Objective The efficacies of nedaplatin-combined chemotherapy were compared with those of cisplatin-combined chemotherapy in patients with advanced malignant tumors. Methods Two hundred and sixty-two patients were divided into two groups randomly, the nedaplatin(NDP) group (M94, F36, median age 58y) and the eisplatin(Cis) group (M95, F37, median age 57y). Cycles were repeated every 4 weeks. Effects were assessed after 2 cycles. First-line schedules were chosen, and nedaplatin and cisplatin were used respectively. Results The results showed that the remission rate (50.8 %) in NDP group was significantly higher than that (40.2 %) in Cis group (P<0.05). The NDP had better efficacy than Cis especially in treating ovary cancer and esophageal cancer. The toxicity of NDP was milder for gastro-intestinal tract but more serious for bone marrow than that of Cis(P<0.01). Conclusion As a new broad-spectrum anti-tumor agent, NDP could be a better choice than cisplatin in the treatment of malignant tumors. It is especially of better efficacy in treating ovary cancer and esophageal cancer, and could be recommended as the first-line drugs.

It is significant for theory and application to study on marine microbial exopolysaccharides with differential structures and activities endowed by the specific marine environment.The recent progress of the research on the structures and bioactivities of marine microbial ex- opolysaccharides was reviewed,and the prospect of the research and development of the marine microbial exopolysaecharides was also expec- ted.

The package leaflet is a legal document relevant with drug information, which plays an important role for instructing the rational use of the medicinal product for the patient population. During the registration application in the EU countries, the patient readability test on package leaflet is the essential requirement to ensure the leaflet information easy-to-understand and avoid any risk caused by misunderstanding. The readability research on package leaflet can improve its quality and drug use safety to patients. Currently, CFDA does not publish any regulation/guidance on the drug application in China. By the successful case of registration application of Danshen Capsule as the herbal medicine in the EU, this paper not only discusses the relevant requirements of readability test in the EU, but also offers the regulatory advice on future regulations of readability research of the pharmaceutical products in China.

Objective To investigate the influence of hydrogen peroxide (H2O2) on the antifungal effect of 5 azoles (fluconazole, itraconazole, ketoconazole, miconazole, and sulconazole) against drug-resistant Candida albicans. Methods Eight strains of drug-resistant Candida albicans and two strains of drug-susceptible Candida albicans were used in this study. The minimal inhibitory concentration for 80% (MIC80) of each individual antifungal drug was determined by broth microdilution antifungal susceptibility testing; the MIC80 of the antifungal drug was also determined when in combination with H2O2 by checkerboard microdilution assay. Then the fractional inhibitory concentration index (FICI) was calculated to decide the synergism, indifference, or antagonism of H2O2 with azoles. Results The FICI values of the 8 drug-resistant strains for combination of H2O2with 5 azoleswere less than 0. 5, indicating the presence of synergism. The FICI values of the two drug- susceptible strains were between 0. 5 and 2, indicating the presence of indifference. Conclusion H2 O2 and the azoles (fluconazole, itraconazole, ketoconazole, miconazole and sulconazole) possess synergism effect against drug-resistant Candida albicans.

Objective To investigate the influence of hydrogen peroxide (H2O2) on the antifungal effect of 5 azoles (fluconazole, itraconazole, ketoconazole, miconazole, and sulconazole) against drug-resistant Candida albicans. Methods Eight strains of drug-resistant Candida albicans and two strains of drug-susceptible Candida albicans were used in this study. The minimal inhibitory concentration for 80% (MIC80) of each individual antifungal drug was determined by broth microdilution antifungal susceptibility testing; the MIC80 of the antifungal drug was also determined when in combination with H2O2 by checkerboard microdilution assay. Then the fractional inhibitory concentration index (FICI) was calculated to decide the synergism, indifference, or antagonism of H2O2 with azoles. Results The FICI values of the 8 drug-resistant strains for combination of H2O2 with 5 azoles were less than 0.5, indicating the presence of synergism. The FICI values of the two drug- susceptible strains were between 0.5 and 2, indicating the presence of indifference. Conclusion H2O2 and the azoles (fluconazole, itraconazole, ketoconazole, miconazole and suiconazole) possess synergism effect against drug-resistant Candida albicans.

