal abscess is simple,safe,and effective.