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1.
目的优化麻疹减毒活疫苗的冻干工艺。方法以预冻过程(温度、时间)、升华干燥过程(温度、时间、真空控制值)、解析干燥过程(温度、时间、真空控制值)冻干参数为影响因素,应用L(827)正交试验设计冻干曲线,对8批麻疹减毒活疫苗半成品进行冻干,采用直观分析法的综合平均值R()iⅠ和极差R(i)j分析不同批次冻干制品的干损率、病毒滴度、热稳定性和残余水分,筛选最优因素水平组合,并对其进行适用性验证。结果优化的麻疹减毒活疫苗冻干工艺参数为:预冻:温度5~-25℃、时间0.5h,温度-25~-40℃采用大于1℃/min的冻结速率,温度-40℃、保持时间3h;升华干燥:温度-40~-20℃、时间1.5h、真空控制值0.16mbar,温度-20℃、保持时间8h、真空控制值0.16mbar,温度-20~30℃、时间5h、真空控制值0.16mbar;解析干燥:温度保持30℃、时间6h、真空控制值0.005mbar,以优化的麻疹减毒活疫苗冻干工艺冻干的制品成型良好,干损率平均为1.36%,稳定性好,残余水分在1.62%~1.67%之间。结论优化的麻疹减毒活疫苗冻干工艺适合麻疹疫苗大规模生产。  相似文献   

2.
对透明质酸钠冻干球的生产工艺进行研究,为规模化生产提供依据。以差示量热分析技术测定的共晶点和共熔点确定预冻和一次干燥的温度并设定冻干工艺曲线,以外观性状为指标对不同质量分数的透明质酸钠溶液进行筛选,并进行冻干工艺优化和验证。结果显示,质量分数1.5%的透明质酸钠溶液,-40℃预冻2 h,-5℃一次干燥12 h,40℃二次干燥4 h,冷冻干燥阶段均采用极限真空,如此制备的冻干球呈光滑球形,成形良好。选定的处方和冻干工艺可行,经验证明能够持续稳定地生产出外观质量符合要求的产品。  相似文献   

3.
目的优化口服重组幽门螺杆菌疫苗的冻干工艺,以降低冻干过程中制剂瓶的破瓶率。方法通过改变冻干工艺中预冻、升华干燥、解析干燥阶段的工艺参数,对12批口服重组幽门螺杆菌疫苗进行冻干试验,在保证样品外观、水分、p H值及无菌检查合格的前提下,以制剂瓶的破瓶率为指标筛选最优冻干工艺。结果口服重组幽门螺杆菌疫苗的最优冻干工艺条件为:预冻期2 h内冷冻至-45℃并维持4.5 h;升华干燥时阶段性升温,总历时34 h;解析干燥时28℃维持12 h。按此工艺冻干后的口服重组幽门螺杆菌疫苗样品的外观、水分、p H值及无菌检查均在合格范围内,且制剂瓶的破瓶率为0。结论优化后的口服重组幽门螺杆菌疫苗冻干工艺稳定可靠,为今后的大规模生产奠定了基础。  相似文献   

4.
本文研究了注射用盐酸甲砜霉素甘氨酸酯的处方及工艺。采用正交试验设计,以冻干得率为考察指标,考察冷冻温度、升华温度、冻干时间、灌装体积4个因素不同水平的冻干效果。结果表明,注射用盐酸甲砜霉素甘氨酸酯最佳冻干工艺为A3B2C1D3,即预冻温度-45℃,升华温度-0℃,冻干时间50h,灌装量10mL为最佳工艺。该冻干工艺合理可行,冻干产品质量稳定,符合生产需求。  相似文献   

5.
为建立合适的丁二磺酸腺苷蛋氨酸冻干工艺,采用真空冷冻干燥法,对丁二磺酸腺苷蛋氨酸冻干条件如共晶点、装量、预冻程序、升华温度、升华真空度及解吸干燥温度等进行研究。结果显示:冻干工艺:装量为液面高度小于10 mm,预冻程序为预冻至-40℃,然后回温至-10℃,再降至-50℃,在真空度10~30 Pa,-25℃下升华,35℃解吸干燥。此工艺制备的丁二磺酸腺苷蛋氨酸外观好,产品质量符合国家标准。  相似文献   

