Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.
China ; Clinical Trials as Topic ; standards ; Drug Evaluation ; Drug Therapy ; standards ; trends ; Drugs, Chinese Herbal ; standards ; therapeutic use ; Humans ; Quality Control ; Research

Objective To develop a method to determine trace Pb and Cd in mineral water, tap water and sea water. Methods Pb and Cd in the samples were enriched in the sulphydryl cotton column under the conditions that the pH of the samples was adjusted to 7 and collected by washing the column with 4 ml of 0.2 mol/L HCl solution. The concentration of Pb and Cd was determined by flame atomic absorption spectrophotometry. Results Pb and Cd were not detected in four kinds of mineral water samples, but in tap water and sea water, Pb was 1.56 ?g/L and 0.43 ?g/L, Cd was 0.62 ?g/L and 0.07 ?g/L respectively. The rates of recovery were 96.6%-104.0% and RSD was

AIM:To investigate the effect of Haikun Shenxi Capsule(fucoidan)on disorder of lipid metabolism on the patients with chronic kidney disease(CKD).METHODS:98 patients with CKD 3、4 stage were divided into 2 groups at random:control group were given routine therapy and therapy group were given routine therapy plus Haikun Shenxi Capsule.The changes of the levels of TCH,TG,HDL-Ch,LDL-Ch,VLDL-Ch,ApoA-1,ApoB in 2 groups were observed.RESULTS:The level of TCH,TG decreased significantly(P 0.05).CONCLUSION:Haikun Shenxi Capsule has a positive effect on disorder of lipid metabolism on the patients with CKD.

Background Flickering light is different from the normal light environment.Animal experiment proved that flickering light can induce myopia.But its mechanism remains unclear.Objective This study was to investigate the expression of c-fos gene in retina of myopic C57BL/6J mice induced by flickering light and monocular form deprivation.Methods Ninety clean C57BL/6J mice aged 28-day-old with the similar refraction in both eyes were randomly assigned to five groups.Fifteen mice in the control group were exposed to continuous white light environment.The white flickering light with the frequency of 10,5,2 Hz were used to irradiate the mice respectively in high frequency flickering group (15 mice),moderate frequency flickering group (15 mice) and low frequency flickering group (15 mice),respectively.The right eyes of other 30 mice were monocularly occluded with a semitransparent hemispherical thin plastic shell to establish the form deprivation models and then were exposed to white light environment.The diopter and ocular axial length were measured by murine-specific eccentric infrared photorefraction and A-scan ultrasonography before experiment and two weeks after the treatments.At the end of experiment,the mice were sacrificed by neck dislocation.Mice eyes were enucleated and retinal samples were prepared for the detect of c-fos protein and its mRNA by immunohistochemistry,Western blot and reverse transcription polymerase chain reaction (RT-PCR),respectively.Results Immunohistochemistry showed that the expressing rate ofc-fos protein in retina was (68.000±10.368)％,(51.000±6.519)％,(46.000±6.519)％,(31.000±7.416)％ and (25.000 ± 7.071)％ in the control group,high frequency flickering group,moderate frequency flickering group,low frequency flickering group and form deprivation group respectively 2 weeks after experiment.The expression rates of c-fos protein in retina in different frequencies of flickering light groups and form deprivation group were significantly lower than that in the control group (t =3.104,4.017,6.490,7.661,all P＜0.05),with the lowest rate in the form deprivation group (P＜0.05).The expression of c-fos detected by Western blot assay exhibited that the relative values of c-fos protein in retina (c-fos/GAPDH) was 0.804±0.050,0.687±0.047,0.667±0.036,0.558±0.036 and 0.532 ±0.056,respectively in the control group,high frequency flickering group,moderate frequency flickering group,low frequency flickering group and form deprivation group,illustrating significantly lowing in different frequencies of flickering light groups and form deprivation group compared with control group (t =2.961,3.184,6.971,6.276,all P＜0.05),whereas the c-fos in the low frequency group and form deprivation group,c-fos protein was less expressed in comparison with the higher frequency flicking group (P＜0.05).The expression level of c-fos mRNA (c-fos mRNA/GAPDH mRNA) in retina was 0.820±0.056,0.663±0.061,0.627±0.034,0.521±0.041 and 0.474 ±0.045 in the control group,high frequency flickering group,moderate frequency flickering group,low frequency flickering group and form deprivation group,respectively.These results demonstrated a significant decline in the expression of c-fos mRNA in different frequencies of flickering group and form deprivation group compared with the control group(t=3.262,5.070,7.173,8.305,all P＜0.05),and the inhibition ability of low frequency of flickering group and form deprivation group was much stronger.Conclusions The c-fos gene level in the retina has a negative relationship with the severity of myopia induced by flickering light and form deprivation.

Heparinases,a kind of polysaccharide lyases,can degrade heparin and heparin sulfate to low molecular weight polysaccharides.It has been noted that many bacteria have heparinases although only few of them have been purified and characterized.Heparinases I,II and III from Flavobacterium heparinum have been extensively studied for many years and been commercialized recently.Heparinases have some important applications in the industry and clinic as well as in the determination of heparin structure,which is a very important anticoagulant drug used world-widely.The recent progresses in isolation of heparinase-producing bacteria,genome mapping of heparinase homologs in sequenced bacteria and archaea genomes,purification of heparinases and the study of their biochemistry and regulation were reviewed.The recombinant expression of these enzymes as well as important applications of heparinases and their potential applications in the future will also be highlighted.

