注射用药用辅料甘露醇细菌内毒素检查方法研究

为了建立注射用药用辅料甘露醇的细菌内毒素检查方法,根据《中华人民共和国药典二部（2010年版）》中的“细菌内毒素检查法及指导原则”进行试验。将甘露醇溶解稀释至100mg·mL-1,用标示灵敏度A为0．125EU·mL-1的鲎试剂检测其细菌内毒素。结果表明,100mg·mL-1的甘露醇及稀释液对细菌内毒素检查无干扰。说明鲎试剂方法用于甘露醇的细菌内毒素检查是可行、有效的。     

超滤技术去除羟基喜树碱中细菌内毒素的研究

考察了超滤技术去除羟基喜树碱原料药中细菌内毒素的效果。采用10 kDa截留分子量超滤膜对羟基喜树碱原料药溶解液进行超滤,以动态浊度法定量检测超滤前后羟基喜树碱中细菌内毒素的含量。结果表明:样液超滤前细菌内毒8.103 5 EU/mL,超滤后为0.307 6 EU/mL,内毒素去除率为96.20%,其有效成分羟基喜树碱的透过率为96.1%。超滤技术可以很好的去除羟基喜树碱原料药溶解液中细菌内毒素,有效成分损失极其微少,可提高其用药安全性。     

Saccharomyces cerevisiae fermentation products reduce bacterial endotoxin concentrations and inflammation during grain-based subacute ruminal acidosis in lactating dairy cows

Subacute ruminal acidosis (SARA) is a metabolic disorder in dairy cows that is associated with dysbiosis of rumen and hindgut microbiomes, translocation of immunogenic compounds from the gut lumen into blood circulation, and systemic inflammatory response. In this study we hypothesized that Saccharomyces cerevisiae fermentation products (SCFP) attenuate the increases in ruminal and peripheral bacterial endotoxin concentrations and the inflammation resulting from repeated induction of SARA. Lactating Holstein dairy cows (parity 2 and 3+, n = 32) were fed diets with or without SCFP (all from Diamond V) and subjected to 2 episodes of SARA challenges. Cows received a basal total mixed ration (TMR) containing 34% neutral detergent fiber and 18.6% starch, dry matter (DM) basis. Treatments were randomly assigned to control (basal TMR and 140 g/d of ground corn with no SCFP) or 1 of 3 SCFP treatments: basal TMR and 14 g/d Original XPC (SCFPa), 19 g/d NutriTek (SCFPb-1×), or 38 g/d NutriTek (SCFPb-2×) mixed with 126, 121, or 102 g/d of ground corn, respectively. Treatments were implemented from 4 wk before until 12 wk after parturition. During wk 5 (SARA1) and wk 8 of lactation (SARA2), grain-based SARA challenges were conducted by gradually replacing 20% of DM of the basal TMR over 3 d with pellets containing 50% wheat and 50% barley. Ruminal fluid, fecal, and blood samples were collected weekly during Pre-SARA1 (wk 4, as baseline), Post-SARA1 (wk 7), and Post-SARA2 (wk 10 for blood and wk 12 for rumen and fecal parameters) stages, and twice a week during the challenges SARA1 and SARA2. Rumen papillae samples were taken only during Pre-SARA1 and Post-SARA2. We measured the concentrations of free lipopolysaccharides (LPS) in the rumen fluid and feces; free LPS and lipoteichoic acid (LTA) endotoxins in peripheral plasma; interleukin (IL)-1β and IL-6 in peripheral serum; acute-phase proteins, serum amyloid A (SAA), and LPS-binding protein in peripheral plasma; haptoglobin (Hp) in peripheral serum; and myeloperoxidase (MPO) in rumen papillae. Induction of SARA episodes increased free LPS concentrations in rumen fluid and tended to increase LTA in peripheral plasma. The SARA episodes increased concentration of circulating SAA and tended to increase that of IL-1β compared with Pre-SARA1. Induction of SARA did not affect the concentrations of circulating IL-6, Hp, and MPO. The SCFP supplementation reduced plasma concentrations of LTA and SAA and serum concentration of IL-1β compared with control. Additionally, SCFPb-2× tended to reduce ruminal LPS in second-parity cows compared with control. Overall, SCFP supplementation appeared to stabilize the rumen environment and reduce proinflammatory status, hence attenuating adverse digestive and inflammatory responses associated with SARA episodes.     

