OBJECTIVE:To study the consistency policies of generic drugs in China,America and Japan comparatively,and provide reference for perfecting quality and efficacy consistency evaluation of generic drugs in China. METHODS:Generic drugConsistency evaluationQuality evaluationDESIwere used as keywords to search the related literatures or information of ge-neric drugs published or reported in CNKI,Web of Science,Elsevier,Springer database and USA FDA website during Jan. 1st, 1950-Jun. 30th,2016. And comparative analysis was conducted for the historical background,evaluation methods and policy influ-ences of consistency policies of generic drugs in China,America and Japan. RESULTS:There were differences in the historical background,evaluation methods,major participants and policy influences of consistency policies of generic drugs in China,Ameri-ca and Japan. The evaluation for generic drugs in USA was reevaluation of the drugs effectiveness under the history of drug registra-tion regulation was imperfect. With experts'review,it was evaluated based on FDA,enterprises,scientific literature evidence and experts review. Main evaluation method was in vitro dissolution test in Japan. The consistency evaluation of generic drug in China focused on the generic drug marketing authorization,mainly using in vivo bioequivalence. And the standards of reference prepara-tions were from the basically similar drugs to the original drugs. CONCLUSIONS:Compared with innovation-based countries like America and Japan,the availability of reference preparations in China is low,and policy environment is more complex. China should further improve the laws and regulations,giving reasonable buffer period,considering the diversity of evaluation methods, exemptions in special circumstances and current situation of pharmaceutical industry,paying attention to the balance between techni-cal supervision and system supervision.

Objective To observe the protective effect of dexamethasone, the inhibitor of nuclear factor-Kappa B, on the ischemia-perfusion injury of rat lung during the period of lung preservation. Methods Twenty-four rats were randomly divided into two groups: the control group and the trial group. The harvested lung blocks were flushed with and stored in the low-potassium-dextran (LPD) solution in control group, but in the trail group LPD containing dexamethasone solution was used. The lungs were stored at 4 ℃ for 16 h in both groups. The isolated rat lung reperfusion models were established and the donor lungs were perfused for 1 h. PaO_2 and PawP were measured at every 15 min intervals during reperfusion. After reperfusion, the lung tissue wet-to-dry (W/D) ratio and myeloperoxidase (MPO) activity were obtained. The protein and mRNA expression of intercellular adhesion molecule-1 (ICAM-1), nuclear factor-Kappa B (NF-?B) was also detected by using immunohistochemistry and semi-quantitative RT-PCR at the end of reperfusion. Results The levels of decreased PaO_2 and increased PawP in trail group were lower than in control group at the every interval time in the samples obtained 15 min after reperfusion (P

SJAMP and HLAMP are glucose-containing acidic mucopolysacc-harides isolated from sea cucumbers, Stichopus Japonicus and Holot-huria Lecospilota respectively. Their effects on the interaction of thrombin with endothelial cells were studied. Human vascular endothelial cells isolated from umbilical veins treated with 0.1% collagenasc were cultured with MEM medium. The contents of von Willebrand factor (vWF) and 6-keto-PGFla, stable hydrolysis product of PGI,, in the culture medium were measured with ELISA and immunoradioassay technique. The addition of thrombin to confluent monolayer endothelial cells resulted in a significant increase in the release of vWF and 6 ~ keto-PGFla in the culture medium. When heparin,SJAMP or HLAMP was added, no significant amount of vWF or 6~keto-PGFla could be detected in the medium .Whereas preincubation of thrombin with heparin, SJAMP or HLAMP respectively inhibited the thrombin-induced vWF and 6-keto-PGF 10 release and this effect was well correlated with the dose of heparin, SJAMP or HLAMP, indicating that SJAMP, HLAMP as well as heparin had inhibitory effect on the interaction of thrombin with endothelial cells

The antimutagenicity of 14 compounds, cysteine (1), cinnamic acid (2), rutin (3), tannic acid (4), germanium dioxide (5),fluoro uracil (6), sodium copper chlorophylline (7),?-sitosterol (8), vitamin C (9), coumarin (10), vitamin E (11), L-glutathine (oxidized form) (12), L-glutathine (reduced form) (13) and organic germanium (14), were investigated using Salmonella typhimurium/microsome assay in TA100.Three modes of action, i.e. inhibitory, antimutagenic and desmutagenic effects, were observed-for their antimutagenicity. Results showed that all of test compounds inhibited mutagenicity induced by MNNG and B(a)P with the exception of germanium dioxide. Percent inhibition of compounds 1, 2, 3, 4, 6, 8, 10 and 12 were greater than 90%. 14 compounds exhibited antimutagenic effects on the mutagenic activity of MNNG, and 12 compounds exhibited antimutagenic effects on B(a)P. Germanium dioxide and organic germanium had no such effect. 14 compounds all exerted desmutagenic effects on B (a)P directly before B(a)P acted on cells. According to the potential and modes of action, cysteine, cinnamic acid, rutin, tannic acid and coumarin were better among 14 compounds. The doseresponse relationships of inhibitory and antimutagenic effects on mutation induced by MNNG and B(a)P were found. Each compound has its sufficient range of dosage. These studies suggest that it is necessary to select effective antimutagens to make mixtures, and their synergistic effects should be investigated.

