Pharmaceutical excipients are implementing registration and approval management in our country. As the disadvantages of the registration system appearing continuously, the demand for reform is getting higher and higher. The cry for drug master files ( DMF) model instead of registration and approval management is becoming more prominent. Based on the understanding of DMF sys-tem, the article discussed the positive roles of the excipients standards and guidelines construction in DMF implementation using phar-maceutical excipients supervision experience in the United States as the reference and starting from the standards and guidelines system of excipients, which aimed to provide suggestions for the supervision and management of pharmaceutical excipients, and improve the quality and safety of pharmaceutical excipients and drugs.

Objective To evaluate the diagnostic value of DCE-MRI and breast MR reporting and data system(BI-RADS-MR)in differentiation of breast lesions. Methods Seventy-five patients with 75 pathological-confirmed breast lesions underwent DCE-MRI before treatment and DCE-MRI quantitative analysis. Two senior doc-tors assessed the imaging features blindly by BI-RADS-MR. The pathology results were set as a gold standard. The receiver operating characteristic curve(ROC)interpretation of two physician′s curve analysis was used to evaluate the sensitivity,specificity of BI-RADS classification. Results According to the BI-RADS MR score,38 breast cancer patients were rated as 1 case in grade Ⅰ,0 case in grade Ⅱ,4 cases in gradeⅢ,13 cases in gradeⅣ,20 cases in grade V;37 breast benign tumors were rated as 17 cases in grade Ⅰ,5 cases in grade Ⅱ,12 cases in gradeⅢ,3 cases in gradeⅣandⅤ0 cases. The statistical difference of Tpeak,S max,K1 between benign and malig-nant breast tumors were significant(P<0.05). On ROC,the area under the curve was 0.940,95%confidence in-terval was from 0.887 to 0.994. The sensitivity of BI-RADS in the diagnosis of breast cancer was 94.59%and speci-ficity was 92.11%. Conclusion DCE-MRI combined with BI-RADS-MR classification in diagnosis of benign and malignant breast tumors has an important value and can improve diagnosis and differential diagnosis level.

BACKGROUND: Researches show that erythropoietin (EPO) can stimulate the proliferation and protraction of endothelial progenitor cells to form new vessels, so EPO may play an important role in proliferation and differentiation of bone marrow-derived mesenchymal stem cells (MSCs). OBJECTIVE: To explore the effects of EPO on the proliferation and cell cycle of MSCs. DESIGN, TIME AND SETTING: From July to November 2007, the observation of comparative cell trial was performed at the Hematologic Diseases Institute of General Hospital Lanzhou Military Area Command of Chinese PLA. MATERIALS: Bone marrow liquid specimens were provided by voluntary donors. The informed consents were obtained from all patients, and the experiment was approved by Hospital Ethics Committee. METHODS: Using Percoll solution, MSCs were isolated from bone marrow by the method of density centrifugation. Flow cytometry was applied to detect the cell cycles of the second and third passages. MSCs were incubated with different doses of EPO (0.25, 0.50, 1.00, 2.00, 5.00 U/mL) in serum free culture media, and cells cultured with no EPO were regarded as control. All cells were cultured for 24, 48, and 72 hours. MAIN OUTCOME MEASURES: ①Proliferation of MSCs was measured by MTT assays after 24, 48, and 72 hours; ②Cell cycle was measured by flow cytometry assays after incubated with 10 U/mL EPO for 72 hours. RESULTS: After MSCs was incubated with EPO, the cell proliferation index was significantly increased in a dose and time dependent manner. The effects on the proliferation of MSCs were highest in 5 U/mL group. Compared with the control group, EPO could significantly decrease G0 /G1 ratio, and increase S and G2/M stage ratio (P

