Safety,efficacy and quality control are the three essential elements for drugs,including traditional Chinese medicine(TCM). Currently,rapid development of life sciences,medicine and phar?macy provides new prospects for TCM. Considering the long history of TCM application,modern phar? macology and toxicology, global standards and expectations on the safety of TCM, how to evaluate the safety of TCM scientifically has become a key to the research and development of TCM. This review aims to discuss current technical requirements of non-clinical safety study of TCM as well as the challenges.

OBJECTIVE:To improve hydroscopicity and fluidity of traditional Chinese drug extractum by spray drying and to improve affixes to the wall of the drier during drying for providing reasonable relative humidity of production.METHODS:The compounding of adjuvant and the technology were optimized by orthogonal experiment,and the hydroscopicity and fluidity of powdered extract were investigated.RESULTS:The hydroscopicity of traditional Chinese drug extractum can be greatly decreased by adding 3% gum arabic and 7% ?-CD.The optimum technological conditions were as follows:extractum density of 1.10g? mL-1,temperature of intake airflow of 170℃,atomization pressure of 0.5Mpa,and feed material speed of 400mL? h-1 by orthogonal experiment.The critical relative humidity of the optimum formula was 64%.CONCLUTION:The problems of time consuming and moisture absorption of traditional Chinese drug extractum existed in the traditional old technology can be improved in this new technology.

Objective The paclitaxel loaded solid lipid nanoparticles (PTX-SLNs) were prepared by an ultrasonic-dispersion emulsification technique. The stability of PTX-SLNs was investigated in this study. Methods The technology was preferenced by stability, Zeta potential, particle diameter, and entrapment efficiency as indexes. The doses of lipid materials and coemulsifier, the ultrasonic time, and the ultrasonic power were investigated in detail. Results The optimum prescriptions were definited by one-factor and orthogonal test. The adjuvant: glyceryl monostearate (100/150 mg), Fabaceous Lecithin (100 mg), coemulsifier Pluronic F68∶Tween 80 (2∶1). The samples were sonicated with an energy output of 300 W in 20 min after emulsified at (75?5) ℃. Conclusion The PTX-SLNs are successfully prepared and PTX-SLNs with high stability are fairly dispersed in colloidal solution. This technology has a nice prospect with safety and reliability.

Objective To find out about the current state of development and existing problems in non governmental hospitals and to explore their development direction by collecting quantitative and qualitative data. Methods Investigations in the form of questionnaires were made into all the non governmental hospitals province wide and a descriptive analysis was made of the data collected. Results Non governmental hospitals in the province witnessed fast development, and yet they were generally small scaled, lacked actual strength, and were unevenly distributed, claiming only 3% of the market share; they paid special attention to the unique features of specialties and employed flexible operational modes, and yet they were still confronted with such problems as insufficient support policies from the government and personnel instability. Conclusion There is still a long way to go before the monopoly of state run hospitals is broken, diversified modes of hospital running are developed, and fair and orderly competition is formed so as to enhance the vitality of medical institutions. Administrative departments of health should fully realize the role and social functions of non governmental hospitals and actively lead their development in a healthy direction with sound policies.

Background Deficiency of neurotrophic factor is associated with the damage of optic nerve in glaucoma.Reaserches showed that ectopically applied neurotrophic factor has a transient neuroprotective effect in glaucoma model,and the viral expression of adeno-associated neurotrophie factor may provide long-term supplementation of neurotrophic factor and neuroprotection in tissues.Objective The present study Was to investigate the neuroproteetive effect of adeno-associated viral(AAV)-mediated brain-derived neurotrophic factor (BDNF)on retinal ganglion cells(RGCs)in DBA/2J mice with experimental glaucoma. Methods 10 clean DBA/2J mice were administered intravitreal injection with 1 microliter of AAV-BDNF-GFP in the left eyes at the age of 6 months,and the right eyes were injected with the same volume of saline solution as control.Intraocular pressure (IOP)was measured with Tonolab in the mice every month.Retinas were obtained after 3 months for the investigation of GFP expression in RGCs using fluorescence microscopy.Immunohistochemistry Was performed by applying TUJ1 and Cy3 antibodies to identify surviving RGCs. Results The IOP of DBA/2J mice were 11.90 mmHg and 11.40 mmHg in the right eyes and left eyes,respectively,at 4 months.The IOP of DBA/2J mice began to rise at 5 months and reached its peak in 8 month-old mice.There was no statistically significant difference in IOPs between the right eyes and the left eyes from 4 month-through 9 month-old mice(t=-1.78-0.61,P=0.11-0.90).Three months after intrlavitreal injection of AAV-BDNF-GFP,GFP was positively expressed in RGCs of retinas with the expression rate of 46.33%±8.08%.The over-expression of BDNF led to more RGCs survival than the control eyes (3168.13±1319.33/mm2 vs 2024.81±796.38/mm2,t=2.75,P=0.02). Conclusion These data suggest that BDNF can exert a protective effect in DBA/2J glaucoma mice.

