浅谈大输液车间的工艺设计

结合已做工程及国际先进理念重点阐述了大输液车间工艺设计需要考虑的因素,同时依据新版GMP要求对大输液生产的流程、布局、设备选型进行了较详细的讨论。     

树脂膜熔渗工艺(RFI)的研究现状

本文介绍了树脂膜熔渗工艺的研究现状及发展状况。     

输液生产中可见异物的控制

探讨影响大输液中可见异物的因素及控制办法。从影响大输液可见异物的5个主要方面（注射用水、原辅材料、空调净化系统、过滤灌装、人员）进行分析,并在生产中加强控制,明显降低了输液产品中可见异物数量。     

输液瓶瓶身黑点产生的原因探讨

针对输液瓶瓶身黑点缺陷,根据实际生产经验,分析了其产生的原因,采取一定的措施,取得了预期的效果.     

PVC输液管用着色剂的稳定性

对一种PVC输液器管路着色剂的稳定性进行了测试.实验结果表明色母本身耐迁移性良好,与酸、碱、水和油都不存在沾色问题.     

TPE输液器中苯乙烯和环己酮的相容性

采用气相色谱法,对一次性使用热塑性弹性体(TPE)输液器的单体材料苯乙烯和黏合剂环己酮的溶出性进行了研究。以7种不同类型的注射液模拟临床使用条件,经TPE输液器输出后用乙酸乙酯或正己烷萃取,并分析其萃取液。结果表明:苯乙烯在0.1800~14.40、1.137~90.96、0.08780~7.024μg/ml,环己酮在0.4050~32.40、1.137~90.96、0.2014~16.11μg/ml的浓度范围内线性关系良好(r=0.9999),各输液平均加标回收率均在93%~108%之间,相对标准偏差均小于3.1%;输液温度越高,环己酮的溶出量越多,苯乙烯在脂肪乳注射液中更易溶出。该方法准确快速、灵敏度和重复性好,可用于TPE输液器中苯乙烯和环己酮溶出量的检测。     

大输液车间的工艺设计

随着我国国民经济的发展,科技水平的提高,大输液制造业行业也获得了长足的发展。为了更好地推动我国大输液制造业的发展,完善大输液车间的工艺设计是十分重要的。结合实际,简单的介绍了大输液车间工艺流程以及布置,并对工艺设计的影响因素以及要求进行了简单的阐述。     

Acute Effects of Ocrelizumab Infusion in Multiple Sclerosis Patients

B cell-depleting therapies such as ocrelizumab (OCR) are highly effective in people with multiple sclerosis (MS). Especially at treatment start and initial infusion, infusion-related reactions (IRR) are a common adverse event. The relevance of acute changes of cell-depleting therapies on peripheral immune compartments and routine lab testing is important for clinical practice. We systematically analyzed routine blood parameters, detailed blood immunophenotyping and serum cytokine profiles in 45 MS patients starting on OCR. Blood samples were collected before and after corticosteroid premedication and directly after each OCR infusion of the first three ocrelizumab infusions. Blood B cells were rapidly depleted and accompanied only by a mild cytokine release at the first OCR infusion. Cytokine release was not significantly detectable from a third application in line with decreasing IRRs. B cell depletion was accompanied by short-lived changes in other immune cell populations in number, activation and cytokine secretion after each OCR infusion. Standard lab parameters did not show any clinically relevant changes. Our data demonstrate only mild changes during the first OCR infusion, which are not present any more during long-term treatment.     

真空导入工艺用不饱和聚酯树脂的研制

本文研究合成的不饱和聚酯树脂具有较低的粘度和较好的固化特性,粘度控制在0.21Pa.s左右,非常适用于真空导入工艺,该树脂采用真空导入工艺成型的玻璃钢制品各项性能都非常优越,有些性能指标几乎是通用树脂手糊成型性能的两倍左右。     

输液自动止液器止液膜的研究

为了弄清楚膜结构自动止液器的止液原理及安装使用要求,以促进产品推广应用,首先测试了止液膜的孔径结构及尺寸分布、接触角和耐静水压值,然后对其止液机理进行了理论分析,并建立了止液膜的止液高度、安装高度和孔径要求的计算公式,最后实验模拟验证了自动止液器输液器的止液效果.结果发现,止液膜通过与药液间产生表面张力,来平衡止液膜和针头间药液柱产生的静水压,从而实现止液效果.考虑一般输液管的长度在1.6 m左右,止液膜的平均孔径必须小于11.85 μm才具有止液效果.当要求止液器具有防血液回流效果时,其安装高度应该大于12.2 cm.     