Objective To evaluate the protective effect by inhibiting nuclear factor-kappa B (NF-?B) by N-acetyl-L-cysteine(NAC) on donor rat lung. Methods 24 SD rats were randomly divided into two groups, the control group and the experiment group. The harvested lung blocks were flushed with and stored in the low-potassium-dextran (LPD) solution in control group, but in the experiment group, LPD solution containing NAC was used. The lungs were preserved at 4℃ for 16 hours in both groups. Isolated rat lung reperfusion models were established and the donor lungs were perfused for 1 hour. PaO_2 and PAwP were measured at every 15 min intervals during reperfusion. After reperfusion, the lung tissue wet-to-dry (W/D) ratio and myeloperoxidase(MPO) activity were obtained. The protein and mRNA expressions of intercellular adhesion molecule-1(ICAM-1) and nuclear factor-kappa B(NF-?B) were also observed by using immunohistochemistry and semi-quantitative RT-PCR at the end of reperfusion. Results After reperfusion for 60 minutes, in experiment group, PaO_2 drop in and increase PAwP lower than in control group (P

Objective To report a new minimally invasive and cosmetic approach for atrial septal defect repair. Methods 46 patients ranged 3.6 to 32 (12.5?7 7) years underwent minimal right vertical infra axillary thoracotomy for atrial septal defect repairs under beating hearts from January 1997 to March 2000. One had a functional single atrum,two had an associated partial anomalous pulmonary venous connection,and three had the moderate pulmonary hypertension. Results The average bypass time was (30 3?7 8) min. There was no operative or late mortality and no morbidity directly related to the thoracotomy with beating heart. 37 patients had been Followed up for 3 months to 2 4 years(1 3?0 6) years. All of patients were free of symptoms. Conclusions The minimal right vertical infra axillary thoracotomy is a safe,cosmetic and minimal invasive approach to median sternotomy for repair of atrial septal defect or anomalous pulmonary venous connection.

Lux reporter plays an important role in molecular biology,clinical microbiology and biochemical detection,owing to its high sensitivity,fast reaction and convenience.Here the component,types and characteristics of lux reporter system were introduced.Moreover,the recent advance of its application in environment detection,food safety,new drug discovery and tumor locating were reviewed.

Objective To evaluate the effectiveness of transurethral holmium laser treatment for multiple complex bladder pathological changes.Methods Clinical data of 507 cases of transurethral holmium laser resection for multiple complex bladder pathological changes under endoscope from 2001 to 2005 were retrospectively reviewed.A total of 17 types of bladder pathological changes were encountered,and 2 or more types of pathological changes occurred simultaneously in 111 cases,including 36 cases of 3 types of coexisting changes.Results Primary operation was performed in 505 patients,and two-stage operation was performed in 2 patients.The operation time was 5~35 min(mean,20 min).No obturator nerve reflex and other complications were seen.The operation was accomplished in 3 patients with cardiac pacemaker and 3 patients with coronary stent.Follow-up examinations in all the cases for 12~24 months revealed no relapse.Conclusions Transurethral holmium laser resection for multiple complex bladder pathological changes is safe and reliable.During the procedure,the degree of resection depth in the bladder wall can be precisely controlled.It can be used as the first choice for minimally invasive treatment of multiple complex bladder pathological changes.

Objective To understand the key points of the differential diagnosis between osteitis condensanse ilii(OCI)and early sacroiliitis.Methods From 1997 to 2004,33 cases of OCI were examined with HLA-B27 determination and sacroiliac joint CT scan,and needle biopsy was performed in some cases when needed.Data of clinical history,laboratory,CT scan,as well as pathological examination were collected and analyzed.Results Sacroiliitis was diagnosed in 17(51.5%)cases of the 33 X-ray OCI cases either by CT scan or by pathological examination.Clinical features of these 17 cases included:(1)HLA-B27 was positive in more than 80%of these cases;(2)The age in these cases was younger than that in the OCI cases;(3)About 1/3 of these cases were male,and most of the female were unmarried and nanparous;(4)Most of the cases were with the signs of sacroiliits;(5)? globulin/ ESR/CRP/alkali phosphatase were elevated in most cases.However,among OCI cases,the prevalence of HLA-B27 was similar to general population;all of the cases were female;most of them were pluripara,and few cases were with the signs of sacroiliitis or laboratory abnormalities.Conclusion In X-ray OCI,many cases might be early sacroiliitis.Attention should be paid to avoid misdiagnosis.

Objective To study pathological feature of sacroiliitis of spondyloarthropathies (SpA) in different stages,and improve the threshold of early diagnosis of SpA.Method Samples of sacroiliac joints (SIJ) of 8 patients with ankylosing spondylitis (AS) and 5 patients with undifferential spondyloarthropathies (uSpA) were taken when SIJ steroid injection was performed.The pathological feature was studied.Results Synovitis,including lining cell hyperplasia and inflammatory cell infiltration in looseconnective tissue,local cartilage degeneration,fibrosis and inflammatory cell infiltration in subchondral bony plate and marrow cave were found in 6 (86%,6/7) samples in patients with normal/suspectable SIJ CT scan.In the CT Ⅱ and Ⅲ degree sacroiliitis,marked degeneration and fibrosis of cartilage,inflammatory cell infiltration,pannus formation and subchondral bony plate destruction were increasingly prominent.In the advanced sacroiliitis (CT Ⅳ degree),destruction and calcification of cartilage and subchondral bony plate were the major feature.Eosinopil (EO) was increased in the infiltration cells of synovium and subchrodral bony plate in 3 samples.Conclusion Synovitis,including hyperplasia of lining cell and the infiltration of inflammatory cell in loose connective tissue,and local cartilage degeneration and inflammatory cell infiltration,and destruction of subchondral bony plate are the early changes identified in sacroiliitis.Pathological examination can improve the threshold of early diagnosis of sacroiliitis in case it cannot be confirmed with CT scan.