By analysis on existing problems of the classification, the suggestions were put forward to provide a reference for improving the classification of medical devices.
Equipment and Supplies ; classification

AIM: To prepare Ganmaoqing micro-pills (Rhizomaer Radix Baphicacanthis Cusiae. Folium Isatidis, etc). METHODS: Extruded-spheronizing granulator and fluidized coating-machine were applied for Ganmaoqing micro-pills' production. RESULTS: According to the method mentioned above, the content of Ganmaoqing micro-pills wasreached 96.27% paracetauol in labelled indicator. CONCLUSION: The method is feasible and convenient, the result is extract with stable quality.

Objective To investigate the effect of lipid ultrasonic microbubble on the cellular absorption rate of antiparallel phosphorothioate triplex-forming oligonucleotide(TFO) and the expression of the tissue factor(TF) in endothelial cells.Methods The GT21-apsTFO,specific to the gene sequence of the shearing stress response element,was synthesized and the lipid ultrasonic microbubble carrying TFO was constructed.The ECV304 cells were divided into 4 groups:control group(SSRE),received shear stress only for 6h;TFO+ ultrasonic irradiation group(TFO+U),treated with 60?l TFO in final concentration of 0.2?mol/L and ultrasonic irradiation for 30s simultaneously;TFO-lipid microbubble group(TFO-M),treated with 60?l lipid microbubble loaded with TFO in final concentration of 0.2?mol/L;and TFO-lipid microbubble + ultrasonic irradiation group(TFO-M+U),treated with 60?l lipid microbubble loaded with TFO(final concentration was 0.2?mol/L) and ultrasonic irradiation for 30s simultaneously.Cells in the last 3 groups were treated with shear stress for 6h with pressure of 1.2Pa 24h after transfection.The fluorescent microscope was used to observe the cellular absorption rate of TFO.The immunofluorescence method and RT-PCR were employed to determine the protein and mRNA expressions of TF.Results The transfection efficiency of the TFO was higher in TFO-M+U group(38.83%?6.52%) than in TFO-M group(9.50%?2.88%) and TFO+U group(12.66%?3.01%,P

Objective To observe the change of nitric oxide(NO) content and explore its cell source following brain ischemic injury. Methods We established the model of transient global brain ischemia/reperfusion (IR) in rat. The concentration of NO and its cell source were investigated by detection of NO content, NDP histochemical staining, double label technique of immunofluorescence and stereological analysis after brain ischemia. Results (1)The content of NO increased at 12 h and peaked on days 1～3 after IR. The content of NO decreased gradually on the 5th day after IR. (2)The density of NDP positive cells increased and peaked on the 1st day after IR. The positive cells distributed mainly in the temporal cortex, hippocampus and periventricular zone after IR. The positive cells were found to reduce gradually or disappear on the 14th day after IR. (3)Few NDP positive and GFAP immunofluorescence positive cells were found to coexist at the early period of IR(1～3 d). The percentage of coexisting cells was 10%～15%. Conclusion The content of NO increases at the early period after ischemic brain injury. The main cell type to produce NO is neuron.

Objective To comparatively analyze the HIV disease progression and the death situa-tion between injecting drug users (IDUs) with HIV infection and those with HIV/HCV co-infection.Meth-ods The counts of CD4+T cells were collected through a retrospective study and the data about death situa-tion were collected with follow-up cards from 2006 to 2014 .A statistical analysis was conducted for the two groups .Results Among the 175 cases with HIV infection , the average value of primary CD 4+T cell counts was 370 cell/μl and 25.71%of them, primary CD4+T cell counts were less than 200 cell/μl.The average change rate of CD4+T cell counts was -1.50 cell/μl in month.The annual mortality rate was 18.18%. Among the 325 cases with HIV/HCV co-infection, the average value of primary CD4+T cell counts was 420 cell/μl and 20.45%of them, primary CD4+T cell counts were less than 200 cell/μl.The average change rate of CD4+T cell counts was -2.76 cell/μl in month.The annual mortality rate was 32.14%.The differ-ences between the groups were significant (P<0.05).Conclusion Compared with patients with HIV infec-tion, those with HIV/HCV co-infection showed significantly decreased CD 4+T cell counts , resulting in a faster disease progression and a faster death .It was urgent for the management department to work out HIV prevention and therapeutic measures .