现代高纯水

论述了超大规模集成电路与高纯水的关系以及对水质的要求;研究了高纯水制备的几个关键新技术及提高高纯水质量的方法,该方法能有效地降低高纯水中的总有机碳、细菌、细菌内毒素、溶解氧等;讨论了高纯水常用各种管材的污染,并列举了大量数据和应用实例。     

用细菌内毒素检查法检测巴氏灭活前后内毒素的变化

低温乙醇法生产白蛋白的过程中，通过对60℃、10h加温灭活病毒前后细菌内毒素含量的测定，证明巴氏灭活不仅能灭活病毒，还可以去除部分热原质。     

头孢孟多酯钠细菌内毒素检查法可行性研究

建立了头孢孟多酯钠细菌内毒素检查方法。按2005年版中国药典第2部收载的细菌内毒素检查法规定,用2个不同厂家的鲎试剂对其分别进行了检查。结果表明,采用0.5 EU/mL的鲎试剂并将样品质量浓度稀释至3.33 mg/mL时,对该实验无干扰作用,细菌内毒素限值为0.15 EU/mg。头孢孟多酯钠可用细菌内毒素检查法代替热原检查法进行检验,方法灵敏、可靠、方便、经济。     

三磷酸胞苷二钠注射液细菌内毒素检查法的研究

考察三磷酸胞苷二钠注射液细菌内毒素检查方法。按《中国药典》2000年版二部,制定本品细菌内毒素限值,并研究三磷酸胞苷二钠注射液对细菌内毒素检查试验的干扰情况,以确定本品是否适用细菌内毒素检查法。本品可采用细菌内毒素检查法,并建立了本品细菌内毒素检查法质量标准。     

注射用脑蛋白水解物细菌内毒素检查法的建立

目的建立检查注射用脑蛋白水解物细菌内毒素的方法。方法按照中国药典2010年版（二部）附录XIE细菌内毒素检查法,对3批样品进行干扰试验和细菌内毒素检查。结果注射用脑蛋白水解物的游离氨基酸质量浓度0.5 mg/mL时,供试品不干扰细菌内毒素检查。结论建立的注射用脑蛋白水解物细菌内毒素检查法可行,细菌内毒素限值确定为0.5 EU/mg。     

Endotoxins and inflammation in hemodialysis patients

Long‐term endotoxin challenge may promote frequent complications in dialysis patients, namely malnutrition, chronic inflammation, and atherosclerosis, which are recognized as the so‐called MIA syndrome. Circulating soluble vascular cell adhesion molecule‐1 (sVCAM‐1) levels may be used to determine the stage of atherosclerosis. This study aimed to assess endotoxin level in hemodialysis (HD) patients and its role in inducing inflammation. The study was conducted on 50 HD patients, chosen from four dialysis centers in Alexandria. Serum blood samples were collected for the determination of albumin and C‐reactive protein (CRP), and whole blood samples were used for the measurement of hemoglobin level. A heparinized whole blood sample was taken postdialysis for endotoxin assay by limulus amebocyte lysate test, and in addition to sVCAM‐1 was estimated using enzyme‐linked immunosorbent assay. The mean endotoxin level was 76.30 pg/mL;80% exhibited values higher than 60 pg/mL. Half the studied patients had CRP values that exceeded the upper limit of the laboratory reference range (<6.0 mg/L). A statistically significant correlation was found between endotoxin and CRP levels (r = 0.47, P = 0.001). The mean pre‐HD level of VCAM was 1851.00 ng/mL, while the mean post‐HD level was 2829.00 ng/mL with statistically significant correlation (r = 0.354, P = 0.012) and it also correlated significantly with endotoxin as well as CRP levels. Endotoxemia may play an important role in the aggravation of endothelial dysfunction in HD patients as indicated by the post‐HD rise in sVCAM‐1.     

The influence of calcium on the chromogenic Limulus Amoebocyte Lysate assay of lipopolysaccharide endotoxins in liquid milk

Calcium ions were shown to have a profound effect on the chromogenic Limulus Amoebocyte Lysate assay of lipopolysaccharides in liquid milk. There appeared to be two optima within the range of 0–1.0 mM added calcium chloride, with an inhibition of the assay at calcium ion concentrations between 0.2 and 0.4 mM, and above 0.6 mM. With products of this nature, standardization of calcium ion content is required for meaningful comparisons of results between samples. Further investigation is required to assess the possible influence of other serum constituents.