To study the role of BK virus(BK polyomavirus)in the development of the hemorrhagic cystitis(HC)after hematopoietic stem cell transplantation(HSCT)and analyze the risk fators for BK viruri4a and HC.Methods From August 2006 to November 2007,blood and urine samples were collected from 80 patients undergoing HSCT.BK virus DNA was detected with PCR.Cytomegalovirus (CMV)antigen was detected with immunofluorescence histochemical examination.A control group including 20 healthy individuals was established.Results Late-onset HC occurred in 15 of the 80 HSCT patients with an incidence of 18.8%.The median onset time of HC was 44(13-150)days after transplantation.BK viruria was detected in 30 of the 80 HSCT patients(37.5%)and the positive rate of viruria in the HC patients was 86.7%(13/15).The median time of BK viruria detection in HC patients wag 23(0-56)days after transplantation,being earlier than the onset time of HC.The persistence time of BK viruria was 7(2-14) weeks,being much longer than that of HC(11 days).CMV antigen viremia was detected in 12 of the 80 transplanted patients.with a positive rate of 36.7% in patients with BK viruria and 40.0% in HC patients.Nine of the 30 HC patients developed acute graft versus host disease(Agvhd)of grade Ⅱ-Ⅳ(30.0%).BK virus was not detected in the urine of the remainimg two HC patients and the 20 control subjects as well as in all the blood samples.Univariate analysis indicated that CMV viremia and Agvhd of grade Ⅱ-Ⅳ were agsociated with the occurrence of BK viruria.Condusions BK viruria is the main cauge of the late-onset HC after HSCT.CMV infection and Agvhd may contribute to the occurrence of HC agsociatieg with BK virus.

OBJECTIVE:To provide evidence for strengthening education and training before clinical practice and employment guidance among pharmacy junior students of our university. METHODS:Anonymous questionnaire survey was conducted for our university. Questionnaire survey included student employment intention and internship units,relationship of internships with employ-ment,the tendency of employment after graduation,personal attitude about pharmaceutical professional development prospect,ex-pected monthly income in the first year of their career,etc. RESULTS:Totally 71 questionnaires were sent out,71 were effectively received. Among all respondents,74.3%(52 students)believed employment intention had great relationship with internship units;24.3%(17 students)thought employment intention had not great relationship with internship units;moreover,one student thought employment intention had no any relationship with internship units. Most students(94.3%,66 students)with good attitude on in-ternships believed it could accumulate work experience;32.9%(23 students) thought they could stay in the internship unit after practice;moreover,17.1%(12 students) believed practice had little effect on employment. Among them,94.0%(63 students) tended to be employed after graduation,and only 6.0% chose a graduate school to continue their studies. Among the students who chose employment after graduation,76.1%(51 students)tended to engage in pharmaceutical related work,while 17.9%(12 stu-dents) tended to be engaged in work nothing to do with pharmacy or self-employed. The majority (69.6%,48 students) believed that pharmaceutical major prospect was general and pharmaceutical major development varied from person to person;17.4%(12 students)thought pharmaceutical major had good prospect and was promising;13.0%(9 students)believed that pharmaceutical ma-jor had no good prospect and didn't know its prospect. Most of the students(78.2%,54 students)expected a monthly income of 2500-5000 yuan in the first year of their career;18.9%expected a monthly income more than 5000 yuan(13 students);the minor-ity expected a monthly income of 1500-2500 yuan or more than 8000 yuan. CONCLUSIONS:The view of students on internship and employment have a certain gap with the social situation. Related departments of colleges and universities need to adjust the thought of students and strengthen guidance.

OBJECTIVETo investigate the effects of immunologic effector cells to enhance apoptosis induced by adriamycin (ADR) in multi-drug resistant human breast cancer cell line MCF7/ADR.

METHODSThe immunologic effector cells were induced and expanded by IFN-gamma, McAb CD3, IL-1 and IL-2. The expression of P-glycoprotein (P-gp) and its relation to apoptosis in target cells were detected by TUNEL technique and immunohistochemical staining. Flow cytometry (FCM) was carried out to determine the expression level of human breast cancer related P185 antigen and the positive rate of Annexin V-FITC/PI expression. The subcellular distribution of ADR and Annexin V expression in the target cells were detected by fluorescence microscopy.