Flavonoids are the secondary metabolites of plants , which are found in many plants .Flavonoids have extensive phar-macological actions , such as anti-inflammation, anti-tumor, anti-bacteria and anti-virus, scavenging free radicals , osteoporosis preven-tion and cardiovascular protection .Based on the analysis of relative literatures published at home and abroad in recent years , the mech-anisms of anti-inflammatory effects of flavonoids were reviewed , including arachidonic acid metabolism pathway , cytokine and its recep-tor, cell second messenger, active oxygen, nitrogen monoxide, platelet activating factor and its receptor , nuclear factor, intercellular adhesion molecule and so on .The review aimed to provide theoretical basis for the further development and research .

Aim: To elucidate the structure of an acidic polysaccharide from Cordyceps sinensis and to study its protective effect on renal cell injury by cisplatin. Methods: After Cordyceps sinensis acidic polysaccharide( CAPS) was isolated and purified, the purity and molecule weight were detected by high performance gel permeation chro-matography( HPGPC). Based on the UV spectrum, FT-IR spectrum, monosaccharide composition and GC-MS, the structures were elucidated. Cisplatin-induced injury of Madin-Darby canine kidney( MDCK) cell line was protec-ted by the blood serum with CAPS. Results: The purity of CAPS, with a molecule weight of 2. 7×10~4, was about 99%. It consisted mainly of mannose, glucose and galactose. When the serum with CAPS reached 2.5%, it showed difference compared with the cisplatin group (P <0. 05) on the protective effect of renal cell injury. It showed significant difference( P <0.01) when the serum with CAPS exceeded 5%. Conclusion: CAPS has a pro-tective effect on the renal cell injury in vitro.

Objective To analyze the relationship between clinical competence of baccalaureate nursing students and its potential related factors,and investigate the results of curriculum reform of 4-year nursing undergraduate education.Methods The records of 263 baccalaureate nursing graduates were retrieved.Variables including age,years of college education,sex,college entrance examination scores,average scores of basic courses,average scores of public courses and average scores of professional courses were collected.Clinical competence was measured by the clinical practice tests at various clinical units.The linear regression analysis was performed to find out the influencing factors of clinical competence.Results The clinical competence was significantly related to sex,average scores of public courses and average scores of professional courses(P

Background Oscillatory potentials (OPs) of scotopic electroretinogram (ERG) plays an important role in the evaluation of visual function in multiple retinal diseases.However,the origin of OPs is uncompletely clear.It is essential to analyze the time domain and frequency domain components for the further study of OPs.Objective The present study was to investigate the change characteristics of frequency spectrum of scotopic OPs with age and stimulating intensity.Methods RCS-rdy+-p+rats with the ages of 21,25,32,35,37,46,60,90 days were selected iu this study and 3 rats for each.Scotopic flash ERG were recorded from all the rats with RETI-scan system.Gold-foil ring cornea recording electrode was used as the recording electrode and the steel needle electrode was used as the reference and earth electrode during the record.The intensity of stimulating light was set at-20,-10,-5,0 and 5 dB respectively.Data were output into the computer and processed by the software Matlab7.0.Results The principle frequency corresponding to maximum amplitude component was 80-120 Hz in the various ages of rats under the different stimulating conditions above.With the increase of the intensity of stimulating light,high frequency component (200-250 Hz) began to appear and the amplitudes showed a gradually raise upon the intensity of light.The major component was subdivided into two peaks at 0 dB stimulation.Further,the age affected the major frequency peak with the maximum value at 60-day-old rats and the minimum value at 25-day-old rats.Also,the pass-band width of main amplitude appeared to be maximal at 60-day-old rats and minimal at 25-day-old rats.Conclusions OPs in Rcsrdy+-p+ rats are influenced by stimulating intensity and agc.Stimulating intensity affects the amplitude and age lead to the change of distribution of primary frequency of OPs.It is possible to know the influences of the degeneration of rods and be helpful to diagnosis this kind of disease.

Objective To explore the roles of macrophage inflammatory protein-1?(MIP-1?)in hypoxic-ischemic encephalopathy(HIE)of newborn infarnts.Methods Serum samples were obtained in 24,72 h and 7 d after birth respectively from 34 newborn infants with HIE,and 20 newborn infants without HIE as control group.Enzyme-linked immunosorbent assay(ELISA)method was used to determine the serum concentrations of MIP-1?.Results Levels of MIP-1? in newborn infants with HIE [(12.47?2.51)ng/L]were significantly higher than that of newborn infants without HIE [(8.63?2.63)ng/L](P0.05).Conclusions MIP-1? are involved in HIE of neonates,and the more severe damage,the higher levels in serum,which suggests that,as an inflammatory mediator,the MIP-1? may play an important role in involvement of brain hypoxic-ischemic damage.