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 explore the effect of gastrodia elata on learning and memory abilities and synaptic transmission protein(P38,Ca2+ -CaMK Ⅱ α,CREB)expression of hippocampus in model rats with Alzheimer's disease(AD).Methods 24 adult Wistar rats were randomly divided into control group,test group and intervention group.A dose of Aβ1-40 was injected into the hippocampus of rats on test group and intervention group,the control rats were injected with normal saline.When the models were successful,the rats of control group and test groups were given with sodium carboxymethyl cellulose(50g/kg),the rats of intervention group were given with gastrodia elata powder( 50 g/kg),lasting 15 days,Morris water maze test was used for learning and memory abilities study.The expression of P38,Ca2+-CaMK Ⅱ α and CREB protein were detected by immunohistochemistry method.Results Behavioral tests showed the mean escape latencies and search time of test group were obviously increased than those of control group and intervention group,the percentage of search distance on test groups was less than that of control group and intervention group(P ＜ 0.01 ).Immunohistochemistry results showed P38,Ca2+- CaMK Ⅱ α and CREB positive cells and optical density in hippocampus CA1 on test group were less than those of control group and intervention group ( all P ＜ 0.01 ) ( P38:58.92 ± 10.82,0.208 ± 0.037 ; Ca2+-CaMK Ⅱ α:72.38 ± 14.67,0.174 ± 0.036 ; CREB:53.86 ±5.31,0.161 ±0.043 in test group;P38:87.32 ±9.56,0.371 ±0.046 ; Ca2+ -CaMK Ⅱ α:98.16 ± 16.29,0.283 ± 0.051 ; CREB:86.76 ± 7.73,0.356 ± 0.052 in intervention group; P38:102.54 ± 16.73,0.563 ± 0.078 ; Ca2 + -CaMK Ⅱ α:123.46 ± 17.65,0.436 ± 0.057 ; CREB:125.43 ±9.16,0.524 ± 0.057 in control group ).Conclusion Gastrodia elata can treat AD by increasing expression of P38,Ca2 + -CaMK Ⅱ α and CREB.

Objective To observe the effect of cerebral blood flow on Broca aphasia patient of cerebrovascular disease by early rehabilitative intervention, to evaluate the result of early rehabilitative intervention, to ques the marker evaluating early effect. Methods 41 Broca aphasia patients were divided to rehabilitation groups (23 patients) and control groups(18 patients) according to the sequence of hospitalization, and meanwhile 37 patients of health examination were chosen as health control groups, the patients of rehabilitation groups were treated with drug and rehabilitative intervention but the patients of control group were treated only with drug, the average cerebral blood flow of left middle cerebral artery of both groups and health control group was examined with transcranium doppler before and after treatment. Results The average cerebral blood flow of left middle cerebral artery of rehabilitation group and control group was not different before treatment, the rehabilitation group and control group was less than health control group; the average cerebral blood flow of left middle cerebral artery of rehabilitation group and control group was increased obviously after treatment than that before treatment; the average cerebral blood flow of left middle cerebral artery was not different between rehabilitation group and health control group after treatment, it was different between control group and health control group; the average cerebral blood flow of left middle cerebral artery was increased obviously on rehabilitation group than that on control group after treatment. Conclusions the early rehabilitative intervention can increase the average cerebral blood flow of left middle cerebral artery of Broca aphasia patient accelerate the functional restoration; TCD can be regarded as an early marker to evaluate early effect.

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 the influence of ion concentration change out of cells on calcium transportation and the relationship between the rising of calcium concentration in the Caco-2 cells and its apoptosis to offer the theoretical and experimental bases for clinical study and digestive tract physiology and patholoogy. Methods Confocal laser scanning microscope(CLSM) and flow cytometry(FCM) were used in this study. Results (1) Diversion of Ca 2+ into cells was increased with the decrease of Fe 3+ concentration out of Caco-2 cells(the final consistence of DFO was 100-300??mol/L),but was hindered with the increase of Fe 3+ concentration out of them(the final consistence fo FAC was 10-100??mol/L) as observed under CLSM; (2) The cell state was fine and its viability was more than 90% as observed under CLSM after treated by A 23187 and Fluo-3/AM(examined with FDA);(3) The Ca 2+ concentration in the Caco-2 cells was increased by A 23187 and this function was dose depended.The Caco-2 cell apoptosis was induced by the increase of Ca 2+ in cells,which was examined with FCM.Conclusion The Ca 2+ transportation was increased with the decrease of Fe 3+ concentration out of Caco-2 cells but was hindered with the increase of Fe 2+ concentration out of them.The Caco-2 cell apoptosis was induced by the increase of Ca 2+ concentration in them.