ObjectiveTo study the metastructure volumes of medial temporal lobe in diagnosis the patients with Alzheimer's disease (AD) using 3 dimensional MRI.Methods23 AD patients according to DSM-Ⅳ criteria and 23 normal controls (NC) were examined with 3D-MRI.Hippocampus formation,amygdala,entorhinal cortex ( EC ),perirhinal cortex ( PC),and comu temporale were measured with 3D-MRI.ResultsSensitivity and specificity of diagnosis AD were 73.9％,97％ ( Hippocampus formation) ;39.1％,95.7％ (amygdala) ;73.9％,95.7％ (EC) ;95.7％,87.0％ (PC) and 34.8％,39.1％ ( cornu temporale).Overall discriminate function =cornu temporal × 3.887 + PC × 5.960 - EC × 0.074 + amygdale × 3.489 + hippocampus formation × 6.656- 22.449.Over-all-accuracy was 91.3％.ConclusionThe total volume of PC can better diagnosis the mild to moderate AD than other structure of medial temporal lobe.The changes of the medial temporal lobe volume could be used in diagnosis the patients with Alzheimer's disease.

Immunogenicity for medical devices of animal origin is the key and difficult point during immune safety evaluation for these devices. This paper firstly investigated the effect of collagen sponge of animal origin on mouse splenic lymphocyte transformation and proliferation, and then analyzed the influence factors on the MTT method and CFSE method. The results showed that collagen sponge extract cannot significantly induce transformation and proliferation of mouse splenic lymphocyte in vitro.
Animals ; Cells, Cultured ; Collagen ; pharmacology ; Lymphocyte Activation ; drug effects ; Mice ; Porifera ; chemistry ; Spleen ; cytology

To discuss IC50 application in cytotoxicity tests of medical devices, we firstly investigated the vibrating condition and endpoint of MTT method specified in ISO 10993-5: 2009. Furthermore, we demonstrated the application of IC50 in the result evaluation of MTT method. The experimental results show that usage of IC50 in quantitative evaluation of MTT method is feasible.
Equipment and Supplies ; adverse effects ; standards ; Inhibitory Concentration 50 ; Toxicity Tests ; methods

Objective To explore pathogenic bacteria distribution and drug susceptibility testing results in children with purulent meningitis in Jinan area. Methods A total of 54 children with purulent meningitis were selected from January 2010 to December 2014, the cerebrospinal fluid smear and culture, according to the national standard of clinical inspection technology for bacteria isolation and identification by disc diffusion method for drug sensitive test were retrospectively analyzed. Results A total of 54 strains of pathogenic bacteria including 36 strains of gram-positive coccus, and 17 strains of gram-negative bacillus and one strain of suspected Neisseria meningitides were found. A total of 31 strains gram positive coccus is Streptococcus pneumoniae, and most gram-negative bacilli is E. coli. In the Gram-positive coccus, 61.3% was sensitive to penicillin, and more than 90% was sensitive to ceftriaxone and cefepime, 83.3% was sensitive to meropenem, 94.7% resistant to azithromycin, and 58.1% resistant to oxazocilline. In Gram-negative bacilli, 60% was sensitive to ampicillin sulbactam 71.4% was sensitive to cephalosporin , 57.1% was sensitive to ceftriaxone , 66.6% was sensitive to cefepime. Conclusions From cerebrospinal fluid cultured of purulent meningitis, Streptococcus pneumoniae and E. coli were major pathogenic bacteria in children with purulent meningitis in Jinan area.

Objective To observe the change of plasma neuropeptide Y(NPY) concentration in patients with essential hypertension,and its relevance to target organ damage.Methods The plasma NPY concentration was determined by radioimmunoassay(RIA) in 115 patients with essential hypertension,including 45 patients with single target damage(left ventricle hypertrophy 21,stroke 13,nephropathy 11) and 19 patients with multiple target damage,with 30 normal as controls.Results 1) Plasma NPY concentration in patients with essential hypertension was significantly higher than normal controls(P0.05).Conclusion NPY may involve in the physiopathologic progress of essential hypertension and associate with the development of target organ damage.Evaluation of plasma NPY concentration may be valuable biomarker in estimation the severity of hypertension and target organ damage.