测定水中总铁的含量以吐温20作助溶剂的硫氰酸钾比色法

目的建立操作简便、重现性好、空白值低的测定水中总铁的方法。方法采用非离子表面活性剂吐温20（Tween2／3）作助溶剂对硫氰酸钾比色法做进一步改进。结果改进后的方法测定水中总铁,与当前广泛使用的二氮杂菲法比较,其结果差异无统计学意义（P〉0.05）,且铁含量在0～25μg范围内线性关系良好。最低检出浓度为0．02mg／L。回收率在94％～100％之间。变异系数为CV=1．9％。结论该方法操作简便,试剂空白值低,显色稳定,便于推广应用。     

外源性肺表面活性物质在ARDS中的治疗作用

Several studies have demonstrated that alterations of pulmonary surfactant system contribute to the lung dysfunction associated with acute respiratory distress syndrome (ARDS). There have been many animal experiments and clinical investigations evaluating exogenous surfactant in ARDS models or patients. Exogenous surfactant administration has proven inconsistent as a therapeutic modality for patients with ARDS. Various factors that may influence a host response to exogenous surfactant, these factots include: the nature and severity of the underlying injury,the surfactant preparation utilized, the amount, frequency, and method of surfactant administration, the mode of ventilation used during and after surfactant delivery, and the timing or surfactant administration over the course of the illness     

维生素A联合牛肺表面活性物质治疗新生儿呼吸窘迫综合征的临床研究

目的探讨维生素A软胶囊联合注射用牛肺表面活性剂治疗新生儿呼吸窘迫综合征的临床疗效。方法选取2013年11月—2015年11月重庆市合川区妇幼保健计划生育服务中心收治的新生儿呼吸窘迫综合征患儿80例,采用随机数字表法将患儿分为对照组和治疗组,每组各40例。对照组气管内给予注射用牛肺表面活性剂,首剂量40~100 mg/kg,根据病情需要6~24 h重复用药,最多3次,72 h后不再给药。治疗组在对照组基础上口服维生素A软胶囊4 500 U/d,以配方奶为载体,每天11:00~12:00一次性给予。两组患儿均连续治疗7 d。观察两组的临床疗效,同时比较两组治疗前后血气指标、机械通气参数、氧化应激指标。结果治疗后,对照组、治疗组的总有效率分别为72.6%、90.0%,两组总有效率比较差异具有统计学意义(P0.05)。治疗后,两组二氧化碳分压(Pa CO2)、呼吸频率(RR)、呼气末正压(PEEP)、吸入气中氧浓度分数(Fi O2)、丙二醛(MDA)均显著降低,氧分压(Pa O2)、p H值、超氧化物歧化酶(SOD)、谷胱甘肽过氧化物酶(GSH-Px),均显著升高,同组治疗前后差异具有统计学意义(P0.05);且治疗组这些指标的改善程度优于对照组,两组比较差异具有统计学意义(P0.05)。结论维生素A软胶囊联合注射用牛肺表面活性剂治疗新生儿呼吸窘迫综合征具有较好的临床疗效,能够改善肺功能,减轻机体抗氧化能力,具有一定的临床推广应用价值。     

Glass Leachables as a Nucleation Factor for Free Fatty Acid Particle Formation in Biopharmaceutical Formulations

Surfactants are essential components in protein formulations protecting them against interfacial stress. One of the current industry-wide challenges is enzymatic degradation of parenteral surfactants such as polysorbate 20 (PS20) and polysorbate 80, which leads to the accumulation of free fatty acids (FFAs) potentially forming visible particles over the drug product shelf-life. While the concentration of FFAs can be quantified, the time point of particle formation remains unpredictable. In this work, we studied the influence of glass leachables as nucleation factors for FFA particle formation. We demonstrate the feasibility of nucleation of FFA particles in the presence of inorganic salts like NaAlO₂ and CaCl₂ simulating relevant glass leachables. We further demonstrate FFA particle formation depending on relevant aluminum concentrations. FFA particle formation was subsequently confirmed with lauric/myristic acid in the presence of different quantities and compositions of glass leachables obtained by several sterilization cycles using different types of glass vials. We further verified the formation of particles in aged protein formulation containing degraded PS20 through the spiking of glass leachables. Particles were characterized as a complex of glass leachables, such as aluminum and FFAs. Based on our findings, we propose a likely pathway for FFA particle formation that considers specific nucleation factors.     

