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Li X.-F.,National Institute for the Food and Drug Control | Guo T.,National Institute for the Food and Drug Control
Chinese Journal of Biologicals | Year: 2011

Rotavirus (RV) is an important pathogen of severe diarrhea in infants worldwide. Since there is no specific drug for RV infection, the development of safe and effective vaccine is of important significance. In the three kinds of domestic and imported commercial RV vaccines, Rotarix is of type G1P [8]. Since RV type G1 is epidemic widely, this paper reviews the status of Rotarix. Source


Liu M.-L.,National Institute for the Food and Drug Control | Wei N.-Y.,National Institute for the Food and Drug Control | Zhou Y.,National Institute for the Food and Drug Control | Ma S.-C.,National Institute for the Food and Drug Control
Chinese Journal of New Drugs | Year: 2012

Objective: To establish a method for detection of the residual solvents in bulk torasemide, such as methanol, dichloromethane, toluene and 1, 4-dioxane. Methods: The residual solvents in torasemide were determined by gas chromatography (GC) with HP-5 capillary column (30 m × 0.53 mm, 1 μm) with FID detector and with nitrogen as the carries gas. The injector temperature was 220°C; the detector temperature was 240°C; the column temperature rose by program, that was, the initial temperature was 40°C, maintained for 10 min, raise to 200°C at a rate of 40°C · min -1, and then maintained for 3 min. The flow rate of N 2 was 5 mL · min -1. Results: The solvents were completely separated, and the calibration curves of each solvent had good linear relationship within a certain range. Conclusion: This method is accurate and reliable. It can be applied in detection of residual solvents in torasemide. Source


Song A.-J.,National Institute for the Food and Drug Control | Xu S.-H.,National Institute for the Food and Drug Control | Li X.-H.,National Institute for the Food and Drug Control | Nie J.-H.,National Institute for the Food and Drug Control | And 4 more authors.
Chinese Journal of Biologicals | Year: 2013

Objective: To evaluate the quality of the fourth generation of domestic screening kit for HIV in blood samples. Methods: Thirty-three batches of the fourth generation of kits for combined screening of HIV antigen and antibody in blood samples, manufactured by seven manufacturers (A-G) from March 2012 to March 2013, were evaluated by using national references for HIV-1 p24 antigen and HIV antibody. The changing tendency of S/Co values of weak positive national reference P5 for HIV-1 p24 antigen tested by kits A (imported), B and C was analyzed. The coefficients of variation (CVs) of test results of P5 as well as strong positive national reference 18 and moderate positive national reference 19 for HIV-2 antibody by the three kits were analyzed, based on which the theoretical minimum detection limits were calculated. Results: All the kits met the requirements for national references. Non-specific positive results were found in all the kits except A and C. Both the test results by domestic and imported kits were stable, and no abnormal results (more than ± 3 SD) were observed. The CVs of interassay of national references P5, 18 and 19 were not more than 25%. The inter-precision of kit A (imported) was higher than those of domestic kits of the same kind. The mean minimum detection limit of national reference for p24 antigen was 3.2 IU/ml. The minimum detection limit of 82% (27/33) of kits were less than the acceptable criteria of national reference panel for HIV-1 p24 antigen, while 70% (23/33) than that for HIV antibody. Conclusion: The qualities of the fourth generation of domestic screening kit for HIV in blood samples manufactured from March 2012 to March 2013 in China met the current national requirements, while the minimum detection limit and inter-precision should be further improved as compared with those of imported kits. Source

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