自制高分子材料超声造影剂及初步实验研究

目的自制一种新型的高分子材料超声微泡造影剂,并观察其对新西兰大白兔的肾能量多普勒显像效果.方法采用水/油/水(water/oil/water,w/o/w)乳液-溶剂蒸发、冷冻干燥法制备聚乳酸/羟基乙酸(poly lacticcoglycolic acid,PLGA)超声微泡造影剂,用扫描电镜观察微泡大小、形态,用血细胞计数仪测定微泡浓度.用生理盐水稀释粉末样PLGA超声微泡造影剂至浓度为108/ml左右,然后按0.2 ml/kg的剂量经兔耳缘静脉注射至兔体内,用能量多普勒观察其对兔肾显影的增强效果,同时监测兔基本生命体征变化.结果 PLGA超声微泡造影剂均一度高,平均粒径3 μm左右,最大直径6 μm.与造影前相比,PLGA超声微泡造影剂能够明显增强兔肾能量多普勒显影效果,并且显像时间长.显像过程中未见兔基本生命体征有明显的变化.结论 PLGA超声微泡造影剂能够明显增强兔肾能量多普勒显影效果,显像时间长,尚未发现明显的副作用,是一类具有广泛应用前景的新型超声造影剂.     

浅谈固体制剂生产偏差的管理

目的对固体制剂生产中的偏差管理进行探讨。方法介绍偏差及偏差管理的相关概念,结合GMP规范的具体要求,阐述了固体制剂生产的偏差范围、偏差处理程序及具体的实施方法。结果与结论在固体制剂生产中,偏差管理贯穿于固体制剂生产的全过程,是质量保证体系的重要组成部分。     

A perspective on the use of Pleurotus for the development of convenient fungi-made oral subunit vaccines

This review provides an outlook of the medical applications of immunomodulatory compounds taken from Pleurotus and proposes this fungus as a convenient host for the development of innovative vaccines. Although some fungal species, such as Saccharomyces and Pichia, occupy a relevant position in the biopharmaceutical field, these systems are essentially limited to the production of conventional expensive vaccines. Formulations made with minimally processed biomass constitute the ideal approach for developing low cost vaccines, which are urgently needed by low-income populations. The use of edible fungi has not been explored for the production and delivery of low cost vaccines, despite these organisms’ attractive features. These include the fact that edible biomass can be produced at low costs in a short period of time, its high biosynthetic capacity, its production of immunomodulatory compounds, and the availability of genetic transformation methods. Perspectives associated to this biotechnological application are identified and discussed.     

Sol Particle Immunoassay (SPIA)

We describe the use of inorganic (metal) colloidal particles as a label for immunoassays. Dose-response curves for human placental lactogen (HPL) and human chorionic gonadotrophin (HCG) were obtained with sandwich immunoassays, using conjugates consisting of antibody-coated colloidal gold or silver particles. Several techniques were used to measure the amount of bound conjugate, viz. colorimetry and carbon rod atomic absorption spectrophotometry (CRAAS). At higher antigen concentrations the results of the assay could be read by the naked eye.

Using gold particles as label and CRAAS as detection method, we found a detection limit for a sandwich HPL sol particle immunoassay (SPIA) of 1,4 pmol/l, which was equal to that of an optimalized competitive radioimmunoassay. When using a colorimeter the detection limit for HPL of this SPIA was 5,4 pmol/l, which was superior to that of a corresponding sandwich enzyme-immunoassay (EIA). HPL and HCG were also simultaneously determined, using micro-titration plates, coated with a mixture of anti-HPL and anti-HCG, and a mixture of silver particle anti-HPL conjugate and gold particle anti-HCG conjugate. CRAAS was used to measure the bound amount of silver and gold conjugate. This simultaneous assay requires more work in order to obtain better sensitivities.     

新疆生产建设兵团基层卫生机构医生工作倦怠的现状及分析

目的了解新疆生产建设兵团基层医生工作倦怠现况,为稳定西部基层卫生队伍提供理论依据。方法采用多阶段分层抽样方法,用马斯勒倦怠问卷对372名医生进行调查。结果有89.2%的医生出现了中度以上的倦怠感;高工作要求、内部及外部工作资源的缺失导致＂情绪衰竭＂、＂消极工作＂和低＂个人成就感＂的倦怠症状。结论需要从长远规划上,通过定向培养、进修培训、对口支援等措施,降低基层卫生人员的倦怠水平。     

Expression,purification, immunogenicity,and protective efficacy of a recombinant Tc24 antigen as a vaccine against Trypanosoma cruzi infection in mice