慢性阻塞性肺疾病患者血清肺表面活性蛋白D水平变化及其临床意义

目的探讨慢性阻塞性肺疾病患者血清肺表面活性蛋白D水平变化及其临床意义。方法选取COPD急性加重期患者30例、COPD稳定期患者30例及对照者30例,分别测定其血清SP-D水平,并与COPD患者严重程度进行相关分析。结果 COPD急性加重、稳定期患者血清SP-D水平均高于对照组(P0.05);COPD急性加重组患者血清SP-D水平明显高于稳定期组(P0.05)。相关性分析结果显示:COPD急性加重、稳定期患者血清SP-D水平与一秒钟用力呼气容积占预计值百分比(FEVl%pred)均呈负相关(P0.05)。结论 COPD急性加重、稳定期患者血清SP-D水平均高于对照组,血清SP-D水平变化可作为判定COPD病情严重程度的指标之一。     

联合检测痰及血清SP-A水平对肺结核诊断价值的研究

目的研究肺结核患者痰及血清中肺表面活性物质相关蛋白A(SP-A)的表达,探讨痰及血清SP-A在肺结核诊断中的意义。方法将101例肺结核患者、85名健康人、30例慢性阻塞性肺疾病(COPD)患者分别分为肺结核组、健康组及COPD组,采用ELISA方法检测各组痰及血清中SP-A的表达。结果肺结核组患者血清中SP-A明显高于健康对照组及COPD组,差异有统计学意义(P<0.05);而肺结核组痰SP-A表达与各组间差异无统计学意义;根据检测结果绘制ROC曲线,确定痰SP-A的Cutoff值为0.12(OD值),以此进行肺结核病的诊断,敏感性为40.60%,特异性88.00%,诊断准确率为62.37%;根据检测结果绘制ROC曲线,确定血清SP-A的Cutoff值为0.66(OD值),血清SP-A在肺结核病诊断中的敏感性为70.30%,特异性80.00%,诊断准确率为74.73%;联合检测痰及血清SP-A进行肺结核病的诊断,敏感性为92.08%,特异性68.24%、诊断准确率为81.18%;菌阳肺结核组痰SP-A与痰排菌量具有相关性,其相关系数为0.30。结论联合检测痰及血清SP-A的表达可提高肺结核的诊断率;SP-A有可能成为诊断肺结核的一种新的辅助诊断指标。     

雾化吸入肺表面活性物质治疗新生儿胎粪吸入综合征

目的 探讨雾化吸入肺表面活性物质（pulmonary surfactant,PS)治疗新生儿胎粪吸入综合征（meconium aspairation syndrome,MAS)的有效性及临床价值。方法 采用雾化吸入PS治疗12例MAS患儿，其中8例接受PS2次，2例接受PS3次。结果 给予首剂PS15min后患儿青紫迅速消失，皮肤转红润，经皮测定血氧饱和度（TcSaO2)升高，30min后患儿低氧血症迅速改善，动脉血氧分压（PaO2)，动脉血氧分压和吸入氧浓度比值（PaO2/FiO2)，动脉肺泡血氧分压比值（a/APO2)较治疗前显著增高（P＜0．05），重复应用PS后亦有相似的疗效。结论 PS能有效地改善MAS患儿肺顺应性及氧合功能，重复应用PS可巩固和加强疗效。     

Effect of the test media and toxicity of LAS on the growth of <Emphasis Type="Italic">Isochrysis galbana</Emphasis>

In this paper, the toxicity of linear alkylbenzene sulfonate (LAS) was evaluated in the marine microalga Isochrysis galbana using data of growth inhibition toxicity tests at 96-h exposure time. Toxicity was examined in standard conditions and by means of the modification of two variables of the test media: (1) the dilution water and (2) the content of nutrients in the test medium. For this purpose, a total of 10 toxicity test were designed: five dilution waters, four natural marine waters and one synthetic seawater; each in two different nutritive conditions, saturated nutrient concentration (SC) by the addition of modified f/2 nutritive medium, and natural nutrient concentration (NC), i.e., without the addition of f/2. At threshold toxicity levels, the dilution waters used in the test and the nutrient concentrations did not affect the toxicity of LAS. At IC₅₀ concentrations, the toxicity of LAS is influenced by both variables: under SC conditions, the toxic effect of LAS diminishes, obtaining in all the tests IC₅₀ > 10 mg/L LAS. Under NC conditions, IC₅₀ concentrations ranging between 3.15 and 9.26 mg/L LAS have been obtained.     

壬苯醇醚—9外用避孕药药理和毒理研究

壬苯醇醚-9最低有效杀精子浓度0.2～0.25mg/ml。小鼠ip的LD_(50)为128.5±7.7mg/kg、大鼠阴道给药的LD_(50)>500mg/ml。33倍人用剂量亚急性试验给药组与空白对照组无明显差异(P>0.05)。100mg/ml浓度不抑制阴道乳酸杆菌。1mg/皿进行的Ames试验结果阴性。家兔阴道刺激试验结果总分值为6.63,在可接受范围。