6.
目的采用冷冻干燥法制备1型糖尿病噬菌体展示疫苗。方法将正交试验筛选的不同冻干保护剂与1型糖尿病噬菌体展示疫苗混合,优化冻干曲线进行冻干。检测冻干前后噬菌体疫苗的滴度,并通过各项指标对冻干后的疫苗进行评价。结果经筛选,最佳保护剂配方为:10.85%海藻糖+17.37%甘氨酸(w/v);最佳冻干曲线为:S1:-40℃4h,1.5℃/min;S2:-15℃5h,1.5℃/min;S3:25℃4h,1.5℃/min;真空度:0.02mbar。冻干后疫苗滴度下降不超过0.5pfu/ml,外观及电镜观察疫苗样品形态均较好,玻璃态转化温度能达到220℃以上,含水量小于3%。结论以海藻糖、甘氨酸为保护剂,采用冷冻干燥法制备的1型糖尿病噬菌体展示疫苗具有保护剂组成成分少、热稳定性强、含水量低、冻干曲线简化、保存时间长等特点。  相似文献   

7.
目的以梅州金柚柚子皮为原料,研究柚皮真空冷冻干燥工艺技术,确定最佳工艺参数和加工工艺,为柚皮综合利用提供参考依据。方法通过单因素实验和正交实验设计,以冻干速率作为考察指标,研究了压力(真空度)、加热温度、物料厚度对真空冷冻干燥速率的影响。结果实验表明,对冻干柚皮干燥速率的影响主次顺序为加热温度、压力(真空度)、物料厚度,最佳工艺条件分别为:加热温度50℃、压力(真空度)40 Pa、物料厚度5 mm,在此干燥工艺条件下,产品在色泽等方面保持较好。结论该正交试验筛选出的工艺稳定可行。  相似文献   

8.
为了对银杏叶提取物冷冻干燥工艺进行优化,文章进行了传热传质模型的建立及简化,测量了银杏叶提取物的干层传质阻力系数等,进行了工艺模拟,给出了温度在-40—-15℃,压力从2—40 Pa的范围,升华时间小于100 h的模拟结果,模拟结果显示:压力越低升华时间越短,温度越高升华时间越短。在温度较低时,压力的变化对升华时间影响较大,温度较高时,压力的变化对升华时间影响较小。据此模拟结果及冻干显微镜实验,确定了优化的工艺操作参数为P_C=8 Pa,制品的最高温度为32℃,并进行了冻干实验,实验获得冻干产品性能好。该方法可以为其他药品的冷冻干燥最优参数的确定及升华时间的预测提供借鉴。  相似文献   

9.
为了发展丹参叶绿茶产品,本文研究了不同干燥方法对丹参叶有效成分的影响。以丹酚酸B和叶绿素含量等指标确定了热风干燥和真空冷冻干燥的最佳工艺参数,并与丹参叶中的有效成分进行比较。最终确定的热风干燥的最佳工艺参数为温度60℃,风速0.6m/s,物料厚度为2层。真空冷冻干燥的最佳工艺参数为采用-25℃进行预冻,保持2h左右的时间,50Pa升华22h左右,20℃解析14h。结果表明真空冷冻干燥是丹参叶绿茶保质干燥的最佳方法,其对丹参叶中的丹酚酸B和叶绿素含量保留率分别为98.76%和82.21%。  相似文献   

10.
李俊奇  李保国 《化工进展》2015,34(8):3128-3132
对药品冻干过程进行优化的关键是在保证药品质量不受损害的情况下尽量缩短干燥时间。因此,对冻干过程进行准确的监控是十分重要的,既要保证药品的温度保持在合理的范围内,对干燥结束时间进行准确地判断,同时又要对冻干过程压力和温度进行良好的控制以达到冻干过程的最优化。本文对近年来药品真空冷冻干燥过程监控技术的研究进展进行了综述,主要有基于动态参数估计法(DPE)的监控系统、基于卡尔曼滤波法的监测系统、露点法判断一次干燥结束点、模型预测控制法(MPC)。提出药品真空冷冻干燥监控技术的研究应着重于以下几点:考虑辐射、对流和导热3种传热方式在冻干传热过程中所占的比重,建立二维、三维冻干模型以更加精确地监测药品冻干过程的参数,在此基础上研究对加热隔板温度和冻干室压力的实时最优控制策略,以对药品冻干过程进行及时、有效地控制。  相似文献   

