生物制药废水预处理试验研究

目的对生物制药污水预处理进行试验研究。方法采用UASB与混凝沉淀两种方法。结果与结论针对CODcr浓度为18000mg·L-1的原水,经USBA系统20h的处理后,出水水质能达到CODcr≤5000mg·L-1以下。     

药氧雾化吸入治疗慢性阻塞性肺病的临床研究

目的:以中医药疗法治疗慢性阻塞性肺病(COPD).方法:中药制剂经氧气超声雾化吸入,按照疗程观察.结果:随机分为治疗组和对照组,治疗组有效率为87.00%,对照组有效率为75.00%,治疗组疗效优于与对照组(P《0.05).结论:中药经氧气雾化吸入治疗慢性阻塞性肺病有效,值得推广运用.     

An overview on in situ micronization technique – An emerging novel concept in advanced drug delivery

The use of drug powders containing micronized drug particles has been increasing in several pharmaceutical dosage forms to overcome the dissolution and bioavailability problems. Most of the newly developed drugs are poorly water soluble which limits dissolution rate and bioavailability. The dissolution rate can be enhanced by micronization of the drug particles. The properties of the micronized drug substance such as particle size, size distribution, shape, surface properties, and agglomeration behaviour and powder flow are affected by the type of micronization technique used. Mechanical communition, spray drying and supercritical fluid (SCF) technology are the most commonly employed techniques for production of micronized drug particles but the characteristics of the resulting drug product cannot be controlled using these techniques. Hence, a newer technique called in situ micronization is developed in order to overcome the limitations associated with the other techniques. This review summarizes the existing knowledge on in situ micronization techniques. The properties of the resulting drug substance obtained by in situ micronization were also compared.     

Allometric scaling and prediction of concentration-time profiles of coagulation factors in humans from animals

Abstract

1. Allometric scaling is a useful tool in early drug development and can be used for the prediction of human pharmacokinetic (PK) parameters from animal PK parameters. The main objective of this work was to predict concentration-time profiles of coagulation factors in humans in a multi-compartment system using animal PK parameters.

2. The prediction of concentration-time profiles in humans in a multi-compartment system was based on the predicted values of clearance and volumes of distribution (V_c, V_ss and V_β) from animals. Five coagulation factors from the literature were chosen that were described by two-compartment model in both humans and animals. Clearance and volumes of distribution from animals were allometrically scaled to humans and then were used to predict concentration-time profiles in humans.

3. The predicted concentration-time profile for a given coagulation factor was accurate for most of the time points. Percent prediction error range varied across coagulation factors. The prediction error >50% was observed either at 1 or a maximum of two time points for a given drug.

4. The study indicated that the allometric scaling can be useful in the prediction of concentration-time profiles of coagulation factors in humans from animals and may be helpful in designing a first-in-human study.     

Air pollution‐associated procoagulant changes: the role of circulating microvesicles

Summary. Background: Epidemiological studies suggest an association between exposure to particulate matter (PM) in air pollution and the risk of venous thromboembolism (VTE). Objectives: To investigate the underlying pathophysiological pathways linking PM exposure and VTE. Patients and methods: We assessed potential associations between PM exposure and coagulation and inflammation parameters, including circulating microvesicles, in a group of 233 patients with diabetes. Results: The numbers of circulating blood platelet‐derived and annexin V‐binding microvesicles were inversely associated with the current levels of PM_2.5 or PM₁₀, measured on the day of sampling. Recent past exposure to PM₁₀, up to 1 week prior to blood sampling, estimated at the patients’ residential addresses, was associated with elevated high‐sensitivity C‐reactive protein (CRP), leukocytes and fibrinogen, as well as with tissue factor (TF)‐dependent procoagulant changes in thrombin generation assays. When longer windows of past exposure were considered, up to 1 year preceding blood sampling, procoagulant changes were evident from the strongly increased numbers of red blood cell‐derived circulating microvesicles and annexin V‐binding microvesicles, but they no longer associated with TF. Past PM exposure was never associated with activated partial thromboplastin time (aPTT), prothrombin time (PT), or factor (F) VII, FVIII, FXII or D‐dimers. Residential distance to a major road was only marginally correlated with procoagulant changes in FVIII and thrombin generation. Conclusions: Increases in the number of microvesicles and in their procoagulant properties, rather than increases in coagulation factors per se, seem to contribute to the risk of VTE, developing during prolonged exposure to air pollutants.