RESULTSThe immunologic effector cells down-regulated the expression of P185 and P-gp in MCF7/ADR cells. The accumulation and subcellular distribution of ADR in MCF7/ADR cells were increased after co-culture with the immunologic effector cells. After treatment with the immunologic effector cells in combination with ADR, apoptosis rate of the target cells was 10 times higher than that induced by ADR alone, and 13 times higher than that induced by the immunologic effector cells alone.

CONCLUSIONImmunologic effector cells can simultaneously down-regulate the expression of P185 and P-gp in MCF7/ADR cell line, and increase the apoptosis rate of MCF7/ADR cells in combination with ADR.

ATP-Binding Cassette, Sub-Family B, Member 1 ; metabolism ; Antibiotics, Antineoplastic ; pharmacology ; Apoptosis ; drug effects ; Breast Neoplasms ; immunology ; metabolism ; pathology ; Cell Line, Tumor ; Down-Regulation ; Doxorubicin ; pharmacology ; Drug Resistance, Multiple ; Drug Resistance, Neoplasm ; Female ; Humans ; Killer Cells, Lymphokine-Activated ; immunology ; Receptor, ErbB-2 ; metabolism

OBJECTIVETo investigate the possibility of differentiation of human mesenchymal stem cells (hMSC) into epidemic cells in vitro.

METHODShMSCs were segregated from normal adult human bone marrow by Percoll solution (1.073 g/ml) , and were cultured, purified, and amplified to 3th passage in vitro. Then the hMSCs were randomly divided into control group ( with treatment of normal L-DMEM medium) and experimental group (with treatment of L-DMEM medium containing epidermal growth factor,insulin,tretinoin, calcium chloride). After 7 days of culture, the morphologic changes of hMSCs in the 2 groups were observed with inverted phase contrast microscope. The expressions of P63 and PCK of hMSCs were assessed with immunohistochemical methods.

RESULTSThe shape of hMSCs in experimental group became irregular or oblong in shape, while that in control group were still in spindle shape. Immunohistochemical results showed that hMSCs were P63 and PCK positive in the experimental group, while those in control group were negative.

CONCLUSIONHuman mesenchymal stem cells can differentiate into epidemic cell in vitro.

Bone Marrow Cells ; cytology ; metabolism ; Cell Differentiation ; Cells, Cultured ; Epithelial Cells ; cytology ; Humans ; Keratins ; metabolism ; Membrane Proteins ; metabolism ; Mesenchymal Stromal Cells ; cytology

OBJECTIVETo summarize the incidence of various adverse reactions in the clinical application of L-asparaginase (L-Asp), and to analyze the cause of hepatic encephalopathy in three cases.

METHODSThe complete data of 23 patients in our department from December 2009 to December 2010 were collected. Their blood ammonia levels, transaminase, serum albumin and blood coagulation function before, during and after the L-Asp application were assayed.

RESULTS(1) All patients had elevated blood ammonia level after the L- Asp application. This occurred 2 days after the beginning of treatment and the median time to reach peak level (ranged from 194 to 446 μmol/L, with a median value of 300 μmol/L) was 4 days. It returned to normal level after a median time of 5 days (ranged 3-7 days) with drug withdrawal. Of the 23 patients studied, 3 developed hepatic encephalopathy. (2) All patients appeared lower blood fibrinogen, 10 cases (43.5%) with lower fibrinogen only, while 13 cases (56.5%) with both prolonged APTT and lower fibrinogen. The lowest level of fibrinogen was detected at 1 week after drug application. Of the 23 patients, 14 (60.9%) had mild lower blood fibrinogen (1-2 g/L), and 9 (39.1%) had significantly lower fibrinogen (0-1 g/L). (3) Six cases (26.1%) had slightly elevated level of transaminase (<2 times the upper limits of normal), 8 (34.8%) appeared hypoalbuminemia.

CONCLUSIONAs the incidence of elevated blood ammonia levels was high in the application of L-Asp, the level of blood ammonia should be closely monitored to avoid the occurrence of hepatic encephalopathy, especially in elderly patients and patients with previous liver disease or long-term heavy drinking. L-Asp can also lead to low fibrinogen level, hypoalbuminemia and abnormal transaminase. Monitoring the blood coagulation function and liver function is required and, if necessary, plasma infusion and liver protection therapy are required.

Adolescent ; Adult ; Aged ; Ammonia ; blood ; Asparaginase ; adverse effects ; therapeutic use ; Female ; Hepatic Encephalopathy ; chemically induced ; Humans ; Male ; Middle Aged ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; blood ; drug therapy ; Young Adult