OBJECTIVE:To establish a method for the determination of related substances in Vildagliptin tablets. METHODS:HPLC method was adopted. The determination was performed on Xterra MS C18 column with mobile phase consisted of [phosphate buffer-water-acetonitrie-methanol(400 : 600 : 15 : 15,V/V/V/V)]-[phosphate buffer-acetonitrile-methanol(400 : 450 : 150,V/V/V)](gra-dient elution)at the flow rate of 1.2 mL/min. The detection wavelength was set at 210 nm and column temperature was 35 ℃. The sample size was 10 μL. RESULTS:The linear ranges were 18.80-188.0 μg/mL for impurity A(r=0.9995),22.64-226.4 μg/mL for impurity B(r=0.9996),21.74-217.4 μg/mL for impurity C(r=0.9997),19.12-191.2 μg/mL for impurity D(r=0.9998). The limits of detection were 4.18,2.68,1.12,1.34 μg/mL,respectively;RSDs of precision,stability and reproducibility tests were lower than 3%;the recoveries of impurity A,B,C and D were 97.9%-103.1%(RSD=2.01%,n=9),98.8%-104.1%(RSD=1.93%,n=9),98.0%-103.6%(RSD=1.81%,n=9),100.8%-104.1%(RSD=0.98%,n=9),respectively. CONCLU-SIONS:The method is simple and accurate,and can be used for the determination of related substances in Vildagliptin tablets.

Objective:To establish a method for the determination of the related substances in ticagrelor tablets. Methods:An op-timal HPLC method was set up and a Hypersil BDS C18 column (200 mm × 4. 6 mm, 5μm) was adopted. The mobile phase A was wa-ter (pH was adjusted to 3. 0 by phosphoric acid) and the mobile phase B was acetonitrile with gradient elution at a flow rate of 1. 0 ml ·min-1 , and the detection wavelength was set at 255 nm. The column temperature was 30 ℃, and the volume of injection was 5 μl. Results:The resolutions between ticagrelor and the adjacent impurity ( impurity E) , and between ticagrelor and the known impurities were all greater than 1. 5. Impurity A-H all had a good linear relationship within the range of 2. 0-20. 0 μg·ml-1(r>0. 996 0). The average recovery was 99. 8%, 98. 1%, 96. 5%, 101. 2%, 99. 3%, 100. 7%, 102. 1% and 103. 4% with RSD of 1. 02%, 0. 88%, 1. 13%, 0. 56%, 0. 79%, 1. 11%, 0. 63% and 1. 39%, respectively(n=9). Conclusion:The method is reproducible and accurate in the determination of the related substances in ticagrelor tables.

Purpose To observe the effect of Anti-c-myc on the apoptosis of HL60 cells and leukemicpatients' leukocytes. Methods HL60 cells and leukemic patients, leukocytes were treated with anti-c-mycoligomer-5' d(CTT CTC GAG GCA GGA GGG)3'-complementary to the transcriptional initiation of c-mycmRNA. After 10 hours, we detected the apoptosis by several methods: DNA agarose gel electropboresis,ELISA(enzyme- linked immunosorbent assay), Flow Cytometric Analysis, and Accounting the number ofapoptotic cells after stained with Wright' s. Results The apoptosis of HL60 cells were induced by theanti-c-myc oligomer, and the induction of apoptosis was dose-dependent, i. e. more HL60 cells vereapoptotic as we treated them with higher dose of the antisense oligodeoxynucleotides. Furthermore, the antic-myc oligomer also induced the apoptosis of leukemic patients, leukocytes, but had no effect on theapoptosis of normal leukocytes. Conclusions These results imply that we can treat acute myeloidleukemia with the anti-c-myc oligomer through apoptosis-inducing, and it has good specificity. This studyprovides basis for leukemia treatment.

Objective To investigate the chemical constituents from the roots of Polygala japonica. Methods The compounds were isolated by silica gel, ODS, and macroporous resin column chromatography and their structures were determined by means of spectral analysis. Results Eight compounds were isolated and characterized as ?-D-(3-O-sinapoyl)-fructofuranosyl-?-D-(6-O-sinapoyl)-glucopyranoside (Ⅰ), arillatose A (Ⅱ), sibiricose A_5 (Ⅲ), sibiricose A_6 (Ⅳ), neolancerin (Ⅴ), polygalaxanthone Ⅲ (Ⅵ), sibiricaxanthone A (Ⅶ) and polygalatol (Ⅷ). Conclusion These compounds are extracted from this plant for the first time. Compound Ⅴ is obtained from natural products for the first time.

Functional magnetic resonance imaging(fMRI) is a very powerful method to understand the mechanism of brain function with non-invasive localization, high spatial and temporal resolution. The essential fMRI technique is blood oxygen level dependent (BOLD-fMRI). Basic principles and methodological applications of BOLD-fMRI are reviewed in this paper.