Purpose To investigate the diagnostic value of multi-slice spiral CT (MSCT) enhanced scanning in borderline and invasive ovarian tumor,and to provide valuable image evidence for clinical treatment.Materials and Methods One hundred and one patients with pathological-confirmed borderline and invasive ovarian tumor in the First Affiliated Hospital of Jinzhou Medical University from October 2012 to October 2016 were selected,and the preoperative abdominal MSCT enhanced imaging,clinical and pathological data were retrospectively analyzed.The MSCT imaging was observed,and the prediction model of MSCT differentiating borderline and invasive ovarian tumor was established.Results The differences of onset age,menopausal status,tumor solid components,maximum diameter,septa and margin were all statistically significant between borderline and invasive ovarian tumor groups (P＜0.05).The prediction model of MSCT differentiating borderline and invasive ovarian tumor was established using multivariate Logistic regression,on the basis of following variables (OR＞l,P＜0.05):tumor size,solid components and septa.The sensitivity and specificity of the prediction model were respectively 81.3％ (95％ CI:0.622-1.000) and 85.7％ (95％ CI:0.741-0.973) in predicting borderline ovarian tumor for patients before menopause,and respectively 92.1％ (95％ CI:0.835-1.000) and 91.7％ (95％ CI:0.761-1.000) for those after menopause.Conclusion MSCT enhanced scanning is helpful to differential diagnose of borderline and invasive ovarian tumor,and it has important significance for clinical treatment and prognosis evaluation.

OBJECTIVE:To discuss the effect of anti-tuberculosis therapy on plasma concentration of calcineurin phosphatase inhibitors in renal transplant recipients.METHODS:The change in plasma concentration of calcineurin phosphatase inhibitors in 2 renal transplant recipients who were complicated with tuberculosis infection before or after renal transplantation was analyzed.The patients were routinely treated with cyclosporine(CsA)or tacrolimus(FK506)+ mycophenolate mofetil(MMF)+ prednisolone(Pred).Monoclone fluorescence polarization immunoassay(FPIA)was employed to determine the concentration of CsA or FK506 in different time point before and after administration of antituberculosis drugs.RESULTS:Plasma concentration of CsA was down-regulated significantly by Rifampicin,and the daily dose of CsA has to be increased to more than 3 times the previous concentration before meeting the target concentration.The concentration of FK506 was slightly down-regulated by rifapentine.CONCLUSION:The concentration of CsA or FK506 and the adverse effect of antituberculotic drugs should be closely monitored for renal transplant recipients complicated with tuberculosis infection.

OBJECTIVE:To study pharmacokinetics of cyclosporine in healthy volunteers, and to investigate the relationship of drug exposure with blood sampling time after treatment. METHODS: The data of trial at the first 12 blood sampling time points after medication were collected from bioequivalence test in 24 healthy volunteers (trial preparation vs. reference preparation). Multiple linear regression analysis was used to study the blood concentrations of cyclosporine at different sampling time points and the area under the blood concentration-time curve (AUC). RESULTS: The concentrations at two points were adopted to estimate AUC. The correlation coefficient of different cyclosporines could reach 0.9 with estimation deviations less than 15%. The AUC of cyclosporine of trial preparation could be estimated by C8 and C12, and that of reference preparation by C2.5 and C12. CONCLUSION: The AUC estimated by concentrations at two points can meet clinical demand. There is great difference in estimate point among different preparations.

According the features of mine sweeping mission and the requirements of the armaments,the compound structure to reflect,absorb,block and attenuate the blast waves and to give dynamic protection against diffracted waves is designed,which is based on the theories of biomedical engineering,explosive mechanics and material mechanics.The calculation through3D nonlinear dynamic finite element and simultaneous tests are used in the de-velopment of the structure.These theories above-mentioned applied to the experiments and medical science com-bined with mechanical engineering,a series of technical problems in the protection against the injuries to human bodies by blast waves,detonations and mine fragments are solved.Through practical application,the outfit has been granted and finalized by Finalization Board of Armaments and given the name GGF110mine sweeping protective outfit.It has been equipped with the army and pointed for the first time to be used by the UN peacekeeping troops.