Objective To explore the effect of vaproate sodium (VP) on Bcl-2 and Bax expression of hippocampus in seizures rats induced by pentylenetetrazole(PTZ).Methods Twenty-four adult Wistar rats were randomly divided into normal control (NC) group, PTZ group and VAP group. A dose of PTZ [35 mg/(kg?day)] was intraperitoneally injected into the rats of PTZ group and VAP group until the kindling criterion was reached. After kindling, the rats of VAP group were administered intraperitoneally with VAP[15 mg/(kg?day)];the rats of PTZ group were administered intraperitoneally with normal saline. After 30 minutes, seizures were induced by administering PTZ intraperitoneally. The influence of VAP on Bcl-2 and Bax immmunoreactivity on hippocampus neurons was studied by immunohistochemistry method.Results Bax positive cells in hippocampus in PTZ group were more than in VAP group and NC group(all P

Objective To study the clinical type and features of cerebral watershed infarction (CWI)in eldedy patients and its relationship with plasma lysophosphatidic acid(LPA).Method Analyzed the clinical data of 106 cases of CWI patients(CWI group)confirmed by cranial MRI,and compared plasma LPA levels in patients with different types of CWI,non-CWI patients(non-CWI group,36 cases)and healthy controls(control group,32 cases).Results In CWI group,anterior-cortex type 22 cases,LPA(4.93±0.72)μmol/L,posterior-cortex type 17 cases,LPA(4.75±0.81)μmoi/L,subcortical type 47 cases,LPA (5.46±1.03)μmol/L,mixed type 20 cages,LPA(6.02±1.12)μmol/L.In non-CWIgroup,LPA(5.37±1.24)μmol/L.In control group,LPA(2.92 ±0.36)μmol/L.The levels of LPA significandy increased in various types of CWI(P<0.05 or<0.01).of which mixed type and subcortical type were the highest,and the level of LPA in mixed type WaS higher than that in anterior-cortex type and posterior-cortex type(P<0.05).The level of LPA in non-CWI group was higher than that in control group,but there wss no significant difference compared with various types of CWI.Conclusions Subcortical type is the primal type in elderly CWI patients,the main cause of which is the atherosclerotic plaque formation and lumen stenosis.Platelet activation and its microemboli play an important role in the pathophysiology.LPA levels are significantly higher in various types of CWI,of which mixed type is the highest.LPA can be used as an important molecular marker to guide the sub-type treatment of CWI in elderly patients.

Objective To study the effect of lipopolysaccharide ( LPS ) on the activity of primary cultured macrophages and the distribution of divalent metal transporter 1 ( DMT1 ) and ferroportin 1 ( FPN1 ) .Methods Primary cell culture , MTT chromotest , cytochemistry chromotest and cell immunofluorescence techniques were used in this work . Results DMT1 was mainly distributed in the cytoplasm , which illuminates that DMT1 mediates the macrophage intracellular transit of iron from phagolysosome to cytoplasm .FPN1 was distributed in the cytoplasm and membrane , and the cytoplasm was the main site of FPN 1 distribution in macrophages .Conclusion Iron liberation from heme inside the phagolysosome occurs after erythrophagocytosis and it is possible that FPN 1 mediates intracellular transit of iron released by heme catabolism .The study found that LPS promoted the cell growth and this effect was reached to the peak in the 10 -5μg/L LPS group, but the cell growth was blocked with the increase of LPS concentration .

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.

Objective To systematically review the efficacy of arthroscopic distal clavicle resection (DCR) in repair of rotator cuff (RCR) with acromioclavicular arthritis.Methods The Cochrane Library,PubMed,Medline EMbase,CBM and WanFang Data were searched for studies up to May 2016 concerning the efficacy of arthroscopic distal clavicle resection in repair of rotator cuff with acromioclavicular arthritis.Two reviewers independently screened the literature according to the inclusion and exclusion criteria,extracted the data and assessed the methodological quality of the studies included.Next,meta-analysis was performed using RevMan 5.3 software to compare the efficacy between the patients undergoing arthroscopic DCR plus RCR and those undergoing simple arthroscopic RCR.The randomized control trails (RCT) and clinical control trials (CCT) included were evaluated according to Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0) and Methodological Index for Non-randomized Studies (MINORS),respectively.Results A total of 5 studies (3 RCTs and 2 CCTs) involving 465 patients were included.No statistically significant difference was found between the RCR and the DCR plus RCR patients in Visual Analogue Scale (VAS) score,Constant score,American Shoulder and Elbow Surgeons (ASES) score,shoulder range of motion (ROM),postoperative acromioclavicular pain or rotator cuff retear (P ＞ 0.05).The 3 RCTs showed moderate bias risk and the 2 CCTs scored 21 MINORS points.Conclusion Since current evidence shows no advantages of arthroscopic DCR over RCR in repair of rotator cuff with acromioclavicular arthritis in VAS score,Constant score,ASES score,shoulder ROM,postoperative acromioclavicular pain or rotator cuff retear,arthroscopic DCR should not be recommended for routine use in clinic.