The Tc24 calcium binding protein from the flagellar pocket of Trypanosoma cruzi is under evaluation as a candidate vaccine antigen against Chagas disease. Previously, a DNA vaccine encoding Tc24 was shown to be an effective vaccine (both as a preventive and therapeutic intervention) in mice and dogs, as evidenced by reductions in T. cruzi parasitemia and cardiac amastigotes, as well as reduced cardiac inflammation and increased host survival. Here we developed a suitable platform for the large scale production of recombinant Tc24 (rTc24) and show that when rTc24 is combined with a monophosphoryl-lipid A (MPLA) adjuvant, the formulated vaccine induces a Th1-biased immune response in mice, comprised of elevated IgG2a antibody levels and interferon-gamma levels from splenocytes, compared to controls. These immune responses also resulted in statistically significant decreased T. cruzi parasitemia and cardiac amastigotes, as well as increased survival following T. cruzi challenge infections, compared to controls. Partial protective efficacy was shown regardless of whether the antigen was expressed in Escherichia coli or in yeast (Pichia pastoris). While mouse vaccinations will require further modifications in order to optimize protective efficacy, such studies provide a basis for further evaluations of vaccines comprised of rTc24, together with alternative adjuvants and additional recombinant antigens.     

HACCP在调味紫菜生产加工中的应用

目的提高调味紫菜卫生质量,确保调味紫菜卫生安全。方法随机选择连云港市8家调味紫菜生产企业,应用HACCP的基本原理与方法,对调味紫菜的生产工艺全过程进行危害分析,确定关键控制点及关键限值,并进行相应的监控和纠偏。结果确定了4个关键控制点,关键控制点及关键限值分别为:(1)原料验收:关键限值为查验供应商的产品合格证明,保证原料来自安全海域;(2)调味料验收:关键限值为查验供应商提供的产品合格证明;(3)金属检测:关键限值为Fe:直径≤0.8mm,非Fe:直径≤1.2mm;(4)烧烤:关键限值为烧烤温度≥260℃,输送带转速≤85r/min。结论将HACCP应用于调味紫菜的生产加工过程,可显著提高调味紫菜的卫生质量。     

言语参数测量在脑损伤后神经性言语障碍患者中的应用

目的 探讨应用客观指标评估神经性言语障碍患者嗓音障碍的有效性,分析神经性言语障碍患者的嗓音声学特征。 方法 采用言语主观功能评估将29例言语障碍患者分为重度言语障碍组（19例）和轻度言语障碍组（10例）,用计算机言语测量仪对患者进行评估,比较和分析2组患者的最长声时（MPT）、最大数数能力（MCA）、平均基频、基频标准差、基频范围、平均强度、共振峰、下颌距和舌距的异常发生比率及其均值差异。 结果 所有患者的MPT和MCA值均存在异常,且重度组患者的MPT值［（4.37±3.89）s］明显短于轻度组［（8.22±4.03）s］,MCA 值［（3.39±3.77）s］亦明显弱于轻度组［（8.56±3.24）s］,组间差异均有统计学意义（P<0.05）。重度组在平均基频、基频标准差、F2（i）以及舌距指标中存在异常情况的比率为73.68%、63.16%、73.68%和78.95%,明显高于轻度组（30.00%、30.00%、30.00%和40.00%）,且组间差异均有统计学意义（P<0.05）。 结论 言语参数测量可以有效评估脑损伤后神经性言语障碍患者的言语功能;神经性言语障碍患者出现言语呼吸功能受损的现象非常普遍,值得重视。     

无痛穿刺贴膜的制作及性能评价

目的：制作无痛穿刺贴膜并进行实验检测、效果评价,以期解决穿刺疼痛的问题。方法以羧甲基纤维素钠、海藻酸钠、聚乙烯醇124、甘油、灭菌注射用水、利多卡因、布比卡因、0.5%的冰片、乙基纤维素,制作无痛穿刺贴膜,观察分析贴膜体外粘附力、释放药物性能、皮肤渗透试验、镇痛效果测定等多项指标。结果贴膜体外粘附力各个时间段均达400 g/cm2以上;贴膜药物释放率和渗透率随贴膜粘附时间增加而增加速率和浓度;贴膜帖敷5 min后小白鼠扭体次数减少,10 min收到明显效果,15 min效果持续平稳。结论本实验制作的无痛穿刺贴膜性能安全稳定、镇痛效果肯定,适于穿刺治疗前帖敷。