BACKGROUND: No particular marker molecule of bone marrow mesenchymal stem cells (BMSCs) is presently found, so its determination is difficult. BrdU marker has no radioactive pollution. Some studies have confirmed that BrdU marker has no damage to cell function without ultraviolet radiation. OBJECTIVE: To investigate in vitro identification and labeling methods and biological characteristics of adult BMSCs. DESIGN, TIME AND SETTING: The cell experiment was conducted at the General Hospital of Lanzhou Military Area Command of Chinese PLA between June and December 2007. MATERIALS: Bone marrow was collected from 5 healthy adult volunteers. BrdU was purchased from Sigma, USA. METHODS: 10 mL adult bone marrow was harvested to isolate mononuclear cells by density gradient. Cells were cultured in DMEM containing 10% fetal bovine serum and proliferated at a density of 2?108 L-1. At the third passage, BMSCs was inoculated in medium supplemented with osteoblast inductor and stained with alkaline phosphatase. Subsequently, BMSCs were inoculated in medium supplemented with lipoblast inductor and stained with oil red O. Cells were incubated with BrdU at different concentrations of 5, 10 and 15 ?mol/L for 12, 24, 48, 72 and 96 hours, and then detected by immunocytochemistry. MAIN OUTCOME MEASURES: Cell growth and proliferation were observed under an inverted light microscope. Cell phenotype, osteoblast and lipoblast differentiation were identified by flow cytometry. BrdU-positive labeling rate and cell growth after labeling were investigated. RESULTS: In vitro cultured BMSCs were homogenous population and exhibited a spindle-shaped fibroblastic morphology. BMSCs expressed CD44 and CD71, but did not express CD34 and HLA-DR. BMSCs can differentiate into osteoblasts and lipoblasts. Most BMSCs were labeled by BrdU. With the increase in labeling concentration and over time, BrdU positive rate gradually increased and exceeded 90% after labeling with BrdU (10 ?mol/L) for 72 hours, with the labeling identifiable in nine consecutive passages. At the third passage, 90% BMSCs were in G0/G1 phase, and 88.62% in G0/G1 phase after labeling. BrdU has little effect on morphous and proliferation of labeled cells. CONCLUSION: Adult BMSCs can be identified through morphological character, specific surface antigens and multipotential differentiation in vitro. BrdU labeling provides a feasible means for a dynamic observation of the survival, growth and differentiation of the implanted BMSCs. The optimal dosage and timing of BrdU labeling are respectively 10 ?mol/L and 72 hours.

OBJECTIVE:To provide for rational use of Tripterygium glycosides tablet clinically. METHODS:The utilization of Tripterygium glycosides tablet were collected from hospital information system(HIS)in our hospital during Jun. 2012-Jun. 2014. Then the data about the basic information,patients’age,departments and diagnosis,were analyzed by the Excel. RESULTS:The application of Tripterygium glycosides tablet remained stable since Jun. 2012. There were 4 600 prescriptions in average every year, and the age of patients was distributed from 11 to 90. Tripterygium glycosides tablet was mainly used in rheumatology department (52.11%),followed by TCM rheumatology department(20.62%),skin disease and venereal disease department(18.15%),ne-phrology department(3.52%)and integrated traditional and western medicine cardiology department(1.77%). It was mainly used to treat rheumatoid arthritis,Sjogren's syndrome,polymyalgia rheumatica,osteoporosis and nephrotic syndrome. CONCLUSIONS:The application of Tripterygium glycosides tablet as immunosuppressant is widely used,but the age of patient is with wide distribu-tion;the narrow gap exists between minimum effective dose and minimum lethal dose;so ADR should be concerned closely.

Aiming at the existing problem of inequality and being unscientific in the evaluation of comprehensive quality of medical students, through literature research and expert opinion method, and from multi angles , the author constructed the evaluation index system of comprehensive quality of scientific medicine, using AHP to determine the weights of evaluation indexes, and established a fuzzy evaluation model of the comprehensive quality of medical students, and on this basis, improved the calculation method of fuzzy evaluation and the maximal subjection degree of the evaluation result. The specific examples of the evaluation results showed that the method was effective and could reflect the comprehensive quality of med-ical students in a comprehensive and objective way, and it had great significance to the comprehensive quality evaluation of medical students.