Dosing Limitation for Intra-Renal Arterial Infusion of Mesenchymal Stromal Cells

The immunomodulatory and regenerative properties of mesenchymal stromal cells (MSCs) make MSC therapy a promising therapeutic strategy in kidney disease. A targeted MSC administration via the renal artery offers an efficient delivery method with limited spillover to other organs. Although local administration alleviates safety issues with MSCs in systemic circulation, it introduces new safety concerns in the kidneys. In a porcine model, we employed intra-renal arterial infusion of ten million allogenic adipose tissue-derived MSCs. In order to trigger any potential adverse events, a higher dose (hundred million MSCs) was also included. The kidney function was studied by magnetic resonance imaging after the MSC infusion and again at two weeks post-treatment. The kidneys were assessed by single kidney glomerular filtration rate (skGFR) measurements, histology and inflammation, and fibrosis-related gene expression. None of the measured parameters were affected immediately after the administration of ten million MSCs, but the administration of one hundred million MSCs induced severe adverse events. Renal perfusion was reduced immediately after MSC administration which coincided with the presence of microthrombi in the glomeruli and signs of an instant blood-mediated inflammatory reaction. At two weeks post-treatment, the kidneys that were treated with one hundred million MSCs showed reduced skGFR, signs of tissue inflammation, and glomerular and tubular damage. In conclusions, the intra-renal administration of ten million MSCs is well-tolerated by the porcine kidney. However, higher concentrations (one hundred million MSCs) caused severe kidney damage, implying that very high doses of intra-renally administered MSCs should be undertaken with caution.     

注入水水质对注水开发效果的影响

注入水的影响将导致油藏原油的物性、化学组成及地层水性质发生变化。了解油藏内流体性质的变化规律，对制定合理注采方案非常重要。     

煤矸石酸浸液制备高铝型聚合硫酸铝铁

用煤矸石酸浸液制备了高铝型聚合硫酸铝铁(PAFS),研究了铁铝物质的量比、p H、聚合时间、聚合温度对PAFS去浊性能的影响,获得了制备PAFS的优化工艺条件:c(Al3++Fe3+)=0.6mol/L、铁铝物质的量比为7∶10、p H为0.9、聚合时间为6 h、聚合温度为80℃、室温熟化24 h。最后对优化工艺条件下的产物进行了物相分析。     

气体扩散法合成花状碳酸化羟基磷灰石微球

利用较为简单的气体扩散法合成出了花状的碳酸化羟磷灰石微球,研究了羟磷灰石微球的组成和表面活性剂三聚磷酸钠对其形貌的影响,并用扫描电子显微镜(SEM)、傅立叶转换红外光谱(FT-IR)、X射线衍射(XRD)等方法对所得产物进行了表征.研究结果显示,矿化时间的长短对晶体形貌无太大影响,而改变三聚磷酸钠的浓度则会导致晶体形貌发生变化.不同浓度下形成的生物矿物均是碳酸化羟基磷灰石,这是由CO32-取代羟基磷灰石中(PO4)的位点所产生的结果.     

胶塞硅油在输液制剂中的迁移研究

通过不同硅化级别胶塞包装的注射用水制剂和不同型号硅油(二甲基硅油)的模拟注射液,进行注射剂瓶倒置的60℃高温加速试验,研究胶塞硅油在输液制剂中的迁移情况。结果表明:注射用水制剂中的硅油量受胶塞硅化级别和硅油型号的影响;胶塞硅化级别越高,硅油残留量越大,注射用水制剂中不溶性微粒越多,硅油挂壁现象越明显;粘度低的硅油更容易迁移。药企应关注胶塞表面的硅油残留量及其在输液制剂中的迁移性,根据药性选择合适的胶塞。     

高钙输液瓶降低生产成本的几个途径

为了降低玻璃输液瓶的生产成本,提高输液瓶的使用性能,以获得经济效益,采用低铝高钙配方并使用低价原料和助剂,实践证明是可行的.     

一次性输液器中金属元素的测定与分析

目的测定输液器中钡、铬、铜、铅、锡、镉六种金属元素的含量。方法参照GB 8368-2005的样品处理方法,利用ICP-MS对其进行金属元素分析。结果在全国范围内随机抽取的50批供试品中,该六种金属元素含量全部符合要求:钡、铬、铜、铅、锡的总含量1μg·m L~(-1),镉的含量0.1μg·m L~(-1)。结论通过随机测试分析,可为输液器的安全使用和监管提供一定数据参考。