OBJECTIVE:To further perfect our Pharmaceutical Administration Law of PRC.METHODS:Contractive methods were used to analyze comparatively the legal liabilities in US FDCA and Pharmaceutical Administration Law of PRC with regard to awarding system for reporters,penalty terms and the disposition of the confiscated drugs.RESULTS&CON?CLUSION:Compared with the PRC Pharmaceutical Administration Law,the US FDCA is more comprehensive and more consummate.We should follow the legislative spirit in FDCA and take it as a reference to improve our Pharmaceutical Ad?ministration Law.

OBJECTIVE:To provide references for the establishment of drug recall system in China.METHODS: The drug recall system in U.S.A. was introduced so as to get some enlightenment for the drug safety in China.RESULTS & CONCLUSION: We could use the drug recall system in U.S.A. for references to improve our law criterion system and carry out drug recall system on a large scale.

Objective:To explore the chemical-biological evaluation pattern for the quality control and evaluation of Chinese materia medica solid preparations( CMMSP) according with the characteristics of Chinese traditional medicines. Methods:Lonicera granule as the model drug, the bacteria sensitive tests [minimal inhibitory concentration (MIC) and minimal bactericidal concentration(MBC)] were applied to study the antimicrobial effect of Lonicera extract on 4 kinds of standard strains ( Staphylococcus aureus, Streptococcus pneumoni-ae, Escherichia coli and Pseudomonas aeruginosa). The standard curves of the relationship between the anti-bacterial ring diameter for sensitive bacterial and the concentration of Lonicera extracts were established, and the biological potency of Lonicera granule from differ-ent manufacturers was calculated and compared with the result of the HPLC method ( measured by chlorogenic acid) . Results:The anti-microbial test showed that Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli and Pseudomonas aeruginosa were susceptible to Lonicera, and the antibacterial circle edge for Staphylococcus aureus was clear with higher sensitivity. There was a good linear relation-ship between the logarithmic dose and the response effect when the concentration of Lonicera was within the range of 0. 014 2-0. 068 0 g· ml-1(r=0.990 9). Conclusion:As a quality control method for Lonicera and Lonicera granules, the bioassay is feasible, which can ef-fectively cooperate with the traditional test method for the quality control of Lonicera and its preparations.

Renal function is closely associated with the risk of mortality ,cardiovascular events ,and progression to end stage of renal disease for patients with chronic kidney disease ( CKD ).Equations for estimated glomerular filtration rate ( GFR) based on serum creatinine or Cystatin C are frequently used in clinical evaluation of renal function.Although renal function can be more accurately assessed due to improvement in equations for estimated GFR ,it is difficult to overcome the inherent defect of creatinine based GFR estimation.Abundant ,evidence showed that Cystatin C based GFR estimation presented higher accuracy of prognosis assessment in CKD patients than creatinine based GFR estimation ,thus reduce the unnecessary nephrologist referral and measurements for low risk patients ,and also guarantee the timely recognization and intervention for high risk patients.This article deeply reviewed the role of serum creatinine or Cystatin C played in CKD diagnosis and prognosis assessment.

Objective:To establish an HPLC method for the simultaneous determination of 7 flavonoids in Fengliaochangweikang capsules, and optimize the extraction process for total flavones. Methods:The extraction process was optimized by orthogonal test. The analysis was performed on a Waters RP18 column (250 mm × 4. 6 mm,5 μm). The mobile phase A was methanol-water (80 :20) and the mobile phase B was methanol-0. 2% formic acid (17 :83) with gradient elution. The flow rate was 1. 0 ml·min-1 and the column temperature was 35℃. The detection wavelength changed as follows:0-27 min,λ1 = 260 nm;27-60min,λ2 = 360 nm. Results:The 7 flavonoids obtained the baseline separation in 60 min, and the linear correlation coefficients were all above or equal to 0. 9900. The average recovery was 95. 95%-97. 84% and RSD was 0. 81%-1. 33%. The optimum extraction conditions were as follows:solid-liquid ratio was 1 :15,AB-8 macroporous adsorption resin was used, the ultrasonic extraction time was 30min, and the ethanol concentration was 60%. Conclusion:The established method has the advantages of simple operation, high precision and good repeatability,which shows certain guiding significance for the quality control and detection of Fengliaochangweikang capsules.

Objective Nanomedicine is a branch of nanotechnology; it applies scientific principles and established methods of nanotechnology in healthcare. Small sized nanoparticles exhibit unique material properties. Nanoparticle therapeutic agents can be delivered with minimal invasiveness in vivo,and react more specifically to target tissues.Breast cancer is the most common cancer among women.Its incidence increases every year globally.Conventional therapeutic methods for breast cancer are effective,but have many limitations.In recent years the rapid development of nanotechnology medicine provides new solutions for those problems.There are many types of nanoengineered drug delivery systems (nDDS),each with distinguishing properties, including organic and inorganic materials, for example liposomes, polymers, antibodies, metals, magnets, carbons and ceramics. Nanomedicine may have passive and active targeting strategies. Both can enhance the accumulation of the drug in tumor sites. Specific nanoparticles can also kill or damage tumor cells.As its research advances fast,a wide application of nanomedicine in treating breast cancer is getting adopted.Many agents and formulations of nanomedicine are approved for clinical trials or approved for prescription.