11.
12.
Whitlockite (WH) is the second most abundant inorganic component of human bone, accounting for approximately 25% of bone tissue. This study investigated the role of WH in bone remodeling and formation in a mouse spinal fusion model. Specifically, morphology and composition analysis, tests of porosity and surface area, thermogravimetric analysis, an ion-release test, and a cell viability test were conducted to analyze the properties of bone substitutes. The MagOss group received WH, Group A received 100% beta-tricalcium phosphate (β-TCP), Group B received 100% hydroxyapatite (HAp), Group C received 30% HAp/70% β-TCP, and Group D received 60% HAp/40% β-TCP (n = 10 each). All mice were sacrificed 6 weeks after implantation, and micro-CT, hematoxylin and eosin (HE) staining, and Masson trichome (MT) staining and immunohistochemistry were performed. The MagOss group showed more homogeneous and smaller grains, and nanopores (<500 nm) were found in only the MagOss group. On micro-CT, the MagOss group showed larger fusion mass and better graft incorporation into the decorticate mouse spine than other groups. In the in vivo experiment with HE staining, the MagOss group showed the highest new bone area (mean: decortication group, 9.50%; A, 15.08%; B, 15.70%; C, 14.76%; D, 14.70%; MagOss, 22.69%; p < 0.0001). In MT staining, the MagOss group demonstrated the highest new bone area (mean: decortication group, 15.62%; A, 21.41%; B, 22.86%; C, 23.07%; D, 22.47%; MagOss, 26.29%; p < 0.0001). In an immunohistochemical analysis for osteocalcin, osteopontin, and CD31, the MagOss group showed a higher positive area than other groups. WH showed comparable bone conductivity to HAp and β-TCP and increased new bone formation. WH is likely to be used as an improved bone substitute with better bone conductivity than HAp and β-TCP.  相似文献   

13.
利用相平衡原理得出的焦油蒸馏时一次汽化温度的计算方法,其结果与按经验公式的计算结果进行了比较,同时讨论了一次汽化温度与焦油馏分产率及二段蒸发器过热蒸汽用量的关系。  相似文献   

14.
—Due to its chemistry, no structural adhesive system (epoxies, acrylics, etc.) is likely to offer an ideal combination of toughness, strength, moisture resistance, and ambient-temperature curing. Therefore, for effective use of adhesives in primary structures, an engineer must be able to identify adhesives that represent an optimum compromise among the different properties. In this paper, we present techniques for screening high-strength, ambient-temperature-curing adhesives for (1) moisture resistance under sustained loading and (2) fracture resistance in a way that is directly related to joint performance.  相似文献   

15.
Angiogenesis is one of the hallmarks of cancer. Several studies have shown that vascular endothelium growth factor (VEGF) plays a leading role in angiogenesis progression. Antiangiogenic medication has gained substantial recognition and is commonly administered in many forms of human cancer, leading to a rising interest in cancer therapy. However, this treatment method can lead to a deteriorating outcome of resistance, invasion, distant metastasis, and overall survival relative to its cytotoxicity. Furthermore, there are significant obstacles in tracking the efficacy of antiangiogenic treatments by incorporating positive biomarkers into clinical settings. These shortcomings underline the essential need to identify additional angiogenic inhibitors that target numerous angiogenic factors or to develop a new method for drug delivery of current inhibitors. The great benefits of nanoparticles are their potential, based on their specific properties, to be effective mechanisms that concentrate on the biological system and control various important functions. Among various therapeutic approaches, nanotechnology has emerged as a new strategy for treating different cancer types. This article attempts to demonstrate the huge potential for targeted nanoparticles and their molecular imaging applications. Notably, several nanoparticles have been developed and engineered to demonstrate antiangiogenic features. This nanomedicine could effectively treat a number of cancers using antiangiogenic therapies as an alternative approach. We also discuss the latest antiangiogenic and nanotherapeutic strategies and highlight tumor vessels and their microenvironments.  相似文献   

16.
通过对工程建设项目特点剖析,提出了工程建设项目全过程造价管理、全要素造价管理、全风险造价管理、全团队造价管理等四项造价管理技术,针对其特点提出全面造价管理的管理技术要则,并提出要注重事前管理控制、项目信息的收集和加工、加强项目的动态性管理、重视项目管理的科学性和艺术性等各项要求。  相似文献   

17.
介绍了双塔再生工艺的原理、改造前后的工艺流程 ,运行情况 ,并对改造进行了经济效益分析。  相似文献   

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针对国内甘氨酸生产厂家排放的工业废水中含有多种污染物(一定量的氯化铵、少量的乌洛托品及微量的甘氨酸)的特点,提出采用多效真空降膜蒸发系统兼热泵技术回收废液中的氯化铵,回收氯化铵后排放的冷凝水进入冷凝水净化系统进行处理的综合治理方案。此工艺克服了采用常规蒸发技术从低浓度氯化铵废液中提取氯化铵带来的能耗大、对设备腐蚀性强的缺点,本项治理技术不仅解决了工业废水对环境的污染,而且有较高的经济效益。  相似文献   

20.
<正> After June this year China's regions growingmiddle and late rice had widespread blastand sheath/culm blight.Such diseasesplagued 19.2 million hectares.Starting fromJuly the market for new fungicides that cancontrol blast and sheath/culm blight for ricewas more and more active.Makers of traditional pesticides for thecontrol of blast have to contend with fiercecompetition from new pesticides in marketthis year.Kitazine,iprobenfos,isoprothiolane and tricyclazole,oftenused by farmers in the past,are graduallybeing replaced by new varieties with high  相似文献   

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