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.

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.

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

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.

Objective To study the effect of Chinese medicine combined with large dose interferon in the postoperative adjuvant therapy of malignant melanoma of the skin.Methods A high dose of interferon alpha-2b (GanLeneng) (1200 IU/per day) was used in 20 cases of malignant melanoma of skin for 7 days.One course of treatment was 3 months,8 consecutive courses of treatment and traditional Chinese medicine (0.25 g) were administered 1 hour before meals,2 times a day,taking three weeks per month.Results One patient in 20 cases of patients did not receive timely treatment and resulted in death.The remaining patients were were still live from 2012 to the present.Local and distant metastasis lesions disappeared during the course of treatment.Conclusions Traditional Chinese medicine combined with high-dose interferon in cutaneous malignant melanoma as adjuvant treatment plays an important role.

Objective To compare the effect of active compression-decompression cardiopulmonary resuscitation(ACD-CPR) with standard- cardiopulmonary resuscitation(S-CPR) on ventricular function in a canine ventricular fibrillation model. Methods Ventricular fibrillation was induced in anesthetized and instrumented canine. Twenty-four dogs were randomly assigned to either ACD-CPR group or S-CPR group.After 4 minutes of untreated VF,two-dimension echocardiography was used to evaluate the left ventricular end-diastolic volume(LVEDV),left ventricular end-systolic volume(LVESV) and left ventricular ejection fraction (LVEF) of every canine of the two groups when they were undergoing cardiopulmonary resuscitation. Results During ventricular fibrillation, both ACD-CPR group and S-CPR group showed decreased LVEDV compared with pre-ventricular fibrillation, but not statistically significant( P ＞0.05).LVEDV was increased in ACD-CPR group compared with S-CPR group, but not statistically significant (P＞ 0. 05). Both ACD-CPR group and S-CPR group showed significantly increased LVESV compared with pre-ventricular fibrillation,of which the difference was statistically significant ( P ＜0. 001). Both ACD-CPRgroup and S-CPR group showed significantly decreased LVEF compared with pre-ventricular fibrillation,of which the difference was statistically significant (P ＜0. 001). LVEF was increased in ACD-CPR group compared with S-CPR group,of which the difference was statistically significant ( P = 0.019). Conclusions Compared with S-CPR,ACD-CPR resulted in higher LVEF.

OBJECTIVE： To study the pharmacokinetics of domestic carvedilol and relative bioavailability of carvedilol capsule in Chinese volunteer.METHODS： Eight volunteers orally took a single dose of 30mg test preparation and 25mg control preparation in a random crossover and self-control method.Samples were determined by RP-HPLC fluorescent method.RESULTS： Profiles of carvedilol in vivo could be described as open two-compartment model.The main pharmacokinetics parameters of test and control preparations were as follows： Cmax（98.89± 27.60） ng/ml、 （70.06± 27.29） ng/ml， Tmax（0.4 849± 0.2 635） h、 （0.6 037± 0.1 707） h， CL（0.1 621± 0.08 057） （mg· h） /（ng· ml） 、 （0.1 796± 0.09 198） （mg· h） /（ng· ml） ， V/F(c)（0.2 127± 0.1 260） mg/(ng· ml)、 （0.2 777± 0.1 860） mg/（ng· ml） ， T1/2β （2.011± 1.709） h、 （1.959± 1.156） h， AUC（233.1± 97.12） ng/（ml· h） 、 （168.0± 70.61） ng/（ml· h） ； Mean relative bioavailability in man was (111.3± 15.18)％ .CONCLUSION： The results can be used for design of therapeutic scheme.

Objective　To study the ultrastructural changes of 8 human fetus hearts of different months Method　by TEM and SEM chemical digestion. Results　The shape and ultrastructure of myocytes became complicated gradually with development. Conclusion　All the changes are related to function of blood supply of human fetal heart.