Objective To examine the effect of hydroxyethyl starch (HES 6%, 200/0.5) on reticuloendothelial system (RES) function in hemorrhagic shock. Methods Thirty 8 to 12-week-old Wistar rats weighing 250-350g were randomly divided into two groups: HES group ( n = 15) and control group ( n =15) . The animals were anesthetized with intraperitoneal 0.5% pentobarbital sodium 30mg ?kg-1 Bilateral common carotid arteries were exposed and cannulated for MAP monitoring and blood-letting. Blood was gradually removed until MAP dropped to 40mm Hg, which was maintained for 60min. Then same amount of HES (HES group) or Dextran (control group) was infused. The Kupffer cells were separated and purified before hemorrhagic shock (T0), at 12h (T1) 24h (T2) 48h (T3) and 72h (T4) after HES or DEX infusion, when the animals recovered from shock. Phagocytic activity of Kupffer cells (KC) was measured by counting the amount of Latex particles ingested by KC. Results At the same intervals (T1-4) there was no significant difference in phagocytic activity of KC between the two groups. There was no significant difference in phagocytic activity of KC between T0 (baseline) and T1-4 in both groups.Conclusions The phagocytic activity of Kupffer cells in not affected by removed of 20-30% blood volume which was replaced by same amount of HES.

OBJECTIVE: To observe the effect of formaldehyde inhalation on the allergic rhinitis mice model. METHOD: Forty-eight male BALB/C mice in six experimental group were exposure to (A) saline control; (B) Der p1; (C) formaldehyde (3.0 mg/m3); (D) Derp1 + formaldehyde (1.5 mg/m3); (E) Der p1 + formaldehyde (3.0 mg/M3); (F) Der p1+ formaldehyde (6.0 mg/m3). The concentrations of IL-4, IL-10 and IFN-γ in the peripheral serum were measured by enzyme-linked immunosorbent assay(ELISA). Nasal mucosal inflammation was evaluated by HE staining. Result: Formaldehyde exposure could increase the number of allergic rhinitis mice with sneezing and rubbing nose. The levels of IL-4 and IL-10 in group B, D, E and F were higher than that ingroup A (P < 0.05). Compared with the group C, the group D, E and F could effectively increase serum IL-4 and IL-10. The concentration of IL-4 in group E and F was higher than that of group B, while the group C was lower (P < 0.05). The concentration of IL-10 in group D, E and F was higher than that in group B (P < 0.05). The expression of IFN-γ in group B, D, E and F was lower than that in group A. While, the IFN-γ expression in group B was lower than that of group C and higher than that in group F (P < 0.05). Moreover, the concentration of IFN-γ in group D, E and F was lower compared with group C (P < 0.05). The nasal mucosa HE staining showed that the density of EOS increased simultaneously in formaldehyde exposure allergic rhinitis groups. CONCLUSION The study showed that formaldehyde exposure can promote Th2 cytokines and eosinophil infiltration and then aggravate the allergic rhinitis symptoms.
Animals ; Antigens, Dermatophagoides ; Arthropod Proteins ; Cysteine Endopeptidases ; Disease Models, Animal ; Enzyme-Linked Immunosorbent Assay ; Formaldehyde ; adverse effects ; Inflammation ; Inhalation Exposure ; adverse effects ; Interferon-gamma ; blood ; Interleukin-10 ; blood ; Interleukin-4 ; blood ; Male ; Mice ; Mice, Inbred BALB C ; Nasal Mucosa ; Rhinitis, Allergic ; chemically induced

Quantitative immunoassay technique is the common method of quantitative detection in clinical laboratory. Several important branches of quantitative immunoassay were formed by changing the tracer or the Antigen-antibody complex separation method, including radioimmunoassay, fluorescent immunoassay, enzyme immunoassay, chemiluminescence, colloidal gold, immuno-turbidimetric analysis and homogeneous immunoassay. Different immunoassay techniques have their own characteristics, also apply to different detecting conditions in clinic. This paper reviewed several common kinds of quantitative immunoassay technology, and discussed both their advantages and disadvantages, which provide reference for the application and development of clinical testing technology.

Objective To investigate whether Berberine can inhibit the invasion of Streptococcus pueum oniae ( S.pn) to A549 cells in vitro. Methods A549 cells were pretreated with the different concentrations of Berberine and incubated together with S.pn. A549 cells were lysed with 0.025%Triton X-100.Diluted lysate was streaked on TSAB plate and incubated overnight. The colonies on the plate were counted. Results The counts on the plates were 52 ± 21,29 ± 11,13 ± 10,0,0 per well when the concentration of Berberine was 0,25,50,100,200μg/mL, respectively. No invasion was observed when the concentration of Berberine was 100 μg/mL. Conclusion Berberine can inhibit the invasion of S.pn to A549 cells in dose-dependent maner in vitro.