ABSTRACT
@#At the end of 2022, the National Medical Products Administration (NMPA), in conjunction with the National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College raised for the first time the important issue of clinical research globally: whether the source of the death time of clinical trials based on the simple follow-up records is credible, and proposed a consensus document on the source of the death time of clinical trials. The results were published in The Lancet Regional Health-Western Pacific, which attracted wide attention and recognition from the international industry. This is the first time that the China consensus on quality standards for clinical research has been ahead of the U.S. Food and Drug Administration and other international colleagues. The NMPA has been leading China in promoting the scientific development of clinical research, so as to constantly establish and improve the scientific regulatory system and ecological system, and promote China's full integration into the global pharmaceutical research and development system. China clinical research institutions and the whole industry are also gradually from standardized development to scientific development, high-quality development process. In this study, we summarized the scientific and subject-oriented development of China clinical research industry in recent years, and continuously strengthened the international competitiveness of China pharmaceutical industry. It is suggested that scientific thinking model should be used to deal with the normative problems in clinical research and promote the development of medical model to scientific model.
ABSTRACT
A sensitive high performance liquid chromatography-electrospray ionization-mass spectrometry (HPLC-ESI-MS) method was established for the determination of eplerenone (EP) in human plasma. The plasma samples of EP were extracted with ethyl acetate and separated by HPLC on a reversed phase C18 column with a mobile phase of 10 mmol x L(-1) ammonium acetate water solution-methanol (30 : 70, v/v). EP was determined with electrospray ionization-mass spectrometry (ESI-MS) in the selected ion monitoring (SIM) mode. The calibration curves were linear over the range of 2-4 000 ng x mL(-1) for EP. The lower limit of quantification was 2 ng x mL(-1). The method has been successfully applied in the pharmacokinetic study of the EP tablets. The main pharmacokinetic parameters of EP after oral administration of 25 mg, 50 mg, 100 mg were as follows, t1/2: (4.9 +/- 2.1), (4.7 +/- 1.5), (5.9 +/- 1.2) h; AUC(0-infinity): (4 402 +/- 1 735), (8 150 +/- 2 509), (13 783 +/- 4 102) microg x h x L(-1); and MRT: (6.2 +/- 2.1), (6.6 +/- 1.3), and (7.2 +/- 1.6) h. Parameters of EP after oral administration of multiple doses of 50 mg were as follows, t1/2: (6.1 +/- 1.7) h; AUC(ss): (10 071 +/- 4220) microg x h x L(-1); MRT: (8.1 +/- 2.3) h; and DF: (3.2 +/- 1.0).
Subject(s)
Humans , Chromatography, High Pressure Liquid , Methods , Spectrometry, Mass, Electrospray Ionization , Methods , Spironolactone , Blood , PharmacokineticsABSTRACT
@#Objective To investigate the morphological effect of fluid shear stress on pig iliac endothelium cells cultured solely or co-cultured with pig small intestinal submucosa.Methods The shear stress of 40×10-5 N/cm2 were carried out for 12 h on both groups.The images were recorded every 30 min.The directional angles were calculated.Results In the group of cell cultured solely:The defluvium of cells was obvious at the 1st hour,but the shape of cells didn't change.At the 4th hour,the defluvium of cells was little,the cell became round from its initiatory polygon shape.At the 8th hour,the defluvium of cell could not be observed.The shape of cells became fusiform and gracile.The cells arranged along the direction of flow field in the local area.At the 12th hour,the cells became more and more gracile.The trend of realignment of cells along the direction of flow field was obviously.The directional angles of cells at the 12th hour was significantly different from the zero hour.In the group of cell co-cultured with small intestinal submucosa:At the 1st hour,some of cells were brushed off mildly.The defluvium of cells could not been observed since the 2nd hour.The directional angles didn't change significantly in the 12 hours.Conclusion The shear stress of 40×10-55 N/cm2 cannot influence the cell of co-cultured but do influence the cell cultured solely.