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 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.

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.

Eighteen adult rabbits were randomly divided into three groups: normal, control and experimental group. The model of global cerebral ischemia was produced by four-vessel occulsion. The cerebral temporal cortex samples were collected to determine volume of the water, LPO and Ca~(2+) concentration,SOD activity,and pathologic examinations of the cortex were made by optical and electronic microscope. The results showed that fructose-1, 6-diphosphate (FDP) reduced the water content and intracellular Ca~(2+)level, restrained the LPO production, enhanced the SOD activity of the brain. It is concluded that FDP protects cerebral biological membrane to a certain degree from ischemia and reperfusion injury.

Application ofmolecular diagnostic technique has shown greatpotential and technical advantages in the diagnosis and treatment of cardiovascular disease ( CVD ) .It can be used toscreening , diagnosis , treatment and prognostic evaluation of CVD disease .Early screening helps to notice the risk of the disease, make us take appropriate measures to reduce the health care costs and improve outcomes .To achieve the highest diagnostic efficiency by applying different molecular diagnostic strategies in different diseases.In term of treatment, molecular diagnostic technologies are mainly used in the drug discovery , personalized drug therapy and treatment options; In addition, prognostic assessment of CVD is also an important development direction of molecular diagnostic technique .However, there are severe challenges remained in applying molecular diagnostic techniques in CVD disease , such as the basic andclinicalapplication research and the quality control , etc.

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.

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.